A "motor learning based intervention for lower extremities (MOBILE)" to target walking performance in ambulant children with cerebral palsy: A feasibility study.

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The International Classification of Functioning (ICF) in disabilities framework outlines three domains to consider when looking at impact of a disability on a child; body/structure, activity and participation. Interventions to target body/structure have been widely studied but the focus is now shifting towards activity and participation. Activity and participation targeted interventions using Motor Learning Theory (MLT) have shown positive results on walking performance, gross motor skills and upper limb rehabilitation in CP. This study aims to determine feasibility and acceptability of a motor learning-based intervention for lower extremities (MOBILE) targeting walking performance in ambulant children with CP to inform a future randomized controlled trial (RCT). Methods Fourteen ambulant children with CP, aged 6–17, with a walking goal will be recruited from community disability services. They will undergo a tailored intensive MOBILE intervention to target walking goals amounting to 30 hours practice in 6 weeks or less. Outcomes will include feasibility of recruitment, adherence, retention and outcome measures, and acceptability of the intervention. Clinical outcome measures will include the Gait Outcomes Assessment List, Six Minute Walk Test, modified Timed Up and Go, Ten metre walk test, Range of Motion and the Child Health Utility instrument. Feasibility outcomes will be reported using descriptive statistics such as percentages and confidence intervals. Discussion Long-term retention of walking improvements in CP following interventions targeting the body/structure domain of the ICF are reportedly poor. The MOBILE intervention based on its theoretical framework could lead to improvements in walking performance with a possibility of long-term retention and impact on activity and participation. The feasibility of the study design and acceptability of the intervention needs to be investigated to inform a future definitive trial. " } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://hrbopenresearch.org/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://hrbopenresearch.org/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://hrbopenresearch.org/articles/8-46/v1", "name": "A "motor learning based intervention for lower extremities (MOBILE)"..." } } ] } Home Browse A "motor learning based intervention for lower extremities (MOBILE)"... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article O'Shaughnessy C, McCarthy R, Minehane D et al. A "motor learning based intervention for lower extremities (MOBILE)" to target walking performance in ambulant children with cerebral palsy: A feasibility study. [version 1; peer review: 2 approved with reservations] . HRB Open Res 2025, 8 :46 ( https://doi.org/10.12688/hrbopenres.14101.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol A "motor learning based intervention for lower extremities (MOBILE)" to target walking performance in ambulant children with cerebral palsy: A feasibility study. [version 1; peer review: 2 approved with reservations] Caitríona O'Shaughnessy https://orcid.org/0000-0002-4242-4114 1,2 , Raymond McCarthy 2 , Dereena Minehane 2 , Jennifer Ryan https://orcid.org/0000-0003-3768-2132 1 , Ailish Malone https://orcid.org/0000-0002-7997-4099 1 Caitríona O'Shaughnessy https://orcid.org/0000-0002-4242-4114 1,2 , Raymond McCarthy 2 , [...] Dereena Minehane 2 , Jennifer Ryan https://orcid.org/0000-0003-3768-2132 1 , Ailish Malone https://orcid.org/0000-0002-7997-4099 1 PUBLISHED 04 Apr 2025 Author details Author details 1 Physiotherapy, CP Life Research Centre, Royal College of Surgeons in Ireland, Dublin, Leinster, D02YN77, Ireland 2 CDNT 4 Dunshaughlin, Enable Ireland, Meath, Leinster, C15K0FV, Ireland Caitríona O'Shaughnessy Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Raymond McCarthy Roles: Investigation, Writing – Review & Editing Dereena Minehane Roles: Investigation, Writing – Review & Editing Jennifer Ryan Roles: Conceptualization, Methodology, Supervision, Validation, Writing – Review & Editing Ailish Malone Roles: Conceptualization, Methodology, Project Administration, Supervision, Validation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS Abstract Background Cerebral Palsy (CP) is the largest contributor to childhood physical disability with abnormal gait pattern such as toe walking commonly reported. The International Classification of Functioning (ICF) in disabilities framework outlines three domains to consider when looking at impact of a disability on a child; body/structure, activity and participation. Interventions to target body/structure have been widely studied but the focus is now shifting towards activity and participation. Activity and participation targeted interventions using Motor Learning Theory (MLT) have shown positive results on walking performance, gross motor skills and upper limb rehabilitation in CP. This study aims to determine feasibility and acceptability of a motor learning-based intervention for lower extremities (MOBILE) targeting walking performance in ambulant children with CP to inform a future randomized controlled trial (RCT). Methods Fourteen ambulant children with CP, aged 6–17, with a walking goal will be recruited from community disability services. They will undergo a tailored intensive MOBILE intervention to target walking goals amounting to 30 hours practice in 6 weeks or less. Outcomes will include feasibility of recruitment, adherence, retention and outcome measures, and acceptability of the intervention. Clinical outcome measures will include the Gait Outcomes Assessment List, Six Minute Walk Test, modified Timed Up and Go, Ten metre walk test, Range of Motion and the Child Health Utility instrument. Feasibility outcomes will be reported using descriptive statistics such as percentages and confidence intervals. Discussion Long-term retention of walking improvements in CP following interventions targeting the body/structure domain of the ICF are reportedly poor. The MOBILE intervention based on its theoretical framework could lead to improvements in walking performance with a possibility of long-term retention and impact on activity and participation. The feasibility of the study design and acceptability of the intervention needs to be investigated to inform a future definitive trial. READ ALL READ LESS Keywords Cerebral Palsy, Motor Learning Theory, goal-directed therapy, paediatric physiotherapy, Neurological Rehabilitation, Intensive therapy Corresponding Author(s) Caitríona O'Shaughnessy ( [email protected] ) Ailish Malone ( [email protected] ) Close Corresponding authors: Caitríona O'Shaughnessy, Ailish Malone Competing interests: No competing interests were disclosed. Grant information: Health Research Board [HRCI-HRB-2022-006].This work was also supported by the Royal College of Surgeons Ireland, Strategic Academic Recruitment (StAR) programme linked with professional doctorate programme of lead researcher and the International Organisation of Physiotherapists in Paediatrics Research Grant. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 O'Shaughnessy C et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: O'Shaughnessy C, McCarthy R, Minehane D et al. A "motor learning based intervention for lower extremities (MOBILE)" to target walking performance in ambulant children with cerebral palsy: A feasibility study. [version 1; peer review: 2 approved with reservations] . HRB Open Res 2025, 8 :46 ( https://doi.org/10.12688/hrbopenres.14101.1 ) First published: 04 Apr 2025, 8 :46 ( https://doi.org/10.12688/hrbopenres.14101.1 ) Latest published: 29 Jan 2026, 8 :46 ( https://doi.org/10.12688/hrbopenres.14101.2 )  There is a newer version of this article available. Suppress this message for one day. Introduction Cerebral Palsy (CP) is the largest contributor to childhood physical disability with a prevalence of 1.6/1000 births in developed countries 1 . It is characterised by a non-progressive injury to the brain sustained prenatally or after birth up to the age of two 2 . The sequelae in the developing child change over time and can include spasticity, muscle weakness and motor planning impairments resulting in musculoskeletal changes that impact on gross motor skills and walking ability 3 . The extent of impairment is categorised using the Gross Motor Functional Classification System (GMFCS) which outlines the child’s level of mobility. Children at levels I-II are ambulatory without the use of aids but can have difficulties with walking endurance, speed and balance. Children at level III use an aid to walk short distances 4 . Gait pattern differences such as toe walking and crouched gait are prevalent in CP and walking performance deteriorates over time with reduced participation in recreational activities, increased pain and fatigue, reduced independence with self-care and reduced activity reported 5 . Improved walking goals are therefore commonly targeted by children, parents and health professionals 6 . A large body of studies have targeted the body/structure domain of the ICF framework 7 . These studies focused on surgical interventions (muscle lengthening, osteotomy), medical interventions (Botulinum Neurotoxin (BoNT), baclofen) and casting/splinting to improve range of motion (ROM) or alignment to support better walking 8 – 10 . There is some evidence these interventions improve ROM on a short term basis but only weak evidence they improve walking performance 11 . High recurrence rates are reported for ankle contractures following BoNT, casting and surgery 12 and there is emerging evidence that BoNT can have a detrimental effect on the muscle tissue leading to permanent changes at the cellular level 13 . These interventions target the ROM and alignment of the joints but improving these factors does not necessarily translate to changes in motor pattern or the skill of walking. Therefore, there is scope to explore interventions that target the source of the walking impairment and not just the resultant tissue adaptations. Therapies that target walking include treadmill training (TT), robot assisted gait training (RAGT) and over-ground walking. A Cochrane review analysing these reported low to moderate quality evidence with a lot of variance among the studies 14 but acknowledged that TT and RAGT allowed for more repetitive practice and are worth further investigation. RCTs rated as good quality showed that task specificity and provision of auditory and visual feedback with gait training led to better outcomes that are clinically significant 15 and can have a positive impact on motor learning with larger effect sizes seen when different forms of feedback were provided during over-ground training and TT 16 . Repetitive practice, task-specific training and provision of feedback are all elements important to motor skill acquisition according to motor learning theory 17 . Motor Learning Theory (MLT) encompasses a wide range of concepts and theories related to how motor skills are acquired. There are many intervention approaches which have been developed using frames of reference from MLT 18 – 20 . Interventions that use MLT in upper limb rehabilitation in CP 18 and for improving gross motor skills in ambulant children with CP 21 have been given the “green light” for use, indicating a large body of good quality evidence 11 . Walking is a motor skill and interventions that target walking in this population, which include motor learning concepts such as repetitive practice, task specificity and provision of feedback, are showing promise. It is therefore worth investigating if an intervention that is specifically designed to include motor learning principles to improve walking performance could be feasible. A 2023 systematic review which compiled the evidence for motor rehabilitation in children and adolescents also recommended that any interventions designed to improve a motor skill for children with CP should be goal-directed, individualised to the child, intensive, task-specific, involve repetitive practice, active use and should encourage modification of the task and environment to maximise motivation and to suit the child’s skill level 22 . These elements are all reflected in a tool developed to support clinicians who use motor learning principles while providing interventions for upper limb function in CP 23 . These principles and strategies have been translated into an intervention to target lower limb function with a specific focus on the motor skill of walking. The aim of this study is to determine the feasibility of the study design and acceptability of the MOtor learning Based Intervention for Lower Extremities (MOBILE) intervention to target walking performance in ambulant children with CP. Specific Objectives: Investigate the feasibility of recruitment, adherence and retention. Investigate the feasibility of a battery of outcome measures including time to complete, parent and child feedback and assessor experience. Explore the acceptability of the intervention. Analyse fidelity in the delivery of the program. Gather data to power a future definitive trial. Methods Study design This is a single-arm prospective feasibility trial. Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 24 guided the design of the protocol. This study is registered on clinicaltrials.gov (NCT06454656) available at https://clinicaltrials.gov/study/NCT06454656?id=NCT06454656&rank=1 . Last updated on August 21 st 2024 prior to enrolment. Participants Participants will be recruited from community-based, state funded, children’s therapy services (Enable Ireland). Eligibility criteria A child/young person will be included in the study if they meet the following inclusion criteria and none of the exclusion criteria: Inclusion Aged 6–17 with a primary diagnosis of CP (GMFCS Levels I–III) Has a specific walking related goal Has capacity to follow instruction Has a primary caregiver who can support a home program Exclusion Has had surgery within 6 months or BoNT/baclofen within 3 months of intervention start date Has a dual diagnosis that impacts ability to follow instruction Has a significant cognitive impairment Recruitment strategy Recruitment will be rolled out in stages to ensure sample size is met. Stage 1 will include 13 Enable Ireland led Children’s Disability Network Teams (CDNTs) located in Leinster (Wicklow, Dublin, Meath, Kildare, Kilkenny) and Cavan. The lead investigator will contact each team and invite them to an information evening to explain the study. Information leaflets and posters will also be sent to each CDNT. The physiotherapists will be asked to identify potential participants based on the eligibility criteria. Those identified will be provided with information leaflets and will be asked to contact the gatekeeper. Participants may also be recruited from the specialist motor management services linked to the above-named teams. The study will also be advertised on Enable Ireland websites, CP Life Research Centre newsletter, CP Foundation Ireland newsletter and social media sites managed by Enable Ireland, CP Life Research Centre and CP Foundation Ireland. Stage 2 will extend recruitment to the remainder of Enable Ireland led CDNTs and their linked motor management services in the rest of the country. Informed consent will be obtained by the lead investigator in writing from eligible participants who confirm willingness to participate in the research study. Assessments will take place in children’s services clinic in county Meath. The therapist led sessions will take place in a clinic space close to the child’s home address where possible or in an outdoor environment close to that clinic if the walking goal is specifically related to an environmental variant. This is to ensure the therapy is provided within the participant’s community. Sample size For feasibility studies a sample size of 12 is recommended as it is amenable to statistical analysis being divisible by 2,3,4 and 6 and gain in precision for each increase of 1 in sample size is less pronounced when it reaches 12 25 . This number is rounded up to 14 to allow for 10% attrition rate. Intervention The MOBILE intervention to target walking performance will be completed by all participants. The design is grounded in MLT and considers factors such as stage of motor skill acquisition, environment, feedback and types of practice 26 , 27 . The intervention design is described using a tool developed to validate the content of upper limb motor learning interventions 23 . The full MOBILE protocol is available as extended data at https://doi.org/10.6084/m9.figshare.28524788.v1 . To determine the dose of the intervention, evidence was gathered from upper limb motor learning studies and walking-based interventions. In upper limb studies goal-directed training has been shown to lead to better gross motor outcomes than activity-based programs taking between 14 to 25 hours total practice time to achieve goals. Improvements in upper limb function have been shown to require between 30 and 40 hours of practice 28 , 29 . Interventions using treadmills or RAGT ranged from 4 to 12 weeks in duration with 2–5 sessions per week and sessions averaging 30 minutes in length which was deemed a sufficient intensity to show effect 14 . The MOBILE intervention will target each participants’ self-selected goal, therefore each participant will complete a minimum of 14 to 25 hours of practice. As there is limited data for improvements in gait or walking goals with MLT interventions, we will aim for each participant to perform 30 hours of practice which will allow for interruptions due to illness or other unforeseen circumstances. As the participants will be walking in their usual pattern between sessions, a massed practice format will be adopted with a minimum of two sessions per week scheduled. Therefore a maximum of 6 weeks is permitted to complete all 30 hours of practice of which a minimum of 80% will need to be supervised by the intervention therapist. These parameters were decided on following input from patient and public involvement (PPI) which was considered vital based on Faccioli’s recommendation that interventions need to consider the capacity of families and children to implement interventions 22 . The PPI group voiced their preference for therapist led sessions in clinic versus home programs. To target motor skill acquisition, improvement and retention, principles of neuroplasticity are embedded in the intervention design. Neuroplasticity is the brain’s adaptive capacity to encode experiences as well as learn new behaviours and skills even after brain injury. Key elements that should be considered when designing rehabilitative therapies include; intensity and specificity of practice, salience, transference and repetition 30 . Patient and Public Involvement (PPI) contributed to the design of this intervention. A young person and parent advisory group were consulted on intensity and frequency of sessions and preferences around home based versus clinic based sessions. This along with the evidence base in upper limb MLT studies contributed to the design of the intervention. Input from people with lived experience and the self-selected goal-targeted nature of the intervention will maximise adherence to the protocol. Any child presenting with a plantarflexion contracture will have a heel loaded mould or cast made to allow them to experience heel contact while re-learning the motor skill of walking. This will be worn during intervention only. Plantarflexion contractures occur in 13% (GMFCS I), 24% (GMFCS II) and 46% (GMFCS III) of children with CP 31 which reduces their heel contact time and alters their energy use 32 . If a child has a suitable splint or orthotic which supports heel contact they can use their own device during treatment sessions. The intervention and casting, if required, will be delivered by the lead researcher who is a paediatric physiotherapist trained in serial casting, motor learning theory and orthotic prescription. Any other usual care received during this time will be documented. If participants wish to discontinue the intervention, reason for dropout will be recorded. Outcomes Outcomes will be measured at baseline (T 0 ), immediately post intervention (T 1 ) and at 12 weeks post-intervention completion (T 2 ) as outlined in Figure 1 attached as separate file (See legend at end of document). Reminders will be provided ahead of assessment dates to improve retention. All participants will be encouraged to complete all assessments regardless of completion of intervention. Figure 1. MOBILE Trial Timeline and Outcomes Measured Pg.8 Outlines the outcomes that will be measured at each timepoint throughout the study. N-Number of participants, T 0 – Time point 0, T 1 - Time point one, T 2 -Time point 2. Attached as separate file. https://doi.org/10.6084/m9.figshare.28524986 . Feasibility of Study Design The primary outcome is feasibility of the study design with consideration given to elements that would inform on progression to RCT 33 . Recruitment rates will be calculated as a percentage of eligible numbers recruited. Adherence will be calculated as a percentage (total hours practiced/ planned dose). Records will be kept by intervention therapist and participants to capture practice time for each session in clinic and at home. Retention will be calculated as a percentage of recruited participants at final follow up. Adverse events and serious adverse events (SAE) will be documented on relevant forms and reported to sponsor for SAE. Willingness to be randomized in a future trial will be reported. Feasibility of battery of outcome measures Patient and Public Involvement (PPI) informed what outcomes are important to this population with appearance of walk, fatigue/endurance, pain, how they feel about their lives and how they feel about their walk highlighted as priorities. Time it takes to complete outcome measures will be recorded for all assessments. Participant/Parent and assessor experience of outcome measures will be captured through semi structured interviews. The assessor is a physiotherapist trained in all measures who will not be involved in delivering the intervention and will also be blinded to adherence levels. Clinical outcome measures (T 0 , T 1 , T 2 ) The Gait Outcomes Assessment List (GOAL) is a parent proxy/self-report questionnaire developed to measure functional mobility and goals for ambulant children with CP. It correlates well with standard functional measures and gait analysis 34 . It includes all domains reported by parents and young people during PPI and will be used to determine the goals for the intervention. This measure will be used in a power calculation to determine the sample size for a future definitive trial. (used with permission) The 6 Minute Walk Test (6MWT) is a measure of gait endurance and has been validated for use in CP 35 . It has established Minimum Clinically Important Difference (MCID) values 36 . The 10 metre self-selected speed walking test has been shown to correlate well with physical activity levels 37 The Modified Timed Up and Go (mTUG) was created to test balance and basic mobility in children with physical disabilities and has been validated for use in CP 38 . It has established MCIDs for each level of GMFCS I-III 39 . Range of Motion of ankle dorsiflexion and knee extension will be measured using a goniometer. The Cerebral Palsy Integrated Pathway protocol for positioning will be used to standardise the measurements 40 . Quality of Life will be measured using the Child Health Utilities instrument (CHU-9D) which is a self-report measure that can calculate quality adjusted life years 41 . (used with permission) Acceptability of the Intervention Semi-structured interviews will be conducted at the end of the intervention by a research team member not involved in delivering the intervention. These interviews, with the parent/participant, will explore the components of the Theoretical Framework of Acceptability such as self-efficacy, burden, perceived effectiveness and affective attitude 42 . Choice of intervention frequency and mode of delivery will also be explored. Fidelity of the Intervention Delivery Fidelity of the intervention will be measured using a specific measure developed and piloted by the lead researcher based on the intervention protocol. Videos of therapist led sessions will be recorded and scored using the measure by a member of the research team not involved in the intervention, who is experienced with motor learning interventions. Data collection and analysis Data will be collected on case report forms (available as extended data) and stored in a secure folder on an encrypted server. Interviews will be voice recorded and transcribed on Microsoft Teams TM using HP ProBook 450 G7 Videos will be uploaded to a Microsoft Teams folder which can only be accessed by the lead researcher and fidelity assessor. Descriptive analysis of baseline characteristics will be carried out. These include CP type, age of child, GMFCS level, previous surgery/BoNT intervention, orthotic device worn. The analysis will be completed in two stages. Stage one will summarise the feasibility outcomes. Recruitment, attrition and adherence rates will be reported using descriptive statistics such as percentages and 95% confidence intervals. Acceptability of the intervention and experience of the outcome measures will be described descriptively using thematic analysis of the interview transcripts. Stage two will summarise the clinical outcomes data post intervention and 12 weeks after. As it is inappropriate to use feasibility trial data to formally test for a treatment effect, the analyses will primarily be of a descriptive nature. Interval estimates of the potential effect will be produced in the form of a 95% confidence interval and where MCIDs are reported for this population a “yes/no” will be reported if MCIDs are achieved or not. Discussion The MOBILE intervention has an evidence-based design and could improve walking performance in ambulant children with CP. The protocol is in keeping with the most recent recommendations for intervention design for developing motor skills 22 and includes the opinions of young people with lived experience and their parents in the design. Due to the individualised and goal-targeted design, the potential benefits of the MOBILE intervention could also include longer retention of acquired motor skills which could diminish decline in functional walking skills with age and achievement of goals to support greater participation and physical activity. Due to the time commitment and intensity of the intervention it is important to determine how feasible and acceptable it is to carry out in a community environment, embedded in practice, to inform whether a fully powered RCT could be completed to determine its efficacy. This study will inform if outcome measures such as the GOAL can be used to target a meaningful walking goal, if the participants and their parents perceive it to be effective and worthwhile and if any modifications or changes to the format of delivery could be made to improve feasibility. As there is scope for participants to choose an intensity and frequency schedule to suit their preferences, the interventionist will be able to reflect on their own experience of delivering the intervention in different formats to see if there is one that appears to be better tolerated by the participants and the therapist. A limitation in this study is the small sample size from one regional location which may lack variety in socioeconomic backgrounds or cultural variance. This could impact the variety of data collected in interviews. Another limitation is that there is only one interventionist. This will make it challenging to determine if the protocol is easy to administer with fidelity maintained by multiple therapists across different clinics as would be needed in a multi-centre RCT. Reflexive writing will be undertaken by the intervention therapist throughout the study and discussions with wider team will be done during analysis of qualitative information to limit bias. Patient and public involvement will be used when all data is gathered to help with interpretation of results and plan for dissemination. The final study will be published in an open access peer reviewed journal and opportunities to present at conferences will be sought. Ethical considerations Ethical approval has been granted through Enable Ireland and the Royal College of Surgeons Ireland Research Ethics Committees. Enable Ireland Research Ethics and Quality Committee (REQC) approval received on 17 th of June 2024. Reference Number: RA96 Royal College of Surgeons Research Ethics Committee approval received on the 5 th of March 2024. Reference Number: REC202312001 This study adheres to the Declaration of Helsinki for studies involving human subjects 43 Explicit, informed, written consent will be obtained from the parent/guardian of each participant. Written assent will also be obtained from each participant. Should a participant turn 18 during the study they will be asked to complete an updated informed written consent. Participants will be informed of their right to withdraw at any stage without affecting their usual care. Both ethics committees will be informed of any changes to protocol via respective revision procedures. Protocol version control Version 1 30/06/2023 Version 1.2 27/04/2024 Intervention Manual format change from Tidier Checklist to template for upper limb motor learning strategy tool. Change to frequency and intensity options for intervention provided based on PPI advisory panels. Version 1.2.1 09/08/2024 Recruitment strategy expanded to include participants accessing motor management services in Enable Ireland. Primary clinical outcome measure for power calculation changed from 6minute walk test to Gait Outcome Assessment List. Version 1.2.2 27/02/2025 Updates to background information with evidence from new systematic review added. More detail added to study limitations and discussion. Study sponsorship Royal College of Surgeones Ireland Sponsorship Office- [email protected] Maurice Dowling- Sponsor Officer Data availability statement Underlying data No data are associated with this article. Extended data Figshare: TIDieR Description MOBILE. https://doi.org/10.6084/m9.figshare.28524953 44 . Figshare: MOBILE Protocol. https://doi.org/10.6084/m9.figshare.28524788 45 . Figshare: MOBILE Fidelity Checklist. https://doi.org/10.6084/m9.figshare.28524764 46 . Figshare: Data Management Plan. https://doi.org/10.6084/m9.figshare.28524650 47 . Figshare: Patient Information Leaflet. https://doi.org/10.6084/m9.figshare.28524803 48 . Figshare: Consent Form. https://doi.org/10.6084/m9.figshare.28524830 49 . Figshare: Case Report Form. https://doi.org/10.6084/m9.figshare.28525043 50 . Figshare: WHO Trial Registration Data Set. https://doi.org/10.6084/m9.figshare.28533185 51 . Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Reporting guidelines Figshare: SPIRIT checklist for ‘A "motor learning based intervention for lower extremities (MOBILE)" to target walking performance in ambulant children with cerebral palsy: A feasibility study’. https://doi.org/10.6084/m9.figshare.28525082 52 . Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Author contributions Caitríona O’Shaughnessy: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Raymond McCarthy: Investigation, Writing – Review & Editing Dereena Minehane: Investigation, Writing – Review & Editing Dr. Jennifer Ryan: Conceptualization, Methodology, Supervision, Validation, Writing – Review & Editing Dr. Ailish Malone:Conceptualization, Methodology, Project Administration, Supervision, Validation, Writing – Review & Editing Acknowledgements I would like to acknowledge and thank the contributions of the patient and public involvement advisory groups which included 5 young people with lived experience of Cerebral Palsy and their parents as well as a further 5 parents of children with lived experience. I would finally like to extend deep gratitude to Dr. Brian Hoare of Monash children’s Hospital, CPTeaching and LaTrobe University for the support, advice and training he provided me while exploring the idea of motor learning theory and its potential implications for lower limb rehabilitation of children with Cerebral Palsy. And to his colleague Dr. Atefeh Taghizadeh who kindly shared her work on the upper limb motor learning strategy tool checklist and motor learning training manual which were instrumental in supporting the development of the MOBILE protocol. Faculty Opinions recommended References 1. McIntyre S, Goldsmith S, Webb A, et al. : Global prevalence of Cerebral Palsy: a systematic analysis. Dev Med Child Neurol. 2022; 64 (12): 1494–1506. PubMed Abstract | Publisher Full Text | Free Full Text 2. MacLennan AH, Thompson SC, Gecz J: Cerebral Palsy: causes, pathways, and the role of genetic variants. Am J Obstet Gynecol. 2015; 213 (6): 779–88. 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PubMed Abstract | Publisher Full Text | Free Full Text 43. World Medical Association: World medical association declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ. 2001; 79 (4): 373–4. PubMed Abstract | Free Full Text 44. O'Shaughnessy C: TIDieR description of MOBILE.docx. figshare; 2025; [cited 2025Mar4]. https://figshare.com/articles/online_resource/TIDieR_Description_of_MOBILE_docx/28524953/1 45. O'Shaughnessy C: MOBILE_protocol description.docx. figshare; 2025; [cited 2025Mar4]. https://figshare.com/articles/online_resource/MOBILE_Protocol_Description_docx/28524788/1 46. O'Shaughnessy C: MOBILE fidelity checklist.docx. figshare; 2025; [cited 2025Mar4]. https://figshare.com/articles/online_resource/MOBILE_Fidelity_Checklist_docx/28524764/1 47. O'Shaughnessy C: Data management plan MOBILE.docx. figshare; 2025; [cited 2025Mar4]. https://figshare.com/articles/online_resource/Data_Management_Plan_MOBILE_docx/28524650/1 48. O'Shaughnessy C: MOBILE parent information leaflet.pdf. figshare; 2025; [cited 2025Mar4]. https://figshare.com/articles/online_resource/MOBILE_Parent_Information_Leaflet_pdf/28524803/1 49. O'Shaughnessy C: MOBILE consent form V1.2.docx. figshare; 2025; [cited 2025Mar4]. https://figshare.com/articles/online_resource/Consent_Form_V1_2_docx/28524830/251 50. O'Shaughnessy C: MOBILE trial case report form V2.docx. figshare; 2025; [cited 2025Mar4]. https://figshare.com/articles/online_resource/MOBILE_Trial_Case_Report_Form_V2_docx/28525043/1 51. O'Shaughnessy C: WHO trial registration Data Set. figshare; 2025; [cited 2025Mar4]. https://figshare.com/articles/online_resource/WHO_Trial_Registration_Data_Set/28533185/1 52. O'Shaughnessy C: SPIRIT checklist for MOBILE study. figshare; 2025; [cited 2025Mar4]. https://figshare.com/articles/online_resource/SPIRIT_Checklist_for_publication_pdf/28525082/1 Comments on this article Comments (0) Version 2 VERSION 2 PUBLISHED 04 Apr 2025 ADD YOUR COMMENT Comment Author details Author details 1 Physiotherapy, CP Life Research Centre, Royal College of Surgeons in Ireland, Dublin, Leinster, D02YN77, Ireland 2 CDNT 4 Dunshaughlin, Enable Ireland, Meath, Leinster, C15K0FV, Ireland Caitríona O'Shaughnessy Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Raymond McCarthy Roles: Investigation, Writing – Review & Editing Dereena Minehane Roles: Investigation, Writing – Review & Editing Jennifer Ryan Roles: Conceptualization, Methodology, Supervision, Validation, Writing – Review & Editing Ailish Malone Roles: Conceptualization, Methodology, Project Administration, Supervision, Validation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information Health Research Board [HRCI-HRB-2022-006].This work was also supported by the Royal College of Surgeons Ireland, Strategic Academic Recruitment (StAR) programme linked with professional doctorate programme of lead researcher and the International Organisation of Physiotherapists in Paediatrics Research Grant. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (2) version 2 Revised Published: 29 Jan 2026, 8:46 https://doi.org/10.12688/hrbopenres.14101.2 version 1 Published: 04 Apr 2025, 8:46 https://doi.org/10.12688/hrbopenres.14101.1 Copyright © 2025 O'Shaughnessy C et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics VIEWS $counts.viewCount downloads Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article O'Shaughnessy C, McCarthy R, Minehane D et al. A "motor learning based intervention for lower extremities (MOBILE)" to target walking performance in ambulant children with cerebral palsy: A feasibility study. [version 1; peer review: 2 approved with reservations] . HRB Open Res 2025, 8 :46 ( https://doi.org/10.12688/hrbopenres.14101.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 04 Apr 2025 Views 0 Cite How to cite this report: Waqas S. Reviewer Report For: A "motor learning based intervention for lower extremities (MOBILE)" to target walking performance in ambulant children with cerebral palsy: A feasibility study. [version 1; peer review: 2 approved with reservations] . HRB Open Res 2025, 8 :46 ( https://doi.org/10.21956/hrbopenres.15494.r47068 ) The direct URL for this report is: https://hrbopenresearch.org/articles/8-46/v1#referee-response-47068 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 15 May 2025 Shoaib Waqas , University of Biological and Applied Sciences, Lahore, Pakistan Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15494.r47068 Abstract Could you Please include a brief mention of the theoretical framework (Motor Learning Theory) in the abstract for clarity. Introduction Clarify the novelty of MOBILE compared to existing MLT interventions (e.g., how it differs from ... Continue reading READ ALL Abstract Could you Please include a brief mention of the theoretical framework (Motor Learning Theory) in the abstract for clarity. Introduction Clarify the novelty of MOBILE compared to existing MLT interventions (e.g., how it differs from treadmill training or upper-limb MLT approaches). Briefly define "feasibility" and "acceptability" as per Sekhon’s framework (cited in methods) to align with objectives. Methods Intervention : Provide more detail on the "tailored" components (e.g., examples of walking goals or feedback strategies). Data Analysis : Clarify how MCIDs will inform future RCT power calculations (e.g., GOAL as primary outcome). Discussion Expand on how findings will directly inform RCT design (e.g., sample size, intervention refinements). Discuss potential barriers to adherence (e.g., family capacity) and mitigation strategies. Mention data anonymization/storage details (though covered in extended data). Protocol Version Control Link version changes to specific limitations (e.g., expanded recruitment to address sample diversity). Overall Recommendations Clarify Novelty : Differentiate MOBILE from existing MLT interventions (e.g., task-specificity for walking vs. upper limb). Strengthen Feasibility Metrics : Explicitly link recruitment targets (n=14) to progression criteria for RCT (e.g., ≥80% adherence). Expand Intervention Details : Provide examples of motor learning strategies (e.g., feedback types, task modification). Highlight PPI Impact : Show how advisory groups shaped intervention design (e.g., clinic vs. home preference. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Pediatric Physical Therapy I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Waqas S. Reviewer Report For: A "motor learning based intervention for lower extremities (MOBILE)" to target walking performance in ambulant children with cerebral palsy: A feasibility study. [version 1; peer review: 2 approved with reservations] . HRB Open Res 2025, 8 :46 ( https://doi.org/10.21956/hrbopenres.15494.r47068 ) The direct URL for this report is: https://hrbopenresearch.org/articles/8-46/v1#referee-response-47068 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 29 Jan 2026 Caitríona O'Shaughnessy , Physiotherapy, CP Life Research Centre, Royal College of Surgeons in Ireland, Dublin, D02YN77, Ireland 29 Jan 2026 Author Response Abstract Could you Please include a brief mention of the theoretical framework (Motor Learning Theory) in the abstract for clarity. We agree it is important to mention Motor ... Continue reading Abstract Could you Please include a brief mention of the theoretical framework (Motor Learning Theory) in the abstract for clarity. We agree it is important to mention Motor Learning Theory. We added a brief description that MLT encompasses multiple concepts that shape our understanding of how motor skills are acquired and developed. Introduction Clarify the novelty of MOBILE compared to existing MLT interventions (e.g., how it differs from treadmill training or upper-limb MLT approaches). The novelty and need for MOBILE is explained in three main points. RAGT and treadmill training, while having one or two elements that are known to influence motor learning, were not designed specifically to target motor learning (Introduction, fourth paragraph). Upper limb and gross motor MLT approaches do not specifically focus on lower limbs or walking as the target (Introduction, paragraph 5) There is currently a lack of interventions designed using MLT that specifically target walking as a motor skill (Introduction, final paragraph). Briefly define "feasibility" and "acceptability" as per Sekhon’s framework (cited in methods) to align with objectives. Definitions of feasibility and acceptability have been added to the section preceding the objectives as suggested. Methods Intervention: Provide more detail on the "tailored" components (e.g., examples of walking goals or feedback strategies). Three new paragraphs (paragraphs 4-6) have been added to the intervention section providing more detail on the tailored components of the intervention. Some examples of walking goals, feedback strategies and other factors are provided. It has also been added that the intervention therapist will keep a reflective diary throughout which will document how each session developed and why tasks were chosen. This will serve as the basis for developing an instruction manual for other therapists wishing to replicate the intervention. Data Analysis: Clarify how MCIDs will inform future RCT power calculations (e.g., GOAL as primary outcome). We have expanded the final paragraph of the data analysis subsection to clarify that MCIDs are only being used to estimate a potential effect in the two measures where there are established MCIDs for this population. The GOAL was selected as the primary clinical outcome measure by the PPI advisory group as it was the most meaningful measure to them. There currently are no established MCIDs for the GOAL therefore a power calculation will be done on the data collected for the total GOAL score. Discussion Expand on how findings will directly inform RCT design (e.g., sample size, intervention refinements). The third and fourth paragraphs of the discussion section have been expanded to provide more detail on how the results will inform an RCT design including (1) potential need for a multi-centre design will be judged on time for recruitment and geographical spread, (2) balance of clinic and home-based programs will be judged on qualitative feedback from interviews and adherence rates and (3) intensity and frequency or other intervention design refinements will be considered based on qualitative analysis from the interviews and feasibility metrics A fifth paragraph has been added to further discuss how the information collected by the interventionist will help to refine the intervention manual. Discuss potential barriers to adherence (e.g., family capacity) and mitigation strategies. The second paragraph of the discussion has been expanded to discuss potential barriers to adherence and mitigating strategies. Briefly, these include participant fatigue or competing demands with school or hobbies, balancing appointments and home programs with other family demands, and physical fatigue or muscle soreness. Rest breaks will be given as needed, appointments will be scheduled to suit families as best possible and home programs will be simple and incorporated into their hobbies or other activities where possible. Mention data anonymization/storage details (though covered in extended data). Brief mention of anonymisation and storage has been added to the first paragraph of the “data collection and analysis” subsection, which now explains that anonymised data will be uploaded to a secure SharePoint folder. We also direct readers to our data management plan under extended data. Protocol Version Control Link version changes to specific limitations (e.g., expanded recruitment to address sample diversity). Linked version change 1.2.1 expansion of recruitment strategy to address more diversity in sample size as suggested. Other changes were due to new evidence emerging or feedback from PPI groups rather than limitations prompting changes. Overall Recommendations 1. Clarify Novelty: Differentiate MOBILE from existing MLT interventions (e.g., task-specificity for walking vs. upper limb). Addressed above in the introduction. 2. Strengthen Feasibility Metrics: Explicitly link recruitment targets (n=14) to progression criteria for RCT (e.g., ≥80% adherence). Specific feasibility metrics for progression were not included for this study as there will likely be many refinements and adjustments to the protocol based on an integrated analysis of the quantitative and qualitative data collected. This is described in an addition to the first line under “Feasibility of Study Design” in the Outcome section of the methodology, It is also added that PPI groups will be involved in the decision-making process around recommendations on progression to RCT. 3. Expand Intervention Details: Provide examples of motor learning strategies (e.g., feedback types, task modification). Addressed above in detail. 4. Highlight PPI Impact: Show how advisory groups shaped intervention design (e.g., clinic vs. home preference. More detail was added to the PPI paragraph and are highlighted in the comments to reviewer 1. Abstract Could you Please include a brief mention of the theoretical framework (Motor Learning Theory) in the abstract for clarity. We agree it is important to mention Motor Learning Theory. We added a brief description that MLT encompasses multiple concepts that shape our understanding of how motor skills are acquired and developed. Introduction Clarify the novelty of MOBILE compared to existing MLT interventions (e.g., how it differs from treadmill training or upper-limb MLT approaches). The novelty and need for MOBILE is explained in three main points. RAGT and treadmill training, while having one or two elements that are known to influence motor learning, were not designed specifically to target motor learning (Introduction, fourth paragraph). Upper limb and gross motor MLT approaches do not specifically focus on lower limbs or walking as the target (Introduction, paragraph 5) There is currently a lack of interventions designed using MLT that specifically target walking as a motor skill (Introduction, final paragraph). Briefly define "feasibility" and "acceptability" as per Sekhon’s framework (cited in methods) to align with objectives. Definitions of feasibility and acceptability have been added to the section preceding the objectives as suggested. Methods Intervention: Provide more detail on the "tailored" components (e.g., examples of walking goals or feedback strategies). Three new paragraphs (paragraphs 4-6) have been added to the intervention section providing more detail on the tailored components of the intervention. Some examples of walking goals, feedback strategies and other factors are provided. It has also been added that the intervention therapist will keep a reflective diary throughout which will document how each session developed and why tasks were chosen. This will serve as the basis for developing an instruction manual for other therapists wishing to replicate the intervention. Data Analysis: Clarify how MCIDs will inform future RCT power calculations (e.g., GOAL as primary outcome). We have expanded the final paragraph of the data analysis subsection to clarify that MCIDs are only being used to estimate a potential effect in the two measures where there are established MCIDs for this population. The GOAL was selected as the primary clinical outcome measure by the PPI advisory group as it was the most meaningful measure to them. There currently are no established MCIDs for the GOAL therefore a power calculation will be done on the data collected for the total GOAL score. Discussion Expand on how findings will directly inform RCT design (e.g., sample size, intervention refinements). The third and fourth paragraphs of the discussion section have been expanded to provide more detail on how the results will inform an RCT design including (1) potential need for a multi-centre design will be judged on time for recruitment and geographical spread, (2) balance of clinic and home-based programs will be judged on qualitative feedback from interviews and adherence rates and (3) intensity and frequency or other intervention design refinements will be considered based on qualitative analysis from the interviews and feasibility metrics A fifth paragraph has been added to further discuss how the information collected by the interventionist will help to refine the intervention manual. Discuss potential barriers to adherence (e.g., family capacity) and mitigation strategies. The second paragraph of the discussion has been expanded to discuss potential barriers to adherence and mitigating strategies. Briefly, these include participant fatigue or competing demands with school or hobbies, balancing appointments and home programs with other family demands, and physical fatigue or muscle soreness. Rest breaks will be given as needed, appointments will be scheduled to suit families as best possible and home programs will be simple and incorporated into their hobbies or other activities where possible. Mention data anonymization/storage details (though covered in extended data). Brief mention of anonymisation and storage has been added to the first paragraph of the “data collection and analysis” subsection, which now explains that anonymised data will be uploaded to a secure SharePoint folder. We also direct readers to our data management plan under extended data. Protocol Version Control Link version changes to specific limitations (e.g., expanded recruitment to address sample diversity). Linked version change 1.2.1 expansion of recruitment strategy to address more diversity in sample size as suggested. Other changes were due to new evidence emerging or feedback from PPI groups rather than limitations prompting changes. Overall Recommendations 1. Clarify Novelty: Differentiate MOBILE from existing MLT interventions (e.g., task-specificity for walking vs. upper limb). Addressed above in the introduction. 2. Strengthen Feasibility Metrics: Explicitly link recruitment targets (n=14) to progression criteria for RCT (e.g., ≥80% adherence). Specific feasibility metrics for progression were not included for this study as there will likely be many refinements and adjustments to the protocol based on an integrated analysis of the quantitative and qualitative data collected. This is described in an addition to the first line under “Feasibility of Study Design” in the Outcome section of the methodology, It is also added that PPI groups will be involved in the decision-making process around recommendations on progression to RCT. 3. Expand Intervention Details: Provide examples of motor learning strategies (e.g., feedback types, task modification). Addressed above in detail. 4. Highlight PPI Impact: Show how advisory groups shaped intervention design (e.g., clinic vs. home preference. More detail was added to the PPI paragraph and are highlighted in the comments to reviewer 1. Competing Interests: None to declare Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 29 Jan 2026 Caitríona O'Shaughnessy , Physiotherapy, CP Life Research Centre, Royal College of Surgeons in Ireland, Dublin, D02YN77, Ireland 29 Jan 2026 Author Response Abstract Could you Please include a brief mention of the theoretical framework (Motor Learning Theory) in the abstract for clarity. We agree it is important to mention Motor ... Continue reading Abstract Could you Please include a brief mention of the theoretical framework (Motor Learning Theory) in the abstract for clarity. We agree it is important to mention Motor Learning Theory. We added a brief description that MLT encompasses multiple concepts that shape our understanding of how motor skills are acquired and developed. Introduction Clarify the novelty of MOBILE compared to existing MLT interventions (e.g., how it differs from treadmill training or upper-limb MLT approaches). The novelty and need for MOBILE is explained in three main points. RAGT and treadmill training, while having one or two elements that are known to influence motor learning, were not designed specifically to target motor learning (Introduction, fourth paragraph). Upper limb and gross motor MLT approaches do not specifically focus on lower limbs or walking as the target (Introduction, paragraph 5) There is currently a lack of interventions designed using MLT that specifically target walking as a motor skill (Introduction, final paragraph). Briefly define "feasibility" and "acceptability" as per Sekhon’s framework (cited in methods) to align with objectives. Definitions of feasibility and acceptability have been added to the section preceding the objectives as suggested. Methods Intervention: Provide more detail on the "tailored" components (e.g., examples of walking goals or feedback strategies). Three new paragraphs (paragraphs 4-6) have been added to the intervention section providing more detail on the tailored components of the intervention. Some examples of walking goals, feedback strategies and other factors are provided. It has also been added that the intervention therapist will keep a reflective diary throughout which will document how each session developed and why tasks were chosen. This will serve as the basis for developing an instruction manual for other therapists wishing to replicate the intervention. Data Analysis: Clarify how MCIDs will inform future RCT power calculations (e.g., GOAL as primary outcome). We have expanded the final paragraph of the data analysis subsection to clarify that MCIDs are only being used to estimate a potential effect in the two measures where there are established MCIDs for this population. The GOAL was selected as the primary clinical outcome measure by the PPI advisory group as it was the most meaningful measure to them. There currently are no established MCIDs for the GOAL therefore a power calculation will be done on the data collected for the total GOAL score. Discussion Expand on how findings will directly inform RCT design (e.g., sample size, intervention refinements). The third and fourth paragraphs of the discussion section have been expanded to provide more detail on how the results will inform an RCT design including (1) potential need for a multi-centre design will be judged on time for recruitment and geographical spread, (2) balance of clinic and home-based programs will be judged on qualitative feedback from interviews and adherence rates and (3) intensity and frequency or other intervention design refinements will be considered based on qualitative analysis from the interviews and feasibility metrics A fifth paragraph has been added to further discuss how the information collected by the interventionist will help to refine the intervention manual. Discuss potential barriers to adherence (e.g., family capacity) and mitigation strategies. The second paragraph of the discussion has been expanded to discuss potential barriers to adherence and mitigating strategies. Briefly, these include participant fatigue or competing demands with school or hobbies, balancing appointments and home programs with other family demands, and physical fatigue or muscle soreness. Rest breaks will be given as needed, appointments will be scheduled to suit families as best possible and home programs will be simple and incorporated into their hobbies or other activities where possible. Mention data anonymization/storage details (though covered in extended data). Brief mention of anonymisation and storage has been added to the first paragraph of the “data collection and analysis” subsection, which now explains that anonymised data will be uploaded to a secure SharePoint folder. We also direct readers to our data management plan under extended data. Protocol Version Control Link version changes to specific limitations (e.g., expanded recruitment to address sample diversity). Linked version change 1.2.1 expansion of recruitment strategy to address more diversity in sample size as suggested. Other changes were due to new evidence emerging or feedback from PPI groups rather than limitations prompting changes. Overall Recommendations 1. Clarify Novelty: Differentiate MOBILE from existing MLT interventions (e.g., task-specificity for walking vs. upper limb). Addressed above in the introduction. 2. Strengthen Feasibility Metrics: Explicitly link recruitment targets (n=14) to progression criteria for RCT (e.g., ≥80% adherence). Specific feasibility metrics for progression were not included for this study as there will likely be many refinements and adjustments to the protocol based on an integrated analysis of the quantitative and qualitative data collected. This is described in an addition to the first line under “Feasibility of Study Design” in the Outcome section of the methodology, It is also added that PPI groups will be involved in the decision-making process around recommendations on progression to RCT. 3. Expand Intervention Details: Provide examples of motor learning strategies (e.g., feedback types, task modification). Addressed above in detail. 4. Highlight PPI Impact: Show how advisory groups shaped intervention design (e.g., clinic vs. home preference. More detail was added to the PPI paragraph and are highlighted in the comments to reviewer 1. Abstract Could you Please include a brief mention of the theoretical framework (Motor Learning Theory) in the abstract for clarity. We agree it is important to mention Motor Learning Theory. We added a brief description that MLT encompasses multiple concepts that shape our understanding of how motor skills are acquired and developed. Introduction Clarify the novelty of MOBILE compared to existing MLT interventions (e.g., how it differs from treadmill training or upper-limb MLT approaches). The novelty and need for MOBILE is explained in three main points. RAGT and treadmill training, while having one or two elements that are known to influence motor learning, were not designed specifically to target motor learning (Introduction, fourth paragraph). Upper limb and gross motor MLT approaches do not specifically focus on lower limbs or walking as the target (Introduction, paragraph 5) There is currently a lack of interventions designed using MLT that specifically target walking as a motor skill (Introduction, final paragraph). Briefly define "feasibility" and "acceptability" as per Sekhon’s framework (cited in methods) to align with objectives. Definitions of feasibility and acceptability have been added to the section preceding the objectives as suggested. Methods Intervention: Provide more detail on the "tailored" components (e.g., examples of walking goals or feedback strategies). Three new paragraphs (paragraphs 4-6) have been added to the intervention section providing more detail on the tailored components of the intervention. Some examples of walking goals, feedback strategies and other factors are provided. It has also been added that the intervention therapist will keep a reflective diary throughout which will document how each session developed and why tasks were chosen. This will serve as the basis for developing an instruction manual for other therapists wishing to replicate the intervention. Data Analysis: Clarify how MCIDs will inform future RCT power calculations (e.g., GOAL as primary outcome). We have expanded the final paragraph of the data analysis subsection to clarify that MCIDs are only being used to estimate a potential effect in the two measures where there are established MCIDs for this population. The GOAL was selected as the primary clinical outcome measure by the PPI advisory group as it was the most meaningful measure to them. There currently are no established MCIDs for the GOAL therefore a power calculation will be done on the data collected for the total GOAL score. Discussion Expand on how findings will directly inform RCT design (e.g., sample size, intervention refinements). The third and fourth paragraphs of the discussion section have been expanded to provide more detail on how the results will inform an RCT design including (1) potential need for a multi-centre design will be judged on time for recruitment and geographical spread, (2) balance of clinic and home-based programs will be judged on qualitative feedback from interviews and adherence rates and (3) intensity and frequency or other intervention design refinements will be considered based on qualitative analysis from the interviews and feasibility metrics A fifth paragraph has been added to further discuss how the information collected by the interventionist will help to refine the intervention manual. Discuss potential barriers to adherence (e.g., family capacity) and mitigation strategies. The second paragraph of the discussion has been expanded to discuss potential barriers to adherence and mitigating strategies. Briefly, these include participant fatigue or competing demands with school or hobbies, balancing appointments and home programs with other family demands, and physical fatigue or muscle soreness. Rest breaks will be given as needed, appointments will be scheduled to suit families as best possible and home programs will be simple and incorporated into their hobbies or other activities where possible. Mention data anonymization/storage details (though covered in extended data). Brief mention of anonymisation and storage has been added to the first paragraph of the “data collection and analysis” subsection, which now explains that anonymised data will be uploaded to a secure SharePoint folder. We also direct readers to our data management plan under extended data. Protocol Version Control Link version changes to specific limitations (e.g., expanded recruitment to address sample diversity). Linked version change 1.2.1 expansion of recruitment strategy to address more diversity in sample size as suggested. Other changes were due to new evidence emerging or feedback from PPI groups rather than limitations prompting changes. Overall Recommendations 1. Clarify Novelty: Differentiate MOBILE from existing MLT interventions (e.g., task-specificity for walking vs. upper limb). Addressed above in the introduction. 2. Strengthen Feasibility Metrics: Explicitly link recruitment targets (n=14) to progression criteria for RCT (e.g., ≥80% adherence). Specific feasibility metrics for progression were not included for this study as there will likely be many refinements and adjustments to the protocol based on an integrated analysis of the quantitative and qualitative data collected. This is described in an addition to the first line under “Feasibility of Study Design” in the Outcome section of the methodology, It is also added that PPI groups will be involved in the decision-making process around recommendations on progression to RCT. 3. Expand Intervention Details: Provide examples of motor learning strategies (e.g., feedback types, task modification). Addressed above in detail. 4. Highlight PPI Impact: Show how advisory groups shaped intervention design (e.g., clinic vs. home preference. More detail was added to the PPI paragraph and are highlighted in the comments to reviewer 1. Competing Interests: None to declare Close Report a concern COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Lemay M. Reviewer Report For: A "motor learning based intervention for lower extremities (MOBILE)" to target walking performance in ambulant children with cerebral palsy: A feasibility study. [version 1; peer review: 2 approved with reservations] . HRB Open Res 2025, 8 :46 ( https://doi.org/10.21956/hrbopenres.15494.r46650 ) The direct URL for this report is: https://hrbopenresearch.org/articles/8-46/v1#referee-response-46650 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 08 May 2025 Martin Lemay , Universite du Quebec a Montreal, Montreal, Québec, Canada Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15494.r46650 This single-arm feasibility trial evaluates the MOBILE intervention to improve walking in children with cerebral palsy aged 6-17 (GMFCS Levels I-III). Participants will receive 14-30 hours of therapy over 6 weeks, targeting self-selected walking goals using motor learning principles. Feasibility ... Continue reading READ ALL This single-arm feasibility trial evaluates the MOBILE intervention to improve walking in children with cerebral palsy aged 6-17 (GMFCS Levels I-III). Participants will receive 14-30 hours of therapy over 6 weeks, targeting self-selected walking goals using motor learning principles. Feasibility outcomes like recruitment, adherence, and retention will be assessed, along with clinical outcomes such as gait endurance, mobility, and quality of life. The study incorporates patient and public involvement (PPI) to ensure the intervention meets participants' needs. This well-thought-out protocol, however, relies on a relatively small sample size and should better consider the heterogeneity of CP. Rationale and objectives The introduction refers only to children with GMFCS levels I to III, but it is important to acknowledge that CP also includes children classified at levels IV and V. While these individuals are typically non-ambulant and may not be the primary focus of this study, briefly recognizing their existence and the broader spectrum of motor impairments within CP would provide a more complete overview of the condition. I would consider explicitly articulating the specific gap this feasibility study aims to address—for example, the current lack of motor learning–based interventions specifically tailored to improve lower limb function in ambulant children with cerebral palsy. The study objectives are clearly articulated and appropriate for a feasibility study. They effectively lay the groundwork for a future investigation into the efficacy of the MOBILE intervention. Study design CP is highly heterogeneous, with significant variability in severity and associated conditions. How can you account for these differences in your study design and methodology to ensure that your findings are applicable to all children with CP, regardless of their specific diagnosis or functional level? This is especially important in the context of a study involving only 14 participants across a broad age range, where individual differences may play a crucial role in the outcomes. Also, while the multi-stage recruitment strategy is well thought out, it relies heavily on therapist referrals and might not capture a diverse enough sample. It is indicated that consent will be obtained. Both consent (from the guardian) and assent (from the child) should typically be obtained when conducting research with children, with the assent process tailored to the child's age and level of understanding The rationale for the chosen dose of the intervention is well-justified The involvement of a young person and parent advisory group in shaping the intervention and providing input on session intensity, frequency, and mode of delivery enhances the relevance and acceptability of the intervention for the target population. However,more details on the advisory group consultation are needed, including the number of participants, the frequency of meetings, and the specific nature of their contributions. While the clinical outcome measures appear relevant, it would be useful to provide a brief rationale for their inclusion. Replication The protocol follows the SPIRIT guidelines, which is a well-established standard for clinical trials. This provides a solid framework for replication. The original SPIRIT 2013 guidelines have undergone updates and refinements in recent years. Have these more recent developments been taken into account in the preparation of this protocol? More details on the categorization of participants in terms of age, GMFCS level, comorbidities, type of walking, and other relevant factors are needed. The “ Fidelity of the Intervention Delivery ” section provides a clear overview of the actions taken to ensure consistent provision of the intervention across therapists. However, it is important to include more information on the therapist, its training and experience, and other relevant factors that may impact the delivery of the intervention. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Cerebral palsy; Motor learning; Adapted physical activity; rehabilitation I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Lemay M. Reviewer Report For: A "motor learning based intervention for lower extremities (MOBILE)" to target walking performance in ambulant children with cerebral palsy: A feasibility study. [version 1; peer review: 2 approved with reservations] . HRB Open Res 2025, 8 :46 ( https://doi.org/10.21956/hrbopenres.15494.r46650 ) The direct URL for this report is: https://hrbopenresearch.org/articles/8-46/v1#referee-response-46650 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 29 Jan 2026 Caitríona O'Shaughnessy , Physiotherapy, CP Life Research Centre, Royal College of Surgeons in Ireland, Dublin, D02YN77, Ireland 29 Jan 2026 Author Response Rationale and objectives The introduction refers only to children with GMFCS levels I to III, but it is important to acknowledge that CP also includes children classified at ... Continue reading Rationale and objectives The introduction refers only to children with GMFCS levels I to III, but it is important to acknowledge that CP also includes children classified at levels IV and V. While these individuals are typically non-ambulant and may not be the primary focus of this study, briefly recognizing their existence and the broader spectrum of motor impairments within CP would provide a more complete overview of the condition. I have expanded the description of the GMFCS levels to include those at level IV and V as suggested. This description is at the end of paragraph one of the introduction and describes why levels I to III were chosen with the focus of the study targeting children who walk functionally with independence. I would consider explicitly articulating the specific gap this feasibility study aims to address—for example, the current lack of motor learning–based interventions specifically tailored to improve lower limb function in ambulant children with cerebral palsy. In the final paragraph of the introduction, before the aims, I describe the research currently published that includes concepts of motor learning theory to target walking which include task specificity, repetitive practice and provision of feedback. I have added a sentence that explicitly states the lack of motor learning-based interventions to target lower limbs for walking goals as correctly articulated by the reviewer. Also in response to reviewer two, more detail was added to introduction paragraphs four and five describing the interventions in the current evidence base which adds to the gap this study aims to address. Study Design CP is highly heterogeneous, with significant variability in severity and associated conditions. How can you account for these differences in your study design and methodology to ensure that your findings are applicable to all children with CP, regardless of their specific diagnosis or functional level? This is especially important in the context of a study involving only 14 participants across a broad age range, where individual differences may play a crucial role in the outcomes. Also, while the multi-stage recruitment strategy is well thought out, it relies heavily on therapist referrals and might not capture a diverse enough sample For this study, the focus is on a very specific cohort within the CP population. Due to the inclusion and exclusion criteria only children/ young people with good cognitive ability and no other co-morbidities that would impact on their ability to concentrate are eligible for this particular intervention. This was important as the intervention relies on the participants ability to problem solve and analyse their own movement patterns. In terms of the age range and different physical presentations within the eligible cohort the interviews will aim to capture where individual differences may impact on the outcomes. Ideally a larger cohort of participants would be preferred however the number had to be feasible within the constraints of this study’s particular timeline and resources. Also, due to Ireland’s population size, the number of eligible participants in the area that would be feasible to travel for this intervention would not be large. If a multi-centre design was being used in different locations, a larger number of participants would be more feasible and this is something we would consider for future work, with appropriate funding. In relation to the recruitment strategy, in Ireland, all children with a physical disability are linked to their local public team and will be known to their local therapist but advertisement of the study is being done through other avenues including CP advocacy groups to ensure all interested potential participants have an opportunity to engage with the research team, even if their therapist does not refer them directly. It is indicated that consent will be obtained. Both consent (from the guardian) and assent (from the child) should typically be obtained when conducting research with children, with the assent process tailored to the child's age and level of understanding Both assent and consent will be obtained. In the second to last paragraph under the subheading “recruitment strategy” where I discuss Informed consent procedure, I have added the information regarding participant assent also and have included a figshare link to the assent form in the extended data section The involvement of a young person and parent advisory group in shaping the intervention and providing input on session intensity, frequency, and mode of delivery enhances the relevance and acceptability of the intervention for the target population. However,more details on the advisory group consultation are needed, including the number of participants, the frequency of meetings, and the specific nature of their contributions. The paragraph discussing the PPI contributions in the intervention description section now contains more detail in relation to the young person and parent advisory group as suggested. It now describes how 5 young people aged 10 to 17 and 12 parents contributed to either a half-day in-person session or a 2 hour online session to discuss the intervention design and outcome measures. While the clinical outcome measures appear relevant, it would be useful to provide a brief rationale for their inclusion. Where the clinical outcome measures are listed I adjusted the phrasing for the 6 minute walk test, 10 metre self-selected speed walking test and the modified timed up and go test to explain that these three measures were selected due to their previous use in related studies and have either shown good correlation to physical activity levels which is important under the ICF guidelines or they have established MCIDs for this population which can give an indication as to whether any meaningful difference was achieved by the participants. I also added further description to rationalise using range of motion and quality of life measures which includes recognizing that contractures and surgical interventions are common in this population and quality of life measures can capture the overall impact an intervention has on an individual. Replication The protocol follows the SPIRIT guidelines, which is a well-established standard for clinical trials. This provides a solid framework for replication. The original SPIRIT 2013 guidelines have undergone updates and refinements in recent years. Have these more recent developments been taken into account in the preparation of this protocol? At the time of creating and publishing this protocol the SPIRIT 2013 checklist was the most up to date version and is referenced below the extended data section with a link to a figshare document. I have added “2013” in the study design section to highlight that this was the version used. The newest version SPIRIT 2025 was published this year and contains an extra open science section, requires more information regarding comparators and harms and a section on patient and public involvement. I have reviewed the newest checklist and the main changes that are relevant to my protocol are the open science section and the PPI section. I am confident that my protocol contains the information recommended by the 2025 guideline for both additional items on the checklist. More details on the categorization of participants in terms of age, GMFCS level, comorbidities, type of walking, and other relevant factors are needed. The inclusion and exclusion criteria outline the age range, GMFCS level and comorbidities that will be expected. Comorbidities such as any condition that impacts cognition and attention are excluded. In the data collection and analysis section I included, body distribution and gait aids used to provide more detail in terms of type of walking that will be described descriptively. I added rationale for not categorizing participants based off baseline characteristics for analysis due to the small sample size but state that the interviews will allow exploration of any challenges or experiences that may have been impacted by factors such as age or GMFCS level. I also added a paragraph to the intervention description describing how each session will be tailored to a participant based on the categories described by the reviewer. The intervention will be adapted to each child therefore there will be no specific tasks practiced based off a participant’s walking ability or age and therefore further categorization will not add any extra value. The intervention therapist will keep a reflexive diary to show how tasks were adapted based of these characteristics. The “ Fidelity of the Intervention Delivery ” section provides a clear overview of the actions taken to ensure consistent provision of the intervention across therapists. However, it is important to include more information on the therapist, its training and experience, and other relevant factors that may impact the delivery of the intervention. Further details have been provided on the fidelity assessor and intervention therapist in relation to experience level and training for both. This can be found under the subheading “fidelity of the intervention delivery” and describes the fidelity assessor as an occupational therapist with extensive experience in upper limb motor learning therapies and the interventionist as a physiotherapist with experience in supporting children with childhood onset disabilities with further training completed in upper limb motor learning interventions and certificate in a new online motor learning training platform. Rationale and objectives The introduction refers only to children with GMFCS levels I to III, but it is important to acknowledge that CP also includes children classified at levels IV and V. While these individuals are typically non-ambulant and may not be the primary focus of this study, briefly recognizing their existence and the broader spectrum of motor impairments within CP would provide a more complete overview of the condition. I have expanded the description of the GMFCS levels to include those at level IV and V as suggested. This description is at the end of paragraph one of the introduction and describes why levels I to III were chosen with the focus of the study targeting children who walk functionally with independence. I would consider explicitly articulating the specific gap this feasibility study aims to address—for example, the current lack of motor learning–based interventions specifically tailored to improve lower limb function in ambulant children with cerebral palsy. In the final paragraph of the introduction, before the aims, I describe the research currently published that includes concepts of motor learning theory to target walking which include task specificity, repetitive practice and provision of feedback. I have added a sentence that explicitly states the lack of motor learning-based interventions to target lower limbs for walking goals as correctly articulated by the reviewer. Also in response to reviewer two, more detail was added to introduction paragraphs four and five describing the interventions in the current evidence base which adds to the gap this study aims to address. Study Design CP is highly heterogeneous, with significant variability in severity and associated conditions. How can you account for these differences in your study design and methodology to ensure that your findings are applicable to all children with CP, regardless of their specific diagnosis or functional level? This is especially important in the context of a study involving only 14 participants across a broad age range, where individual differences may play a crucial role in the outcomes. Also, while the multi-stage recruitment strategy is well thought out, it relies heavily on therapist referrals and might not capture a diverse enough sample For this study, the focus is on a very specific cohort within the CP population. Due to the inclusion and exclusion criteria only children/ young people with good cognitive ability and no other co-morbidities that would impact on their ability to concentrate are eligible for this particular intervention. This was important as the intervention relies on the participants ability to problem solve and analyse their own movement patterns. In terms of the age range and different physical presentations within the eligible cohort the interviews will aim to capture where individual differences may impact on the outcomes. Ideally a larger cohort of participants would be preferred however the number had to be feasible within the constraints of this study’s particular timeline and resources. Also, due to Ireland’s population size, the number of eligible participants in the area that would be feasible to travel for this intervention would not be large. If a multi-centre design was being used in different locations, a larger number of participants would be more feasible and this is something we would consider for future work, with appropriate funding. In relation to the recruitment strategy, in Ireland, all children with a physical disability are linked to their local public team and will be known to their local therapist but advertisement of the study is being done through other avenues including CP advocacy groups to ensure all interested potential participants have an opportunity to engage with the research team, even if their therapist does not refer them directly. It is indicated that consent will be obtained. Both consent (from the guardian) and assent (from the child) should typically be obtained when conducting research with children, with the assent process tailored to the child's age and level of understanding Both assent and consent will be obtained. In the second to last paragraph under the subheading “recruitment strategy” where I discuss Informed consent procedure, I have added the information regarding participant assent also and have included a figshare link to the assent form in the extended data section The involvement of a young person and parent advisory group in shaping the intervention and providing input on session intensity, frequency, and mode of delivery enhances the relevance and acceptability of the intervention for the target population. However,more details on the advisory group consultation are needed, including the number of participants, the frequency of meetings, and the specific nature of their contributions. The paragraph discussing the PPI contributions in the intervention description section now contains more detail in relation to the young person and parent advisory group as suggested. It now describes how 5 young people aged 10 to 17 and 12 parents contributed to either a half-day in-person session or a 2 hour online session to discuss the intervention design and outcome measures. While the clinical outcome measures appear relevant, it would be useful to provide a brief rationale for their inclusion. Where the clinical outcome measures are listed I adjusted the phrasing for the 6 minute walk test, 10 metre self-selected speed walking test and the modified timed up and go test to explain that these three measures were selected due to their previous use in related studies and have either shown good correlation to physical activity levels which is important under the ICF guidelines or they have established MCIDs for this population which can give an indication as to whether any meaningful difference was achieved by the participants. I also added further description to rationalise using range of motion and quality of life measures which includes recognizing that contractures and surgical interventions are common in this population and quality of life measures can capture the overall impact an intervention has on an individual. Replication The protocol follows the SPIRIT guidelines, which is a well-established standard for clinical trials. This provides a solid framework for replication. The original SPIRIT 2013 guidelines have undergone updates and refinements in recent years. Have these more recent developments been taken into account in the preparation of this protocol? At the time of creating and publishing this protocol the SPIRIT 2013 checklist was the most up to date version and is referenced below the extended data section with a link to a figshare document. I have added “2013” in the study design section to highlight that this was the version used. The newest version SPIRIT 2025 was published this year and contains an extra open science section, requires more information regarding comparators and harms and a section on patient and public involvement. I have reviewed the newest checklist and the main changes that are relevant to my protocol are the open science section and the PPI section. I am confident that my protocol contains the information recommended by the 2025 guideline for both additional items on the checklist. More details on the categorization of participants in terms of age, GMFCS level, comorbidities, type of walking, and other relevant factors are needed. The inclusion and exclusion criteria outline the age range, GMFCS level and comorbidities that will be expected. Comorbidities such as any condition that impacts cognition and attention are excluded. In the data collection and analysis section I included, body distribution and gait aids used to provide more detail in terms of type of walking that will be described descriptively. I added rationale for not categorizing participants based off baseline characteristics for analysis due to the small sample size but state that the interviews will allow exploration of any challenges or experiences that may have been impacted by factors such as age or GMFCS level. I also added a paragraph to the intervention description describing how each session will be tailored to a participant based on the categories described by the reviewer. The intervention will be adapted to each child therefore there will be no specific tasks practiced based off a participant’s walking ability or age and therefore further categorization will not add any extra value. The intervention therapist will keep a reflexive diary to show how tasks were adapted based of these characteristics. The “ Fidelity of the Intervention Delivery ” section provides a clear overview of the actions taken to ensure consistent provision of the intervention across therapists. However, it is important to include more information on the therapist, its training and experience, and other relevant factors that may impact the delivery of the intervention. Further details have been provided on the fidelity assessor and intervention therapist in relation to experience level and training for both. This can be found under the subheading “fidelity of the intervention delivery” and describes the fidelity assessor as an occupational therapist with extensive experience in upper limb motor learning therapies and the interventionist as a physiotherapist with experience in supporting children with childhood onset disabilities with further training completed in upper limb motor learning interventions and certificate in a new online motor learning training platform. Competing Interests: None to declare. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 29 Jan 2026 Caitríona O'Shaughnessy , Physiotherapy, CP Life Research Centre, Royal College of Surgeons in Ireland, Dublin, D02YN77, Ireland 29 Jan 2026 Author Response Rationale and objectives The introduction refers only to children with GMFCS levels I to III, but it is important to acknowledge that CP also includes children classified at ... Continue reading Rationale and objectives The introduction refers only to children with GMFCS levels I to III, but it is important to acknowledge that CP also includes children classified at levels IV and V. While these individuals are typically non-ambulant and may not be the primary focus of this study, briefly recognizing their existence and the broader spectrum of motor impairments within CP would provide a more complete overview of the condition. I have expanded the description of the GMFCS levels to include those at level IV and V as suggested. This description is at the end of paragraph one of the introduction and describes why levels I to III were chosen with the focus of the study targeting children who walk functionally with independence. I would consider explicitly articulating the specific gap this feasibility study aims to address—for example, the current lack of motor learning–based interventions specifically tailored to improve lower limb function in ambulant children with cerebral palsy. In the final paragraph of the introduction, before the aims, I describe the research currently published that includes concepts of motor learning theory to target walking which include task specificity, repetitive practice and provision of feedback. I have added a sentence that explicitly states the lack of motor learning-based interventions to target lower limbs for walking goals as correctly articulated by the reviewer. Also in response to reviewer two, more detail was added to introduction paragraphs four and five describing the interventions in the current evidence base which adds to the gap this study aims to address. Study Design CP is highly heterogeneous, with significant variability in severity and associated conditions. How can you account for these differences in your study design and methodology to ensure that your findings are applicable to all children with CP, regardless of their specific diagnosis or functional level? This is especially important in the context of a study involving only 14 participants across a broad age range, where individual differences may play a crucial role in the outcomes. Also, while the multi-stage recruitment strategy is well thought out, it relies heavily on therapist referrals and might not capture a diverse enough sample For this study, the focus is on a very specific cohort within the CP population. Due to the inclusion and exclusion criteria only children/ young people with good cognitive ability and no other co-morbidities that would impact on their ability to concentrate are eligible for this particular intervention. This was important as the intervention relies on the participants ability to problem solve and analyse their own movement patterns. In terms of the age range and different physical presentations within the eligible cohort the interviews will aim to capture where individual differences may impact on the outcomes. Ideally a larger cohort of participants would be preferred however the number had to be feasible within the constraints of this study’s particular timeline and resources. Also, due to Ireland’s population size, the number of eligible participants in the area that would be feasible to travel for this intervention would not be large. If a multi-centre design was being used in different locations, a larger number of participants would be more feasible and this is something we would consider for future work, with appropriate funding. In relation to the recruitment strategy, in Ireland, all children with a physical disability are linked to their local public team and will be known to their local therapist but advertisement of the study is being done through other avenues including CP advocacy groups to ensure all interested potential participants have an opportunity to engage with the research team, even if their therapist does not refer them directly. It is indicated that consent will be obtained. Both consent (from the guardian) and assent (from the child) should typically be obtained when conducting research with children, with the assent process tailored to the child's age and level of understanding Both assent and consent will be obtained. In the second to last paragraph under the subheading “recruitment strategy” where I discuss Informed consent procedure, I have added the information regarding participant assent also and have included a figshare link to the assent form in the extended data section The involvement of a young person and parent advisory group in shaping the intervention and providing input on session intensity, frequency, and mode of delivery enhances the relevance and acceptability of the intervention for the target population. However,more details on the advisory group consultation are needed, including the number of participants, the frequency of meetings, and the specific nature of their contributions. The paragraph discussing the PPI contributions in the intervention description section now contains more detail in relation to the young person and parent advisory group as suggested. It now describes how 5 young people aged 10 to 17 and 12 parents contributed to either a half-day in-person session or a 2 hour online session to discuss the intervention design and outcome measures. While the clinical outcome measures appear relevant, it would be useful to provide a brief rationale for their inclusion. Where the clinical outcome measures are listed I adjusted the phrasing for the 6 minute walk test, 10 metre self-selected speed walking test and the modified timed up and go test to explain that these three measures were selected due to their previous use in related studies and have either shown good correlation to physical activity levels which is important under the ICF guidelines or they have established MCIDs for this population which can give an indication as to whether any meaningful difference was achieved by the participants. I also added further description to rationalise using range of motion and quality of life measures which includes recognizing that contractures and surgical interventions are common in this population and quality of life measures can capture the overall impact an intervention has on an individual. Replication The protocol follows the SPIRIT guidelines, which is a well-established standard for clinical trials. This provides a solid framework for replication. The original SPIRIT 2013 guidelines have undergone updates and refinements in recent years. Have these more recent developments been taken into account in the preparation of this protocol? At the time of creating and publishing this protocol the SPIRIT 2013 checklist was the most up to date version and is referenced below the extended data section with a link to a figshare document. I have added “2013” in the study design section to highlight that this was the version used. The newest version SPIRIT 2025 was published this year and contains an extra open science section, requires more information regarding comparators and harms and a section on patient and public involvement. I have reviewed the newest checklist and the main changes that are relevant to my protocol are the open science section and the PPI section. I am confident that my protocol contains the information recommended by the 2025 guideline for both additional items on the checklist. More details on the categorization of participants in terms of age, GMFCS level, comorbidities, type of walking, and other relevant factors are needed. The inclusion and exclusion criteria outline the age range, GMFCS level and comorbidities that will be expected. Comorbidities such as any condition that impacts cognition and attention are excluded. In the data collection and analysis section I included, body distribution and gait aids used to provide more detail in terms of type of walking that will be described descriptively. I added rationale for not categorizing participants based off baseline characteristics for analysis due to the small sample size but state that the interviews will allow exploration of any challenges or experiences that may have been impacted by factors such as age or GMFCS level. I also added a paragraph to the intervention description describing how each session will be tailored to a participant based on the categories described by the reviewer. The intervention will be adapted to each child therefore there will be no specific tasks practiced based off a participant’s walking ability or age and therefore further categorization will not add any extra value. The intervention therapist will keep a reflexive diary to show how tasks were adapted based of these characteristics. The “ Fidelity of the Intervention Delivery ” section provides a clear overview of the actions taken to ensure consistent provision of the intervention across therapists. However, it is important to include more information on the therapist, its training and experience, and other relevant factors that may impact the delivery of the intervention. Further details have been provided on the fidelity assessor and intervention therapist in relation to experience level and training for both. This can be found under the subheading “fidelity of the intervention delivery” and describes the fidelity assessor as an occupational therapist with extensive experience in upper limb motor learning therapies and the interventionist as a physiotherapist with experience in supporting children with childhood onset disabilities with further training completed in upper limb motor learning interventions and certificate in a new online motor learning training platform. Rationale and objectives The introduction refers only to children with GMFCS levels I to III, but it is important to acknowledge that CP also includes children classified at levels IV and V. While these individuals are typically non-ambulant and may not be the primary focus of this study, briefly recognizing their existence and the broader spectrum of motor impairments within CP would provide a more complete overview of the condition. I have expanded the description of the GMFCS levels to include those at level IV and V as suggested. This description is at the end of paragraph one of the introduction and describes why levels I to III were chosen with the focus of the study targeting children who walk functionally with independence. I would consider explicitly articulating the specific gap this feasibility study aims to address—for example, the current lack of motor learning–based interventions specifically tailored to improve lower limb function in ambulant children with cerebral palsy. In the final paragraph of the introduction, before the aims, I describe the research currently published that includes concepts of motor learning theory to target walking which include task specificity, repetitive practice and provision of feedback. I have added a sentence that explicitly states the lack of motor learning-based interventions to target lower limbs for walking goals as correctly articulated by the reviewer. Also in response to reviewer two, more detail was added to introduction paragraphs four and five describing the interventions in the current evidence base which adds to the gap this study aims to address. Study Design CP is highly heterogeneous, with significant variability in severity and associated conditions. How can you account for these differences in your study design and methodology to ensure that your findings are applicable to all children with CP, regardless of their specific diagnosis or functional level? This is especially important in the context of a study involving only 14 participants across a broad age range, where individual differences may play a crucial role in the outcomes. Also, while the multi-stage recruitment strategy is well thought out, it relies heavily on therapist referrals and might not capture a diverse enough sample For this study, the focus is on a very specific cohort within the CP population. Due to the inclusion and exclusion criteria only children/ young people with good cognitive ability and no other co-morbidities that would impact on their ability to concentrate are eligible for this particular intervention. This was important as the intervention relies on the participants ability to problem solve and analyse their own movement patterns. In terms of the age range and different physical presentations within the eligible cohort the interviews will aim to capture where individual differences may impact on the outcomes. Ideally a larger cohort of participants would be preferred however the number had to be feasible within the constraints of this study’s particular timeline and resources. Also, due to Ireland’s population size, the number of eligible participants in the area that would be feasible to travel for this intervention would not be large. If a multi-centre design was being used in different locations, a larger number of participants would be more feasible and this is something we would consider for future work, with appropriate funding. In relation to the recruitment strategy, in Ireland, all children with a physical disability are linked to their local public team and will be known to their local therapist but advertisement of the study is being done through other avenues including CP advocacy groups to ensure all interested potential participants have an opportunity to engage with the research team, even if their therapist does not refer them directly. It is indicated that consent will be obtained. Both consent (from the guardian) and assent (from the child) should typically be obtained when conducting research with children, with the assent process tailored to the child's age and level of understanding Both assent and consent will be obtained. In the second to last paragraph under the subheading “recruitment strategy” where I discuss Informed consent procedure, I have added the information regarding participant assent also and have included a figshare link to the assent form in the extended data section The involvement of a young person and parent advisory group in shaping the intervention and providing input on session intensity, frequency, and mode of delivery enhances the relevance and acceptability of the intervention for the target population. However,more details on the advisory group consultation are needed, including the number of participants, the frequency of meetings, and the specific nature of their contributions. The paragraph discussing the PPI contributions in the intervention description section now contains more detail in relation to the young person and parent advisory group as suggested. It now describes how 5 young people aged 10 to 17 and 12 parents contributed to either a half-day in-person session or a 2 hour online session to discuss the intervention design and outcome measures. While the clinical outcome measures appear relevant, it would be useful to provide a brief rationale for their inclusion. Where the clinical outcome measures are listed I adjusted the phrasing for the 6 minute walk test, 10 metre self-selected speed walking test and the modified timed up and go test to explain that these three measures were selected due to their previous use in related studies and have either shown good correlation to physical activity levels which is important under the ICF guidelines or they have established MCIDs for this population which can give an indication as to whether any meaningful difference was achieved by the participants. I also added further description to rationalise using range of motion and quality of life measures which includes recognizing that contractures and surgical interventions are common in this population and quality of life measures can capture the overall impact an intervention has on an individual. Replication The protocol follows the SPIRIT guidelines, which is a well-established standard for clinical trials. This provides a solid framework for replication. The original SPIRIT 2013 guidelines have undergone updates and refinements in recent years. Have these more recent developments been taken into account in the preparation of this protocol? At the time of creating and publishing this protocol the SPIRIT 2013 checklist was the most up to date version and is referenced below the extended data section with a link to a figshare document. I have added “2013” in the study design section to highlight that this was the version used. The newest version SPIRIT 2025 was published this year and contains an extra open science section, requires more information regarding comparators and harms and a section on patient and public involvement. I have reviewed the newest checklist and the main changes that are relevant to my protocol are the open science section and the PPI section. I am confident that my protocol contains the information recommended by the 2025 guideline for both additional items on the checklist. More details on the categorization of participants in terms of age, GMFCS level, comorbidities, type of walking, and other relevant factors are needed. The inclusion and exclusion criteria outline the age range, GMFCS level and comorbidities that will be expected. Comorbidities such as any condition that impacts cognition and attention are excluded. In the data collection and analysis section I included, body distribution and gait aids used to provide more detail in terms of type of walking that will be described descriptively. I added rationale for not categorizing participants based off baseline characteristics for analysis due to the small sample size but state that the interviews will allow exploration of any challenges or experiences that may have been impacted by factors such as age or GMFCS level. I also added a paragraph to the intervention description describing how each session will be tailored to a participant based on the categories described by the reviewer. The intervention will be adapted to each child therefore there will be no specific tasks practiced based off a participant’s walking ability or age and therefore further categorization will not add any extra value. The intervention therapist will keep a reflexive diary to show how tasks were adapted based of these characteristics. The “ Fidelity of the Intervention Delivery ” section provides a clear overview of the actions taken to ensure consistent provision of the intervention across therapists. However, it is important to include more information on the therapist, its training and experience, and other relevant factors that may impact the delivery of the intervention. Further details have been provided on the fidelity assessor and intervention therapist in relation to experience level and training for both. This can be found under the subheading “fidelity of the intervention delivery” and describes the fidelity assessor as an occupational therapist with extensive experience in upper limb motor learning therapies and the interventionist as a physiotherapist with experience in supporting children with childhood onset disabilities with further training completed in upper limb motor learning interventions and certificate in a new online motor learning training platform. Competing Interests: None to declare. Close Report a concern COMMENT ON THIS REPORT Comments on this article Comments (0) Version 2 VERSION 2 PUBLISHED 04 Apr 2025 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 3 Version 2 (revision) 29 Jan 26 read read Version 1 04 Apr 25 read read Martin Lemay , Universite du Quebec a Montreal, Montreal, Canada Shoaib Waqas , University of Biological and Applied Sciences, Lahore, Pakistan Christopher J Newman , University of Lausanne, Lausanne, Switzerland Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2026 Newman C. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 24 Feb 2026 | for Version 2 Christopher J Newman , University of Lausanne, Lausanne, Switzerland 0 Views copyright © 2026 Newman C. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This protocol describes a pilot feasibility study of a gait oriented intervention for ambulant children with CP (GMFCS 1 to 3) based on motor-learning theories (I would avoid the singular "theory" in the text, since there is no unique motor learning theory, but the recent populae concept of "motor learning based approaches" in CP, melds a number of theoretical underpinnings). This protocol added to the full intervention protocol accessible via hypertext, provides clear and sufficient information, on what the research group plans to do and how the study will be performed. The sample size of 12 based on one of the numerous rules of thumb from the literature on pilot studies, is arguable (see e.g. Julious 2025), but will provide sufficient insight to move forward to potential larger scale studies. I would remove the divisibility criteria since it has no pertinence to the researcher current design (no subgroups or crossovers). Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable References 1. Julious S: Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics . 2005; 4 (4): 287-291 Publisher Full Text Competing Interests No competing interests were disclosed. Reviewer Expertise Child neurorehabilitation I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Newman CJ. Peer Review Report For: A "motor learning based intervention for lower extremities (MOBILE)" to target walking performance in ambulant children with cerebral palsy: A feasibility study. [version 1; peer review: 2 approved with reservations] . HRB Open Res 2025, 8 :46 ( https://doi.org/10.21956/hrbopenres.15751.r53254) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/8-46/v2#referee-response-53254 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2026 Lemay M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 30 Jan 2026 | for Version 2 Martin Lemay , Universite du Quebec a Montreal, Montreal, Québec, Canada 0 Views copyright © 2026 Lemay M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions I would like to thank the authors for carefully addressing my comments. I have two remaining concerns that I believe warrant further consideration. In your response to one of my comments, you mentioned that "This was important as the intervention relies on the participants' ability to problem solve and analyse their own movement patterns." I would recommend adding more details on this aspect, as it raises concerns that participants may rely on an internal focus of attention, which can be problematic, especially for a movement like walking that requires a certain level of automatization. For example, see this paper: Zorlular R, Akinci M, Elbasan B. Effects of focus of attention on gait parameters and balance performance in children with unilateral cerebral palsy: a randomized controlled trial. Disabil Rehabil. 2026;48(3):829-841. Concerning the 4th paragraph of the Introduction, while I agree that feedback is important, excessive feedback could be detrimental in some contexts, as participants might become overly reliant on it to perform the task. Therefore, it would be useful to discuss how often feedback will be provided in the intervention. For a detailed discussion on the frequency of feedback in motor learning in children with CP, see: Schoenmaker, J., Houdijk, H., Steenbergen, B., Reinders-Messelink, H. A., & Schoemaker, M. M. (2023). Effectiveness of different extrinsic feedback forms on motor learning in children with cerebral palsy: a systematic review. Disability and Rehabilitation, 45(8), 1271–1284. Competing Interests No competing interests were disclosed. Reviewer Expertise Cerebral palsy; Motor learning; Adapted physical activity; rehabilitation I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 04 Feb 2026 Caitríona O'Shaughnessy, Physiotherapy, CP Life Research Centre, Royal College of Surgeons in Ireland, Dublin, D02YN77, Ireland Thank you for your response and we are happy to further expand on your concerns. In relation to Concern 1: In your response to one of my comments, you mentioned that "This was important as the intervention relies on the participants' ability to problem solve and analyse their own movement patterns." I would recommend adding more details on this aspect, as it raises concerns that participants may rely on an internal focus of attention, which can be problematic, especially for a movement like walking that requires a certain level of automatization. For example, see this paper: Zorlular R, Akinci M, Elbasan B. Effects of focus of attention on gait parameters and balance performance in children with unilateral cerebral palsy: a randomized controlled trial. Disabil Rehabil. 2026;48(3):829-841. Response: We agree that an internal focus of attention can be problematic if relied upon excessively. While the statement that “a participant’s ability to problem solve and analyse their own movement patterns” could imply that internal focus of attention may be used, this is not the case as planned for this intervention. As you will see in the first paragraph of the intervention description, we state that the intervention “considers factors such as stage of motor skill acquisition, environment, feedback and types of practice”. In the full description of the intervention protocol listed in the extended data https://doi.org/10.6084/m9.figshare.28524788.v1 we provide a full list of the available strategies to be implemented. Strategies that rely on problem solving and analysing their own movement could include ability to develop one’s own goal, participate in repetitive practice, dual-task practice, imagery practice, self-talk instructions, self-evaluation instructions, bridging settings and external focus of attention, to name a few. This is a complex intervention that has many options of strategies that can be used depending on the participant’s level of skill acquisition, understanding, ability level and motivation and will be tailored by the interventionist. Concern 2: Concerning the 4th paragraph of the Introduction, while I agree that feedback is important, excessive feedback could be detrimental in some contexts, as participants might become overly reliant on it to perform the task. Therefore, it would be useful to discuss how often feedback will be provided in the intervention. For a detailed discussion on the frequency of feedback in motor learning in children with CP, see: Schoenmaker, J., Houdijk, H., Steenbergen, B., Reinders-Messelink, H. A., & Schoemaker, M. M. (2023). Effectiveness of different extrinsic feedback forms on motor learning in children with cerebral palsy: a systematic review. Disability and Rehabilitation, 45(8), 1271–1284. Response: We agree that the balance of feedback is important and have addressed this in detail in the full protocol, appended to this article as extended data https://doi.org/10.6084/m9.figshare.28524788.v1 . Under Principle 3: Type of Feedback, there are 9 different elements that are considered and within these 9 elements there are 33 different strategies that can be implemented as part of this intervention. As described above, this is a complex intervention that will be tailored to the individual based on their stage of skill acquisition and development. The scope of feedback strategies available allow for different modes of delivery, different frequencies, different timings of delivery, the nature of the feedback and the content which, will be modified and changed as the participant progresses through the study. Initially they may require error limitation and frequent feedback to ensure success and increase motivation. However, as they progress in their skill development feedback can be reduced, withdrawn or self-feedback encouraged. Under the frequency element there are options for continuous feedback, faded feedback, summary feedback or bandwidth corrective feedback which can be used when the interventionist determines that this approach best suits that participant’s stage of skill development. As this is a feasibility trial, it was important to include all available options for motor learning strategies and it is one of the aims of this study that the qualitative analysis of the interventionists reflective diary will provide insight into which strategies were used more frequently and why they were chosen. This will hopefully allow for refinement of the protocol to allow easier training of other interventionists in the future. In response to both concerns we hope that direction towards the more detailed protocol for the intervention satisfies. Due to space constraints in the main manuscript, it was not possible to provide a full description of all the strategies that could be utilized. View more View less Competing Interests No competing interests reply Respond Report a concern Lemay M. Peer Review Report For: A "motor learning based intervention for lower extremities (MOBILE)" to target walking performance in ambulant children with cerebral palsy: A feasibility study. [version 1; peer review: 2 approved with reservations] . HRB Open Res 2025, 8 :46 ( https://doi.org/10.21956/hrbopenres.15751.r53173) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/8-46/v2#referee-response-53173 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Waqas S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 15 May 2025 | for Version 1 Shoaib Waqas , University of Biological and Applied Sciences, Lahore, Pakistan 0 Views copyright © 2025 Waqas S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Abstract Could you Please include a brief mention of the theoretical framework (Motor Learning Theory) in the abstract for clarity. Introduction Clarify the novelty of MOBILE compared to existing MLT interventions (e.g., how it differs from treadmill training or upper-limb MLT approaches). Briefly define "feasibility" and "acceptability" as per Sekhon’s framework (cited in methods) to align with objectives. Methods Intervention : Provide more detail on the "tailored" components (e.g., examples of walking goals or feedback strategies). Data Analysis : Clarify how MCIDs will inform future RCT power calculations (e.g., GOAL as primary outcome). Discussion Expand on how findings will directly inform RCT design (e.g., sample size, intervention refinements). Discuss potential barriers to adherence (e.g., family capacity) and mitigation strategies. Mention data anonymization/storage details (though covered in extended data). Protocol Version Control Link version changes to specific limitations (e.g., expanded recruitment to address sample diversity). Overall Recommendations Clarify Novelty : Differentiate MOBILE from existing MLT interventions (e.g., task-specificity for walking vs. upper limb). Strengthen Feasibility Metrics : Explicitly link recruitment targets (n=14) to progression criteria for RCT (e.g., ≥80% adherence). Expand Intervention Details : Provide examples of motor learning strategies (e.g., feedback types, task modification). Highlight PPI Impact : Show how advisory groups shaped intervention design (e.g., clinic vs. home preference. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Pediatric Physical Therapy I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 29 Jan 2026 Caitríona O'Shaughnessy, Physiotherapy, CP Life Research Centre, Royal College of Surgeons in Ireland, Dublin, D02YN77, Ireland Abstract Could you Please include a brief mention of the theoretical framework (Motor Learning Theory) in the abstract for clarity. We agree it is important to mention Motor Learning Theory. We added a brief description that MLT encompasses multiple concepts that shape our understanding of how motor skills are acquired and developed. Introduction Clarify the novelty of MOBILE compared to existing MLT interventions (e.g., how it differs from treadmill training or upper-limb MLT approaches). The novelty and need for MOBILE is explained in three main points. RAGT and treadmill training, while having one or two elements that are known to influence motor learning, were not designed specifically to target motor learning (Introduction, fourth paragraph). Upper limb and gross motor MLT approaches do not specifically focus on lower limbs or walking as the target (Introduction, paragraph 5) There is currently a lack of interventions designed using MLT that specifically target walking as a motor skill (Introduction, final paragraph). Briefly define "feasibility" and "acceptability" as per Sekhon’s framework (cited in methods) to align with objectives. Definitions of feasibility and acceptability have been added to the section preceding the objectives as suggested. Methods Intervention: Provide more detail on the "tailored" components (e.g., examples of walking goals or feedback strategies). Three new paragraphs (paragraphs 4-6) have been added to the intervention section providing more detail on the tailored components of the intervention. Some examples of walking goals, feedback strategies and other factors are provided. It has also been added that the intervention therapist will keep a reflective diary throughout which will document how each session developed and why tasks were chosen. This will serve as the basis for developing an instruction manual for other therapists wishing to replicate the intervention. Data Analysis: Clarify how MCIDs will inform future RCT power calculations (e.g., GOAL as primary outcome). We have expanded the final paragraph of the data analysis subsection to clarify that MCIDs are only being used to estimate a potential effect in the two measures where there are established MCIDs for this population. The GOAL was selected as the primary clinical outcome measure by the PPI advisory group as it was the most meaningful measure to them. There currently are no established MCIDs for the GOAL therefore a power calculation will be done on the data collected for the total GOAL score. Discussion Expand on how findings will directly inform RCT design (e.g., sample size, intervention refinements). The third and fourth paragraphs of the discussion section have been expanded to provide more detail on how the results will inform an RCT design including (1) potential need for a multi-centre design will be judged on time for recruitment and geographical spread, (2) balance of clinic and home-based programs will be judged on qualitative feedback from interviews and adherence rates and (3) intensity and frequency or other intervention design refinements will be considered based on qualitative analysis from the interviews and feasibility metrics A fifth paragraph has been added to further discuss how the information collected by the interventionist will help to refine the intervention manual. Discuss potential barriers to adherence (e.g., family capacity) and mitigation strategies. The second paragraph of the discussion has been expanded to discuss potential barriers to adherence and mitigating strategies. Briefly, these include participant fatigue or competing demands with school or hobbies, balancing appointments and home programs with other family demands, and physical fatigue or muscle soreness. Rest breaks will be given as needed, appointments will be scheduled to suit families as best possible and home programs will be simple and incorporated into their hobbies or other activities where possible. Mention data anonymization/storage details (though covered in extended data). Brief mention of anonymisation and storage has been added to the first paragraph of the “data collection and analysis” subsection, which now explains that anonymised data will be uploaded to a secure SharePoint folder. We also direct readers to our data management plan under extended data. Protocol Version Control Link version changes to specific limitations (e.g., expanded recruitment to address sample diversity). Linked version change 1.2.1 expansion of recruitment strategy to address more diversity in sample size as suggested. Other changes were due to new evidence emerging or feedback from PPI groups rather than limitations prompting changes. Overall Recommendations 1. Clarify Novelty: Differentiate MOBILE from existing MLT interventions (e.g., task-specificity for walking vs. upper limb). Addressed above in the introduction. 2. Strengthen Feasibility Metrics: Explicitly link recruitment targets (n=14) to progression criteria for RCT (e.g., ≥80% adherence). Specific feasibility metrics for progression were not included for this study as there will likely be many refinements and adjustments to the protocol based on an integrated analysis of the quantitative and qualitative data collected. This is described in an addition to the first line under “Feasibility of Study Design” in the Outcome section of the methodology, It is also added that PPI groups will be involved in the decision-making process around recommendations on progression to RCT. 3. Expand Intervention Details: Provide examples of motor learning strategies (e.g., feedback types, task modification). Addressed above in detail. 4. Highlight PPI Impact: Show how advisory groups shaped intervention design (e.g., clinic vs. home preference. More detail was added to the PPI paragraph and are highlighted in the comments to reviewer 1. View more View less Competing Interests None to declare reply Respond Report a concern Waqas S. Peer Review Report For: A "motor learning based intervention for lower extremities (MOBILE)" to target walking performance in ambulant children with cerebral palsy: A feasibility study. [version 1; peer review: 2 approved with reservations] . HRB Open Res 2025, 8 :46 ( https://doi.org/10.21956/hrbopenres.15494.r47068) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/8-46/v1#referee-response-47068 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Lemay M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 08 May 2025 | for Version 1 Martin Lemay , Universite du Quebec a Montreal, Montreal, Québec, Canada 0 Views copyright © 2025 Lemay M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This single-arm feasibility trial evaluates the MOBILE intervention to improve walking in children with cerebral palsy aged 6-17 (GMFCS Levels I-III). Participants will receive 14-30 hours of therapy over 6 weeks, targeting self-selected walking goals using motor learning principles. Feasibility outcomes like recruitment, adherence, and retention will be assessed, along with clinical outcomes such as gait endurance, mobility, and quality of life. The study incorporates patient and public involvement (PPI) to ensure the intervention meets participants' needs. This well-thought-out protocol, however, relies on a relatively small sample size and should better consider the heterogeneity of CP. Rationale and objectives The introduction refers only to children with GMFCS levels I to III, but it is important to acknowledge that CP also includes children classified at levels IV and V. While these individuals are typically non-ambulant and may not be the primary focus of this study, briefly recognizing their existence and the broader spectrum of motor impairments within CP would provide a more complete overview of the condition. I would consider explicitly articulating the specific gap this feasibility study aims to address—for example, the current lack of motor learning–based interventions specifically tailored to improve lower limb function in ambulant children with cerebral palsy. The study objectives are clearly articulated and appropriate for a feasibility study. They effectively lay the groundwork for a future investigation into the efficacy of the MOBILE intervention. Study design CP is highly heterogeneous, with significant variability in severity and associated conditions. How can you account for these differences in your study design and methodology to ensure that your findings are applicable to all children with CP, regardless of their specific diagnosis or functional level? This is especially important in the context of a study involving only 14 participants across a broad age range, where individual differences may play a crucial role in the outcomes. Also, while the multi-stage recruitment strategy is well thought out, it relies heavily on therapist referrals and might not capture a diverse enough sample. It is indicated that consent will be obtained. Both consent (from the guardian) and assent (from the child) should typically be obtained when conducting research with children, with the assent process tailored to the child's age and level of understanding The rationale for the chosen dose of the intervention is well-justified The involvement of a young person and parent advisory group in shaping the intervention and providing input on session intensity, frequency, and mode of delivery enhances the relevance and acceptability of the intervention for the target population. However,more details on the advisory group consultation are needed, including the number of participants, the frequency of meetings, and the specific nature of their contributions. While the clinical outcome measures appear relevant, it would be useful to provide a brief rationale for their inclusion. Replication The protocol follows the SPIRIT guidelines, which is a well-established standard for clinical trials. This provides a solid framework for replication. The original SPIRIT 2013 guidelines have undergone updates and refinements in recent years. Have these more recent developments been taken into account in the preparation of this protocol? More details on the categorization of participants in terms of age, GMFCS level, comorbidities, type of walking, and other relevant factors are needed. The “ Fidelity of the Intervention Delivery ” section provides a clear overview of the actions taken to ensure consistent provision of the intervention across therapists. However, it is important to include more information on the therapist, its training and experience, and other relevant factors that may impact the delivery of the intervention. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Cerebral palsy; Motor learning; Adapted physical activity; rehabilitation I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 29 Jan 2026 Caitríona O'Shaughnessy, Physiotherapy, CP Life Research Centre, Royal College of Surgeons in Ireland, Dublin, D02YN77, Ireland Rationale and objectives The introduction refers only to children with GMFCS levels I to III, but it is important to acknowledge that CP also includes children classified at levels IV and V. While these individuals are typically non-ambulant and may not be the primary focus of this study, briefly recognizing their existence and the broader spectrum of motor impairments within CP would provide a more complete overview of the condition. I have expanded the description of the GMFCS levels to include those at level IV and V as suggested. This description is at the end of paragraph one of the introduction and describes why levels I to III were chosen with the focus of the study targeting children who walk functionally with independence. I would consider explicitly articulating the specific gap this feasibility study aims to address—for example, the current lack of motor learning–based interventions specifically tailored to improve lower limb function in ambulant children with cerebral palsy. In the final paragraph of the introduction, before the aims, I describe the research currently published that includes concepts of motor learning theory to target walking which include task specificity, repetitive practice and provision of feedback. I have added a sentence that explicitly states the lack of motor learning-based interventions to target lower limbs for walking goals as correctly articulated by the reviewer. Also in response to reviewer two, more detail was added to introduction paragraphs four and five describing the interventions in the current evidence base which adds to the gap this study aims to address. Study Design CP is highly heterogeneous, with significant variability in severity and associated conditions. How can you account for these differences in your study design and methodology to ensure that your findings are applicable to all children with CP, regardless of their specific diagnosis or functional level? This is especially important in the context of a study involving only 14 participants across a broad age range, where individual differences may play a crucial role in the outcomes. Also, while the multi-stage recruitment strategy is well thought out, it relies heavily on therapist referrals and might not capture a diverse enough sample For this study, the focus is on a very specific cohort within the CP population. Due to the inclusion and exclusion criteria only children/ young people with good cognitive ability and no other co-morbidities that would impact on their ability to concentrate are eligible for this particular intervention. This was important as the intervention relies on the participants ability to problem solve and analyse their own movement patterns. In terms of the age range and different physical presentations within the eligible cohort the interviews will aim to capture where individual differences may impact on the outcomes. Ideally a larger cohort of participants would be preferred however the number had to be feasible within the constraints of this study’s particular timeline and resources. Also, due to Ireland’s population size, the number of eligible participants in the area that would be feasible to travel for this intervention would not be large. If a multi-centre design was being used in different locations, a larger number of participants would be more feasible and this is something we would consider for future work, with appropriate funding. In relation to the recruitment strategy, in Ireland, all children with a physical disability are linked to their local public team and will be known to their local therapist but advertisement of the study is being done through other avenues including CP advocacy groups to ensure all interested potential participants have an opportunity to engage with the research team, even if their therapist does not refer them directly. It is indicated that consent will be obtained. Both consent (from the guardian) and assent (from the child) should typically be obtained when conducting research with children, with the assent process tailored to the child's age and level of understanding Both assent and consent will be obtained. In the second to last paragraph under the subheading “recruitment strategy” where I discuss Informed consent procedure, I have added the information regarding participant assent also and have included a figshare link to the assent form in the extended data section The involvement of a young person and parent advisory group in shaping the intervention and providing input on session intensity, frequency, and mode of delivery enhances the relevance and acceptability of the intervention for the target population. However,more details on the advisory group consultation are needed, including the number of participants, the frequency of meetings, and the specific nature of their contributions. The paragraph discussing the PPI contributions in the intervention description section now contains more detail in relation to the young person and parent advisory group as suggested. It now describes how 5 young people aged 10 to 17 and 12 parents contributed to either a half-day in-person session or a 2 hour online session to discuss the intervention design and outcome measures. While the clinical outcome measures appear relevant, it would be useful to provide a brief rationale for their inclusion. Where the clinical outcome measures are listed I adjusted the phrasing for the 6 minute walk test, 10 metre self-selected speed walking test and the modified timed up and go test to explain that these three measures were selected due to their previous use in related studies and have either shown good correlation to physical activity levels which is important under the ICF guidelines or they have established MCIDs for this population which can give an indication as to whether any meaningful difference was achieved by the participants. I also added further description to rationalise using range of motion and quality of life measures which includes recognizing that contractures and surgical interventions are common in this population and quality of life measures can capture the overall impact an intervention has on an individual. Replication The protocol follows the SPIRIT guidelines, which is a well-established standard for clinical trials. This provides a solid framework for replication. The original SPIRIT 2013 guidelines have undergone updates and refinements in recent years. Have these more recent developments been taken into account in the preparation of this protocol? At the time of creating and publishing this protocol the SPIRIT 2013 checklist was the most up to date version and is referenced below the extended data section with a link to a figshare document. I have added “2013” in the study design section to highlight that this was the version used. The newest version SPIRIT 2025 was published this year and contains an extra open science section, requires more information regarding comparators and harms and a section on patient and public involvement. I have reviewed the newest checklist and the main changes that are relevant to my protocol are the open science section and the PPI section. I am confident that my protocol contains the information recommended by the 2025 guideline for both additional items on the checklist. More details on the categorization of participants in terms of age, GMFCS level, comorbidities, type of walking, and other relevant factors are needed. The inclusion and exclusion criteria outline the age range, GMFCS level and comorbidities that will be expected. Comorbidities such as any condition that impacts cognition and attention are excluded. In the data collection and analysis section I included, body distribution and gait aids used to provide more detail in terms of type of walking that will be described descriptively. I added rationale for not categorizing participants based off baseline characteristics for analysis due to the small sample size but state that the interviews will allow exploration of any challenges or experiences that may have been impacted by factors such as age or GMFCS level. I also added a paragraph to the intervention description describing how each session will be tailored to a participant based on the categories described by the reviewer. The intervention will be adapted to each child therefore there will be no specific tasks practiced based off a participant’s walking ability or age and therefore further categorization will not add any extra value. The intervention therapist will keep a reflexive diary to show how tasks were adapted based of these characteristics. The “ Fidelity of the Intervention Delivery ” section provides a clear overview of the actions taken to ensure consistent provision of the intervention across therapists. However, it is important to include more information on the therapist, its training and experience, and other relevant factors that may impact the delivery of the intervention. Further details have been provided on the fidelity assessor and intervention therapist in relation to experience level and training for both. This can be found under the subheading “fidelity of the intervention delivery” and describes the fidelity assessor as an occupational therapist with extensive experience in upper limb motor learning therapies and the interventionist as a physiotherapist with experience in supporting children with childhood onset disabilities with further training completed in upper limb motor learning interventions and certificate in a new online motor learning training platform. View more View less Competing Interests None to declare. reply Respond Report a concern Lemay M. Peer Review Report For: A "motor learning based intervention for lower extremities (MOBILE)" to target walking performance in ambulant children with cerebral palsy: A feasibility study. [version 1; peer review: 2 approved with reservations] . HRB Open Res 2025, 8 :46 ( https://doi.org/10.21956/hrbopenres.15494.r46650) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/8-46/v1#referee-response-46650 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. 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