Usability and Feasibility of Myosuit-Assisted Gait Rehabilitation Training in Neurological Patients

Usability and Feasibility of Myosuit-Assisted Gait Rehabilitation Training in Neurological Patients | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Usability and Feasibility of Myosuit-Assisted Gait Rehabilitation Training in Neurological Patients Carmel E. Tulen, Jens C. Möller, Detlef Marks, Adriana Mohap, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8360563/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Lightweight, wearable robots such as the Myosuit are promising tools for inpatient gait rehabilitation and may facilitate transition of gait training to the home environment. Evidence on their usability and feasibility in both settings is limited. This study examined the safety, usability, and feasibility of Myosuit-based gait training in neurological inpatients, with attention to potential home-based training applications. Methods This interventional, open-label, non-randomized study involved inpatients with neurological gait disorders, all first-time Myosuit users. The program, additional to routine rehabilitation, comprised eight 45-minute training sessions over four weeks. Safety was monitored via adverse events/side effects. Usability was assessed with the System Usability Scale (SUS) and the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE). Feasibility measures included recruitment, attrition, and adherence rates, independent use, and motivation. Secondary outcomes were the Functional Ambulation Category (FAC), 10-meter Walk Test, 6-minute Walk Test, and de Morton Mobility Index (DEMMI). Results Fifteen patients enrolled; ten completed the study. Adherence averaged 77.5%. No adverse events occurred. Usability was rated marginally acceptable by patients (SUS 60.77 ± 13.17; USE 4.53 ± 0.76) and therapists (SUS 65.83 ± 15.30; USE 4.87 ± 0.89). Once the device was donned, patients were able to perform all tasks with at least supervision but always required physical assistance for donning. All ten completers recommended Myosuit for clinical use; five would consider home use, typically conditional on disease progression and specific functional needs. All six therapists recommended it; five saw home potential if simplified. FAC and DEMMI improved significantly. Conclusion Myosuit-based gait training appears safe, feasible, and usable for neurological inpatients under supervision, with functional gains observed when it is combined with usual care. The need for physical assistance was concentrated in donning, suggesting that this should be performed by a therapist or at home by a trained caregiver. These findings support a hybrid home-rehabilitation model in which patients begin training in clinic and, after initial learning and adjustments, continue training regularly with caregiver assistance, complemented by periodic therapist oversight (for example, once or twice weekly) to adapt therapy, troubleshoot and ensure safety. This approach can help optimize clinical resources, sustain engagement and expand access to intensive gait rehabilitation beyond the clinic. Trial registration This study was registered under ClinicalTrials.gov (Identifier NCT05485597) Myosuit neurological conditions walking impairment gait training usability feasibility efficacy Figures Figure 1 Figure 2 Background Neurological disorders are the leading cause of long-term disability in adults worldwide and have significant impact on the lives of both patients and their families [ 1 ]. For instance, most individuals with a neurological disorder that live at home face substantial movement disorders and mobility limitations, making it impossible for them to walk quickly or far enough to cross the street, and in severe cases, preventing them from leaving the house at all [ 2 ]. These severe mobility restrictions hinder social (re)integration and limit participation in society, resulting in a significantly reduced health-related quality of life (HRQL) for many individuals [ 3 ]. In contrast, engaging in daily physical activity (PA) after stroke is associated with better HRQL [ 4 ]. Additionally, mobility limitations also lead to sedentary behavior, which is concerning as it causes comorbidities and further physical and mental decline. To prevent inactivity-related decline and improve mood and quality of life, promoting activities in the home setting is essential for this population. However, existing organized activities, such as primary care physical therapy, are often insufficient; many patients lack third-party assistance (e.g., for transportation, guidance, financial resources, or local availability) [ 5 , 6 ]. Additionally, rehabilitation centers frequently provide little support for patients’ needs at home. There is a lack of collaborative healthcare system support and inequities in rehabilitation structures [ 7 ]. Given that millions of people are affected by neurological disorders each year—with high disease burdens, enormous healthcare costs related to inactivity, and a growing shortage of healthcare providers—it is necessary to improve rehabilitation efficiency and offer patients better mobility equipment and therapy services, especially in outpatient and home settings [ 8 ]. Commercial lightweight wearable robots, also known as “exosuits”, “exomuscles” or “dermoskeleton’’, such as the Myosuit, the ReWalk ReStore™ or Keeogo, show promise in enhancing rehabilitation and preventing inactivity at home. Studies have demonstrated their safety and reliability in clinical and home settings [ 9 , 10 ], as well as their potential to serve as assistive devices both indoors and outdoors [ 11 ], improve mobility, and aid in daily activities [ 12 ]. Integrating such robots into home rehabilitation could offer new physical activity options, improve walking abilities, and foster independence [ 10 , 13 ]. Additionally, using the robot in a familiar environment can help establish habits that lead to long-term behavioral changes in movement, which in turn can prevent sedentary behavior and improve clinical functional outcomes [ 14 ]. However, the use of these devices currently faces several challenges—there is still limited evidence regarding the acceptance and feasibility of devices like the Myosuit as part of a rehabilitation program in both clinical and home settings. Factors such as the patient’s medical condition, physical limitations, cognitive abilities, and attitudes toward robot-assisted therapy—particularly among older patients and their therapists—play a significant role and should be carefully considered [ 15 , 16 ]. The price of these devices and their adoption also limit clinical integration. Several studies highlight the need for further research to address these challenges and explore the potential integration of such devices into neurorehabilitation [ 13 , 17 ]. The aim of this study was to assess the usability and feasibility of this new form of therapy in the inpatient setting, and to gain insights into whether inpatients would be suitable for using the wearable robot ‘the Myosuit’ in domestic settings, and if so, under what conditions. We also measured functional assessments at the activity level of the ICF to gauge the effectiveness of the Myosuit gait training. To assess the effectiveness of wearable robots, studies often use standardized gait and mobility assessments such us the Functional Ambulatory Category (FAC), 10-meter Walk Test (10MWT), 6-minute-Walk Test (6MWT) and the De Morton Mobility Index (DEMMI) [ 18 – 21 ]. To the best of our knowledge, this is the first study to examine the usability, feasibility, and effects of gait training with the Myosuit in a neurological inpatient rehabilitation setting. Methods This paper presents the results of a gait rehabilitation program using the Myosuit, integrated into the inpatient rehabilitation program at the Neurological Rehabilitation Clinic, Rehaklinik Zihlschlacht (RZS). A. Study design This open-label, non-randomized, longitudinal, interventional study analyzed the safety, usability, and feasibility of gait training using the wearable robot 'Myosuit' in neurological inpatients with severe to moderate gait impairment. Usability was defined as participants' ability to successfully and safely use the Myosuit with a reasonable level of effort and satisfaction during gait training and/or goal achievement. Satisfaction encompassed user experience, enjoyment, comfort, and general contentment with the device. Feasibility assessed the viability/practicality of 'Myosuit-assisted training' in clinical and home environments. Particular emphasis was placed on assessing participants' ability to operate the device, as well as their motivation and willingness to participate in the intervention. B. Study participants and recruitment Fifteen inpatients from RZS with various neurological gait disorders were enrolled in this trial. All participants were enlisted by a certified physical therapist and took part in the study from November 2022 to November 2023. The patient selection criteria are presented in Table 1 . Written informed consent was obtained from all participants prior to the start of the study. All participants were first-time users of the Myosuit and each underwent the same study protocol. The study protocol was approved by the local Ethics Committee of East Switzerland (EKOS) and is registered at ClinicalTrials.gov (Identifier: NCT05485597). The study was conducted in accordance with the study protocol, the current version of the Declaration of Helsinki, ISO14155, ICH-GCP (as applicable), and the national laws and regulations of Switzerland. Furthermore, the study was subject to monitoring by ETH Zürich (Laboratory for Rehabilitation Technology). Table 1 Study eligibility criteria Inclusion criteria Exclusion criteria • Neurological inpatients at RZS with gait disorders • FAC score between 2 and 4 • Cognition as measured by the Mini Mental State Examination (MMSE) score above 17 points I • Subject is at least 18 years old • A height between 150 cm and 195 cm II • A weight between 45 to 110kg II • Parkinson's disease and Multiple sclerosis III • Neurological patients without gait disorders • Unstable cardiovascular and respiratory conditions • Functional Reach Test (FRT) < 15.24 cm II • 10MWT not possible with the assistance of a person • Major musculoskeletal conditions (e.g., rheumatoid arthritis), major limited lower extremity’s range of motion, orthopedic problems and/or significant lower extremity joint pain that could affect the application of the Myosuit • Significant lower limb contractures (knee flexion or hip flexion contracture of > 10°, Varus deformity > 10°, Valgus deformity > 10°) that could affect the application of the Myosuit • Skin integrity (on surfaces that would contact the device) • Significant osteoporosis (bone fragility) assessed by a medical doctor • Pregnancy • Incapacity to (safely) understand and/or follow instructions (e.g., aphasia, limited knowledge of German) • Incapacity to understand formal consent • Currently participating in other (internal) interventional studies I MMSE scores of 17 or below indicates severe cognitive impairment according to Tombaugh and McIntyre [ 22 ]. II The manufacturer’s guidelines contain overall restrictions for height and weight and other parameters such as FRT. III Individuals diagnosed with Parkinson’s disease and Multiple Sclerosis were excluded from the study, because they typically remain in RZS for only three to four weeks. In addition, due to changes in medication, the results may be unreliable particularly in PD patients. C. Wearable Robot The Myosuit (MyoSwiss AG, Zurich, Switzerland) utilized in this study is a lightweight, soft wearable robot that provides active support for knee and hip extension during the stance phase of the user’s gait cycle (Fig. 1 ). Motion sensors enable the Myosuit to internally regulate support by assessing the user's gait phase and ensuring that extension assistance is delivered at the appropriate time. The support level height can be individually and independently adjusted for each leg, providing a high degree of customization to suit the user’s preferences and needs. By facilitating this crucial gait function, the Myosuit aids the user in carrying out daily activities such as walking, standing, sitting transfers, and stair climbing. The system has a total weight of 5.5kg. The Myosuit is CE-Certified [ 23 ]. The price of the device is approximately 11,000 EUR, depending on the license and additional features. This is significantly lower than other soft exosuits for the lower limb, which can cost at least 30,000 EUR [ 24 ]. D. Intervention During a four-week period, each participant underwent eight individual therapy sessions (two sessions a week), each lasting 45 minutes (session 1 to session 8). During these sessions, participants were asked to execute various task-specific functional exercises/skills using the Myosuit. The functional exercises focused both on performing activities of daily living (ADL) (e.g., sitting transfers, static balance, walking indoor/outdoor and climbing stairs) and on the participants' independent use of the Myosuit (e.g., using the remote control, donning, and doffing the Myosuit). Throughout the therapy sessions, the aim was for the patient to master these key skills using the Myosuit under the guidance of a therapist. The patient’s individual goals were also considered; based on these goals, specific functional exercises were performed with varying frequency. All therapy sessions were guided by a certified therapist. E. Measuring instruments Safety was analyzed based on the recording of occurred serious adverse events (SAEs), adverse events (AE) and negative side effects associated with the use of the Myosuit during the 4-week training period. These included the occurrence of pain symptoms, skin irritations, bruises, excessive fatigue, disproportionate muscle soreness and the risk of falling. Usability was assessed using the System Usability Scale (SUS) [ 25 ] and the Usefulness, Satisfaction and Ease of Use Questionnaire (USE), which were administered at the end of the study (session 9) to both participants and therapists [ 26 ]. For SUS scores were computed following the standard procedure described by Brooke [ 25 ]: item scores ranging from 1 (“strongly disagree”) to 5 (“strongly agree”) were adjusted—positively worded items were scored as the item score minus 1, and negatively worded items as 5 minus the item score. The adjusted scores were then summed and multiplied by 2.5 to yield a total score ranging from 0 to 100. SUS scores were then interpreted using established adjective-based rating scales (e.g., “excellent,” “good”, “fair,” “poor” For the USE questionnaire, analyses were conducted on multiple levels: we assessed mean scores and standard deviation for each of the four subscales (Usefulness, Ease of Use, Ease of Learning, and Satisfaction) and calculated the overall average. The scale ranges from 1 ("strongly disagree") to 7 ("strongly agree"), with 4 representing a neutral response. The feasibility of training with the Myosuit was evaluated by the participation rate and evaluating participants’ independence in using and handling the Myosuit during the gait training session in the inpatient setting. The participant should be able to use the device under supervision at a minimum, allowing the product to be safely employed at home with for, e.g., the assistance of an instructed caregiver. To assess this, human support was systematically recorded for each participant across all training sessions while they performed functional exercises (Table 2 ), with results reported for sessions 1 and 8. To objectively quantify support levels and progress in acquiring essential Myosuit skills, we conducted a structured assessment covering all key competencies required for effective operation in a home setting. The Goal Attainment Scale (GAS) served as the primary outcome for evaluating participants’ progress and overall achievement of these skills. The GAS is a functional scale used to assess achievements and/or the extent of progress towards specific goals in rehabilitation and therapeutic settings. Hereby, a standardized 5-point-scale is used to record the extent to which the established goals are achieved. The scale ranges from − 2 (indicating a significant shortfall in goal attainment) to + 2 (representing performance that exceeds the expected goal level), with 0 indicating the expected level of achievement [ 28 ]. For the skills donning and doffing the Myosuit and completing the task-specific exercises, the scale was defined as follows: -2 = Substantial physical support required (> 50% assistance from therapist); -1 = Moderate physical support required (< 50% assistance from therapist); 0 = performance under supervision (i.e., participant performs at the support level required for home-use of the Myosuit); +1 = independent performance with the Myosuit using walking aids; and + 2 = fully independent performance with the Myosuit, without walking aids. The key skill ‘using the remote control’ was similarly rated: -2 = the therapist fully operated the remote control on behalf of the participant; -1 = the therapist occasionally operated the remote control on behalf of the participant; 0 = the participant operated the remote control with constant verbal assistance (i.e., participant performs at the support level required for home-use of the Myosuit); +1 = the participant operated the remote control with sporadic verbal assistance; and + 2 = the participant operated the remote control fully independently. Additionally, feasibility in both clinical and home settings was analyzed by surveying participants and therapists about their acceptance of and motivation for Myosuit use in these environments. This was performed through a semi-structured interview conducted at the end of the study (session 9). As a secondary outcome measure, the efficacy of the therapy was assessed through core mobility outcomes critical for safe and effective ambulation. These aspects were evaluated using following standardized assessments: FAC [ 18 ] for assessing walking ability, 6MWT [ 19 ] for walking endurance, 10MWT [ 20 ] for walking speed and DEMMI [ 21 ] for assessing person's overall mobility across a spectrum of abilities, from being bed-bound to walking independently. The assessments were administered without the Myosuit at the beginning (session 0) and at end of the study (session 9). Table 2 Task-specific exercises/skills embedded in the study protocol Functional exercises Stand-up Sit-to-stand transfers (stand-up, sitting-down, squats) Static balance Walking indoor (flat surface, uneven surface) Walking outdoor (uneven surface) Climbing stairs (stairs up, stairs down) Skills Using the remote control Donning the Myosuit Doffing the Myosuit F. Statistical analysis Study data were collected and managed using REDCap electronic data capture tools hosted at RZS (version 8.11.2) [ 29 ]. REDCap (Research Electronic Data Capture) is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources. The data analysis was performed in Python 3.13.2. The Shapiro-Wilk test, and visual inspection of residual plots guided the selection of parametric vs. non-parametric tests. Depending on the distribution, we applied either the repeated-measures t-test or the Wilcoxon signed-rank test for dependent samples. To assess differences between patients and therapists in independent SUS and USE scores, we used independent t-test. Assumption of equal variances for independent samples was assessed using Levene’s test. The alpha level was set at 0.05 and p-values were adjusted for multiple testing using the Holm-Bonferroni correction method. Effect sizes (Cohen’s d and rank correlation) were reported for parametric and non-parametric tests respectively. Results A. Study Population A total of 15 individuals were enrolled in the study. The neurological diagnoses and the level of mobility limitations at the time of inclusion varied per participant (Table 3 ). Of the 15 participants, 11 were male and 4 were female. The mean age was 72 years old. Table 3 Demographic characteristics of study participants at the time of inclusion, n = 15 Demographic characteristics Mean [min, max] Age (years) 72 [47–83] MMSE (points) 27 [22–30] FAC (score) 3.6 [ 3 – 4 ] 6MWT – distance (m) 256.3 [26–470] 10MWT – walking speed (m/s) 0.7 [0.3–1] DEMMI (points) 59.4 [39–85] Diagnosis Ischemic stroke Neuropathy I Critical illness polyneuromyopathy Recurrent right glioblastoma Central cord syndrome Number of participants 7 3 3 1 1 I. Chronic inflammatory demyelinating polyneuropathy 1, POEMS-Syndrome 1, Guillain-Barré Syndrome 1 B. Safety No SAEs or AEs occurred during the study, and no negative side effects related with the use of the Myosuit or completion of therapy sessions were reported. However, approximately two-thirds of participants experienced pressure-related discomfort on their tibia caused by the Myosuit cuffs. This discomfort was transient and resolved immediately after the therapist repositioned the cuffs. No device malfunctions occurred. In two instances, only the leg straps had to be replaced; these adjustments did not lead to any interruption or safety issues. C. Usability The SUS results revealed considerable variability in perceived Myosuit usability among patients, with a mean score of 60.8 (SD = 13.2), indicating marginal acceptability overall. Scores ranged from 42.5 to 85, with most participants scoring between 52 (just above the “ok” threshold of 50.9) and 73 (just above the “good” threshold of 71.4) [ 27 ]. This distribution suggests that, despite individual differences, most participants generally rated the device’s user-friendliness as ok to good, reflecting a slightly positive overall assessment. Therapists rated the system’s usability slightly higher than patients, with a mean SUS score of 65.8 (SD = 15.3). Individual scores ranged from 37.5 to 77.5, with most falling between 63.1 and 76.9—above the high marginal acceptability threshold [ 27 ]. Overall, these results indicate that therapists found the usability to be marginally acceptable, with several ratings reaching into the acceptable range. There was not a significant difference in the SUS ratings between patients and therapists (Table 4 ). Table 4 SUS and USE scores of patients and therapists Parameters Patient, mean (SD) n = 13 Therapist, mean (SD) n = 6 Effect size (Cohen’s d) p-value* SUS (score) 60.8 (13.2) 65.8 (15.3) 0.8 0.5 USE – All items 4.5 (0.8) 4.9 (0.9) 0.4 0.1 USE – Usefulness 4 (1.9) 4.4 (1.2) - - USE – Ease of Use 4.4 (1.9) 5 (1.1) - - USE – Ease of Learning 5.4 (2) 6.3 (1) - - USE – Satisfaction 4.9 (2.2) 4.4 (1.1) - - *p-values are obtained using independent sample t-test for SUS scores. The USE scores obtained from both patients and therapists indicated that the Myosuit generally provided a good usability experience. All average USE subscale scores exceeded the neutral midpoint of 4 on the 1–7 scale (1 = strongly disagree, 7 = strongly agree; 4 = neutral), reflecting an overall positive user experience with the system. Patients reported a total USE score of 4.5 (SD = 0.8), while therapists rated it slightly higher at 4.9 (SD = 0.9). There was not a significant difference in the USE ratings between patients and therapist (Table 4 ). Across all subscales, therapists consistently gave higher ratings than patients, except for “Satisfaction,” where patients reported a slightly higher score (4.9 vs. 4.4). The highest ratings were found in the “Ease of Learning” dimension (patients: 5.4; therapists: 6.3), suggesting that both groups perceived the system as intuitive and easy to adopt. Although scores for “Usefulness” (patients: 4; therapists: 4.4) and “Ease of Use” (patients: 4.4; therapists: 5) were somewhat lower, they still remained above the neutral point, reinforcing the system’s overall usability and acceptability. D. Feasibility Of 18 subjects initially approached, 15 started and ten completed the study, resulting in 83.3% recruitment, 33.3% attrition and 77.5% adherence rates (93 attended sessions of 120 offered sessions). Three participants declined to participate: one due to concerns about radiation exposure, and two because they found the use of a robot unnecessarily complicated. The assumption of radiation exposure possibly stems from a misunderstanding about the Myosuit's technology. However, the Myosuit does not emit any form of radiation. The therapist clarified this to the participant, explaining that the device operates with battery-powered motors and sensors, and poses no radiation-related risk. Of the five participants who withdrew early, two did so for device-related reasons: they found the Myosuit uncomfortable and felt unsafe while walking. Another two withdrew because they experienced rapid recovery and no longer required walking assistance. The final participant discontinued participation after starting chemotherapy at another hospital. Participants demonstrated increased independence with the Myosuit by their final training session compared to the first session. They exceeded expectations in achieving their targeted goals, except for donning the device, which had a GAS score below zero at the last session. Participants effectively mastered engaging in functional activities and doffing the device, frequently progressing from requiring therapist supervision to performing these tasks independently (average GAS score > 0) at last training session. They were also able to operate the remote control only with verbal prompts from therapists (average GAS score > 0). The only task that consistently required physical therapist support throughout the entire training period was donning the device (Fig. 2 ). The semi-structured interviews were completed by 13 patients. Eight of the 13 participants felt comfortable using the Myosuit. Positive responses often referenced feelings of safety, support, and increased confidence, especially when therapists’ assistance and supervision were available or after a period of adaptation which was needed to adapt to the Myosuit’s physiological gait pattern. However, five participants expressed discomfort, citing issues such as feeling unsure while walking, the device being too tightly fitted, the backpack feeling too heavy, and orthoses being uncomfortable. Of the 13 participants, six expressed a desire to continue using the Myosuit during further inpatient rehabilitation, while seven preferred to train without it. The expressed positive views emphasized perceived benefits such as support (“safe”), usefulness for specific patient groups (“specially for more impaired patients”), and continued improvements in endurance and walking posture (“the training still brings a lot of benefit”). They valued the concept, stating “the idea is good” and “because it helps.” Conversely, seven participants indicated they would not continue, preferring alternative approaches like strength training or free walking, describing themselves as already functioning well without assistance. Some felt the device was no longer necessary as they recovered (“not necessary anymore”, “I found it good for in between”, “I improved rapidly”) or cited issues with weight and practicality (“device too heavy”). For use in clinical setting, all 13 participants indicated they would recommend the Myosuit to individuals with similar conditions. Regarding home use, the responses indicate that five of 13 participants would consider buying or renting the Myosuit for personal use at a buying price of 10,000–12,000 CHF. Interest was generally conditional—primarily for situations where their health condition worsened or specifically for support on longer distances. Other positive remarks noted willingness to rent rather than buy, and only if the device would provide clear support for standing up and if its functioning is simplified. Most participants, however, declined—citing factors such as not needing the device due to good recovery, too short time for a buying decision, the device being too complicated to use independently (especially for those with additional challenges like visual impairment), the device being too bulky or heavy, or simply not wanting to be seen in a robotic suit at home. The semi-structured interview was completed by all six therapists involved in the study. All six therapists would recommend the therapy with the Myosuit to other patients and therapists in the inpatient setting and enjoyed using the device. Five of six therapists think the Myosuit have potential for home-use, especially if the device is modified for greater simplicity and independence. Positive feedback highlights that the Myosuit could assist with daily living activities, is compact enough for home settings, and may suit younger or more independent users. Several participants suggested that simplifying donning/doffing and adding features like voice control would make solo use more feasible—potentially increasing independence without needing help from another person. However, concerns remain: some doubted its suitability for older patients, and one respondent did not consider home use feasible in its current form, citing the need for significant assistance and the perceived safety of having a therapist present. Overall, the feedback suggests clear promise for home use, but underscores the need for targeted improvements to usability, donning procedure, and support features. The questions of the semi-structured interview, along with the corresponding “yes” and “no” answers without the comments, are provided in the Supplementary Material. E. Effectiveness In general, patients improved their functional abilities according to the clinical assessments (Table 5 ). The FAC and DEMMI significantly improved at the end of the treatment compared to the start of the treatment with large effect sizes (0.9) for both scores. The improvements in the 6MWT and 10MWT were not statistically significant. Table 5 Gait performance of patients at the start and end of the study protocol Parameters At start, mean (SD); n = 13 or n = 12 for 10MWT At end, mean (SD); n = 13 or n = 12 for 10MWT Effect size* p-value* FAC (score) 3.5 (0.5) 4.7 (0.5) 0.9 < 0.05* 6MWT – distance (m) 266.2 (123.4) 347.1 (94.5) 0.7 0.1 DEMMI (points) 58.8 (13.4) 70.31 (14) 0.9 < 0.05* 10MWT – walking speed (m/s) 0.7 (0.2) 0.8 (0.2) 0.4 0.5 10MWT – cadence 80.5 (19.1) 87.9 (20.6) 0.3 0.5 10MWT – step length (m) 0.2 (0.1) 0.6 (0.1) 0.5 0.3 *p-values are obtained using paired t-test for 6MWT distance, DEMMI, 10MWT cadence, 10MWT step length, and Wilcoxon signed-rank test for FAC and 10MWT walking speed. Accordingly, Cohen’s d was computed for 6MWT distance, DEMMI, 10MWT cadence, 10MWT step length, and rank correlation was computed for FAC and 10MWT walking speed. P-values are corrected for multiple testing using the Holm-Bonferroni correction method. Discussion This study evaluated the safety, usability, and feasibility of Myosuit-based gait training for individuals with neurological gait disorders in both clinical and home settings. The findings demonstrate that the use of the Myosuit in supervised settings is safe for gait rehabilitation in patients with various gait impairments, as evidenced by the absence of serious adverse events or negative side effects. Thirteen participants used the device repeatedly, and ten completed the entire training protocol without incident, confirming its suitability for facilitated training scenarios. According to the SUS scale, usability was rated as marginally acceptable by patients and therapists, with therapists expressing a slightly more positive overall impression. On the USE scale, positive scores in ease of learning, satisfaction, and ease of use indicated favorable views of the device in both groups. Therapists perceived the system as useful for patients, whereas patients offered on average a more neutral assessment on this matter. Recruitment and adherence rates were favorable. Most functional training goals were achieved, including walking and training with the Myosuit under supervision. Importantly, assistance does not necessarily require the continuous presence of a therapist. The main task where users consistently needed physical help was donning the device. Once fitted, most participants could walk and perform functional tasks with the Myosuit under supervision or independently. This assistance could be provided by an assistant, a trained caregiver or family member rather than a clinician, meaning that daily operational support could, in principle, be supplied by non-clinical personnel after appropriate training. This expands the potential for Myosuit use beyond traditional in-clinic rehabilitation environments and opens opportunities for home-based implementation. Semi-structured interviews revealed that eight of thirteen felt increasingly comfortable with the Myosuit after initial uncertainty and discomfort, typically resolving with a dedicated adaptation period. Six participants wished to continue using the Myosuit in inpatient rehabilitation; the remaining seven preferred alternative methods, especially due to rapid improvement. All patients reported that they would recommend the Myosuit to others in similar situations, indicating high acceptability and perceived usefulness in supervised clinical settings. Therapists consistently recommended the Myosuit for clinical use to other therapists and to their patients, emphasizing its value as a training tool for moderate gait impairment. They also highlighted the critical importance of proper patient selection, device familiarization, and adequate assistance. Several therapists noted that improvements in donning and remote control would further increase the device's suitability for home use. For independent or home use, patients’ interest declined sharply due to perceived complexity and hesitancy regarding autonomous operation, or because patients no longer needed the device due to rapid improvement; only five of 13 participants were willing to rent or buy the device for use outside a clinic under a person’s supervision. The central challenge—independent donning and operation of the remote control—was frequently cited. Concerns about social acceptance when seen with the device were mentioned only by one patient. Clinical assessments indicated significant improvements in both FAC and DEMMI scores at post-treatment, confirming the potential therapeutic benefit of usual care plus Myosuit gait training in improving mobility. We also observed improvements with respect to the 6MWT and 10MWT that, however, were not statistically significant. Importantly, both patients and therapists identified the device as being most useful during a specific phase of rehabilitation—when patients still felt unsafe or required walking aids or personal support (FAC: 2–3). If rapid improvement occurred and patients no longer needed gait support from the device, the Myosuit was sometimes perceived as limiting rather than supportive. Interview responses emphasized the importance of carefully selecting the optimal rehabilitation period for Myosuit use, while ensuring that personal assistance or supervision was provided until users felt safe engaging in gait training with the device more independently. Taken together, these data suggest that the greatest barrier to independent home use is the donning process, not the actual walking or training once fitted. This points to a potentially scalable solution: a hybrid home rehabilitation model, where the patient performs regular training sessions in the home environment with the help of a trained caregiver, but with scheduled therapist oversight once or twice per week. In this model, the caregiver would assist with donning and provide basic safety physical assistance and supervision, while the therapist—either in person or via tele-rehabilitation—would periodically reassess progress, adjust parameters, and address functional or technical issues. This approach could optimize rehabilitation resources, extend therapy beyond the clinic, and sustain patient engagement while maintaining safety standards. Limitations and future work This study’s modest sample size and the lack of a control group limit its generalizability. The inclusion of a broad range of neurological diagnoses enhanced external validity, but made it challenging to determine which specific subgroups benefit most. Focusing future studies on particular conditions could help clarify which patient characteristics predict optimal use. In rehabilitation, therapists frequently encounter diverse patient types and diagnoses. Notably, this protocol closely mirrors real-world clinical practice, as patients were enrolled sequentially once therapists identified that they could benefit from Myosuit gait training. The protocol did not allow structured analysis of long-term impacts on quality of life, secondary health conditions, or user satisfaction in daily, unsupervised settings; ongoing research should investigate the broader effects of integrating exosuits into at-home and community rehabilitation programs. Qualitative data collection remains crucial. Laboratory-based results are useful but may miss real-world usability challenges and psychosocial barriers such as motivation, social stigma, and perceived autonomy. Future research should therefore test the hybrid caregiver-plus-periodic-therapist-supervision model in larger and more targeted patient cohorts and examine its cost-effectiveness and resource optimization potential compared with traditional therapy schedules. It should also investigate patient motivation, acceptance, and quality-of-life changes associated with sustained Myosuit training in the home and community, and guide device redesign to simplify donning and enhance autonomy. Conclusion Myosuit-based gait training was safe and feasible for patients with neurological gait impairments under supervision and could produce meaningful functional improvements when combined with usual care. Most participants rated usability between “ok” to “good”, with learnability and perceived effectiveness recognized by both patients and therapists. The primary barrier to independent home use is the donning process, which currently necessitates physical assistance. Our findings support a hybrid rehabilitation model as a practical solution. This arrangement could preserve therapist time for higher-level clinical tasks, increase training frequency, improve long-term outcomes, and extend access to intensive gait rehabilitation into the home setting. Future studies should evaluate the safety, efficacy, and cost-effectiveness of this hybrid model to determine its potential for wide-scale integration into neurological rehabilitation programs. Abbreviations AE Adverse Event SAE Serious Adverse Event FAC Functional Ambulation Categories 6MWT 6-Minute Walk Test 10MWT 10-Meter Walk Test DEMMI De Morton Mobility Index SUS System Usability Scale USE Usefulness, Satisfaction and Ease of Use Questionnaire RZS Rehabilitation Center Zihlschlacht m Meter m/s Meters per second Declarations Ethics approval and consent to participate The local Ethics Committee of Eastern Switzerland (EKOS) approved the study design and protocol (REF.-NR.: BASEC 2022-D0059). Written informed consent was obtained from all participants prior to the start of the study. The study is registered at ClinicalTrials.gov (Identifier: NCT05485597). Consent for publication All participants provided written informed consent for the publication of study results and images. Availability of data and materials The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Competing interest The authors declare that they have no competing interests. Funding The Rehaklinik Zihlschlacht AG funded this study. Authors’ contribution CT and LP designed the study, led data collection and analysis. CT wrote the manuscript. DM and CM assisted in designing the study. AM led portions of data analysis, interpretation of results, and assisted in writing the manuscript. LP was the principal investigator, conceived, designed, and led the study, interpreted the data, and assisted in writing the manuscript. All authors read and approved the final manuscript. Acknowledgements We would like to thank all patients and staff who participated in this study for their valuable support during the training sessions and data collection. Authors details Carmel Tulen (Tulen C) 1 , Jens C. Möller (Möller JC) 3 , Detlef Marks (Marks D) 1 , Adriana Mohap (Mohap A) 2 and Liliana P. Paredes (Paredes LP) 2 1 Rehaklinik Zihlschlacht AG, Hauptstrasse 2, 8588 Zihlschlacht. 2 Biomedical Data Science Lab, ETH Zurich, Lengghalde 2, 8008 Zurich 3 Neurologie FMH, Hôpital fribourgeois, Chemin du Village 24, 3280 Meyriez-Murten Correspondence to: Liliana Paredes, Biomedical Data Science Lab, ETH Zurich, Lengghalde 2, 8008 Zurich. Tel: +41 76 281 1985; E-mail: [email protected] References Feigin VL, Vos T, Nichols E, Owolabi MO, Carroll WM, Dichgans M, Deuschl G, Parmar P, Brainin M, Murray C. The global burden of neurological disorders: translating evidence into policy. Lancet Neurol. 2020;19(3):255–65. https://doi.org/10.1016/S1474-4422(19)30411-9 . Taylor-Piliae RE, Latt LD, Hepworth JT, Coull BM. Predictors of gait velocity among community-dwelling stroke survivors. Gait Posture. 2012;35(3):395–9. https://doi.org/10.1016/j.gaitpost.2011.10.358 . Larsson J, Hansson W, Larsen HI, Koskinen LOD, Eklund A, Malm J. Higher-level gait disorders: a population-based study on prevalence, quality of life, depression and confidence in gait and balance. BMJ Neurol Open. 2025;7(1):e000992. https://doi.org/10.1136/bmjno-2024-000992 . Rand D, Eng JJ, Tang PF, Hung C, Jeng JS. Daily physical activity and its contribution to the health-related quality of life of ambulatory individuals with chronic stroke. Health Qual Life Outcomes. 2010;8(1). https://doi.org/10.1186/1477-7525-8-80 . Diaz R, Miller E, Kraus E, Fredericson M. Impact of adaptive sports participation on quality of life. Sports Med Arthrosc Rev. 2019;27(2):73–82. https://doi.org/10.1097/jsa.0000000000000242 . Kalb R, Brown TR, Coote S, Costello K, Dalgas U, Garmon E, Giesser B, Halper J, Karpatkin H, Keller J, Ng AV, Pilutti LA, Rohrig A, Van Asch P, Zackowski KM, Motl RW. Exercise and lifestyle physical activity recommendations for people with multiple sclerosis throughout the disease course. Multiple Scler J. 2020;26(12):1459–69. https://doi.org/10.1177/1352458520915629 . Hartford W, Lear S, Nimmon L. Stroke survivors’ experiences of team support along their recovery continuum. BMC Health Serv Res. 2019;19:1–12. https://doi.org/10.1186/s12913-019-4533-z . Nuara A, Fabbri-Destro M, Scalona E, Lenzi SE, Rizzolatti G, Avanzini P. Telerehabilitation in response to constrained physical distance: an opportunity to rethink neurorehabilitative routines. J Neurol. 2021;269(2):627–38. https://doi.org/10.1007/s00415-021-10397-w . Mcleod JC, Ward SJ, Hicks AL. Evaluation of the Keeogo™ dermoskeleton. 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Activity-based training with the Myosuit: a safety and feasibility study across diverse gait disorders. J Neuroeng Rehabil. 2020;17(1). https://doi.org/10.1186/s12984-020-00765-4 . Wright A, Stone K, Martinelli L, Fryer S, Smith G, Lambrick D, Stoner L, Jobson S, Faulkner J. Effect of combined home-based, overground robotic-assisted gait training and usual physiotherapy on clinical functional outcomes in people with chronic stroke: A randomized controlled trial. Clin Rehabil. 2020;35(6):882–93. https://doi.org/10.1177/0269215520984133 . Morone G, Paolucci S, Cherubini A, De Angelis D, Venturiero V, Coiro P, Iosa M. Robot-assisted gait training for stroke patients: current state of the art and perspectives of robotics. Neuropsychiatr Dis Treat. 2017;13:1303–11. https://doi.org/10.2147/ndt.s114102 . Bragoni M, Broccoli M, Iosa M, Morone G, De Angelis D, Venturiero V, Coiro P, Pratesi L, Mezzetti G, Fusco A, Paolucci S. Influence of Psychologic Features on Rehabilitation Outcomes in Patients with Subacute Stroke Trained with Robotic-Aided Walking Therapy. Am J Phys Med Rehabil. 2013;92(10):e16–25. https://doi.org/10.1097/phm.0b013e3182a20a34 . Steins D, Dawes H, Esser P, Collett J. Wearable accelerometry-based technology capable of assessing functional activities in neurological populations in community settings: a systematic review. J Neuroeng Rehabil. 2014;11(1):36. https://doi.org/10.1186/1743-0003-11-36 . Mehrholz J, Wagner K, Rutte K, Meiβner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007;88(10):1314–9. https://doi.org/10.1016/j.apmr.2007.06.764 . Enright PL. The six-minute walk test. Respir Care. 2003;48(8):783–5. Montero-Odasso M, Schapira M, Soriano ER, Varela M, Kaplan R, Camera LA, Mayorga LM. Gait velocity as a single predictor of adverse events in healthy seniors aged 75 years and older. Journals Gerontol Ser A: Biol Sci Med Sci. 2005;60(10):1304–9. https://doi.org/10.1093/gerona/60.10.1304 . Braun T, Marks D, Thiel C, Grüneberg C. Reliability and validity of the de Morton Mobility Index in individuals with sub-acute stroke. Disabil Rehabil. 2019;41(13):1561–70. https://doi.org/10.1080/09638288.2018.1430176 . Tombaugh TN, McIntyre NJ. The mini-mental state examination: a comprehensive review. J Am Geriatr Soc. 1992;40(9):922–35. https://doi.org/10.1111/j.1532-5415.1992.tb01992.x . Kim J, Kim Y, Kang S, Kim SJ. (2022). Biomechanical Analysis. ReWalk Robotics Ltd. (2019). FDA issues clearance for the ReStore™ Exo-Suit, the first soft robotic system for stroke therapy. Cision PR Newswire . https://ir.golifeward.com/news-releases/news-release-details/fda-issues-clearance-restoretm-exo-suit-first-soft-robotic Suggests Myosuit Reduces Knee Extensor Demand during Level and Incline Gait. Sensors , 22 (16), 6127. https://doi.org/10.3390/s22166127 Brooke J. SUS-A quick and dirty usability scale. Usability evaluation Ind. 1996;189(194):4–7. Gao M, Kortum P, Oswald F. (2018). Psychometric Evaluation of the USE (Usefulness, Satisfaction, and Ease of use) Questionnaire for Reliability and Validity. Proceedings of the Human Factors and Ergonomics Society Annual Meeting , 62 (1), 1414–1418. https://doi.org/10.1177/1541931218621322 Bangor A, Kortum P, Miller J. Determining what individual SUS scores mean: Adding an adjective rating scale. J usability Stud. 2009;4(3):114–23. Turner-Stokes L. Goal attainment scaling (GAS) in rehabilitation: a practical guide. Clin Rehabil. 2009;23(4):362–70. https://doi.org/10.1177/0269G215508101742 . Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN, REDCap Consortium. The REDCap consortium: building an international community of software platform partners. J Biomed Inform. 2019;95:103208. https://doi.org/10.1016/j.jbi.2019.103208 . Additional Declarations No competing interests reported. Supplementary Files Supplement.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8360563","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":581391729,"identity":"261596ee-ceea-4ab4-a1e0-9d7232c0d059","order_by":0,"name":"Carmel E. 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Paredes","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAv0lEQVRIiWNgGAWjYBACPjDJxsDADyYZGBIIamGDkZINzKRqMThAtBbp5mcfPpTZ2Bsf7z/28AeDXR5hLTLHjGfOOJeWuO3MYXYDCYbkYsJaJBKMmXnbDieY3UhmkzBgOJDYQFhL+mfmv23/7Y3nPwZqJ05LjjEzY9sBxg0SzGwSB4jSInOmmLHnXHLijDPJZpINBsmEtfBLt29m+FFmZ8/ffvCZ5I8KO8JaGCRQeAYE1WNoGQWjYBSMglGABQAA3Cw2weXOtckAAAAASUVORK5CYII=","orcid":"","institution":"ETH Zurich","correspondingAuthor":true,"prefix":"","firstName":"Liliana","middleName":"P.","lastName":"Paredes","suffix":""}],"badges":[],"createdAt":"2025-12-14 23:53:24","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8360563/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8360563/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":102426647,"identity":"bd136cc8-83a1-476a-ac58-c3fe7dbe35a8","added_by":"auto","created_at":"2026-02-11 14:42:00","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":849818,"visible":true,"origin":"","legend":"\u003cp\u003eThe soft-Exoskeleton 'Myosuit' ©\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-8360563/v1/9a518cb228f98966e626a3ca.png"},{"id":102426644,"identity":"cbd0be88-5d48-4b5f-90e5-0d40b0b6e303","added_by":"auto","created_at":"2026-02-11 14:41:53","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":50663,"visible":true,"origin":"","legend":"\u003cp\u003eChanges in Goal Attainment Scale (GAS) between session 1 and 8.\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-8360563/v1/69996d04399af59e25afeb8f.png"},{"id":108977396,"identity":"820e79a4-b74b-4adb-a281-0fa39f15c630","added_by":"auto","created_at":"2026-05-11 11:31:38","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1241689,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8360563/v1/638ba19a-aff5-4d93-a382-cd157872847a.pdf"},{"id":102426662,"identity":"2624be02-118c-457d-b45a-6012c14f1033","added_by":"auto","created_at":"2026-02-11 14:42:02","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":16082,"visible":true,"origin":"","legend":"","description":"","filename":"Supplement.docx","url":"https://assets-eu.researchsquare.com/files/rs-8360563/v1/c1df3d079cbe6f605f0bf9aa.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Usability and Feasibility of Myosuit-Assisted Gait Rehabilitation Training in Neurological Patients","fulltext":[{"header":"Background","content":"\u003cp\u003eNeurological disorders are the leading cause of long-term disability in adults worldwide and have significant impact on the lives of both patients and their families [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. For instance, most individuals with a neurological disorder that live at home face substantial movement disorders and mobility limitations, making it impossible for them to walk quickly or far enough to cross the street, and in severe cases, preventing them from leaving the house at all [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. These severe mobility restrictions hinder social (re)integration and limit participation in society, resulting in a significantly reduced health-related quality of life (HRQL) for many individuals [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. In contrast, engaging in daily physical activity (PA) after stroke is associated with better HRQL [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAdditionally, mobility limitations also lead to sedentary behavior, which is concerning as it causes comorbidities and further physical and mental decline. To prevent inactivity-related decline and improve mood and quality of life, promoting activities in the home setting is essential for this population. However, existing organized activities, such as primary care physical therapy, are often insufficient; many patients lack third-party assistance (e.g., for transportation, guidance, financial resources, or local availability) [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Additionally, rehabilitation centers frequently provide little support for patients\u0026rsquo; needs at home. There is a lack of collaborative healthcare system support and inequities in rehabilitation structures [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Given that millions of people are affected by neurological disorders each year\u0026mdash;with high disease burdens, enormous healthcare costs related to inactivity, and a growing shortage of healthcare providers\u0026mdash;it is necessary to improve rehabilitation efficiency and offer patients better mobility equipment and therapy services, especially in outpatient and home settings [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eCommercial lightweight wearable robots, also known as \u0026ldquo;exosuits\u0026rdquo;, \u0026ldquo;exomuscles\u0026rdquo; or \u0026ldquo;dermoskeleton\u0026rsquo;\u0026rsquo;, such as the Myosuit, the ReWalk ReStore\u0026trade; or Keeogo, show promise in enhancing rehabilitation and preventing inactivity at home. Studies have demonstrated their safety and reliability in clinical and home settings [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e], as well as their potential to serve as assistive devices both indoors and outdoors [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e], improve mobility, and aid in daily activities [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Integrating such robots into home rehabilitation could offer new physical activity options, improve walking abilities, and foster independence [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Additionally, using the robot in a familiar environment can help establish habits that lead to long-term behavioral changes in movement, which in turn can prevent sedentary behavior and improve clinical functional outcomes [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eHowever, the use of these devices currently faces several challenges\u0026mdash;there is still limited evidence regarding the acceptance and feasibility of devices like the Myosuit as part of a rehabilitation program in both clinical and home settings. Factors such as the patient\u0026rsquo;s medical condition, physical limitations, cognitive abilities, and attitudes toward robot-assisted therapy\u0026mdash;particularly among older patients and their therapists\u0026mdash;play a significant role and should be carefully considered [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. The price of these devices and their adoption also limit clinical integration. Several studies highlight the need for further research to address these challenges and explore the potential integration of such devices into neurorehabilitation [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe aim of this study was to assess the usability and feasibility of this new form of therapy in the inpatient setting, and to gain insights into whether inpatients would be suitable for using the wearable robot \u0026lsquo;the Myosuit\u0026rsquo; in domestic settings, and if so, under what conditions. We also measured functional assessments at the activity level of the ICF to gauge the effectiveness of the Myosuit gait training. To assess the effectiveness of wearable robots, studies often use standardized gait and mobility assessments such us the Functional Ambulatory Category (FAC), 10-meter Walk Test (10MWT), 6-minute-Walk Test (6MWT) and the De Morton Mobility Index (DEMMI) [\u003cspan additionalcitationids=\"CR19 CR20\" citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eTo the best of our knowledge, this is the first study to examine the usability, feasibility, and effects of gait training with the Myosuit in a neurological inpatient rehabilitation setting.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThis paper presents the results of a gait rehabilitation program using the Myosuit, integrated into the inpatient rehabilitation program at the Neurological Rehabilitation Clinic, Rehaklinik Zihlschlacht (RZS).\u003c/p\u003e \u003cp\u003eA. \u003cb\u003eStudy design\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThis open-label, non-randomized, longitudinal, interventional study analyzed the safety, usability, and feasibility of gait training using the wearable robot 'Myosuit' in neurological inpatients with severe to moderate gait impairment.\u003c/p\u003e \u003cp\u003eUsability was defined as participants' ability to successfully and safely use the Myosuit with a reasonable level of effort and satisfaction during gait training and/or goal achievement. Satisfaction encompassed user experience, enjoyment, comfort, and general contentment with the device.\u003c/p\u003e \u003cp\u003eFeasibility assessed the viability/practicality of 'Myosuit-assisted training' in clinical and home environments. Particular emphasis was placed on assessing participants' ability to operate the device, as well as their motivation and willingness to participate in the intervention.\u003c/p\u003e \u003cp\u003eB. \u003cb\u003eStudy participants and recruitment\u003c/b\u003e\u003c/p\u003e \u003cp\u003eFifteen inpatients from RZS with various neurological gait disorders were enrolled in this trial. All participants were enlisted by a certified physical therapist and took part in the study from November 2022 to November 2023. The patient selection criteria are presented in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Written informed consent was obtained from all participants prior to the start of the study. All participants were first-time users of the Myosuit and each underwent the same study protocol. The study protocol was approved by the local Ethics Committee of East Switzerland (EKOS) and is registered at ClinicalTrials.gov (Identifier: NCT05485597). The study was conducted in accordance with the study protocol, the current version of the Declaration of Helsinki, ISO14155, ICH-GCP (as applicable), and the national laws and regulations of Switzerland. Furthermore, the study was subject to monitoring by ETH Z\u0026uuml;rich (Laboratory for Rehabilitation Technology).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eStudy eligibility criteria\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInclusion criteria\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eExclusion criteria\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026bull; Neurological inpatients at RZS with gait disorders\u003c/p\u003e \u003cp\u003e\u0026bull; FAC score between 2 and 4\u003c/p\u003e \u003cp\u003e\u0026bull; Cognition as measured by the Mini Mental State Examination (MMSE) score above 17 points\u003csup\u003eI\u003c/sup\u003e\u003c/p\u003e \u003cp\u003e\u0026bull; Subject is at least 18 years old\u003c/p\u003e \u003cp\u003e\u0026bull; A height between 150 cm and 195 cm\u003csup\u003eII\u003c/sup\u003e\u003c/p\u003e \u003cp\u003e\u0026bull; A weight between 45 to 110kg\u003csup\u003eII\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026bull; Parkinson's disease and Multiple sclerosis\u003csup\u003eIII\u003c/sup\u003e\u003c/p\u003e \u003cp\u003e\u0026bull; Neurological patients without gait disorders\u003c/p\u003e\u003cp\u003e\u0026bull; Unstable cardiovascular and respiratory conditions\u003c/p\u003e\u003cp\u003e\u0026bull; Functional Reach Test (FRT)\u0026thinsp;\u0026lt;\u0026thinsp;15.24 cm\u003csup\u003eII\u003c/sup\u003e\u003c/p\u003e\u003cp\u003e\u0026bull; 10MWT not possible with the assistance of a person\u003c/p\u003e\u003cp\u003e\u0026bull; Major musculoskeletal conditions (e.g., rheumatoid arthritis), major limited lower extremity\u0026rsquo;s range of motion, orthopedic problems and/or significant lower extremity joint pain that could affect the application of the Myosuit\u003c/p\u003e\u003cp\u003e\u0026bull; Significant lower limb contractures (knee flexion or hip flexion contracture of \u0026gt;\u0026thinsp;10\u0026deg;, Varus deformity\u0026thinsp;\u0026gt;\u0026thinsp;10\u0026deg;, Valgus deformity\u0026thinsp;\u0026gt;\u0026thinsp;10\u0026deg;) that could affect the application of the Myosuit\u003c/p\u003e\u003cp\u003e\u0026bull; Skin integrity (on surfaces that would contact the device)\u003c/p\u003e\u003cp\u003e\u0026bull; Significant osteoporosis (bone fragility) assessed by a medical doctor\u003c/p\u003e\u003cp\u003e\u0026bull; Pregnancy\u003c/p\u003e\u003cp\u003e\u0026bull; Incapacity to (safely) understand and/or follow instructions (e.g., aphasia, limited knowledge of German)\u003c/p\u003e\u003cp\u003e\u0026bull; Incapacity to understand formal consent\u003c/p\u003e\u003cp\u003e\u0026bull; Currently participating in other (internal) interventional studies\u003c/p\u003e\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003csup\u003e \u003cem\u003eI\u003c/em\u003e \u003c/sup\u003e \u003cem\u003eMMSE scores of 17 or below indicates severe cognitive impairment according to Tombaugh and McIntyre\u003c/em\u003e [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e].\u003c/p\u003e \u003cp\u003e\u003csup\u003e\u003cem\u003eII\u003c/em\u003e\u003c/sup\u003e\u003cem\u003eThe manufacturer\u0026rsquo;s guidelines contain overall restrictions for height and weight and other parameters such as FRT.\u003c/em\u003e\u003c/p\u003e \u003cp\u003e \u003csup\u003e \u003cem\u003eIII\u003c/em\u003e \u003c/sup\u003e \u003cem\u003eIndividuals diagnosed with Parkinson\u0026rsquo;s disease and Multiple Sclerosis were excluded from the study, because they typically remain in RZS for only three to four weeks. In addition, due to changes in medication, the results may be unreliable particularly in PD patients.\u003c/em\u003e\u003c/p\u003e \u003cp\u003eC. \u003cb\u003eWearable Robot\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThe Myosuit (MyoSwiss AG, Zurich, Switzerland) utilized in this study is a lightweight, soft wearable robot that provides active support for knee and hip extension during the stance phase of the user\u0026rsquo;s gait cycle (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Motion sensors enable the Myosuit to internally regulate support by assessing the user's gait phase and ensuring that extension assistance is delivered at the appropriate time. The support level height can be individually and independently adjusted for each leg, providing a high degree of customization to suit the user\u0026rsquo;s preferences and needs. By facilitating this crucial gait function, the Myosuit aids the user in carrying out daily activities such as walking, standing, sitting transfers, and stair climbing.\u003c/p\u003e \u003cp\u003eThe system has a total weight of 5.5kg. The Myosuit is CE-Certified [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe price of the device is approximately 11,000 EUR, depending on the license and additional features. This is significantly lower than other soft exosuits for the lower limb, which can cost at least 30,000 EUR [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eD. \u003cb\u003eIntervention\u003c/b\u003e\u003c/p\u003e \u003cp\u003e During a four-week period, each participant underwent eight individual therapy sessions (two sessions a week), each lasting 45 minutes (session 1 to session 8). During these sessions, participants were asked to execute various task-specific functional exercises/skills using the Myosuit. The functional exercises focused both on performing activities of daily living (ADL) (e.g., sitting transfers, static balance, walking indoor/outdoor and climbing stairs) and on the participants' independent use of the Myosuit (e.g., using the remote control, donning, and doffing the Myosuit). Throughout the therapy sessions, the aim was for the patient to master these key skills using the Myosuit under the guidance of a therapist. The patient\u0026rsquo;s individual goals were also considered; based on these goals, specific functional exercises were performed with varying frequency. All therapy sessions were guided by a certified therapist.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eE. \u003cb\u003eMeasuring instruments\u003c/b\u003e\u003c/p\u003e \u003cp\u003eSafety was analyzed based on the recording of occurred serious adverse events (SAEs), adverse events (AE) and negative side effects associated with the use of the Myosuit during the 4-week training period. These included the occurrence of pain symptoms, skin irritations, bruises, excessive fatigue, disproportionate muscle soreness and the risk of falling.\u003c/p\u003e \u003cp\u003eUsability was assessed using the System Usability Scale (SUS) [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e] and the Usefulness, Satisfaction and Ease of Use Questionnaire (USE), which were administered at the end of the study (session 9) to both participants and therapists [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. For SUS scores were computed following the standard procedure described by Brooke [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]: item scores ranging from 1 (\u0026ldquo;strongly disagree\u0026rdquo;) to 5 (\u0026ldquo;strongly agree\u0026rdquo;) were adjusted\u0026mdash;positively worded items were scored as the item score minus 1, and negatively worded items as 5 minus the item score. The adjusted scores were then summed and multiplied by 2.5 to yield a total score ranging from 0 to 100. SUS scores were then interpreted using established adjective-based rating scales (e.g., \u0026ldquo;excellent,\u0026rdquo; \u0026ldquo;good\u0026rdquo;, \u0026ldquo;fair,\u0026rdquo; \u0026ldquo;poor\u0026rdquo;\u003c/p\u003e \u003cp\u003eFor the USE questionnaire, analyses were conducted on multiple levels: we assessed mean scores and standard deviation for each of the four subscales (Usefulness, Ease of Use, Ease of Learning, and Satisfaction) and calculated the overall average. The scale ranges from 1 (\"strongly disagree\") to 7 (\"strongly agree\"), with 4 representing a neutral response.\u003c/p\u003e \u003cp\u003eThe feasibility of training with the Myosuit was evaluated by the participation rate and evaluating participants\u0026rsquo; independence in using and handling the Myosuit during the gait training session in the inpatient setting. The participant should be able to use the device under supervision at a minimum, allowing the product to be safely employed at home with for, e.g., the assistance of an instructed caregiver. To assess this, human support was systematically recorded for each participant across all training sessions while they performed functional exercises (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e), with results reported for sessions 1 and 8. To objectively quantify support levels and progress in acquiring essential Myosuit skills, we conducted a structured assessment covering all key competencies required for effective operation in a home setting. The Goal Attainment Scale (GAS) served as the primary outcome for evaluating participants\u0026rsquo; progress and overall achievement of these skills.\u003c/p\u003e \u003cp\u003eThe GAS is a functional scale used to assess achievements and/or the extent of progress towards specific goals in rehabilitation and therapeutic settings. Hereby, a standardized 5-point-scale is used to record the extent to which the established goals are achieved. The scale ranges from \u0026minus;\u0026thinsp;2 (indicating a significant shortfall in goal attainment) to +\u0026thinsp;2 (representing performance that exceeds the expected goal level), with 0 indicating the expected level of achievement [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. For the skills donning and doffing the Myosuit and completing the task-specific exercises, the scale was defined as follows: -2\u0026thinsp;=\u0026thinsp;Substantial physical support required (\u0026gt;\u0026thinsp;50% assistance from therapist); -1\u0026thinsp;=\u0026thinsp;Moderate physical support required (\u0026lt;\u0026thinsp;50% assistance from therapist); 0\u0026thinsp;=\u0026thinsp;performance under supervision (i.e., participant performs at the support level required for home-use of the Myosuit); +1\u0026thinsp;=\u0026thinsp;independent performance with the Myosuit using walking aids; and +\u0026thinsp;2\u0026thinsp;=\u0026thinsp;fully independent performance with the Myosuit, without walking aids. The key skill \u0026lsquo;using the remote control\u0026rsquo; was similarly rated: -2\u0026thinsp;=\u0026thinsp;the therapist fully operated the remote control on behalf of the participant; -1\u0026thinsp;=\u0026thinsp;the therapist occasionally operated the remote control on behalf of the participant; 0\u0026thinsp;=\u0026thinsp;the participant operated the remote control with constant verbal assistance (i.e., participant performs at the support level required for home-use of the Myosuit); +1\u0026thinsp;=\u0026thinsp;the participant operated the remote control with sporadic verbal assistance; and +\u0026thinsp;2\u0026thinsp;=\u0026thinsp;the participant operated the remote control fully independently.\u003c/p\u003e \u003cp\u003eAdditionally, feasibility in both clinical and home settings was analyzed by surveying participants and therapists about their acceptance of and motivation for Myosuit use in these environments. This was performed through a semi-structured interview conducted at the end of the study (session 9).\u003c/p\u003e \u003cp\u003eAs a secondary outcome measure, the efficacy of the therapy was assessed through core mobility outcomes critical for safe and effective ambulation. These aspects were evaluated using following standardized assessments: FAC [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] for assessing walking ability, 6MWT [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e] for walking endurance, 10MWT [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e] for walking speed and DEMMI [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e] for assessing person's overall mobility across a spectrum of abilities, from being bed-bound to walking independently. The assessments were administered without the Myosuit at the beginning (session 0) and at end of the study (session 9).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eTask-specific exercises/skills embedded in the study protocol\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"1\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFunctional exercises\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStand-up \u003c/p\u003e \u003cp\u003eSit-to-stand transfers (stand-up, sitting-down, squats)\u003c/p\u003e \u003cp\u003eStatic balance\u003c/p\u003e \u003cp\u003eWalking indoor (flat surface, uneven surface)\u003c/p\u003e \u003cp\u003eWalking outdoor (uneven surface)\u003c/p\u003e \u003cp\u003eClimbing stairs (stairs up, stairs down)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSkills\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUsing the remote control\u003c/p\u003e \u003cp\u003eDonning the Myosuit\u003c/p\u003e \u003cp\u003eDoffing the Myosuit\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eF. \u003cb\u003eStatistical analysis\u003c/b\u003e\u003c/p\u003e \u003cp\u003eStudy data were collected and managed using REDCap electronic data capture tools hosted at RZS (version 8.11.2) [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. REDCap (Research Electronic Data Capture) is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources. The data analysis was performed in Python 3.13.2.\u003c/p\u003e \u003cp\u003e The Shapiro-Wilk test, and visual inspection of residual plots guided the selection of parametric vs. non-parametric tests. Depending on the distribution, we applied either the repeated-measures t-test or the Wilcoxon signed-rank test for dependent samples. To assess differences between patients and therapists in independent SUS and USE scores, we used independent t-test. Assumption of equal variances for independent samples was assessed using Levene\u0026rsquo;s test. The alpha level was set at 0.05 and p-values were adjusted for multiple testing using the Holm-Bonferroni correction method. Effect sizes (Cohen\u0026rsquo;s d and rank correlation) were reported for parametric and non-parametric tests respectively.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA. \u003cb\u003eStudy Population\u003c/b\u003e\u003c/p\u003e \u003cp\u003eA total of 15 individuals were enrolled in the study. The neurological diagnoses and the level of mobility limitations at the time of inclusion varied per participant (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Of the 15 participants, 11 were male and 4 were female. The mean age was 72 years old.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDemographic characteristics of study participants at the time of inclusion, n\u0026thinsp;=\u0026thinsp;15\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDemographic characteristics\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean [min, max]\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e72 [47\u0026ndash;83]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMMSE (points)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e27 [22\u0026ndash;30]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFAC (score)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.6 [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6MWT \u0026ndash; distance (m)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e256.3 [26\u0026ndash;470]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e10MWT \u0026ndash; walking speed (m/s)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.7 [0.3\u0026ndash;1]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDEMMI (points)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e59.4 [39\u0026ndash;85]\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiagnosis\u003c/p\u003e \u003cp\u003eIschemic stroke\u003c/p\u003e \u003cp\u003eNeuropathy\u003csup\u003eI\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eCritical illness polyneuromyopathy\u003c/p\u003e \u003cp\u003eRecurrent right glioblastoma\u003c/p\u003e \u003cp\u003eCentral cord syndrome\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eNumber of participants\u003c/b\u003e\u003c/p\u003e \u003cp\u003e7\u003c/p\u003e \u003cp\u003e3\u003c/p\u003e \u003cp\u003e3\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e\n\n\u003cdiv class=\"Heading\"\u003e\u003cem\u003eI. Chronic inflammatory demyelinating polyneuropathy 1, POEMS-Syndrome 1, Guillain-Barr\u0026eacute; Syndrome\u003c/em\u003e 1\u003c/div\u003e \u003cp\u003eB. \u003cb\u003eSafety\u003c/b\u003e\u003c/p\u003e \u003cp\u003eNo SAEs or AEs occurred during the study, and no negative side effects related with the use of the Myosuit or completion of therapy sessions were reported. However, approximately two-thirds of participants experienced pressure-related discomfort on their tibia caused by the Myosuit cuffs. This discomfort was transient and resolved immediately after the therapist repositioned the cuffs. No device malfunctions occurred. In two instances, only the leg straps had to be replaced; these adjustments did not lead to any interruption or safety issues.\u003c/p\u003e \u003cp\u003eC. \u003cb\u003eUsability\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThe SUS results revealed considerable variability in perceived Myosuit usability among patients, with a mean score of 60.8 (SD\u0026thinsp;=\u0026thinsp;13.2), indicating marginal acceptability overall. Scores ranged from 42.5 to 85, with most participants scoring between 52 (just above the \u0026ldquo;ok\u0026rdquo; threshold of 50.9) and 73 (just above the \u0026ldquo;good\u0026rdquo; threshold of 71.4) [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. This distribution suggests that, despite individual differences, most participants generally rated the device\u0026rsquo;s user-friendliness as ok to good, reflecting a slightly positive overall assessment.\u003c/p\u003e \u003cp\u003eTherapists rated the system\u0026rsquo;s usability slightly higher than patients, with a mean SUS score of 65.8 (SD\u0026thinsp;=\u0026thinsp;15.3). Individual scores ranged from 37.5 to 77.5, with most falling between 63.1 and 76.9\u0026mdash;above the high marginal acceptability threshold [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. Overall, these results indicate that therapists found the usability to be marginally acceptable, with several ratings reaching into the acceptable range. There was not a significant difference in the SUS ratings between patients and therapists (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eSUS and USE scores of patients and therapists\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParameters\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePatient, mean (SD)\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;13\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eTherapist, mean (SD)\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;6\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eEffect size (Cohen\u0026rsquo;s d)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ep-value*\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSUS (score)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e60.8 (13.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e65.8 (15.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUSE \u0026ndash; All items\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4.5 (0.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4.9 (0.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUSE \u0026ndash; Usefulness\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4 (1.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4.4 (1.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUSE \u0026ndash; Ease of Use\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4.4 (1.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5 (1.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUSE \u0026ndash; Ease of Learning\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.4 (2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e6.3 (1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUSE \u0026ndash; Satisfaction\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4.9 (2.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4.4 (1.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e*p-values are obtained using independent sample t-test for SUS scores.\u003c/em\u003e \u003c/p\u003e \u003cp\u003eThe USE scores obtained from both patients and therapists indicated that the Myosuit generally provided a good usability experience. All average USE subscale scores exceeded the neutral midpoint of 4 on the 1\u0026ndash;7 scale (1\u0026thinsp;=\u0026thinsp;strongly disagree, 7\u0026thinsp;=\u0026thinsp;strongly agree; 4\u0026thinsp;=\u0026thinsp;neutral), reflecting an overall positive user experience with the system. Patients reported a total USE score of 4.5 (SD\u0026thinsp;=\u0026thinsp;0.8), while therapists rated it slightly higher at 4.9 (SD\u0026thinsp;=\u0026thinsp;0.9). There was not a significant difference in the USE ratings between patients and therapist (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eAcross all subscales, therapists consistently gave higher ratings than patients, except for \u0026ldquo;Satisfaction,\u0026rdquo; where patients reported a slightly higher score (4.9 vs. 4.4). The highest ratings were found in the \u0026ldquo;Ease of Learning\u0026rdquo; dimension (patients: 5.4; therapists: 6.3), suggesting that both groups perceived the system as intuitive and easy to adopt. Although scores for \u0026ldquo;Usefulness\u0026rdquo; (patients: 4; therapists: 4.4) and \u0026ldquo;Ease of Use\u0026rdquo; (patients: 4.4; therapists: 5) were somewhat lower, they still remained above the neutral point, reinforcing the system\u0026rsquo;s overall usability and acceptability.\u003c/p\u003e \u003cp\u003eD. \u003cb\u003eFeasibility\u003c/b\u003e\u003c/p\u003e \u003cp\u003eOf 18 subjects initially approached, 15 started and ten completed the study, resulting in 83.3% recruitment, 33.3% attrition and 77.5% adherence rates (93 attended sessions of 120 offered sessions). Three participants declined to participate: one due to concerns about radiation exposure, and two because they found the use of a robot unnecessarily complicated. The assumption of radiation exposure possibly stems from a misunderstanding about the Myosuit's technology. However, the Myosuit does not emit any form of radiation. The therapist clarified this to the participant, explaining that the device operates with battery-powered motors and sensors, and poses no radiation-related risk. Of the five participants who withdrew early, two did so for device-related reasons: they found the Myosuit uncomfortable and felt unsafe while walking. Another two withdrew because they experienced rapid recovery and no longer required walking assistance. The final participant discontinued participation after starting chemotherapy at another hospital.\u003c/p\u003e \u003cp\u003eParticipants demonstrated increased independence with the Myosuit by their final training session compared to the first session. They exceeded expectations in achieving their targeted goals, except for donning the device, which had a GAS score below zero at the last session. Participants effectively mastered engaging in functional activities and doffing the device, frequently progressing from requiring therapist supervision to performing these tasks independently (average GAS score\u0026thinsp;\u0026gt;\u0026thinsp;0) at last training session. They were also able to operate the remote control only with verbal prompts from therapists (average GAS score\u0026thinsp;\u0026gt;\u0026thinsp;0). The only task that consistently required physical therapist support throughout the entire training period was donning the device (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe semi-structured interviews were completed by 13 patients. Eight of the 13 participants felt comfortable using the Myosuit. Positive responses often referenced feelings of safety, support, and increased confidence, especially when therapists\u0026rsquo; assistance and supervision were available or after a period of adaptation which was needed to adapt to the Myosuit\u0026rsquo;s physiological gait pattern. However, five participants expressed discomfort, citing issues such as feeling unsure while walking, the device being too tightly fitted, the backpack feeling too heavy, and orthoses being uncomfortable.\u003c/p\u003e \u003cp\u003eOf the 13 participants, six expressed a desire to continue using the Myosuit during further inpatient rehabilitation, while seven preferred to train without it. The expressed positive views emphasized perceived benefits such as support (\u0026ldquo;safe\u0026rdquo;), usefulness for specific patient groups (\u0026ldquo;specially for more impaired patients\u0026rdquo;), and continued improvements in endurance and walking posture (\u0026ldquo;the training still brings a lot of benefit\u0026rdquo;). They valued the concept, stating \u0026ldquo;the idea is good\u0026rdquo; and \u0026ldquo;because it helps.\u0026rdquo; Conversely, seven participants indicated they would not continue, preferring alternative approaches like strength training or free walking, describing themselves as already functioning well without assistance. Some felt the device was no longer necessary as they recovered (\u0026ldquo;not necessary anymore\u0026rdquo;, \u0026ldquo;I found it good for in between\u0026rdquo;, \u0026ldquo;I improved rapidly\u0026rdquo;) or cited issues with weight and practicality (\u0026ldquo;device too heavy\u0026rdquo;). For use in clinical setting, all 13 participants indicated they would recommend the Myosuit to individuals with similar conditions. Regarding home use, the responses indicate that five of 13 participants would consider buying or renting the Myosuit for personal use at a buying price of 10,000\u0026ndash;12,000 CHF. Interest was generally conditional\u0026mdash;primarily for situations where their health condition worsened or specifically for support on longer distances. Other positive remarks noted willingness to rent rather than buy, and only if the device would provide clear support for standing up and if its functioning is simplified. Most participants, however, declined\u0026mdash;citing factors such as not needing the device due to good recovery, too short time for a buying decision, the device being too complicated to use independently (especially for those with additional challenges like visual impairment), the device being too bulky or heavy, or simply not wanting to be seen in a robotic suit at home.\u003c/p\u003e \u003cp\u003eThe semi-structured interview was completed by all six therapists involved in the study. All six therapists would recommend the therapy with the Myosuit to other patients and therapists in the inpatient setting and enjoyed using the device. Five of six therapists think the Myosuit have potential for home-use, especially if the device is modified for greater simplicity and independence. Positive feedback highlights that the Myosuit could assist with daily living activities, is compact enough for home settings, and may suit younger or more independent users. Several participants suggested that simplifying donning/doffing and adding features like voice control would make solo use more feasible\u0026mdash;potentially increasing independence without needing help from another person. However, concerns remain: some doubted its suitability for older patients, and one respondent did not consider home use feasible in its current form, citing the need for significant assistance and the perceived safety of having a therapist present. Overall, the feedback suggests clear promise for home use, but underscores the need for targeted improvements to usability, donning procedure, and support features.\u003c/p\u003e \u003cp\u003eThe questions of the semi-structured interview, along with the corresponding \u0026ldquo;yes\u0026rdquo; and \u0026ldquo;no\u0026rdquo; answers without the comments, are provided in the Supplementary Material.\u003c/p\u003e \u003cp\u003eE. \u003cb\u003eEffectiveness\u003c/b\u003e\u003c/p\u003e \u003cp\u003eIn general, patients improved their functional abilities according to the clinical assessments (Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e). The FAC and DEMMI significantly improved at the end of the treatment compared to the start of the treatment with large effect sizes (0.9) for both scores. The improvements in the 6MWT and 10MWT were not statistically significant.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eGait performance of patients at the start and end of the study protocol\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"9\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eParameters\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eAt start, mean (SD);\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;13 or n\u0026thinsp;=\u0026thinsp;12 for 10MWT\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003eAt end, mean (SD);\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;13 or n\u0026thinsp;=\u0026thinsp;12 for 10MWT\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eEffect size*\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003ep-value*\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eFAC (score)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e3.5 (0.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e4.7 (0.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.05*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e6MWT \u0026ndash; distance (m)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e266.2 (123.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e347.1 (94.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003e0.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eDEMMI (points)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e58.8 (13.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e70.31 (14)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.05*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e10MWT \u0026ndash; walking speed (m/s)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e0.7 (0.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e0.8 (0.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003e0.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e10MWT \u0026ndash; cadence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e80.5 (19.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e87.9 (20.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003e0.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e10MWT \u0026ndash; step length (m)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e0.2 (0.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e0.6 (0.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003e0.3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e*p-values are obtained using paired t-test for 6MWT distance, DEMMI, 10MWT cadence, 10MWT step length, and Wilcoxon signed-rank test for FAC and 10MWT walking speed. Accordingly, Cohen\u0026rsquo;s d was computed for 6MWT distance, DEMMI, 10MWT cadence, 10MWT step length, and rank correlation was computed for FAC and 10MWT walking speed. P-values are corrected for multiple testing using the Holm-Bonferroni correction method.\u003c/em\u003e \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study evaluated the safety, usability, and feasibility of Myosuit-based gait training for individuals with neurological gait disorders in both clinical and home settings. The findings demonstrate that the use of the Myosuit in supervised settings is safe for gait rehabilitation in patients with various gait impairments, as evidenced by the absence of serious adverse events or negative side effects. Thirteen participants used the device repeatedly, and ten completed the entire training protocol without incident, confirming its suitability for facilitated training scenarios.\u003c/p\u003e \u003cp\u003eAccording to the SUS scale, usability was rated as marginally acceptable by patients and therapists, with therapists expressing a slightly more positive overall impression. On the USE scale, positive scores in ease of learning, satisfaction, and ease of use indicated favorable views of the device in both groups. Therapists perceived the system as useful for patients, whereas patients offered on average a more neutral assessment on this matter.\u003c/p\u003e \u003cp\u003eRecruitment and adherence rates were favorable. Most functional training goals were achieved, including walking and training with the Myosuit under supervision. Importantly, assistance does not necessarily require the continuous presence of a therapist. The main task where users consistently needed physical help was donning the device. Once fitted, most participants could walk and perform functional tasks with the Myosuit under supervision or independently. This assistance could be provided by an assistant, a trained caregiver or family member rather than a clinician, meaning that daily operational support could, in principle, be supplied by non-clinical personnel after appropriate training. This expands the potential for Myosuit use beyond traditional in-clinic rehabilitation environments and opens opportunities for home-based implementation.\u003c/p\u003e \u003cp\u003eSemi-structured interviews revealed that eight of thirteen felt increasingly comfortable with the Myosuit after initial uncertainty and discomfort, typically resolving with a dedicated adaptation period. Six participants wished to continue using the Myosuit in inpatient rehabilitation; the remaining seven preferred alternative methods, especially due to rapid improvement. All patients reported that they would recommend the Myosuit to others in similar situations, indicating high acceptability and perceived usefulness in supervised clinical settings.\u003c/p\u003e \u003cp\u003eTherapists consistently recommended the Myosuit for clinical use to other therapists and to their patients, emphasizing its value as a training tool for moderate gait impairment. They also highlighted the critical importance of proper patient selection, device familiarization, and adequate assistance. Several therapists noted that improvements in donning and remote control would further increase the device's suitability for home use.\u003c/p\u003e \u003cp\u003eFor independent or home use, patients\u0026rsquo; interest declined sharply due to perceived complexity and hesitancy regarding autonomous operation, or because patients no longer needed the device due to rapid improvement; only five of 13 participants were willing to rent or buy the device for use outside a clinic under a person\u0026rsquo;s supervision. The central challenge\u0026mdash;independent donning and operation of the remote control\u0026mdash;was frequently cited. Concerns about social acceptance when seen with the device were mentioned only by one patient.\u003c/p\u003e \u003cp\u003eClinical assessments indicated significant improvements in both FAC and DEMMI scores at post-treatment, confirming the potential therapeutic benefit of usual care plus Myosuit gait training in improving mobility. We also observed improvements with respect to the 6MWT and 10MWT that, however, were not statistically significant.\u003c/p\u003e \u003cp\u003eImportantly, both patients and therapists identified the device as being most useful during a specific phase of rehabilitation\u0026mdash;when patients still felt unsafe or required walking aids or personal support (FAC: 2\u0026ndash;3). If rapid improvement occurred and patients no longer needed gait support from the device, the Myosuit was sometimes perceived as limiting rather than supportive. Interview responses emphasized the importance of carefully selecting the optimal rehabilitation period for Myosuit use, while ensuring that personal assistance or supervision was provided until users felt safe engaging in gait training with the device more independently.\u003c/p\u003e \u003cp\u003eTaken together, these data suggest that the greatest barrier to independent home use is the donning process, not the actual walking or training once fitted. This points to a potentially scalable solution: a hybrid home rehabilitation model, where the patient performs regular training sessions in the home environment with the help of a trained caregiver, but with scheduled therapist oversight once or twice per week. In this model, the caregiver would assist with donning and provide basic safety physical assistance and supervision, while the therapist\u0026mdash;either in person or via tele-rehabilitation\u0026mdash;would periodically reassess progress, adjust parameters, and address functional or technical issues. This approach could optimize rehabilitation resources, extend therapy beyond the clinic, and sustain patient engagement while maintaining safety standards.\u003c/p\u003e \u003cp\u003e \u003cb\u003eLimitations and future work\u003c/b\u003e \u003c/p\u003e \u003cp\u003eThis study\u0026rsquo;s modest sample size and the lack of a control group limit its generalizability. The inclusion of a broad range of neurological diagnoses enhanced external validity, but made it challenging to determine which specific subgroups benefit most. Focusing future studies on particular conditions could help clarify which patient characteristics predict optimal use. In rehabilitation, therapists frequently encounter diverse patient types and diagnoses. Notably, this protocol closely mirrors real-world clinical practice, as patients were enrolled sequentially once therapists identified that they could benefit from Myosuit gait training. The protocol did not allow structured analysis of long-term impacts on quality of life, secondary health conditions, or user satisfaction in daily, unsupervised settings; ongoing research should investigate the broader effects of integrating exosuits into at-home and community rehabilitation programs.\u003c/p\u003e \u003cp\u003eQualitative data collection remains crucial. Laboratory-based results are useful but may miss real-world usability challenges and psychosocial barriers such as motivation, social stigma, and perceived autonomy.\u003c/p\u003e \u003cp\u003eFuture research should therefore test the hybrid caregiver-plus-periodic-therapist-supervision model in larger and more targeted patient cohorts and examine its cost-effectiveness and resource optimization potential compared with traditional therapy schedules. It should also investigate patient motivation, acceptance, and quality-of-life changes associated with sustained Myosuit training in the home and community, and guide device redesign to simplify donning and enhance autonomy.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eMyosuit-based gait training was safe and feasible for patients with neurological gait impairments under supervision and could produce meaningful functional improvements when combined with usual care. Most participants rated usability between \u0026ldquo;ok\u0026rdquo; to \u0026ldquo;good\u0026rdquo;, with learnability and perceived effectiveness recognized by both patients and therapists. The primary barrier to independent home use is the donning process, which currently necessitates physical assistance.\u003c/p\u003e \u003cp\u003eOur findings support a hybrid rehabilitation model as a practical solution. This arrangement could preserve therapist time for higher-level clinical tasks, increase training frequency, improve long-term outcomes, and extend access to intensive gait rehabilitation into the home setting.\u003c/p\u003e \u003cp\u003eFuture studies should evaluate the safety, efficacy, and cost-effectiveness of this hybrid model to determine its potential for wide-scale integration into neurological rehabilitation programs.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eAE\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eAdverse Event\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSAE\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eSerious Adverse Event\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eFAC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eFunctional Ambulation Categories\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e6MWT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003e6-Minute Walk Test\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e10MWT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003e10-Meter Walk Test\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eDEMMI\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eDe Morton Mobility Index\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSUS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eSystem Usability Scale\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eUSE\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eUsefulness, Satisfaction and Ease of Use Questionnaire\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRZS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eRehabilitation Center Zihlschlacht\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003em\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMeter\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003em/s\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMeters per second\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe local Ethics Committee of Eastern Switzerland (EKOS) approved the study design and protocol (REF.-NR.: BASEC 2022-D0059). Written informed consent was obtained from all participants prior to the start of the study. \u0026nbsp; The study is registered at ClinicalTrials.gov (Identifier: NCT05485597).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;All participants provided written informed consent for the publication of study results and images.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe Rehaklinik Zihlschlacht AG\u0026nbsp;funded this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contribution\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCT and LP designed the study, led data collection and analysis. CT wrote the manuscript. DM and CM assisted in designing the study. AM led portions of data analysis, interpretation of results, and assisted in writing the manuscript. LP was the principal investigator, conceived, designed, and led the study, interpreted the data, and assisted in writing the manuscript. All authors read and approved the final manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank all patients and staff who participated in this study for their valuable support during the training sessions and data collection.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors details\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCarmel Tulen (Tulen C)\u003csup\u003e1\u003c/sup\u003e, Jens C. M\u0026ouml;ller (M\u0026ouml;ller JC)\u003csup\u003e3\u003c/sup\u003e, Detlef Marks (Marks D)\u003csup\u003e1\u003c/sup\u003e, Adriana Mohap (Mohap A)\u003csup\u003e2\u0026nbsp;\u003c/sup\u003eand Liliana P. Paredes (Paredes LP)\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e1\u0026nbsp;\u003c/sup\u003eRehaklinik Zihlschlacht AG, Hauptstrasse 2, 8588 Zihlschlacht.\u003csup\u003e\u003cbr\u003e\u0026nbsp;2\u0026nbsp;\u003c/sup\u003eBiomedical Data Science Lab, ETH Zurich, Lengghalde 2, 8008 Zurich\u003cbr\u003e\u0026nbsp;\u003csup\u003e3\u0026nbsp;\u003c/sup\u003eNeurologie FMH, H\u0026ocirc;pital fribourgeois, Chemin du Village 24, 3280 Meyriez-Murten\u003c/p\u003e\n\u003cp\u003eCorrespondence to:\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eLiliana Paredes, Biomedical Data Science Lab, ETH Zurich, Lengghalde 2, 8008 Zurich. 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FDA issues clearance for the ReStore\u0026trade; Exo-Suit, the first soft robotic system for stroke therapy. \u003cem\u003eCision PR Newswire\u003c/em\u003e. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://ir.golifeward.com/news-releases/news-release-details/fda-issues-clearance-restoretm-exo-suit-first-soft-robotic\u003c/span\u003e\u003cspan address=\"https://ir.golifeward.com/news-releases/news-release-details/fda-issues-clearance-restoretm-exo-suit-first-soft-robotic\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e Suggests Myosuit Reduces Knee Extensor Demand during Level and Incline Gait. \u003cem\u003eSensors\u003c/em\u003e, \u003cem\u003e22\u003c/em\u003e(16), 6127. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.3390/s22166127\u003c/span\u003e\u003cspan address=\"10.3390/s22166127\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBrooke J. SUS-A quick and dirty usability scale. Usability evaluation Ind. 1996;189(194):4\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGao M, Kortum P, Oswald F. (2018). Psychometric Evaluation of the USE (Usefulness, Satisfaction, and Ease of use) Questionnaire for Reliability and Validity. \u003cem\u003eProceedings of the Human Factors and Ergonomics Society Annual Meeting\u003c/em\u003e, \u003cem\u003e62\u003c/em\u003e(1), 1414\u0026ndash;1418. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1177/1541931218621322\u003c/span\u003e\u003cspan address=\"10.1177/1541931218621322\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBangor A, Kortum P, Miller J. Determining what individual SUS scores mean: Adding an adjective rating scale. J usability Stud. 2009;4(3):114\u0026ndash;23.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTurner-Stokes L. Goal attainment scaling (GAS) in rehabilitation: a practical guide. Clin Rehabil. 2009;23(4):362\u0026ndash;70. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1177/0269G215508101742\u003c/span\u003e\u003cspan address=\"10.1177/0269G215508101742\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHarris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN, REDCap Consortium. The REDCap consortium: building an international community of software platform partners. J Biomed Inform. 2019;95:103208. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.jbi.2019.103208\u003c/span\u003e\u003cspan address=\"10.1016/j.jbi.2019.103208\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Myosuit, neurological conditions, walking impairment, gait training, usability, feasibility, efficacy","lastPublishedDoi":"10.21203/rs.3.rs-8360563/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8360563/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eLightweight, wearable robots such as the Myosuit are promising tools for inpatient gait rehabilitation and may facilitate transition of gait training to the home environment. Evidence on their usability and feasibility in both settings is limited. This study examined the safety, usability, and feasibility of Myosuit-based gait training in neurological inpatients, with attention to potential home-based training applications.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis interventional, open-label, non-randomized study involved inpatients with neurological gait disorders, all first-time Myosuit users. The program, additional to routine rehabilitation, comprised eight 45-minute training sessions over four weeks. Safety was monitored via adverse events/side effects. Usability was assessed with the System Usability Scale (SUS) and the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE). Feasibility measures included recruitment, attrition, and adherence rates, independent use, and motivation. Secondary outcomes were the Functional Ambulation Category (FAC), 10-meter Walk Test, 6-minute Walk Test, and de Morton Mobility Index (DEMMI).\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eFifteen patients enrolled; ten completed the study. Adherence averaged 77.5%. No adverse events occurred. Usability was rated marginally acceptable by patients (SUS 60.77\u0026thinsp;\u0026plusmn;\u0026thinsp;13.17; USE 4.53\u0026thinsp;\u0026plusmn;\u0026thinsp;0.76) and therapists (SUS 65.83\u0026thinsp;\u0026plusmn;\u0026thinsp;15.30; USE 4.87\u0026thinsp;\u0026plusmn;\u0026thinsp;0.89). Once the device was donned, patients were able to perform all tasks with at least supervision but always required physical assistance for donning. All ten completers recommended Myosuit for clinical use; five would consider home use, typically conditional on disease progression and specific functional needs. All six therapists recommended it; five saw home potential if simplified. FAC and DEMMI improved significantly.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eMyosuit-based gait training appears safe, feasible, and usable for neurological inpatients under supervision, with functional gains observed when it is combined with usual care. The need for physical assistance was concentrated in donning, suggesting that this should be performed by a therapist or at home by a trained caregiver. These findings support a hybrid home-rehabilitation model in which patients begin training in clinic and, after initial learning and adjustments, continue training regularly with caregiver assistance, complemented by periodic therapist oversight (for example, once or twice weekly) to adapt therapy, troubleshoot and ensure safety. This approach can help optimize clinical resources, sustain engagement and expand access to intensive gait rehabilitation beyond the clinic.\u003c/p\u003e\u003ch2\u003eTrial registration\u003c/h2\u003e \u003cp\u003eThis study was registered under ClinicalTrials.gov (Identifier NCT05485597)\u003c/p\u003e","manuscriptTitle":"Usability and Feasibility of Myosuit-Assisted Gait Rehabilitation Training in Neurological Patients","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-11 14:40:06","doi":"10.21203/rs.3.rs-8360563/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"7486f196-28b4-4cad-99f7-5e9cb546895b","owner":[],"postedDate":"February 11th, 2026","published":true,"recentEditorialEvents":[{"type":"decision","content":"Rejected","date":"2026-05-09T11:27:32+00:00","index":"","fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-05-09T11:41:58+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-11 14:40:06","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8360563","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8360563","identity":"rs-8360563","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}