Examining the Feasibility and Preliminary Effects of Eyes-Open and Eyes-Closed Backward Treadmill Training on Balance, Mobility, and Fear of Falling in Sub-Acute Stroke Survivors: A Pilot Randomized Clinical Trial

Examining the Feasibility and Preliminary Effects of Eyes-Open and Eyes-Closed Backward Treadmill Training on Balance, Mobility, and Fear of Falling in Sub-Acute Stroke Survivors: A Pilot Randomized Clinical Trial | 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 Examining the Feasibility and Preliminary Effects of Eyes-Open and Eyes-Closed Backward Treadmill Training on Balance, Mobility, and Fear of Falling in Sub-Acute Stroke Survivors: A Pilot Randomized Clinical Trial Nawaj Mehtab Pathan, Rahul Saxena, Chandan Kumar This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5170733/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 07 Apr, 2026 Read the published version in Pilot and Feasibility Studies → Version 1 posted 5 You are reading this latest preprint version Abstract Introduction: Gait impairment among stroke survivors is a prevalent and significant issue that necessitates appropriate rehabilitation interventions to address multiple factors such as muscle strength, balance, and coordination. One recommended approach for improving gait function is physical therapy, which helps to improve strength, balance, and coordination by reducing muscle weakness, spasticity, and tone. Other interventions that have demonstrated efficacy in enhancing gait function and mobility among stroke survivors include task-specific, high-velocity gait training. The effects of backward treadmill training were comparable to or superior to those of forward treadmill training in improving balance, gait speed, and stride length. Backward treadmill training can be considered as a potential rehabilitation intervention for stroke survivors with gait impairments. Methods: This study will be a two-arm, double-blinded, 4-week pilot, randomised clinical trial involving 4-week interventions & 2 weeks follow-up. Forty subacute stroke survivors will be recruited from a tertiary care hospital in India. The study participants will be randomly assigned to either the eyes-open backward treadmill training group EOBT(n=20) or the eyes-closed backward treadmill ECBT training group (n=20). The participants in both groups will receive 4-week interventions and standard care. Standard care consists of self-management exercises printed in a booklet. The primary outcomes will include a series of feasibility assessments of the study protocols about the study’s methodological procedures, including subject recruitment and follow-up processes, completion of study protocols, and feasibility acceptability and safety of the intervention such as balance, gait, and fear of fall, which will be evaluated using the Berg Balance Scale, Timed Up and Go Test, and Fall Efficacy Scale. Ethics and Dissemination: Ethical approval was obtained from the Institutional Ethical Committee of Sharda University (Ref No-SU/SMS&R/76-A/2022/73). The research results will be presented at conferences and disseminated through scientific journals subject to peer review. Trial Registration Number: -CTRI/2023/08/056653. Figures Figure 1 Introduction Cerebrovascular accidents are the second leading cause of disability and rank third among all diseases responsible for universal debilitation. 1 . The authors of a study conducted primarily among the Indian population have expressed concern about the steadily increasing stroke incidence rate in India, which is notably higher than that of high-income countries. 2 . The findings from their research on the balance and mobility problems faced by stroke survivors are critical, as the persistence of these issues can lead to a decline in daily motor activities, increasing the risk of falls. However, regaining walking abilities can help stroke patients actively participate in various aspects of life. 3 . According to the findings of their respective studies; it is estimated that approximately 60% of stroke survivors encounter difficulties in overcoming mobility-related impairments. 4 . Several studies have highlighted potential mechanisms that can cause mobility impairments as a result of damage to the central nervous system. These changes can significantly impact the walking speed and distance covered by patients, as well as their ability to walk independently. 5 , 6 , 7 . The combined effects of these changes impede an individual's ability to function normally and result in an uncommon pattern of behaviour. In stroke patients, clinical presentations often show signs of weakness, disrupted movement regulation mechanisms, altered muscle tone, and impaired sensory systems, all of which significantly impact the mobility aspects of stroke survivors. 8 . The Body Weight Support treadmill (BWSt) has become a popular choice for stroke patients undergoing rehabilitation due to its convenience and effectiveness in promoting proper and structured gait training during the initial stages of recovery. 9 . The incorporation of treadmill interventions in conjunction with a bodyweight harness system aims to rectify gait irregularities and address unsynchronised stepping patterns. 10 . The use of robotics in supporting manoeuvres is becoming increasingly inevitable. It primarily aims to bolster the typical gait pattern following a CVA. Repetitively performing these tasks and movements stimulates the motor cortex, accelerating positive neural networking within the CNS. 11 The importance of custom-designed gait training programs, which specifically focus on improving the weight-bearing capabilities of the impaired limb through guided cues, has been emphasised. It has been confirmed that these interventions offer additional benefits. 12 . During the initial stages of motor recovery, stroke survivors who exhibit increased muscle strength and engage in more functional activities are considered significant indicators of cortical-level neuroplastic changes. Nevertheless, it is essential to recognise that reticulospinal excitability suggests a poor prognosis for motor performance and CNS activation mechanisms. 13 . The researchers in their clinical trials found that treadmill-based gait training benefited subacute stroke patients. They suggested it could be effective when combined with task-oriented therapy and other conventional physiotherapy interventions. Previous studies have shown that treadmill training can improve gait and balance in stroke survivors, but there is little agreement on the impact of blocking vision during backward treadmill training. Additionally, many studies were not descriptive or analytical, making it difficult to determine the outcomes of blocking vision during backward treadmill training among stroke patients. 14 , 15 . Blocked vision treadmill training is recommended to improve knee proprioception, equilibrium, and gait in children with diplegic cerebral palsy. 16 The author highlights the practicality of treadmill training with eyes closed for enhancing proprioceptive output, emphasising the potential benefits of this approach. 17 Although no studies have been explicitly conducted among the Indian stroke population to assess the feasibility of backward treadmill training with blocked and unblocked vision, a few studies have compared the therapeutic effects of backward treadmill training with blocked vision with eyes open. However, insufficient data is available to directly compare the interventional effects of backward treadmill training with eyes open and closed. Therefore, the present feasibility study aimed to gather preliminary estimates of the efficacy of backward treadmill training with closed eyes in stroke patients. Stroke survivors often experience gait and mobility impairments, significantly impacting their functional capacity and overall quality of life 18 . Stroke is a significant contributor to global disability, accounting for an estimated 80% of all cases, according to official statistics. 19 . In 2016, it was reported that there were 1 million prevalent cases and 116.4 million disability-adjusted life-years. Gait impairments are a common occurrence among stroke survivors, with more than 80% experiencing them. Approximately 25% of all stroke survivors continue to experience long-term residual gait impairments. 20 . Traditional gait interventions may not always enhance motor recovery and functional outcomes in stroke survivors, despite being used to improve gait function on the ground or treadmill with or without body weight support. In addition, it is essential to develop innovative and effective solutions for individuals who have experienced stroke and continue to exhibit gait impairments, as these individuals require assistance in regaining their independence and mobility. 21 . Body weight-supported treadmill training and targeted exercises have been found to enhance gait functionality in stroke survivors. This form of treadmill training provides partial support through a harness while the individual walks. It has been shown to improve gait speed, stride length, and endurance for those with chronic hemiparesis. Exercises focusing on strengthening, balance, and coordination can help reduce muscle weakness, spasticity, abnormal muscle tone, and unbalanced muscle activation, leading to better gait function. 22 . It is essential to acknowledge that the gait and mobility impairments experienced by stroke survivors are complex and multi-faceted. 23 The recovery of gait in stroke survivors is influenced by various factors, including the severity of the initial injury, the location of the lesion, age, pre-stroke mobility level, and other medical conditions. Moreover, the effectiveness of different interventions in promoting gait function may differ substantially among stroke survivors. 24 . A tailored treatment approach is crucial for the rehabilitation of patients with gait limitations due to stroke. 25 Obesity is a contributing factor to walking impairment in stroke survivors, emphasising the importance of personalised rehabilitation programs to improve gait function. Gait disturbance is a common issue among stroke survivors, impacting their functional independence and mobility. Effective rehabilitation programs must consider the unique needs of stroke survivors to address gait impairment. 26 Stroke survivors commonly experience walking dysfunction, which affects 80% of them. One of the most common symptoms of post-stroke gait is gait asymmetry, which can make the rehabilitation process more challenging. Prior research has found that impaired balance and gait increase the likelihood of falls in stroke survivors. 27 . To rehabilitate stroke survivors' gait successfully, adopting a holistic approach that considers multiple impairments and aims to help them achieve greater independence in their daily lives is crucial. Gait impairment is a significant factor that contributes to long-term post-stroke disability. Therefore, it is necessary to develop a comprehensive and personalized rehabilitation plan that addresses the various contributors to gait impairment in stroke survivors. 28 Gait impairment is a common and severe problem that requires comprehensive rehabilitation interventions to address various aspects, such as muscle strength, stability, and synchronization. Physical therapy is recommended to improve muscle strength, balance, and coordination, reducing muscle weakness, spasticity, and tone. Other effective interventions for enhancing gait function and mobility in stroke survivors include task-specific high-velocity gait training. 29 This form of training has been demonstrated to be more effective in enhancing walking speed and functional mobility among stroke survivors than conventional gait training. However, it's crucial to recognise that the efficacy of interventions may differ among individuals recovering from a stroke, and treatment strategies must be personalised accordingly. In summary, gait impairments after a stroke can significantly impact the functional independence and mobility of stroke survivors. A holistic approach that addresses various aspects, such as muscle strength, stability, and coordination, is necessary to achieve optimal gait rehabilitation outcomes. 30 Gait impairments in stroke survivors can significantly impact their walking speed, dynamic mobility, and risk of falling. These issues can arise from various impairments, such as muscle weakness, spasticity, and balance problems. Comprehensive and personalised rehabilitation programs are necessary to improve gait. Researchers have also investigated the potential of implanted functional electrical stimulation as a treatment option for stroke survivors with gait impairments. 31 Stroke survivors experience various physical limitations that can impact their gait and mobility. Despite the prevalence of gait impairment, more research is necessary to determine the effectiveness of interventions in improving mobility and gait function. Addressing gait impairment is crucial for promoting functional independence and reducing the risk of falls, while vocational rehabilitation can support reintegration into the workforce and improve overall quality of life. Approximately 80% of stroke survivors experience gait impairment, and even with rehabilitation, a quarter of them still require full physical assistance. 32 Gait impairments can increase the risk of falls, leading to fracture injuries and further restrictions on activity and mobility. Rehabilitation interventions aim to improve gait and mobility using traditional methods with or without body weight support. 33 The efficacy of backward treadmill training in enhancing stroke survivors' postural abilities and gait function has been documented in recent studies. The effects of backward treadmill training were comparable or superior to those of forward treadmill training in improving balance, gait speed, and stride length. 34 Therefore, backward treadmill training can be considered a potential rehabilitation intervention for stroke survivors with gait impairments. According to research, early rehabilitation in the subacute phase is generally more effective than delayed rehabilitation. Despite the development of advanced rehabilitation technologies, such as robotic and exoskeleton-assisted hand rehabilitation and MI-based BCI systems, stroke survivors continue to face challenges in regaining adequate hand and finger function. 35 Further research and development are necessary to enhance stroke rehabilitation outcomes. Effective rehabilitation should address both gait deficits and the underlying impairments that contribute to them while also offering functional practice for daily activities, including vocational rehabilitation. Individualized rehabilitation programs incorporating traditional interventions, targeted exercises, and advanced technologies are essential for stroke survivors. These programs should be tailored to their specific needs and focus on early intervention during the subacute phase for optimal recovery. In addition, providing greater access to vocational rehabilitation programs that facilitate the reintegration of stroke patients into the workforce or support their engagement in work-related activities can play a crucial role in enhancing their quality of life and independence. 36 Methods And Materials Study Design The study design will be a two-parallel arm, single-blinded (assessor) pilot RCT. The participants will be randomly allocated into two groups: a backward treadmill training intervention with eyes open group and a backward treadmill training with eyes closed group, with an allocation ratio of one to 1. The study will be conducted for four weeks, involving four weeks of backward treadmill training interventions or a two-week follow-up for both groups. The consolidated standards for reporting the trial flow chart and SPIRIT Checklist of this study are presented. Study Setting This study will be conducted at a torsional physiotherapy center in Chh-Sambhajinagar and other stroke clinics. *EOBTT - Eyes Open Backward Treadmill Training. * ECBTT - Eyes Closed Backward Treadmill Training. Sample Size Calculation A minimum of 30 participants in each group will be classically endorsed for the pilot studies to evaluate the feasibility of the intervention 8 and to estimate the between-group effect for subsequent power analysis in the main study 9 . The intervention protocol will be calculated by fitting, with a sample size of 30 participants per group, given the primary goal of this study, which is to assess the acceptability and feasibility of the study's approach. The ultimate sample size will consist of 40 individuals per group, for a total of 80 participants, to account for an expected 20% dropout rate. Inclusion and exclusion criteria Eligible study participants will be recruited preferring the following inclusion criteria: The patients will give written consent to participate in the study if they are willing to do so. First-ever stroke. Stroke occurrence within 1–3 months (subacute phase). The age groups ranged from 30 to 65 years. Both sexes will be included in the study. Patients with or without ambulatory aid. Patients who can follow commands. Able to speak and understand Marathi, Hindi language A Score ranging from 21–40 on the BBS was used in this study. Non-eligible study participants will be excluded, preferring the following exclusion criteria: - Any other neurological injury affects balance and mobility. Presence of contractures in unilateral or bilateral lower limbs. Limited passive range of motion of the lower limbs. Have an orthopaedic injury that impairs balance. Extremely frail (unable to recognise proprioceptive and sensory sensations due to severe other systematic disorders, e.g., Chronic diabetes, Multiple sclerosis, Parkinson’s disease, etc.) Have scheduled other therapy sessions within the trial period. Recruitment A research team will be formed before the commencement of the trial. Three investigators, including the principal investigator and two neuro physiotherapists, will be primarily responsible for participant recruitment and backward treadmill training interventions with the eyes open and closed. The investigators will receive intensive training from a qualified Neurophysiotherapist to safeguard standardised backward treadmill training interventions with eyes closed and open. Before the backward treadmill with eyes closed and open interventions, a neuro physiotherapist scrutinised the safety of the study participants by standing from the back of the study participant, encouraging them to grasp handrails, and providing verbal cues. Two research assistants will conduct the data collection and telephone follow-up. To ensure the quality of data collection, the two research assistants will be trained in outcome measurements at the pre-and post-intervention levels, including understanding the safety procedures and instructions that standardise their conversations with the participants. The academic supervisors of the doctoral investigator will monitor the entire study procedure on an ongoing basis through regular 2-week follow-ups. Potential study participants visiting the Neurophysiotherapy outpatient department will be recruited directly by the principal investigator and two research assistants. A participant information sheet, including the study investigators' research aim, procedures, and contact details, will be provided to potential participants and explained by the doctoral investigator and two Neurophysiotherapists. Potential participants who indicated a desire to participate in the research will be screened for eligibility based on the inclusion and exclusion standards established by the doctoral investigator and two Neurophysiotherapists. Once they consented to participate, they had to give written informed consent. Participants will be advised that there are no repercussions if they decide to leave the study at any time. Randomisation and allocation concealment The pilot trial will be randomised and controlled in a 1:1 allocation ratio. Based on the estimated sample size, one set of randomisation sequences was generated using an online randomiser: https://www.randomizer.org . To ensure allocation concealment, randomisation sequences will be accomplished by a statistical expert who will not participate in any other part of the study. Specifically, the statistician will use an online randomiser to generate randomisation sequences, including 20 even and 20 odd numbers. Only statisticians will have access to randomisation sequences. The two clinical neurophysiotherapists will call the statistician to decide which group the patient should be allocated to based on predetermined random numbers when the eligible participant consents to participate in the study and finishes the baseline evaluation. Either the backward treadmill training with the eyes open intervention group or the backward treadmill training with the eyes closed intervention group will be randomly assigned to the participants. Blinding Due to the visible nature of the backward treadmill training groups with eyes open and closed, blinding the study investigators and participants was impossible. Thus, blinding will be applied only to this pilot RCT's outcome assessors (i.e., the two research assistants) to avoid potential detection bias during data collection. The two research assistants will be responsible for data collection and telephone follow-up and will not be involved in the participant-related recruitment process. Backward Treadmill Training Group with Eyes Open Along with the typical care given to both intervention groups, participants received backward treadmill training with their eyes open. The intervention regimen will last 60 minutes per session, three sessions per week, for four weeks, based on current research evidence, practice standards/guidelines, theories, and experts’ consensus. To ensure the participants fully mastered backward treadmill training with their eyes open. Before the commencement of the intervention, they will receive at least three 10-minute training sessions until they are accustomed to the before movements correctly and smoothly, along with a home-learning method in an audio-visual format (i.e., a recorded video of their own). Training will be conducted and led by a doctoral investigator or two neurophysiotherapists, and attendance will be recorded. Participants in both intervention groups underwent backward treadmill training with their eyes open in addition to the standard therapy. Based on current research findings, practice standards and guidelines, theories, and expert consensus, the intervention routine will include three weekly sessions, each lasting sixty minutes. For a total of four weeks to guarantee that the participants achieved complete mastery of backward treadmill training while keeping their eyes open. In addition to a home-learning technique in an audio-visual format (i.e., a recorded video of their own), students will receive at least three 10-minute training sessions before the start of the intervention until they become habituated to the prior movements correctly and smoothly. Two neurophysiotherapists or a PhD researcher will administer and supervise the training, and attendance will be tracked. Under the supervision of neurophysiotherapists, each participant will be required to perform backward treadmill training with their eyes open for five minutes while receiving verbal cues and then for the next five minutes without verbal cues to ensure they were performing without hesitation. The neurophysiotherapist will also show the participants the video analysis from the previous training session to ensure they completed the task correctly. For sixty minutes, this group will receive backward treadmill training with their eyes open in addition to standard/routine care. It will include the following components. A ten-minute warm-up, followed by 30 to 45 minutes of regular treatment, includes strengthening, proprioceptive training, slow, sustained stretching exercises, active-assisted upper and lower limb motions, and active-assisted gait training on level surfaces. The various positions practised on the balance board trigger proactive balancing reactions by moving the body weights sideways, front, and backward. Concurrent activation of standing on one leg facilitates the protective responses in various ways. The gait interventions included mobility exercises on level surfaces, training with multiple barriers such as tiny height steppers, rolls, and cones for stepping down from stair climbers, training with parallel bars for walking, and a 10-minute cool-down. Each backward treadmill training session will include a 2-minute rest period if requested by the participants. The backward treadmill training intervention protocol will be modified in clinical practice to create a customised intervention suited to the participant's convenience and preferences concerning the intervention's time and location. Participants will receive a specially designed exercise log to record details about their backward treadmill training practice as soon as possible after each session. This log will include information about the length and frequency of breaks during the backward treadmill training sessions and any potential adverse reactions, such as dizziness, knee pain, musculoskeletal aches, and pain. The research assistants will receive the exercise logs on the day of the individual interventions or OPD follow-up sessions. To improve the participants' compliance with the backward treadmill training intervention, the research assistants will call them every other day to remind them to watch videos and practice at home and to get information about any potential issues they may be having. Backward treadmill training group with eyes closed Participants in both intervention groups will get backward treadmill exercises with their eyes closed in addition to the standard treatment they receive. Based on current research outcomes, practice standards, guidelines, theories, and expert consensus, the intervention regimen will consist of three sessions per week, 60 minutes each, lasting for four weeks. To ensure that participants fully master eye-closed reverse treadmill training, they will receive at least three 10-minute training sessions before the intervention begins. These sessions will help them adapt to the treadmill movements accurately and smoothly. Additionally, participants will have access to a home learning technique in an audio-visual format, including a recorded video of themselves. Two neurophysiotherapists or a PhD researcher will administer and facilitate the training, and attendance will be tracked. To ensure they will not tremble, all participants must do backward treadmill training with their eyes closed while being watched by neurophysiotherapists. This will involve five minutes of verbal feedback and monitoring, followed by five minutes without verbal cues. The neurophysiotherapist will also show the participants the video analysis from the previous training session to ensure they completed the task correctly. For sixty minutes, this group will receive backward treadmill exercise with their eyes closed in addition to standard/routine care, which includes the following: A 10-minute warm-up, followed by 30 to 45 minutes of regular treatment that provides for strengthening, proprioceptive training, slow, prolonged stretching exercises, active-assisted upper and lower limb movements, and active-assisted gait training on level surfaces. The body weight moving forward, backwards, and sideways from various postures on the balance board elicited proactive balancing reflexes. The sequential activation of standing on one leg facilitates reaction protection in multiple ways. Mobility exercises on level terrain, training with various obstacles, such as short height steppers, rolls, cones for stepping down from stair climbers, training with parallel bars for walking, and a 10-minute cool-down were all part of the gait interventions. Participants can take a 2-minute break at the end of each backward treadmill training session. The backward treadmill training intervention protocol will be adjusted in clinical practice to offer a customised intervention according to the participant's convenience and preferences about the time and place of the intervention. Immediately following each backward treadmill training session, participants will receive a specially designed exercise log to record information about their practice, including the length of time they spent on the backward treadmill, how often they took breaks, and any potential adverse reactions, such as dizziness, knee pain, musculoskeletal aches, or pain. The research assistants receive the exercise logs on the day of the individual interventions or OPD follow-up sessions. To help participants better adhere to the backward treadmill training intervention, the research assistants will contact them every other day to remind them to view videos and practice at home. Additionally, they will be able to answer any inquiries regarding the program. Results of the feasibility study and the previously established success criteria The following predetermined criteria will be used to evaluate the viability of this pilot study: Adherence Rate : The percentage of backward treadmill training sessions completed, calculated by dividing the total number of needed sessions by the number of completed sessions, will be used to monitor adherence. A minimum adherence rate of 75% will be used for the intervention to be deemed sufficiently engaging. Participant Satisfaction : A self-designed feedback form will gauge participant satisfaction with the intervention right after the intervention phase (T2). A mean satisfaction score of four out of five on this feedback form will suggest an optimistic acceptance of the intervention. Adverse Events : Participants' exercise diaries will track adverse occurrences to assess the intervention's safety. A low incidence of serious adverse events—less than 10% of participants will have notable adverse events over the study period—will be the criterion for success in safety. Completion of Exercise Logs : Participant engagement in tracking and reporting their experiences will be assessed by the percentage of participants who complete exercise logs consistently throughout the intervention. A completion rate of at least 80% will indicate adequate engagement in logging and reporting intervention experiences. Analysis of Feasibility Outcomes The analysis of feasibility results will employ descriptive statistics, such as mean, standard deviation, frequency counts, and percentages, to summarize exercise log completion rates, adherence, satisfaction, and adverse occurrences. Based on the criteria satisfied in this pilot study, the results of this descriptive approach will give a general picture of the intervention's acceptability and feasibility, and they will help guide any protocol modifications for subsequent research. Outcome Measurements and Follow-Up The outcome measurements for this pilot RCT included three categories: baseline assessment, feasibility and acceptability outcomes, and clinical outcomes. The feasibility and acceptability outcomes will be the primary outcomes, whereas the clinical outcomes will be the secondary outcomes. Two research assistants will conduct all outcomes and follow-ups. The participants' clinical and demographic characteristics The participants' sociodemographic information will be gathered using a self-designed demographic and clinical data form (e.g., age, educational background, employment status, marital status, and household income) and medical history (e.g., date of diagnosis, current stage of stroke, and date and type of treatment) at baseline (T1). Primary outcomes: feasibility and acceptability The feasibility assessment of subject recruitment and the follow-up process will include the following: (1) the time taken to recruit the planned sample size of participants; (2) referral rate—the number of referrals made by clinicians in different departments and hospitals divided by all referrals; (3) recruitment rate—the number of subjects enrolled in the study divided by all subjects eligible for enrolment; (4) retention rate—the number of subjects who completed the study divided by all subjects who enrolled in the study; (5) drop-out rate—the number of subjects who dropped out after randomisation divided by all subjects who enrolled in the study; and (6) feedback from the drop-out subjects to identify their reasons for dropping out. The feasibility of recruitment and follow-up process outcomes will be collected from baseline (T1) to the completion of the intervention (T2). The feasibility assessment of the outcome measures will include the percentage of missing values for each item of the scales used: the Timed Up and Go Test (TUG), the Berg Balance Scale (BBS), and the Fall Efficacy Scale (FES)at baseline (T1), immediately after the intervention (T2), and four weeks after completion of the intervention (T3). Patient and public involvement None of the patients were involved in the study design or any other protocol part. Ethics and dissemination This study was approved by the Institutional Ethical Committee of Sharda University (Ref No-SU/SMS&R/76-A/2022/73). The results of this trial will be published in peer-reviewed journals. Data Management The doctoral investigator and one of the research assistants will enter all collected data into a computer using a double data entry approach. Data cleaning will be conducted before data analysis to ensure that there will be no discrepancies or coding errors after running descriptive and inferential statistics.38 First, the datasets will be checked against the paper recordings of raw data to ensure correct data coding. Double-checking will be performed by another research assistant to ensure accuracy. All electronic data will be retained in a compressed folder using password-protected access systems, and all hard copies of the materials will be maintained in a cabinet at the study sites. The storage and disposal of hard copies of research data strictly follow the regulations and policies of the lead investigator’s institution and study sites, including the Sharda University Research Data Management Guide. Data analysis Statistical analyses will be conducted using IBM SPSS Statistics for Windows version 24.0 (IBM). The intention-to-treat principle was used to manage the missing data. The effect sizes of between-group comparisons will be estimated using Cohen’s d.39 The χ2 test or Fisher’s exact test will be used to examine the comparisons between the control and intervention groups for categorical variables (e.g., educational background, referral rate, and retention rate). An independent t-test or Mann-Whitney U test will be used for continuous variables (e.g., age). The generalised estimating equation model was used for repeated multivariate analysis between the two study groups for the total and domain scores of the BBS, TUG, and FES. The significance level for identifying statistical differences was set at P < 0.05. Discussion The regulation of walking forward and backwards in humans remains a subject of considerable interest. Although substantial research has been conducted, the precise relationship between these networks has yet to be fully elucidated. 37 – 42 Walking is crucial for everyday life, and walking difficulties can result in a loss of independence and decreased social participation. Rehabilitation of post-stroke gait is a complex and ongoing process that necessitates the examination of both neurophysiological and biomechanical mechanisms of gait control to enhance gait functions for post-stroke patients. 43 Partial body weight support (BWS) systems are often utilised in post-stroke gait rehabilitation. When integrated with treadmills, BWS has the potential to improve the individual's capacity to take a substantial number of symmetrical and consistent steps, which is beneficial for recovery. 44 , 45 , 46 No prior research has examined the effects of backward treadmill training while the patient's eyes are closed in subacute stroke patients. This underscores the importance of investigating this method's impact on gait rehabilitation for these individuals. To address this knowledge gap, a comprehensive instructional booklet will be developed and provided to participants in both groups, i.e., the eyes-closed and the eyes-open groups. The booklet will include information from pertinent national and international stroke guidelines, recommendations from stroke-related professional bodies and societies, and relevant research evidence. The safety profile assessment for the backward treadmill training program, which entails both eyes open and closed, will be evaluated as part of the feasibility outcomes for patients with stroke. Previous backward treadmill training interventional studies have not thoroughly examined this aspect. Patients may find the eyes-closed protocol difficult due to the risk of falls and adjusting to the treadmill's rhythm. However, implementing this protocol may still result in adverse events, such as lumbar sprains on the affected side due to muscle weakness and soreness. Therefore, any potential adverse events related to the exercise will be closely monitored and documented in the exercise logs. This research has limitations, including that it only occurred at a single study site. Moreover, the study sample may not be fully representative of all patients with sub-acute stroke experiencing gait, balance, and fear of fall issues. As the backward treadmill training intervention was visible, it was impossible to blind the participants or the backward treadmill training instructor, which could increase the risk of detection bias during the study. However, the outcome assessors will remain blind to the intervention allocation. To assess the feasibility and preliminary effects of an evidence-based backward treadmill training program with eyes closed for patients with sub-acute stroke, a rigorously designed randomised controlled trial (RCT) will be utilised. The benefits and cost-effectiveness of this training program for self-management of gait, balance, and fear of falling impairments in patients with sub-acute stroke may provide valuable guidance for physical therapy professionals and researchers in the long-term management of sub-acute stroke. Additionally, the outcomes of this trial will contribute to a future, large-scale, multicentred randomised controlled trial to further establish the research evidence on the efficacy and safety of backward treadmill training sessions for various other impairments related to fear of falling, gait, and balance issues in sub-acute stroke patients. Strengths Limitations of Study This is the first clinical study to explore the feasibility and preliminary effects of backward treadmill training with eyes closed versus eyes open on fear of falling, balance, and balance in patients with sub-acute stroke. This study will use evidence-based backward treadmill training in both groups, which was derived comprehensively from the best available research evidence, guidelines, theories, and practice standards. The design of this pilot study will be based on the Guidelines issued by the American and Indian Stroke Associations. The current research prefers comprehensive outcome measurements, including a series of feasibility outcomes, which will support the refinement of a clinically feasible backward treadmill training with eyes closed protocol for a future full-scale randomized clinical trial. The sample size of this trial was relatively small and not power-based, which will contribute to only a preliminary analysis of the effects of backward treadmill training with eyes closed on balance, mobility, and fear of falling. Declarations Ethics Approval and Consent to Participate Ethical approval for this study was obtained from the Institutional Ethical Committee of Sharda University (Ref No-SU/SMS&R/76-A/2022/73). All participants provided written informed consent to participate in the trial, following an explanation of the study’s aims, procedures, risks, and benefits. Consent for Publication Participants gave their written informed consent to publish anonymised data collected during the study. Availability of Data and Materials The datasets generated and/or analysed during the current study are available from the corresponding author upon reasonable request. Competing Interests The authors declare that they have no competing interests. Funding This study did not receive any specific grant from public, commercial, or not-for-profit funding agencies. Acknowledgements We want to thank all participants who contributed to this study. Special thanks to the School of Allied Health Sciences, Sharda University, for their valuable support during the process. References W J et al. (2016) ‘Stroke: a global response is needed’, Bulletin of the World Health Organization, 94(9), pp. 634A-635A. 10.2471/BLT.16.181636 Kamalakannan S, et al. Incidence & prevalence of stroke in India: A systematic review. Indian J Med Res. 2017;146(2):175. 10.4103/IJMR.IJMR_516_15 . Shin JW, Kim KD. The effect of enhanced trunk control on balance and falls through bilateral upper extremity exercises among chronic stroke patients in a standing position. J Phys Therapy Sci. 2016;28(1):194–7. 10.1589/JPTS.28.194 . Guzik A, Drużbicki M, Wolan-Nieroda A. (2018) ‘Assessment of two gait training models: conventional physical therapy and treadmill exercise, in terms of their effectiveness after stroke’, Hippokratia, 22(2), p. 51. /pmc/articles/PMC6548526/ (Accessed: 21 July 2021). Druzbicki M et al. (2018) ‘The efficacy of gait training using a body weight support treadmill and visual biofeedback in patients with subacute stroke: A randomized controlled trial’, BioMed Research International, 2018. 10.1155/2018/3812602 Patterson KK, et al. Evaluation of gait symmetry after stroke: A comparison of current methods and recommendations for standardization. Gait Posture. 2010;31(2):241–6. 10.1016/J.GAITPOST.2009.10.014 . Patterson KK, et al. Gait Asymmetry in Community-Ambulating Stroke Survivors. Arch Phys Med Rehabil. 2008;89(2):304–10. 10.1016/J.APMR.2007.08.142 . Drużbicki M, et al. Changes in Gait Symmetry After Training on a Treadmill with Biofeedback in Chronic Stroke Patients: A 6-Month Follow-Up from a Randomized Controlled Trial. Med Sci Monitor: Int Med J Experimental Clin Res. 2016;22:4859. 10.12659/MSM.898420 . S B, et al. Early body weight-supported overground walking training in patients with stroke in subacute phase compared to conventional physiotherapy: a randomized controlled pilot study’, International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue Int de recherches de readaptation. 2019;42(4):309–15. 10.1097/MRR.0000000000000363 . GL G, et al. Effects of Gait Training With Body Weight Support on a Treadmill Versus Overground in Individuals With Stroke. Arch Phys Med Rehabil. 2017;98(4):738–45. 10.1016/J.APMR.2016.11.022 . K, van K. et al. (2020) ‘Lokomat guided gait in hemiparetic stroke patients: the effects of training parameters on muscle activity and temporal symmetry’. Disabil Rehabil, 42(21), pp. 2977–85. 10.1080/09638288.2019.1579259 S P, et al. Stepping training with external feedback relating to lower limb support ability effectively improved complex motor activity in ambulatory patients with stroke: a randomized controlled trial. Eur J Phys Rehabil Med. 2020;56(1):14–23. 10.23736/S1973-9087.19.05907-0 . Li S. (2017) ‘Spasticity, Motor Recovery, and Neural Plasticity after Stroke’, Frontiers in Neurology, 0(APR), p. 120. 10.3389/FNEUR.2017.00120 Baer GD et al. (2017) ‘Treadmill training to improve mobility for people with sub-acute stroke: a phase II feasibility randomized controlled trial’:, https://doi.org/10.1177/0269215517720486 , 32(2), pp. 201–212. doi: 10.1177/0269215517720486. Jeong Y-G, Koo J-W. (2016) ‘The effects of treadmill walking combined with obstacle-crossing on walking ability in ambulatory patients after stroke: a pilot randomized controlled trial’, https://doi.org/10.1080/10749357.2016.1168592 , 23(6), pp. 406–412. doi: 10.1080/10749357.2016.1168592. Shemy SA, El. Effect of Treadmill Training With Eyes Open and Closed on Knee Proprioception, Functional Balance and Mobility in Children With Spastic Diplegia. Annals Rehabilitation Med. 2018;42(6):854. 10.5535/ARM.2018.42.6.854 . Moon S-J, Kim Y-W. Effect of blocked vision treadmill training on knee joint proprioception ofpatients with chronic stroke. J Phys Therapy Sci. 2015;27(3):897. 10.1589/JPTS.27.897 . Salameh I et al. A. (2022) Stance Phase Gait Training Post Stroke Using Simultaneous Transcranial Direct Current Stimulation and Motor Learning-Based Virtual Reality-Assisted Therapy: Protocol Development and Initial Testing, Brain Sciences, 12(6),p. 701. https://doi.org/10.3390/brainsci12060701 Yang Y, Feng J, Wang Y. (2022) Early Diagnosis of Acute Ischemic Stroke by Brain Computed Tomography Perfusion Imaging Combined with Head and Neck Computed Tomography Angiography on Deep Learning Algorithm, Contrast Media & Molecular Imaging, 2022,pp. 1–10. https://doi.org/10.1155/2022/5373585 Naro A, Calabrò S. R. (2022) Improving Upper Limb and Gait Rehabilitation Outcomes in Post-Stroke Patients: A Scoping Review on the Additional Effects of Non-Invasive Brain Stimulation When Combined with Robot-Aided Rehabilitation, Brain Sciences, 12(11),p. 1511. https://doi.org/10.3390/brainsci12111511 Sinha A, Nair AV, Prabhakaran V. (2021) Brain-Computer Interface Training With Functional Electrical Stimulation: Facilitating Changes in Interhemispheric Functional Connectivity and Motor Outcomes Post-stroke, Frontiers in Neuroscience, 15. https://doi.org/10.3389/fnins.2021.670953 Body-weight-supported. treadmill rehabilitation after stroke (no date). https://pubmed.ncbi.nlm.nih.gov/21612471/ Wang F et al. (2022) Gait Training for Hemiplegic Stroke Patients: Employing an Automatic Neural Development Treatment Trainer with Real Time Detection, Applied Sciences, 12(5),p. 2719. https://doi.org/10.3390/app12052719 Punt M et al. (2016) Characteristics of daily life gait in fall and non fall-prone stroke survivors and controls, Journal of Neuroengineering and Rehabilitation, 13(1). https://doi.org/10.1186/s12984-016-0176-z Tan H et al. (2023) Effects of balance training in addition to auxiliary activity on balance function of patients with stroke at high risk for falls, Frontiers in Neurology, 13. https://doi.org/10.3389/fneur.2022.937305 Lo A, L W et al. (2021) The Efficacy of Interlimb-Coordinated Intervention on Gait and Motor Function Recovery in Patients with Acute Stroke: A Multi-Center Randomized Controlled Trial Study Protocol, Brain Sciences, 11(11),p. 1495. https://doi.org/10.3390/brainsci11111495 Falls After a Stroke - European Stroke Organisation. (no date). https://eso-stroke.org/falls-after-a-stroke/ Kim K, Jang S. (2021) Effects of Task-Specific Training after Cognitive Sensorimotor Exercise on Proprioception, Spasticity, and Gait Speed in Stroke Patients: A Randomized Controlled Study, Medicina, 57(10),p. 1098. https://doi.org/10.3390/medicina57101098 Choi Y, Kim J, Yun Y. (2013) Relationship of Physical Impairment, function and Insulin Resistance in stroke patients, International Journal of Contents, 9(3),pp. 62–66. https://doi.org/10.5392/ijoc.2013.9.3.062 Lin M et al. (2021) Adaptive Admittance Control Scheme with Virtual Reality Interaction for Robot-Assisted Lower Limb Strength Training, Machines, 9(11),p. 301. https://doi.org/10.3390/machines9110301 Gait post-stroke. Pathophysiology and rehabilitation strategies (no date). https://pubmed.ncbi.nlm.nih.gov/26547547/ Germanotta M, Iacovelli C, Aprile I. (2022) Evaluation of Gait Smoothness in Patients with Stroke Undergoing Rehabilitation: Comparison between Two Metrics, International Journal of Environmental Research and Public Health, 19(20),p. 13440. https://doi.org/10.3390/ijerph192013440 Chaparro G et al. (2017) Frontal brain activation changes due to dual-tasking under partial body weight support conditions in older adults with multiple sclerosis, Journal of Neuroengineering and Rehabilitation, 14(1). https://doi.org/10.1186/s12984-017-0280-8 Godi M, Giardini M, Schieppati M. (2019) Walking Along Curved Trajectories. Changes With Age and Parkinson's Disease. Hints to Rehabilitation, Frontiers in Neurology, 10. https://doi.org/10.3389/fneur.2019.00532 Serial Backward Locomotor Treadmill Training Improves Bidirectional … no date). Available at: https://pubmed.ncbi.nlm.nih.gov/35359661/. Kramer S et al. (2013) Measuring Activity Levels at an Acute Stroke Ward: Comparing Observations to a Device, Biomed Research International, 2013,pp. 1–8. https://doi.org/10.1155/2013/460482 Awosika OO, Matthews S, Staggs EJ, Boyne P, Song X, Rizik BA, Sucharew HJ, Zhang C, Mungcal G, Moudgal R, Bhattacharya A, Dunning K, Woo D, Kissela BM. Backward locomotor treadmill training combined with transcutaneous spinal direct current stimulation in stroke: a randomized pilot feasibility and safety study. Brain Commun. 2020;2(1). https://doi.org/10.1093/braincomms/fcaa045 . Choi JT, Bastian AJ. Adaptation reveals independent control networks for human walking. Nat Neurosci. 2007;10(8):1055–62. https://doi.org/10.1038/NN1930 . Hoogkamer W, Meyns P, Duysens J. Steps forward in understanding backward gait: from basic circuits to rehabilitation. Exerc Sport Sci Rev. 2014;42(1):23–9. https://doi.org/10.1249/JES.0000000000000000 . Jansen K, De Groote F, Massaad F, Meyns P, Duysens J, Jonkers I. Similar muscles contribute to horizontal and vertical acceleration of center of mass in forward and backward walking: implications for neural control. J Neurophysiol. 2012;107(12):3385–96. https://doi.org/10.1152/JN.01156.2011 . Musienko PE, Zelenin PV, Lyalka VF, Gerasimenko YP, Orlovsky GN, Deliagina TG. Spinal and supraspinal control of the direction of stepping during locomotion. J Neuroscience: Official J Soc Neurosci. 2012;32(48):17442–53. https://doi.org/10.1523/JNEUROSCI.3757-12.2012 . Winter DA, Pluck N, Yang JF. Backward walking: a simple reversal of forward walking? J Mot Behav. 1989;21(3):291–305. https://doi.org/10.1080/00222895.1989.10735483 . Verma R, Arya KN, Sharma P, Garg RK. Understanding gait control in post-stroke: Implications for management. J Bodyw Mov Ther. 2012;16(1):14–21. https://doi.org/10.1016/J.JBMT.2010.12.005 . Hesse S, Bertelt C, Jahnke MT, Schaffrin A, Baake P, Malezic M, Mauritz KH. Treadmill training with partial body weight support compared with physiotherapy in non-ambulatory hemiparetic patients. Stroke. 1995;26(6):976–81. https://doi.org/10.1161/01.STR.26.6.976 . Moseley AM, Stark A, Cameron ID, Pollock A. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2005. https://doi.org/10.1002/14651858.CD002840.PUB2 . 4. Sullivan KJ, Knowlton BJ, Dobkin BH. Step training with body weight support: effect of treadmill speed and practice paradigms on poststroke locomotor recovery. Arch Phys Med Rehabil. 2002;83(5):683–91. https://doi.org/10.1053/APMR.2002.32488 . Supplementary Files SPIRITFillablechecklist.doc Cite Share Download PDF Status: Published Journal Publication published 07 Apr, 2026 Read the published version in Pilot and Feasibility Studies → Version 1 posted Editorial decision: Major revision 07 Jan, 2026 Reviewers agreed at journal 01 Nov, 2025 Reviewers invited by journal 31 Oct, 2025 Editor assigned by journal 18 Nov, 2024 First submitted to journal 16 Nov, 2024 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. 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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-5170733","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":379528458,"identity":"ec7af63e-375d-4c81-96de-aaaa6800a28e","order_by":0,"name":"Nawaj Mehtab Pathan","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAyUlEQVRIiWNgGAWjYLACCQMbORB94AHxWgrSjMFaEoi35sPhxAYQTZQWc/Yzhh8sDJjT54cdfgi0xU5Ot4GAFsueHGMJCQO23I230wyAWpKNzQ4Q0GJwIHcDUAtP7sbZCSAtBxK3EdRy/u3mHxIGEumGs9M/EKnlRu42oC0GCfLSOcTacuP9NwsJgwTDDdI5BQcSDIjxy/m05NsSf/7Ly89O3/zhQ4WdHEEtIMAsAdILVmlAhHIQYPwAJOQbiFQ9CkbBKBgFIw8AAER7RjRHGOoMAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0001-5143-1036","institution":"Sharda University School of Allied Health Sciences","correspondingAuthor":true,"prefix":"","firstName":"Nawaj","middleName":"Mehtab","lastName":"Pathan","suffix":""},{"id":379528459,"identity":"9ccc2b0c-a768-4594-80a2-3b98745321ba","order_by":1,"name":"Rahul Saxena","email":"","orcid":"","institution":"Sharda University School of Allied Health Sciences","correspondingAuthor":false,"prefix":"","firstName":"Rahul","middleName":"","lastName":"Saxena","suffix":""},{"id":379528460,"identity":"553548ce-54e7-4b59-9635-23a85df86eaf","order_by":2,"name":"Chandan Kumar","email":"","orcid":"","institution":"Galgotia University: Galgotias University","correspondingAuthor":false,"prefix":"","firstName":"Chandan","middleName":"","lastName":"Kumar","suffix":""}],"badges":[],"createdAt":"2024-09-28 13:38:26","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5170733/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5170733/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s40814-026-01810-0","type":"published","date":"2026-04-07T15:57:35+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":69830317,"identity":"978f0c60-4886-4b35-b497-1953eaf06b49","added_by":"auto","created_at":"2024-11-25 15:32:14","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":23989,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlow Diagram of Clinical Trial (Consort Guidelines)\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-5170733/v1/f3d0e3bcfd54bd1ba651f632.png"},{"id":106808764,"identity":"da803761-8142-4830-947c-dde69437f48f","added_by":"auto","created_at":"2026-04-13 16:01:08","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":891068,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5170733/v1/a062f844-53d8-46b3-a21c-ee9ba09c359a.pdf"},{"id":69830318,"identity":"29558df7-34fe-4da0-8f1d-06ab1ad71b93","added_by":"auto","created_at":"2024-11-25 15:32:14","extension":"doc","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":140800,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRITFillablechecklist.doc","url":"https://assets-eu.researchsquare.com/files/rs-5170733/v1/9f5316c893242dcc62a4ace5.doc"}],"financialInterests":"","formattedTitle":"Examining the Feasibility and Preliminary Effects of Eyes-Open and Eyes-Closed Backward Treadmill Training on Balance, Mobility, and Fear of Falling in Sub-Acute Stroke Survivors: A Pilot Randomized Clinical Trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eCerebrovascular accidents are the second leading cause of disability and rank third among all diseases responsible for universal debilitation.\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e. The authors of a study conducted primarily among the Indian population have expressed concern about the steadily increasing stroke incidence rate in India, which is notably higher than that of high-income countries.\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e. The findings from their research on the balance and mobility problems faced by stroke survivors are critical, as the persistence of these issues can lead to a decline in daily motor activities, increasing the risk of falls. However, regaining walking abilities can help stroke patients actively participate in various aspects of life.\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e. According to the findings of their respective studies; it is estimated that approximately 60% of stroke survivors encounter difficulties in overcoming mobility-related impairments.\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e. Several studies have highlighted potential mechanisms that can cause mobility impairments as a result of damage to the central nervous system. These changes can significantly impact the walking speed and distance covered by patients, as well as their ability to walk independently.\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e,\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e,\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e. The combined effects of these changes impede an individual's ability to function normally and result in an uncommon pattern of behaviour.\u003c/p\u003e \u003cp\u003eIn stroke patients, clinical presentations often show signs of weakness, disrupted movement regulation mechanisms, altered muscle tone, and impaired sensory systems, all of which significantly impact the mobility aspects of stroke survivors.\u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e. The Body Weight Support treadmill (BWSt) has become a popular choice for stroke patients undergoing rehabilitation due to its convenience and effectiveness in promoting proper and structured gait training during the initial stages of recovery.\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e. The incorporation of treadmill interventions in conjunction with a bodyweight harness system aims to rectify gait irregularities and address unsynchronised stepping patterns.\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e. The use of robotics in supporting manoeuvres is becoming increasingly inevitable. It primarily aims to bolster the typical gait pattern following a CVA. Repetitively performing these tasks and movements stimulates the motor cortex, accelerating positive neural networking within the CNS.\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e The importance of custom-designed gait training programs, which specifically focus on improving the weight-bearing capabilities of the impaired limb through guided cues, has been emphasised. It has been confirmed that these interventions offer additional benefits.\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. During the initial stages of motor recovery, stroke survivors who exhibit increased muscle strength and engage in more functional activities are considered significant indicators of cortical-level neuroplastic changes. Nevertheless, it is essential to recognise that reticulospinal excitability suggests a poor prognosis for motor performance and CNS activation mechanisms.\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. The researchers in their clinical trials found that treadmill-based gait training benefited subacute stroke patients. They suggested it could be effective when combined with task-oriented therapy and other conventional physiotherapy interventions. Previous studies have shown that treadmill training can improve gait and balance in stroke survivors, but there is little agreement on the impact of blocking vision during backward treadmill training. Additionally, many studies were not descriptive or analytical, making it difficult to determine the outcomes of blocking vision during backward treadmill training among stroke patients.\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e,\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e. Blocked vision treadmill training is recommended to improve knee proprioception, equilibrium, and gait in children with diplegic cerebral palsy.\u003csup\u003e\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e The author highlights the practicality of treadmill training with eyes closed for enhancing proprioceptive output, emphasising the potential benefits of this approach.\u003csup\u003e\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eAlthough no studies have been explicitly conducted among the Indian stroke population to assess the feasibility of backward treadmill training with blocked and unblocked vision, a few studies have compared the therapeutic effects of backward treadmill training with blocked vision with eyes open. However, insufficient data is available to directly compare the interventional effects of backward treadmill training with eyes open and closed. Therefore, the present feasibility study aimed to gather preliminary estimates of the efficacy of backward treadmill training with closed eyes in stroke patients.\u003c/p\u003e \u003cp\u003eStroke survivors often experience gait and mobility impairments, significantly impacting their functional capacity and overall quality of life\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e. Stroke is a significant contributor to global disability, accounting for an estimated 80% of all cases, according to official statistics.\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn 2016, it was reported that there were 1\u0026nbsp;million prevalent cases and 116.4\u0026nbsp;million disability-adjusted life-years. Gait impairments are a common occurrence among stroke survivors, with more than 80% experiencing them. Approximately 25% of all stroke survivors continue to experience long-term residual gait impairments.\u003csup\u003e\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u003c/sup\u003e. Traditional gait interventions may not always enhance motor recovery and functional outcomes in stroke survivors, despite being used to improve gait function on the ground or treadmill with or without body weight support. In addition, it is essential to develop innovative and effective solutions for individuals who have experienced stroke and continue to exhibit gait impairments, as these individuals require assistance in regaining their independence and mobility.\u003csup\u003e\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e. Body weight-supported treadmill training and targeted exercises have been found to enhance gait functionality in stroke survivors. This form of treadmill training provides partial support through a harness while the individual walks. It has been shown to improve gait speed, stride length, and endurance for those with chronic hemiparesis. Exercises focusing on strengthening, balance, and coordination can help reduce muscle weakness, spasticity, abnormal muscle tone, and unbalanced muscle activation, leading to better gait function.\u003csup\u003e\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIt is essential to acknowledge that the gait and mobility impairments experienced by stroke survivors are complex and multi-faceted.\u003csup\u003e\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u003c/sup\u003e The recovery of gait in stroke survivors is influenced by various factors, including the severity of the initial injury, the location of the lesion, age, pre-stroke mobility level, and other medical conditions. Moreover, the effectiveness of different interventions in promoting gait function may differ substantially among stroke survivors.\u003csup\u003e\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eA tailored treatment approach is crucial for the rehabilitation of patients with gait limitations due to stroke.\u003csup\u003e\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u003c/sup\u003e Obesity is a contributing factor to walking impairment in stroke survivors, emphasising the importance of personalised rehabilitation programs to improve gait function. Gait disturbance is a common issue among stroke survivors, impacting their functional independence and mobility. Effective rehabilitation programs must consider the unique needs of stroke survivors to address gait impairment.\u003csup\u003e\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e Stroke survivors commonly experience walking dysfunction, which affects 80% of them. One of the most common symptoms of post-stroke gait is gait asymmetry, which can make the rehabilitation process more challenging. Prior research has found that impaired balance and gait increase the likelihood of falls in stroke survivors.\u003csup\u003e\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u003c/sup\u003e. To rehabilitate stroke survivors' gait successfully, adopting a holistic approach that considers multiple impairments and aims to help them achieve greater independence in their daily lives is crucial. Gait impairment is a significant factor that contributes to long-term post-stroke disability. Therefore, it is necessary to develop a comprehensive and personalized rehabilitation plan that addresses the various contributors to gait impairment in stroke survivors.\u003csup\u003e\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eGait impairment is a common and severe problem that requires comprehensive rehabilitation interventions to address various aspects, such as muscle strength, stability, and synchronization. Physical therapy is recommended to improve muscle strength, balance, and coordination, reducing muscle weakness, spasticity, and tone. Other effective interventions for enhancing gait function and mobility in stroke survivors include task-specific high-velocity gait training.\u003csup\u003e\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThis form of training has been demonstrated to be more effective in enhancing walking speed and functional mobility among stroke survivors than conventional gait training. However, it's crucial to recognise that the efficacy of interventions may differ among individuals recovering from a stroke, and treatment strategies must be personalised accordingly. In summary, gait impairments after a stroke can significantly impact the functional independence and mobility of stroke survivors. A holistic approach that addresses various aspects, such as muscle strength, stability, and coordination, is necessary to achieve optimal gait rehabilitation outcomes.\u003csup\u003e\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e\u003c/sup\u003e Gait impairments in stroke survivors can significantly impact their walking speed, dynamic mobility, and risk of falling. These issues can arise from various impairments, such as muscle weakness, spasticity, and balance problems. Comprehensive and personalised rehabilitation programs are necessary to improve gait. Researchers have also investigated the potential of implanted functional electrical stimulation as a treatment option for stroke survivors with gait impairments.\u003csup\u003e\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e\u003c/sup\u003e Stroke survivors experience various physical limitations that can impact their gait and mobility. Despite the prevalence of gait impairment, more research is necessary to determine the effectiveness of interventions in improving mobility and gait function. Addressing gait impairment is crucial for promoting functional independence and reducing the risk of falls, while vocational rehabilitation can support reintegration into the workforce and improve overall quality of life. Approximately 80% of stroke survivors experience gait impairment, and even with rehabilitation, a quarter of them still require full physical assistance.\u003csup\u003e\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e Gait impairments can increase the risk of falls, leading to fracture injuries and further restrictions on activity and mobility. Rehabilitation interventions aim to improve gait and mobility using traditional methods with or without body weight support.\u003csup\u003e\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe efficacy of backward treadmill training in enhancing stroke survivors' postural abilities and gait function has been documented in recent studies. The effects of backward treadmill training were comparable or superior to those of forward treadmill training in improving balance, gait speed, and stride length.\u003csup\u003e\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e\u003c/sup\u003e Therefore, backward treadmill training can be considered a potential rehabilitation intervention for stroke survivors with gait impairments. According to research, early rehabilitation in the subacute phase is generally more effective than delayed rehabilitation. Despite the development of advanced rehabilitation technologies, such as robotic and exoskeleton-assisted hand rehabilitation and MI-based BCI systems, stroke survivors continue to face challenges in regaining adequate hand and finger function.\u003csup\u003e\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e\u003c/sup\u003e Further research and development are necessary to enhance stroke rehabilitation outcomes. Effective rehabilitation should address both gait deficits and the underlying impairments that contribute to them while also offering functional practice for daily activities, including vocational rehabilitation.\u003c/p\u003e \u003cp\u003eIndividualized rehabilitation programs incorporating traditional interventions, targeted exercises, and advanced technologies are essential for stroke survivors. These programs should be tailored to their specific needs and focus on early intervention during the subacute phase for optimal recovery. In addition, providing greater access to vocational rehabilitation programs that facilitate the reintegration of stroke patients into the workforce or support their engagement in work-related activities can play a crucial role in enhancing their quality of life and independence.\u003csup\u003e\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e"},{"header":"Methods And Materials","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design\u003c/h2\u003e \u003cp\u003eThe study design will be a two-parallel arm, single-blinded (assessor) pilot RCT. The participants will be randomly allocated into two groups: a backward treadmill training intervention with eyes open group and a backward treadmill training with eyes closed group, with an allocation ratio of one to 1. The study will be conducted for four weeks, involving four weeks of backward treadmill training interventions or a two-week follow-up for both groups. The consolidated standards for reporting the trial flow chart and SPIRIT Checklist of this study are presented.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eStudy Setting\u003c/h3\u003e\n\u003cp\u003eThis study will be conducted at a torsional physiotherapy center in Chh-Sambhajinagar and other stroke clinics.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003e*EOBTT\u003c/b\u003e- Eyes Open Backward Treadmill Training.\u003c/p\u003e \u003cp\u003e \u003cb\u003e* ECBTT -\u003c/b\u003e Eyes Closed Backward Treadmill Training.\u003c/p\u003e\n\u003ch3\u003eSample Size Calculation\u003c/h3\u003e\n\u003cp\u003eA minimum of 30 participants in each group will be classically endorsed for the pilot studies to evaluate the feasibility of the intervention\u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e and to estimate the between-group effect for subsequent power analysis in the main study\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e. The intervention protocol will be calculated by fitting, with a sample size of 30 participants per group, given the primary goal of this study, which is to assess the acceptability and feasibility of the study's approach. The ultimate sample size will consist of 40 individuals per group, for a total of 80 participants, to account for an expected 20% dropout rate.\u003c/p\u003e\n\u003ch3\u003eInclusion and exclusion criteria\u003c/h3\u003e\n\u003cp\u003eEligible study participants will be recruited preferring the following inclusion criteria:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eThe patients will give written consent to participate in the study if they are willing to do so.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eFirst-ever stroke.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eStroke occurrence within 1\u0026ndash;3 months (subacute phase).\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eThe age groups ranged from 30 to 65 years.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eBoth sexes will be included in the study.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003ePatients with or without ambulatory aid.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003ePatients who can follow commands.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eAble to speak and understand Marathi, Hindi language\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eA Score ranging from 21\u0026ndash;40 on the BBS was used in this study.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003eNon-eligible study participants will be excluded, preferring the following exclusion criteria: -\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eAny other neurological injury affects balance and mobility.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003ePresence of contractures in unilateral or bilateral lower limbs.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eLimited passive range of motion of the lower limbs.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eHave an orthopaedic injury that impairs balance.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eExtremely frail (unable to recognise proprioceptive and sensory sensations due to severe other systematic disorders, e.g., Chronic diabetes, Multiple sclerosis, Parkinson\u0026rsquo;s disease, etc.)\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eHave scheduled other therapy sessions within the trial period.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eRecruitment\u003c/h2\u003e \u003cp\u003eA research team will be formed before the commencement of the trial. Three investigators, including the principal investigator and two neuro physiotherapists, will be primarily responsible for participant recruitment and backward treadmill training interventions with the eyes open and closed. The investigators will receive intensive training from a qualified Neurophysiotherapist to safeguard standardised backward treadmill training interventions with eyes closed and open. Before the backward treadmill with eyes closed and open interventions, a neuro physiotherapist scrutinised the safety of the study participants by standing from the back of the study participant, encouraging them to grasp handrails, and providing verbal cues. Two research assistants will conduct the data collection and telephone follow-up. To ensure the quality of data collection, the two research assistants will be trained in outcome measurements at the pre-and post-intervention levels, including understanding the safety procedures and instructions that standardise their conversations with the participants.\u003c/p\u003e \u003cp\u003eThe academic supervisors of the doctoral investigator will monitor the entire study procedure on an ongoing basis through regular 2-week follow-ups. Potential study participants visiting the Neurophysiotherapy outpatient department will be recruited directly by the principal investigator and two research assistants. A participant information sheet, including the study investigators' research aim, procedures, and contact details, will be provided to potential participants and explained by the doctoral investigator and two Neurophysiotherapists. Potential participants who indicated a desire to participate in the research will be screened for eligibility based on the inclusion and exclusion standards established by the doctoral investigator and two Neurophysiotherapists. Once they consented to participate, they had to give written informed consent. Participants will be advised that there are no repercussions if they decide to leave the study at any time.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eRandomisation and allocation concealment\u003c/h3\u003e\n\u003cp\u003eThe pilot trial will be randomised and controlled in a 1:1 allocation ratio. Based on the estimated sample size, one set of randomisation sequences was generated using an online randomiser: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.randomizer.org\u003c/span\u003e\u003cspan address=\"https://www.randomizer.org\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. To ensure allocation concealment, randomisation sequences will be accomplished by a statistical expert who will not participate in any other part of the study. Specifically, the statistician will use an online randomiser to generate randomisation sequences, including 20 even and 20 odd numbers.\u003c/p\u003e \u003cp\u003eOnly statisticians will have access to randomisation sequences. The two clinical neurophysiotherapists will call the statistician to decide which group the patient should be allocated to based on predetermined random numbers when the eligible participant consents to participate in the study and finishes the baseline evaluation. Either the backward treadmill training with the eyes open intervention group or the backward treadmill training with the eyes closed intervention group will be randomly assigned to the participants.\u003c/p\u003e\n\u003ch3\u003eBlinding\u003c/h3\u003e\n\u003cp\u003eDue to the visible nature of the backward treadmill training groups with eyes open and closed, blinding the study investigators and participants was impossible. Thus, blinding will be applied only to this pilot RCT's outcome assessors (i.e., the two research assistants) to avoid potential detection bias during data collection. The two research assistants will be responsible for data collection and telephone follow-up and will not be involved in the participant-related recruitment process.\u003c/p\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eBackward Treadmill Training Group with Eyes Open\u003c/h2\u003e \u003cp\u003eAlong with the typical care given to both intervention groups, participants received backward treadmill training with their eyes open. The intervention regimen will last 60 minutes per session, three sessions per week, for four weeks, based on current research evidence, practice standards/guidelines, theories, and experts\u0026rsquo; consensus. To ensure the participants fully mastered backward treadmill training with their eyes open. Before the commencement of the intervention, they will receive at least three 10-minute training sessions until they are accustomed to the before movements correctly and smoothly, along with a home-learning method in an audio-visual format (i.e., a recorded video of their own). Training will be conducted and led by a doctoral investigator or two neurophysiotherapists, and attendance will be recorded.\u003c/p\u003e \u003cp\u003eParticipants in both intervention groups underwent backward treadmill training with their eyes open in addition to the standard therapy. Based on current research findings, practice standards and guidelines, theories, and expert consensus, the intervention routine will include three weekly sessions, each lasting sixty minutes. For a total of four weeks to guarantee that the participants achieved complete mastery of backward treadmill training while keeping their eyes open. In addition to a home-learning technique in an audio-visual format (i.e., a recorded video of their own), students will receive at least three 10-minute training sessions before the start of the intervention until they become habituated to the prior movements correctly and smoothly. Two neurophysiotherapists or a PhD researcher will administer and supervise the training, and attendance will be tracked.\u003c/p\u003e \u003cp\u003eUnder the supervision of neurophysiotherapists, each participant will be required to perform backward treadmill training with their eyes open for five minutes while receiving verbal cues and then for the next five minutes without verbal cues to ensure they were performing without hesitation. The neurophysiotherapist will also show the participants the video analysis from the previous training session to ensure they completed the task correctly. For sixty minutes, this group will receive backward treadmill training with their eyes open in addition to standard/routine care.\u003c/p\u003e \u003cp\u003eIt will include the following components. A ten-minute warm-up, followed by 30 to 45 minutes of regular treatment, includes strengthening, proprioceptive training, slow, sustained stretching exercises, active-assisted upper and lower limb motions, and active-assisted gait training on level surfaces. The various positions practised on the balance board trigger proactive balancing reactions by moving the body weights sideways, front, and backward. Concurrent activation of standing on one leg facilitates the protective responses in various ways. The gait interventions included mobility exercises on level surfaces, training with multiple barriers such as tiny height steppers, rolls, and cones for stepping down from stair climbers, training with parallel bars for walking, and a 10-minute cool-down.\u003c/p\u003e \u003cp\u003eEach backward treadmill training session will include a 2-minute rest period if requested by the participants. The backward treadmill training intervention protocol will be modified in clinical practice to create a customised intervention suited to the participant's convenience and preferences concerning the intervention's time and location.\u003c/p\u003e \u003cp\u003eParticipants will receive a specially designed exercise log to record details about their backward treadmill training practice as soon as possible after each session. This log will include information about the length and frequency of breaks during the backward treadmill training sessions and any potential adverse reactions, such as dizziness, knee pain, musculoskeletal aches, and pain.\u003c/p\u003e \u003cp\u003eThe research assistants will receive the exercise logs on the day of the individual interventions or OPD follow-up sessions. To improve the participants' compliance with the backward treadmill training intervention, the research assistants will call them every other day to remind them to watch videos and practice at home and to get information about any potential issues they may be having.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eBackward treadmill training group with eyes closed\u003c/h2\u003e \u003cp\u003eParticipants in both intervention groups will get backward treadmill exercises with their eyes closed in addition to the standard treatment they receive. Based on current research outcomes, practice standards, guidelines, theories, and expert consensus, the intervention regimen will consist of three sessions per week, 60 minutes each, lasting for four weeks. To ensure that participants fully master eye-closed reverse treadmill training, they will receive at least three 10-minute training sessions before the intervention begins. These sessions will help them adapt to the treadmill movements accurately and smoothly. Additionally, participants will have access to a home learning technique in an audio-visual format, including a recorded video of themselves.\u003c/p\u003e \u003cp\u003eTwo neurophysiotherapists or a PhD researcher will administer and facilitate the training, and attendance will be tracked. To ensure they will not tremble, all participants must do backward treadmill training with their eyes closed while being watched by neurophysiotherapists. This will involve five minutes of verbal feedback and monitoring, followed by five minutes without verbal cues. The neurophysiotherapist will also show the participants the video analysis from the previous training session to ensure they completed the task correctly. For sixty minutes, this group will receive backward treadmill exercise with their eyes closed in addition to standard/routine care, which includes the following: A 10-minute warm-up, followed by 30 to 45 minutes of regular treatment that provides for strengthening, proprioceptive training, slow, prolonged stretching exercises, active-assisted upper and lower limb movements, and active-assisted gait training on level surfaces. The body weight moving forward, backwards, and sideways from various postures on the balance board elicited proactive balancing reflexes. The sequential activation of standing on one leg facilitates reaction protection in multiple ways.\u003c/p\u003e \u003cp\u003eMobility exercises on level terrain, training with various obstacles, such as short height steppers, rolls, cones for stepping down from stair climbers, training with parallel bars for walking, and a 10-minute cool-down were all part of the gait interventions. Participants can take a 2-minute break at the end of each backward treadmill training session.\u003c/p\u003e \u003cp\u003eThe backward treadmill training intervention protocol will be adjusted in clinical practice to offer a customised intervention according to the participant's convenience and preferences about the time and place of the intervention. Immediately following each backward treadmill training session, participants will receive a specially designed exercise log to record information about their practice, including the length of time they spent on the backward treadmill, how often they took breaks, and any potential adverse reactions, such as dizziness, knee pain, musculoskeletal aches, or pain.\u003c/p\u003e \u003cp\u003eThe research assistants receive the exercise logs on the day of the individual interventions or OPD follow-up sessions. To help participants better adhere to the backward treadmill training intervention, the research assistants will contact them every other day to remind them to view videos and practice at home. Additionally, they will be able to answer any inquiries regarding the program.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eResults of the feasibility study and the previously established success criteria\u003c/h2\u003e \u003cp\u003eThe following predetermined criteria will be used to evaluate the viability of this pilot study:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eAdherence Rate\u003c/b\u003e: The percentage of backward treadmill training sessions completed, calculated by dividing the total number of needed sessions by the number of completed sessions, will be used to monitor adherence. A minimum adherence rate of 75% will be used for the intervention to be deemed sufficiently engaging.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eParticipant Satisfaction\u003c/b\u003e: A self-designed feedback form will gauge participant satisfaction with the intervention right after the intervention phase (T2). A mean satisfaction score of four out of five on this feedback form will suggest an optimistic acceptance of the intervention.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eAdverse Events\u003c/b\u003e: Participants' exercise diaries will track adverse occurrences to assess the intervention's safety. A low incidence of serious adverse events\u0026mdash;less than 10% of participants will have notable adverse events over the study period\u0026mdash;will be the criterion for success in safety.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eCompletion of Exercise Logs\u003c/b\u003e: Participant engagement in tracking and reporting their experiences will be assessed by the percentage of participants who complete exercise logs consistently throughout the intervention. A completion rate of at least 80% will indicate adequate engagement in logging and reporting intervention experiences.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eAnalysis of Feasibility Outcomes\u003c/h2\u003e \u003cp\u003eThe analysis of feasibility results will employ descriptive statistics, such as mean, standard deviation, frequency counts, and percentages, to summarize exercise log completion rates, adherence, satisfaction, and adverse occurrences. Based on the criteria satisfied in this pilot study, the results of this descriptive approach will give a general picture of the intervention's acceptability and feasibility, and they will help guide any protocol modifications for subsequent research.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eOutcome Measurements and Follow-Up\u003c/h2\u003e \u003cp\u003eThe outcome measurements for this pilot RCT included three categories: baseline assessment, feasibility and acceptability outcomes, and clinical outcomes. The feasibility and acceptability outcomes will be the primary outcomes, whereas the clinical outcomes will be the secondary outcomes. Two research assistants will conduct all outcomes and follow-ups.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eThe participants' clinical and demographic characteristics\u003c/h2\u003e \u003cp\u003eThe participants' sociodemographic information will be gathered using a self-designed demographic and clinical data form (e.g., age, educational background, employment status, marital status, and household income) and medical history (e.g., date of diagnosis, current stage of stroke, and date and type of treatment) at baseline (T1).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003ePrimary outcomes: feasibility and acceptability\u003c/h2\u003e \u003cp\u003eThe feasibility assessment of subject recruitment and the follow-up process will include the following: (1) the time taken to recruit the planned sample size of participants; (2) referral rate\u0026mdash;the number of referrals made by clinicians in different departments and hospitals divided by all referrals; (3) recruitment rate\u0026mdash;the number of subjects enrolled in the study divided by all subjects eligible for enrolment; (4) retention rate\u0026mdash;the number of subjects who completed the study divided by all subjects who enrolled in the study; (5) drop-out rate\u0026mdash;the number of subjects who dropped out after randomisation divided by all subjects who enrolled in the study; and (6) feedback from the drop-out subjects to identify their reasons for dropping out. The feasibility of recruitment and follow-up process outcomes will be collected from baseline (T1) to the completion of the intervention (T2).\u003c/p\u003e \u003cp\u003eThe feasibility assessment of the outcome measures will include the percentage of missing values for each item of the scales used: the Timed Up and Go Test (TUG), the Berg Balance Scale (BBS), and the Fall Efficacy Scale (FES)at baseline (T1), immediately after the intervention (T2), and four weeks after completion of the intervention (T3).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003ePatient and public involvement\u003c/h2\u003e \u003cp\u003eNone of the patients were involved in the study design or any other protocol part.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eEthics and dissemination\u003c/h2\u003e \u003cp\u003eThis study was approved by the Institutional Ethical Committee of Sharda University (Ref No-SU/SMS\u0026amp;R/76-A/2022/73). The results of this trial will be published in peer-reviewed journals.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eData Management\u003c/h2\u003e \u003cp\u003eThe doctoral investigator and one of the research assistants will enter all collected data into a computer using a double data entry approach. Data cleaning will be conducted before data analysis to ensure that there will be no discrepancies or coding errors after running descriptive and inferential statistics.38 First, the datasets will be checked against the paper recordings of raw data to ensure correct data coding. Double-checking will be performed by another research assistant to ensure accuracy. All electronic data will be retained in a compressed folder using password-protected access systems, and all hard copies of the materials will be maintained in a cabinet at the study sites. The storage and disposal of hard copies of research data strictly follow the regulations and policies of the lead investigator\u0026rsquo;s institution and study sites, including the Sharda University Research Data Management Guide.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eData analysis\u003c/h2\u003e \u003cp\u003eStatistical analyses will be conducted using IBM SPSS Statistics for Windows version 24.0 (IBM). The intention-to-treat principle was used to manage the missing data. The effect sizes of between-group comparisons will be estimated using Cohen\u0026rsquo;s d.39 The χ2 test or Fisher\u0026rsquo;s exact test will be used to examine the comparisons between the control and intervention groups for categorical variables (e.g., educational background, referral rate, and retention rate). An independent t-test or Mann-Whitney U test will be used for continuous variables (e.g., age). The generalised estimating equation model was used for repeated multivariate analysis between the two study groups for the total and domain scores of the BBS, TUG, and FES. The significance level for identifying statistical differences was set at P\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe regulation of walking forward and backwards in humans remains a subject of considerable interest. Although substantial research has been conducted, the precise relationship between these networks has yet to be fully elucidated.\u003csup\u003e\u003cspan additionalcitationids=\"CR38 CR39 CR40 CR41\" citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e\u003c/sup\u003e Walking is crucial for everyday life, and walking difficulties can result in a loss of independence and decreased social participation. Rehabilitation of post-stroke gait is a complex and ongoing process that necessitates the examination of both neurophysiological and biomechanical mechanisms of gait control to enhance gait functions for post-stroke patients.\u003csup\u003e\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e\u003c/sup\u003e Partial body weight support (BWS) systems are often utilised in post-stroke gait rehabilitation. When integrated with treadmills, BWS has the potential to improve the individual's capacity to take a substantial number of symmetrical and consistent steps, which is beneficial for recovery.\u003csup\u003e\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e,\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e,\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e\u003c/sup\u003e No prior research has examined the effects of backward treadmill training while the patient's eyes are closed in subacute stroke patients. This underscores the importance of investigating this method's impact on gait rehabilitation for these individuals. To address this knowledge gap, a comprehensive instructional booklet will be developed and provided to participants in both groups, i.e., the eyes-closed and the eyes-open groups. The booklet will include information from pertinent national and international stroke guidelines, recommendations from stroke-related professional bodies and societies, and relevant research evidence.\u003c/p\u003e \u003cp\u003eThe safety profile assessment for the backward treadmill training program, which entails both eyes open and closed, will be evaluated as part of the feasibility outcomes for patients with stroke. Previous backward treadmill training interventional studies have not thoroughly examined this aspect. Patients may find the eyes-closed protocol difficult due to the risk of falls and adjusting to the treadmill's rhythm. However, implementing this protocol may still result in adverse events, such as lumbar sprains on the affected side due to muscle weakness and soreness. Therefore, any potential adverse events related to the exercise will be closely monitored and documented in the exercise logs. This research has limitations, including that it only occurred at a single study site. Moreover, the study sample may not be fully representative of all patients with sub-acute stroke experiencing gait, balance, and fear of fall issues. As the backward treadmill training intervention was visible, it was impossible to blind the participants or the backward treadmill training instructor, which could increase the risk of detection bias during the study. However, the outcome assessors will remain blind to the intervention allocation. To assess the feasibility and preliminary effects of an evidence-based backward treadmill training program with eyes closed for patients with sub-acute stroke, a rigorously designed randomised controlled trial (RCT) will be utilised. The benefits and cost-effectiveness of this training program for self-management of gait, balance, and fear of falling impairments in patients with sub-acute stroke may provide valuable guidance for physical therapy professionals and researchers in the long-term management of sub-acute stroke. Additionally, the outcomes of this trial will contribute to a future, large-scale, multicentred randomised controlled trial to further establish the research evidence on the efficacy and safety of backward treadmill training sessions for various other impairments related to fear of falling, gait, and balance issues in sub-acute stroke patients.\u003c/p\u003e"},{"header":"Strengths Limitations of Study","content":"\u003cul\u003e\n \u003cli\u003eThis is the first clinical study to explore the feasibility and preliminary effects of backward treadmill training with eyes closed versus eyes open on fear of falling, balance, and balance in patients with sub-acute stroke.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eThis study will use evidence-based backward treadmill training in both groups, which was derived comprehensively from the best available research evidence, guidelines, theories, and practice standards.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eThe design of this pilot study will be based on the Guidelines issued by the American and Indian Stroke Associations.\u003c/li\u003e\n \u003cli\u003eThe current research prefers comprehensive outcome measurements, including a series of feasibility outcomes, which will support the refinement of a clinically feasible backward treadmill training with eyes closed protocol for a future full-scale randomized clinical trial.\u003c/li\u003e\n \u003cli\u003eThe sample size of this trial was relatively small and not power-based, which will contribute to only a preliminary analysis of the effects of backward treadmill training with eyes closed on balance, mobility, and fear of falling.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics Approval and Consent to Participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval for this study was obtained from the\u0026nbsp;Institutional Ethical Committee of Sharda University \u003cstrong\u003e(Ref No-SU/SMS\u0026amp;R/76-A/2022/73).\u003c/strong\u003e All participants provided written informed consent to participate in the trial, following an explanation of the study’s aims, procedures, risks, and benefits.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for Publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants gave their written informed consent to publish anonymised data collected during the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of Data and Materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and/or analysed during the current study are available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests\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\u003eThis study did not receive any specific grant from public, commercial, or not-for-profit funding agencies.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe want to thank all participants who contributed to this study. Special thanks to the School of Allied Health Sciences, Sharda University, for their valuable support during the process.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eW J et al. (2016) \u0026lsquo;Stroke: a global response is needed\u0026rsquo;, Bulletin of the World Health Organization, 94(9), pp. 634A-635A. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2471/BLT.16.181636\u003c/span\u003e\u003cspan address=\"10.2471/BLT.16.181636\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKamalakannan S, et al. Incidence \u0026amp; prevalence of stroke in India: A systematic review. 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Step training with body weight support: effect of treadmill speed and practice paradigms on poststroke locomotor recovery. Arch Phys Med Rehabil. 2002;83(5):683\u0026ndash;91. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1053/APMR.2002.32488\u003c/span\u003e\u003cspan address=\"10.1053/APMR.2002.32488\" 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":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-5170733/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5170733/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction:\u003c/strong\u003e Gait impairment among stroke survivors is a prevalent and significant issue that necessitates appropriate rehabilitation interventions to address multiple factors such as muscle strength, balance, and coordination. One recommended approach for improving gait function is physical therapy, which helps to improve strength, balance, and coordination by reducing muscle weakness, spasticity, and tone. Other interventions that have demonstrated efficacy in enhancing gait function and mobility among stroke survivors include task-specific, high-velocity gait training. The effects of backward treadmill training were comparable to or superior to those of forward treadmill training in improving balance, gait speed, and stride length. Backward treadmill training can be considered as a potential rehabilitation intervention for stroke survivors with gait impairments.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eThis study will be a two-arm, double-blinded, 4-week pilot, randomised clinical trial involving 4-week interventions \u0026amp; 2 weeks follow-up. Forty subacute stroke survivors will be recruited from a tertiary care hospital in India. The study participants will be randomly assigned to either the eyes-open backward treadmill training group EOBT(n=20) or the eyes-closed backward treadmill ECBT training group (n=20). The participants in both groups will receive 4-week interventions and standard care. Standard care consists of self-management exercises printed in a booklet. The primary outcomes will include a series of feasibility assessments of the study protocols about the study’s methodological procedures, including subject recruitment and follow-up processes, completion of study protocols, and feasibility acceptability and safety of the intervention such as balance, gait, and fear of fall, which will be evaluated using the Berg Balance Scale, Timed Up and Go Test, and Fall Efficacy Scale.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics and Dissemination: \u003c/strong\u003eEthical approval was obtained from the Institutional Ethical Committee of Sharda University (Ref No-SU/SMS\u0026amp;R/76-A/2022/73). The research results will be presented at conferences and disseminated through scientific journals subject to peer review.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial Registration Number: \u003c/strong\u003e-CTRI/2023/08/056653.\u003c/p\u003e","manuscriptTitle":"Examining the Feasibility and Preliminary Effects of Eyes-Open and Eyes-Closed Backward Treadmill Training on Balance, Mobility, and Fear of Falling in Sub-Acute Stroke Survivors: A Pilot Randomized Clinical Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-11-25 15:32:09","doi":"10.21203/rs.3.rs-5170733/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2026-01-07T11:21:37+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2025-11-01T07:33:12+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-31T19:36:47+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-11-18T09:28:07+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pilot and Feasibility Studies","date":"2024-11-16T13:17:11+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"186a06ed-5d82-472b-9e27-9be2c37efdbe","owner":[],"postedDate":"November 25th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-04-13T16:00:08+00:00","versionOfRecord":{"articleIdentity":"rs-5170733","link":"https://doi.org/10.1186/s40814-026-01810-0","journal":{"identity":"pilot-and-feasibility-studies","isVorOnly":false,"title":"Pilot and Feasibility Studies"},"publishedOn":"2026-04-07 15:57:35","publishedOnDateReadable":"April 7th, 2026"},"versionCreatedAt":"2024-11-25 15:32:09","video":"","vorDoi":"10.1186/s40814-026-01810-0","vorDoiUrl":"https://doi.org/10.1186/s40814-026-01810-0","workflowStages":[]},"version":"v1","identity":"rs-5170733","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5170733","identity":"rs-5170733","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}