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

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.