Walking adaptability training for individuals after stroke (ATTAINS): study protocol for a randomized, waiting-list controlled trial.

BACKGROUND: People with stroke (PwS) in the chronic phase often experience difficulties adapting their gait to meet environmental demands. This so-called walking adaptability is important for safe and independent walking in everyday life. Walking adaptability can be trained on a treadmill with augmented reality (C-mill), but conclusive evidence of its effectiveness in PwS is yet lacking. The primary aim of this study is, therefore, to evaluate the efficacy of C-mill-based task-specific training on walking adaptability in a randomized controlled trial. As a secondary aim, we will conduct a responder analysis to explore potential determinants of treatment effects. METHOD: This is a single-center, randomized, waiting-list controlled trial. We aim to enroll 84 people in the chronic phase (> 6 months) after a first, unilateral supratentorial stroke, who are able to walk independently for 10 min. Following baseline assessment, participants will be randomly assigned to either the experimental group or the waiting-list control group. The experimental group will receive ten 1-h training sessions on the C-mill targeting walking adaptability in a 5-week period. Participants assigned to the waiting-list controlled group will continue their usual care for 5 weeks; thereafter they will receive the same walking adaptability training as the experimental group. To determine the effects of the training, assessments of walking adaptability, as well as other balance and gait-related tasks, will be conducted at baseline (T0) and following the 5-week intervention/waiting period (T1). To allow responder analysis across both groups, the waiting-list control group will have an additional assessment (T2) following their training period. OUTCOME: The two primary outcomes are the time needed to complete the obstacle subtask of the Emory functional ambulation profile (EFAP-obstacle) and the error-corrected time score on the walking adaptability ladder test (WALT). To correct for the two primary outcomes significant effects are assumed for p < 0.025. Secondary outcomes include lab-based tests to assess target stepping and gait stability and commonly used clinical tests to assess balance and walking capacity. Furthermore, home-based walking activity and falls are monitored. DISCUSSION: The results of this study are expected to inform tailored provision of walking adaptability training in PwS in the chronic phase. TRIAL REGISTRATION: ClinicalTrials.gov NCT05827380 (URL: https://clinicaltrials.gov/study/NCT05827380 ). Final protocol submitted on 18-7-2022, registered on 25-04-2023.