Background/Aims: Maintaining mobility in the long term after stroke can be challenging. There is a need to investigate new service delivery models to improve mobility after stroke. A mobility booster program may be a solution, facilitating short-term access to intensive physiotherapy as needed. This project aimed to determine the feasibility of conducting a clinical trial of a short-term, high-dose mobility booster program (HiWalk) and measure clinical outcomes to estimate power for a future efficacy trial.
Methods: A multi-site, assessor-blinded pilot randomised trial was undertaken to compare HiWalk in addition to usual care with usual care alone. Feasibility outcomes include recruitment, adherence, and safety. Clinical outcomes include walking speed, capacity and self-efficacy at 1-month and 6-months.
Results: Forty-seven people after stroke participated in the trial: age 58 (SD 16), time post-stroke 2.7 years (SD 2.1) and baseline fast walking speed 0.9 m/s (SD 0.4). The HiWalk trial was feasible in terms of recruitment (refusal rate 31%, retention at one month 100%), adherence (mean 91% [SD 13] attendance once commenced), safety (5 minor adverse events across 345 sessions) and measurement (98% of data collected at one month). At 1-month, there was a potential positive effect of HiWalk on walking speed (MD 0.06, 95% CI -0.04 to 0.15), distance (MD 6 m, 95% CI -17 to 29) and confidence (MD 3.1/30, 95% CI 0.6 to 5.6).
Conclusions: This pilot trial establishes the feasibility of providing a novel high-dose, short-term booster program. These pilot results suggest a Phase III efficacy trial is warranted.