A pragmatic, decentralized trial of the home-based, autonomous InTandem® neurorehabilitation system: analyses of engagement, safety, and effectiveness from the OrcHESTRAS trial

Chronic stroke-related gait impairment remains a major source of disability. InTandem is an autonomous neurorehabilitation system delivering individualized, progressive rhythmic auditory stimulation for home-based gait rehabilitation. To evaluate: (1) engagement during a 12-week autonomous, home-based intervention, (2) treatment-related changes in walking ability, and (3) differences based on engagement and baseline characteristics. This pragmatic, decentralized trial enrolled adults ≥ 6 months post-stroke with residual gait deficits. Participants were asked to complete three 30-minute sessions per week for up to 12 weeks. Engagement was primarily assessed based on weekly usage. The primary analysis compared the proportion achieving moderate-to-high weekly usage (≥ 4 weeks) to an a priori feasibility benchmark p 1 = 0.60. Changes in 6-Minute Walk Test (6MWT) distances and Timed Up and Go (TUG) times were analyzed using linear mixed-effects models. Moderation of clinical changes was assessed using interaction terms. Of the 204 participants who initiated the home-based autonomous intervention, 167 (81.9%; 95% CI [0.76, 0.87]) engaged for at least 4 weeks, meeting the primary endpoint ( p < 0.001). Overall, 37 participants (18.1%) had Low engagement (≤ 3 weeks), 49 (24.0%) had Moderate engagement (4–8 weeks), and 118 (57.8%) achieved High engagement (≥ 9 weeks). The adjusted changes in 6MWT distance (+ 27.3 ± 5.4 m; 95% CI [16.6, 38.1]) and TUG time (-1.45 ± 0.31 s; 95% CI [-2.06, -0.84]) were significant (both p < 0.001). Each additional week of engagement was associated with a 6.12 m greater improvement in 6MWT distance (SE = 1.97; 95% CI [2.22, 10.02]; p = 0.002). Autonomous, home-based intervention utilizing music-based rhythmic auditory stimulation achieved moderate-to-high engagement and improved poststroke walking. InTandem is a scalable approach to chronic stroke gait rehabilitation. Trial registration Clinicaltrials.gov NCT06051539. Registered on 20 September 2023. https://clinicaltrials.gov/study/NCT06051539.