Efficacy of Multi-Domain Telerehabilitation in Patients with Stroke: A Non-Inferiority, Single-Blind, Randomized Controlled Trial

ObjectiveAlthough telerehabilitation has emerged as a promising and accessible alternative to traditional in-person therapy, robust evidence supporting its clinical effectiveness across multiple functional domains remains limited. We tested the non-inferiority of synchronous multi-domain telerehabilitation for motor, cognitive, language, and disability outcomes in stroke survivors.DesignBicentric, single-blind (assessor-blinded), randomized controlled non-inferiority trial.MethodsFifty-six participants were randomized to home-based telerehabilitation or conventional outpatient therapy. Both groups completed twenty real-time supervised sessions over four weeks. The primary outcome was change in Fugl-Meyer Assessment upper-extremity motor score (0-66); secondary outcomes included Fugl-Meyer Assessment lower-extremity motor (0-34), Aachen Aphasia Test (Italian version) naming/written language/comprehension, Oxford Cognitive Screen orientation and memory subtests, and Barthel Index. Non-inferiority was evaluated using a prespecified margin (Δ=-5.2) and confidence-interval-based linear mixed-effects models (per-protocol primary, intention-to-treat sensitivity); non-inferiority was concluded if the lower bound of the 95% CI for the adjusted between-group contrast at T1 (telerehabilitation minus conventional) was > -Δ.ResultsThe adjusted between-group difference in change for the primary outcome was compatible with non-inferiority at post-treatment, with consistent results in sensitivity analyses. No significant between-group differences were observed in language, cognitive, or functional independence outcomes, and findings were similar at one-month follow-up.ConclusionsSynchronous multi-domain telerehabilitation appears feasible and yields short-term motor recovery comparable to standard outpatient rehabilitation within a prespecified non-inferiority framework. Interpretation is limited by the short follow-up and restricted cognitive outcome coverage.