Efficacy of Multi-Domain Telerehabilitation in Patients with Stroke: A Non-Inferiority, Single-Blind, Randomized Controlled Trial.
Picelli Alessandro, Kiper Pawel, Varalta Valentina, Filippetti Mirko, Righetti Anna, Evangelista Elisa, Di Censo Rita, Fonte Cristina, Federico Sara, Cacciante Luisa, Carletto Alessia, Turolla Andrea, Agostini Michela, Tonin Paolo, Giacomozzi Claudia, Smania Nicola
NeuroRehabilitation · 2026 · PMID 42068283
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.