AI-assisted telerehabilitation in early Parkinson’s disease: a multicenter, randomized, multi-arm comparative trial

Abstract

This exploratory, multicenter, randomized, rater-blinded, multi-arm comparative trial aimed to evaluate the feasibility and exploratory clinical signals of an AI-facilitated telerehabilitation system across different intervention durations in early-stage Parkinson’s disease (PD). One-hundred and twenty PD patients (Hoehn-Yahr stage ≤2.5) were randomized in a 1:1:1 ratio into short-term (1 month), medium-term (2 months), and long-term (3 months) training groups (15–30 min, 5 days/week). The primary outcome was the change in MDS-UPDRS Part III score from baseline to 3 months. Secondary outcomes included change in cognition, mood, gait parameters, activity of daily living, and safety. Final analysis included 71 participants. No significant differences were observed between groups for the primary motor outcome at 3 months. Post hoc responder analysis showed that the 3-month group had higher proportions reaching the exploratory cognitive responder threshold compared with the 1-month group. Exploratory correlations between MoCA changes and motor parameter changes were weak and did not remain statistically significant after false discovery rate correction. No falls or adverse events were recorded throughout the trial. Because the primary endpoint was negative, attrition was high, no usual-care control was included, and the cognitive finding was limited to an exploratory post-hoc responder analysis, these findings do not permit causal inference and should be interpreted as hypothesis-generating, requiring further validation in larger, prespecified multi-arm comparative trials (Chinese Clinical Trial Registry Number: ChiCTR2500108323).