AI-driven cognitive telerehabilitation for stroke: a randomized controlled trial
Abstract
Background Cognitive impairment is a common consequence of stroke, requiring effective rehabilitation strategies. Telerehabilitation has emerged as a promising alternative to in-person cognitive therapy, yet existing systems often lack mechanisms for real-time personalization and engagement monitoring. This study aimed to evaluate the clinical effectiveness of a self-guided AI-driven cognitive telerehabilitation compared to a therapist-supervised rehabilitation in subacute stroke patients. Methods In this multicenter, parallel-group, randomized controlled non-inferiority trial, 63 participants with cognitive impairment within 6 months of stroke onset were randomized 1:1 to either a self-guided AI-driven telerehabilitation group or a therapist-supervised rehabilitation group. Both groups completed 24 sessions within 6 weeks using the same mobile platform. The primary outcomes were cognitive function measures, including the Korean Mini-Mental State Examination-2 (K-MMSE2), Trail Making Tests (A and B), and Digit Span Tests (forward and backward), with non-inferiority formally tested using the K-MMSE2. Secondary outcomes included functional independence, psychosocial measures and usability questionnaire. Results Fifty-five participants completed the study. Both groups showed significant improvements across all primary cognitive measures, with no statistically significant differences between groups. Non-inferiority analysis confirmed that the self-guided AI-driven…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 63 participants or records.
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