Clinical relevance of the effects of robotic rehabilitation for upper limb recovery after stroke in randomized studies: a systematic review with meta-analysis.

Introduction: Recent randomized clinical trials (RCTs) provide evidence on the effects of robot-assisted training (RAT) for upper limb impairments in stroke subjects; however, evidence on the clinical relevance of these differences is lacking. This study aimed to perform a systematic review with meta-analyses of RCTs on clinical relevance, expressed as minimal clinically important difference (MCID), of RAT to improve independence in activities of daily living, arm function, and impairments in patients with stroke. Methods: Four databases were searched. RCTs investigating RAT aimed at recovering motor and functional skills of the upper limb in adult post-stroke patients were included. MCID values were retrieved from specific databases. Two independent reviewers performed screening, data extraction, and assessment of methodological quality. Meta-analyses for both statistical significance and clinical relevance were performed. Clinical relevance was expressed as a standardized MCID overall score (SMOS) for each outcome measure, calculated as the difference between mean outcome measures in experimental and control groups divided by corresponding MCID, when available. Results: Eighty-five studies were included. Conventional meta-analyses showed that RAT, compared to control, had significant effects in the domains of activities of daily living, dexterity, arm function, and strength, but not on pain. Meta-analyses for clinical relevance reported non-clinically relevant differences between groups for all domains. Conclusion: RAT produces some significant improvements for the upper limb, but these differences are not clinically relevant when compared to other therapies. Improvements in using the RAT in clinical practice may not be more clinically relevant than other therapies for stroke patients.