Abstract
Introduction: Robotic Therapy (RT) is shown to improve upper extremity (UE) function, but not the use of affected arm in daily activities. Constraint-Induced Movement Therapy (CIMT), on the other hand, is the most well-established intervention for improving the use of the affected arm. Hypothesis: (1) RT as self-training would improve UE function better than usual self-training. (2) Combination of RT and modified CIMT would improve daily use of affected arm as compared to the combination of RT with usual therapy. Methods: This study was a prospective, single-blinded, randomized, multicenter clinical trial conducted at 24 rehabilitation clinics in Japan. Participants were 129 individuals with hemiplegia (FM<44) at least over 6 months post stroke. They were randomized to one of three interventions for ten weeks (3 days a week): (a) 40 minutes RT as self-training(ReoGo®-J, Teijin Pharma, Japan) with usual therapy (RT group), (b) 40 minutes RT as self-training with 20 minutes modified CIMT (Combination group), and (c) 40 minutes usual self-training with 20 minutes usual therapy (Control group). UE function (Fugl-Meyer Assessment: FM), and arm usage (Motor Activity Log: MAL) was measured. Sub-analysis was conducted divided by the onset period (14 months) and age (65 year). Results: Proximal FM improved significantly in RT group than Control group (p=0.04), especially for age under 65. MAL significantly improved in Combination group than Control group (p=0.05), especially for age over 65. RT group significantly improved on Proximal FM than Combination (p=0.05) and Control (p=0.03) groups, for patients less than 14 months onset. For over 14 months onset, Combination group improved Wrist/Finger FM (p=0.06) and arm usage (p=0.09) than RT group. Conclusions: This study indicate robotic self-training improve UE function of chronic stroke patients than usual self-training. In addition, arm usage only exceeded MCID by the combination therapy of robotic self-training with modified CIMT, and more effective for older patients (age over 65) at chronic stage (over 14 months onset).
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