Department of Occupational Therapy, School of Comprehensive Rehabilitation, College of Health and Human Sciences, Osaka Prefecture University, Japan (T.T.).
Now with: Department of Rehabilitation Science, School of Medicine, Osaka Metropolitan University, Japan (T.T.).
Stroke. 2022 Jul;53(7):2182-2191. doi: 10.1161/STROKEAHA.121.037260. Epub 2022 Mar 29.
BACKGROUND: This study aimed to examine whether robotic self-training improved upper-extremity function versus conventional self-training in mild-to-moderate hemiplegic chronic stroke patients. METHODS: Study design was a multi-center, prospective, randomized, parallel-group study comparing three therapist-guided interventions (1-hour sessions, 3×/wk, 10 weeks). We identified 161 prospective patients with chronic, poststroke, upper-limb hemiplegia treated at participating rehabilitation centers. Patients were enrolled between November 29, 2016, and November 12, 2018 in Japan. A blinded web-based allocation system was used to randomly assign 129 qualifying patients into 3 groups: (1) conventional self-training plus conventional therapy (control, N=42); (2) robotic self-training (ReoGo-J) plus conventional therapy (robotic therapy [RT], N=44); or (3) robotic self-training plus constraint-induced movement therapy (N=43). PRIMARY OUTCOME: Fugl-Meyer Assessment for upper-extremity. SECONDARY OUTCOMES: Motor Activity Log-14 amount of use and quality of movement; Fugl-Meyer Assessment shoulder/elbow/forearm, wrist, finger, and coordination scores; Action Research Arm Test Score; Motricity Index; Modified Ashworth Scale; shoulder, elbow, forearm, wrist, and finger range of motion; and Stroke Impact Scale (the assessors were blinded). Safety outcomes were adverse events. RESULTS: Safety was assessed in 127 patients. An intention-to-treat full analysis set (N=121), and a per-protocol set (N=115) of patients who attended 80% of sessions were assessed. One severe adverse event was recorded, unrelated to the robotic device. No significant differences in Fugl-Meyer Assessment for upper-extremity scores were observed between groups (RT versus control: -1.04 [95% CI, -2.79 to 0.71], =0.40; RT versus movement therapy: -0.33 [95% CI, -2.02 to 1.36], =0.90). The RT in the per-protocol set improved significantly in the Fugl-Meyer Assessment for upper-extremity shoulder/elbow/forearm score (RT versus control: -1.46 [95% CI, -2.63 to -0.29]; =0.037). CONCLUSIONS: Robotic self-training did not improve upper-limb function versus usual self-training, but may be effective combined with conventional therapy in some populations (per-protocol set). REGISTRATION: URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000022509.
背景：本研究旨在探讨机器人自我训练是否优于常规自我训练，以改善轻度至中度偏瘫慢性卒中患者的上肢功能。
方法：研究设计为多中心、前瞻性、随机、平行组研究，比较三种治疗师指导的干预措施（每次 1 小时，每周 3 次，共 10 周）。我们在参与康复中心治疗的慢性、卒中后、上肢偏瘫的 161 名前瞻性患者中识别出了患者。2016 年 11 月 29 日至 2018 年 11 月 12 日，在日本招募患者。使用基于网络的盲法分配系统将 129 名符合条件的患者随机分为 3 组：（1）常规自我训练加常规治疗（对照组，N=42）；（2）机器人自我训练（ReoGo-J）加常规治疗（机器人治疗[RT]，N=44）；或（3）机器人自我训练加强制性运动疗法（N=43）。
主要结局：上肢 Fugl-Meyer 评估。
次要结局：运动活动日志-14 活动量和运动质量；Fugl-Meyer 评估肩部/肘部/前臂、腕部、手指和协调评分；动作研究臂测试评分；运动指数；改良 Ashworth 量表；肩部、肘部、前臂、腕部和手指的活动范围；以及卒中影响量表（评估者设盲）。安全性结局为不良事件。
结果：在 127 名患者中评估了安全性。对意向治疗全分析集（N=121）和参加 80%疗程的方案集（N=115）的患者进行了评估。记录了 1 例严重不良事件，与机器人设备无关。各组 Fugl-Meyer 上肢评分无显著差异（RT 与对照组：-1.04[95%CI，-2.79 至 0.71]，=0.40；RT 与运动疗法：-0.33[95%CI，-2.02 至 1.36]，=0.90）。方案集中的 RT 在上肢 Fugl-Meyer 评估的肩部/肘部/前臂评分中显著改善（RT 与对照组：-1.46[95%CI，-2.63 至 -0.29]；=0.037）。
结论：与常规自我训练相比，机器人自我训练并未改善上肢功能，但可能对某些人群（方案集）联合常规治疗有效。
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