Takebayashi Takashi, Takahashi Kayoko, Amano Satoru, Uchiyama Yuki, Gosho Masahiko, Domen Kazuhisa, Hachisuka Kenji
Department of Occupational Therapy, School of Health Science and Social Welfare, Kibi International University, Takahashi, Japan.
Department of Rehabilitation, School of Allied Health Science, Kitasato University, Sagamihara-shi, Japan.
Front Neurol. 2018 Aug 28;9:730. doi: 10.3389/fneur.2018.00730. eCollection 2018.
Stroke patients experience chronic hemiparesis in their upper extremities leaving negative effects on quality of life. Robotic therapy is one method to recover arm function, but its research is still in its infancy. Research questions of this study is to investigate how to maximize the benefit of robotic therapy using ReoGo-J for arm hemiplegia in chronic stroke patients. Design of this study is a multi-center parallel group trial following the prospective, randomized, open-label, blinded endpoint (PROBE) study model. Participants and setting will be 120 chronic stroke patients (over 6 months post-stroke) will be randomly allocated to three different rehabilitation protocols. In this study, the control group will receive 20 min of standard rehabilitation (conventional occupational therapy) and 40 min of self-training (i.e., sanding, placing and stretching). The robotic therapy group will receive 20 min of standard rehabilitation and 40 min of robotic therapy using ReoGo®-J device. The combined therapy group will receive 40 min of robotic therapy and 20 min of constraint-induced movement therapy (protocol to improve upper-limb use in ADL suggests). This study employs the Fugl-Meyer Assessment upper-limb score (primary outcome), other arm function measures and the Stroke Impact Scale score will be measured at baseline, 5 and 10 weeks of the treatment phase. In analysis of this study, we use the mixed effects model for repeated measures to compare changes in outcomes between groups at 5 and 10 Weeks. The registration number of this study is UMIN000022509. This study is a feasible, multi-site randomized controlled trial to examine our hypothesis that combined training protocol could maximize the benefit of robotic therapy and best effective therapeutic strategy for patients with upper-limb hemiparesis.
中风患者上肢会出现慢性偏瘫，对生活质量产生负面影响。机器人疗法是恢复手臂功能的一种方法，但其研究仍处于起步阶段。本研究的研究问题是探讨如何利用ReoGo-J机器人疗法使慢性中风患者手臂偏瘫的益处最大化。本研究的设计是一项多中心平行组试验，遵循前瞻性、随机、开放标签、盲终点（PROBE）研究模型。参与者和研究环境为120名慢性中风患者（中风后超过6个月），他们将被随机分配到三种不同的康复方案中。在本研究中，对照组将接受20分钟的标准康复治疗（传统职业疗法）和40分钟的自我训练（即打磨、放置和伸展）。机器人疗法组将接受20分钟的标准康复治疗和40分钟使用ReoGo®-J设备的机器人疗法。联合治疗组将接受40分钟的机器人疗法和20分钟的强制性运动疗法（该方案建议改善日常生活活动中的上肢使用）。本研究采用Fugl-Meyer评估上肢评分（主要结局），在治疗阶段的基线、第5周和第10周测量其他手臂功能指标以及中风影响量表评分。在本研究的分析中，我们使用重复测量的混合效应模型来比较各组在第5周和第10周结局的变化。本研究的注册号为UMIN000022509。本研究是一项可行的多中心随机对照试验，旨在检验我们的假设，即联合训练方案可以使机器人疗法的益处最大化，是上肢偏瘫患者最佳的有效治疗策略。
