School of Occupational Therapy, College of Medicine, National Taiwan University, No.17, F4, Xu Zhou Road, Zhongzheng Dist, Taipei City, 100, Taiwan.
Division of Occupational Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, No.1, Changde St., Zhongzheng Dist, Taipei City, 100, Taiwan.
Trials. 2021 Sep 8;22(1):604. doi: 10.1186/s13063-021-05561-6.
The sequence of establishing a proximal stability or function before facilitation of the distal body part has long been recognized in stroke rehabilitation practice but lacks scientific evidence. This study plans to examine the effects of proximal priority robotic priming and impairment-oriented training (PRI) and distal priority robotic priming and impairment-oriented training (DRI).
This single-blind, randomized, comparative efficacy study will involve 40 participants with chronic stroke. Participants will be randomized into the PRI or DRI groups and receive 18 intervention sessions (90 min/day, 3 days/weeks for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the chi-square automatic interaction detector method will be used to examine the comparative efficacy and predictors of outcome, respectively, after PRI and DRI.
Through manipulating the sequence of applying wrist and forearm robots in therapy, this study will attempt to examine empirically the priming effect of proximal or distal priority robotic therapy in upper extremity impairment-oriented training for people with stroke. The findings will provide directions for further studies and empirical implications for clinical practice in upper extremity rehabilitation after stroke.
ClinicalTrials.gov NCT04446273. Registered on June 23, 2020.
在促进远端身体部位的功能之前，先建立近端稳定性或功能的顺序，这在中风康复实践中早已得到认可，但缺乏科学证据。本研究计划检验近端优先机器人启动和损伤导向训练（PRI）和远端优先机器人启动和损伤导向训练（DRI）的效果。
这是一项单盲、随机、对照疗效研究，将涉及 40 名慢性中风患者。参与者将随机分为 PRI 或 DRI 组，并接受 18 次干预课程（每天 90 分钟，每周 3 天，持续 6 周）。在基线、治疗后和 3 个月随访时，将进行 Fugl-Meyer 上肢评定量表、医学研究委员会量表、修订的诺丁汉感觉评估和 Wolf 运动功能测试。将使用双向重复测量方差分析和卡方自动交互检测方法分别检验 PRI 和 DRI 后的比较疗效和结果预测因素。
通过在治疗中操纵手腕和前臂机器人的应用顺序，本研究将尝试通过实证检验近端或远端优先机器人治疗在上肢损伤导向训练中的启动效应，以帮助中风患者。研究结果将为进一步的研究提供方向，并为中风后上肢康复的临床实践提供经验启示。
ClinicalTrials.gov NCT04446273。注册于 2020 年 6 月 23 日。
