机器人双侧手臂训练启动、镜像治疗和以损害为导向的训练对慢性脑卒中患者感觉运动和日常功能的影响：一项单盲、随机对照试验的研究方案。
Effects of robotic priming of bilateral arm training, mirror therapy, and impairment-oriented training on sensorimotor and daily functions in patients with chronic stroke: study protocol of a single-blind, randomized controlled trial.
机构信息
School of Occupational Therapy, College of Medicine, National Taiwan University, 17, F4, Xu Zhou Road, Taipei, Taiwan.
Division of Occupational Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan.
出版信息
Trials. 2022 Jul 15;23(1):566. doi: 10.1186/s13063-022-06498-0.
BACKGROUND
Combining robotic therapy (RT) with task-oriented therapy is an emerging strategy to facilitate motor relearning in stroke rehabilitation. This study protocol will compare novel rehabilitation regimens that use bilateral RT as a priming technique to augment two task-oriented therapies: mirror therapy (MT) and bilateral arm training (BAT) with a control intervention: RT combined with impairment-oriented training (IOT).
METHODS
This single-blind, randomized, comparative efficacy study will involve 96 participants with chronic stroke. Participants will be randomized into bilateral RT+MT, bilateral RT+BAT, and bilateral RT+IOT groups and receive 18 intervention sessions (90 min/day, 3 d/week for 6 weeks). The outcomes will include the Fugl-Meyer Assessment, Stroke Impact Scale version 3.0, Medical Research Council scale, Revised Nottingham Sensory Assessment, ABILHAND Questionnaire, and accelerometer and will be assessed at baseline, after treatment, and at the 3-month follow-up. Analysis of covariance and the chi-square automatic interaction detector method will be used to examine the comparative efficacy and predictors of outcome, respectively, after bilateral RT+MT, bilateral RT+BAT, and bilateral RT+IOT.
DISCUSSION
The findings are expected to contribute to the research and development of robotic devices, to update the evidence-based protocols in postacute stroke care programs, and to investigate the use of accelerometers for monitoring activity level in real-life situations, which may in turn promote home-based practice by the patients and their caregivers. Directions for further studies and empirical implications for clinical practice will be further discussed in upper-extremity rehabilitation after stroke.
TRIAL REGISTRATION
This trial was registered December 12, 2018, at www.
CLINICALTRIALS
gov ( NCT03773653 ).
背景
将机器人疗法（RT）与任务导向疗法相结合是促进中风康复中运动再学习的一种新兴策略。本研究方案将比较使用双侧 RT 作为启动技术来增强两种任务导向疗法的新型康复方案：镜像疗法（MT）和双侧手臂训练（BAT）与对照干预措施：结合损伤导向训练（IOT）的 RT。
方法
这项单盲、随机、对照疗效研究将涉及 96 名慢性中风患者。参与者将随机分为双侧 RT+MT、双侧 RT+BAT 和双侧 RT+IOT 组，并接受 18 次干预疗程（每天 90 分钟，每周 3 天，持续 6 周）。结局将包括 Fugl-Meyer 评估、中风影响量表第 3.0 版、医学研究委员会量表、修订的诺丁汉感觉评估、ABILHAND 问卷以及加速度计，将在基线、治疗后和 3 个月随访时进行评估。协方差分析和卡方自动交互探测器方法将分别用于检查双侧 RT+MT、双侧 RT+BAT 和双侧 RT+IOT 后的比较疗效和结局预测因素。
讨论
研究结果有望促进机器人设备的研发，更新急性后期中风护理计划的循证方案，并研究使用加速度计在现实生活中监测活动水平，这反过来又可以促进患者及其照顾者在家中进行实践。在中风后上肢康复方面，将进一步讨论进一步研究的方向和对临床实践的经验启示。
试验注册
该试验于 2018 年 12 月 12 日在 www.clinicaltrials.gov 注册（NCT03773653）。
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