Shih Tsai-Yu, Wu Ching-Yi, Lin Keh-Chung, Cheng Chia-Hsiung, Hsieh Yu-Wei, Chen Chia-Ling, Lai Chih-Jou, Chen Chih-Chi
Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, Chang Gung University, 259 Wenhua 1st Rd., Guishan Dist, Taoyuan, Taiwan.
Healthy Aging Research Center, Chang Gung University, Taoyuan, Taiwan.
Trials. 2017 Oct 4;18(1):459. doi: 10.1186/s13063-017-2205-z.
Loss of upper-extremity motor function is one of the most debilitating deficits following stroke. Two promising treatment approaches, action observation therapy (AOT) and mirror therapy (MT), aim to enhance motor learning and promote neural reorganization in patients through different afferent inputs and patterns of visual feedback. Both approaches involve different patterns of motor observation, imitation, and execution but share some similar neural bases of the mirror neuron system. AOT and MT used in stroke rehabilitation may confer differential benefits and neural activities that remain to be determined. This clinical trial aims to investigate and compare treatment effects and neural activity changes of AOT and MT with those of the control intervention in patients with subacute stroke.
METHODS/DESIGN: An estimated total of 90 patients with subacute stroke will be recruited for this study. All participants will be randomly assigned to receive AOT, MT, or control intervention for a 3-week training period (15 sessions). Outcome measurements will be taken at baseline, immediately after treatment, and at the 3-month follow-up. For the magnetoencephalography (MEG) study, we anticipate that we will recruit 12 to 15 patients per group. The primary outcome will be the Fugl-Meyer Assessment score. Secondary outcomes will include the modified Rankin Scale, the Box and Block Test, the ABILHAND questionnaire, the Questionnaire Upon Mental Imagery, the Functional Independence Measure, activity monitors, the Stroke Impact Scale version 3.0, and MEG signals.
This clinical trial will provide scientific evidence of treatment effects on motor, functional outcomes, and neural activity mechanisms after AOT and MT in patients with subacute stroke. Further application and use of AOT and MT may include telerehabilitation or home-based rehabilitation through web-based or video teaching.
ClinicalTrials.gov, ID: NCT02871700 . Registered on 1 August 2016.
上肢运动功能丧失是中风后最使人衰弱的缺陷之一。两种有前景的治疗方法，即动作观察疗法（AOT）和镜像疗法（MT），旨在通过不同的传入输入和视觉反馈模式来增强患者的运动学习并促进神经重组。这两种方法都涉及不同模式的运动观察、模仿和执行，但共享镜像神经元系统的一些相似神经基础。用于中风康复的AOT和MT可能会带来不同的益处和神经活动，这些仍有待确定。本临床试验旨在研究和比较亚急性中风患者中AOT和MT与对照干预的治疗效果及神经活动变化。
方法/设计：本研究预计共招募90例亚急性中风患者。所有参与者将被随机分配接受AOT、MT或对照干预，为期3周的训练期（15节课程）。在基线、治疗结束后即刻以及3个月随访时进行结果测量。对于脑磁图（MEG）研究，我们预计每组招募12至15名患者。主要结局将是Fugl-Meyer评估评分。次要结局将包括改良Rankin量表、箱块测试、ABILHAND问卷、心理意象问卷、功能独立性测量、活动监测器、中风影响量表3.0版以及MEG信号。
本临床试验将为亚急性中风患者接受AOT和MT治疗后对运动、功能结局及神经活动机制的治疗效果提供科学证据。AOT和MT的进一步应用可能包括通过基于网络或视频教学的远程康复或家庭康复。
ClinicalTrials.gov，标识符：NCT02871700。于2016年8月1日注册。
