Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke: Rehabilitation Outcomes and Neural Mechanisms by MEG
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 7
- 主要终点
- Change scores of Fugl-Meyer Assessment
研究概览
简要总结
The specific aims of this study will be to:
- investigate the treatment efficacy of Action observation therapy (AOT), mirror therapy (MT) versus a control intervention on motor and functional outcomes of stroke patients.
- compare the mechanisms and changes in cortical neural activity after AOT, MT, and control intervention by using magnetoencephalography (MEG).
- determine the correlations between neural activation changes and clinical outcomes after AOT and MT.
- identify who are the potential good responders to AOT and MT.
详细描述
In this 3-year study project, the investigators will design a comparative, randomized controlled trial to (1) investigate the treatment efficacy of AOT, MT versus a control intervention on motor and functional outcomes of stroke patients, (2) compare the mechanisms and changes in cortical neural activity after AOT, MT, and control intervention by using magnetoencephalography (MEG), (3) determine the correlations between neural activation changes and clinical outcomes after AOT and MT, and (4) identify who are the potential good responders to AOT and MT. An estimated total of 90 patients with subacute stroke will be recruited in this study. All participants will be randomly assigned to receive AOT, MT, or control intervention for a 3-week training period (a total of 15 sessions). Outcome measures will be conducted at baseline, immediately after treatment, and 3 months follow-up. For the MEG study, the investigators anticipate to recruit 12 to 15 patients in each group. The patients can still participate in this study to receive treatments and clinical evaluations even if they do not meet the MEG eligibility criteria or are not willing to participate in the MEG study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as having a unilateral stroke
- •1 to 6 months after stroke onset
- •from 20 to 80 years of age
- •a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60
- •able to follow the study instructions (measured by the Montreal Cognitive Assessment)
- •capable of participating in therapy and assessment sessions
排除标准
- •patients with global or receptive aphasia
- •severe neglect
- •major medical problems, or comorbidities that influenced UE usage or caused severe pain
研究组 & 干预措施
Action observation therapy (AOT)
Action observation therapy (AOT)
干预措施: Action observation therapy (Behavioral)
Mirror therapy (MT)
Mirror therapy (MT)
干预措施: Mirror therapy (Behavioral)
Control group
Customary bilateral UE training
干预措施: Customary bilateral UE training (Behavioral)
结局指标
主要结局
Change scores of Fugl-Meyer Assessment
时间窗: baseline, 3 weeks , 3 months
Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.
次要结局
- Change scores of Modified Rankin Scale(baseline, 3 weeks , 3 months)
- Change scores of Box and Block Test(baseline, 3 weeks , 3 months)
- Change scores of Chedoke Arm and Hand Activity Inventory(baseline, 3 weeks , 3 months)
- Change scores of Wolf Motor Function Test(baseline, 3 weeks , 3 months)
- Change scores of Medical Research Council scale(baseline, 3 weeks , 3 months)
- Change scores of Motor Activity Log(baseline, 3 weeks , 3 months)
- Change scores of Revised Nottingham Sensory Assessment(baseline, 3 weeks , 3 months)
- Change scores of ABILHAND questionnaire(baseline, 3 weeks , 3 months)
- Change scores of Questionnaire Upon Mental Imagery(baseline, 3 weeks , 3 months)
- Change scores of Functional Independence Measure(baseline, 3 weeks , 3 months)
- Change scores of Stroke Impact Scale Version 3.0(baseline, 3 weeks , 3 months)
- Change scores of ActiGraph(baseline, 3 weeks)
- Magnetoencephalography(baseline, 3 weeks)
- Change scores of Visual Analogue Scale for pain(baseline, 3 weeks)
- Change scores of Visual Analogue Scale for fatigue(baseline, 3 weeks)