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临床试验/NCT03246139
NCT03246139已完成不适用

Action Observation, Imagery and Execution as a New Intervention Strategy for Stroke Rehabilitation: Short- and Long-term Treatment Effects and Neural Mechanism

Chang Gung Memorial Hospital4 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2017年8月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
4
主要终点
Change scores of Modified Rankin Scale

研究概览

简要总结

The specific study aims will be:

  1. To investigate the short- and long-term treatment effects of action observation, imagery, and execution therapy (AOIE) compared with an action observation therapy (AO) group and a control treatment group as controls on different aspects of outcomes in patients with stroke.
  2. To examine the neural mechanisms and changes in cortical neural activity after the interventions in stroke patients.
  3. To examine the correlations between AOIE-induced brain activation changes and the clinical efficacy of AOIE.
  4. To identify who are the possible good responders to the therapy based on baseline motor function and motor imagery ability of the participants.

详细描述

The investigators propose a 3-year randomized controlled trial to (1) investigate the short- and long-term treatment efficacy of AOIE, action observation alone, versus control treatment on clinical outcomes of patients with subacute stroke, (2) examine the neural mechanisms and activation changes after the 3 interventions by using an advanced brain imaging technique, magnetoencephalography (MEG), (3) determine the correlations between neural activation changes and clinical outcomes, and (4) identify who are the good responders to the AOIE therapy. An estimated total of 96 patients with subacute stroke will be recruited in this study. All participants will be randomly assigned to receive 1 of the 3 interventions for 3 weeks (a total of 15 sessions). Clinical outcome measures will be conducted at baseline, immediately after treatment (3 weeks), and at 3 months follow-up. The MEG assessment will be conducted at baseline and immediately after treatment (3 weeks). For the MEG study, The investigators anticipate to enroll 12 to 15 patients in each group to complete neuroimaging evaluation because of the specific eligibility criteria and high costs of MEG. The patients can still participate in the study, receiving rehabilitation therapy and clinical evaluations, even if the participants will not be included 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 12 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
  • •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
  • •Additionally, if patients have no metal implants, no head traumas or neurosurgical operations, and can perform MEG motor tasks, the participants can additionally participate in the MEG assessment.

研究组 & 干预措施

Action observation

Active Comparator

干预措施: Action observation (Behavioral)

Action observation, imagery & execution

Experimental

干预措施: Action observation, imagery & execution (Behavioral)

Control treatment

Active Comparator

干预措施: Control treatment (Behavioral)

结局指标

主要结局

Change scores of Modified Rankin Scale

时间窗: baseline, 3 weeks , 3 months

The Modified Rankin Scale is used to assess the degree of stroke disability.

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 Box and Block Test(baseline, 3 weeks , 3 months)
  • Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)(baseline, 3 weeks , 3 months)
  • Change scores of Movement Imagery Questionnaire, revised second version(baseline, 3 weeks , 3 months)
  • Change scores of Functional Independence Measure(baseline, 3 weeks , 3 months)
  • Change scores of physical intensity measured by activity monitors(baseline, 3 weeks , 3 months)
  • Change scores of energy expenditure measured by activity monitors(baseline, 3 weeks , 3 months)
  • Change scores of Stroke Impact Scale (SIS) Version 3.0(baseline, 3 weeks , 3 months)
  • Magnetoencephalography (MEG)(baseline, 3 weeks)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (4)

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