Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
研究概览
详细说明
Design: Double-blind, randomized, controlled clinical trial. Setting: Home-based rehabilitation. Subjects: Patients in the chronic phase (> 6 months) after stroke. Interventions: Patients will be randomized to an active and a control group. In both groups, treatments will be performed at home, daily, over four weeks. Patients in the active group will be instructed to use a device that provides somatosensory stimulation in the form of electrical stimulation of the median nerve for two hours. Patients in the control group will also be instructed to use the device for two hours, and sham stimulation will be administered. In both groups, patients will be instructed to train activities with the paretic hand immediately after nerve stimulation.
Main measures: The primary outcome will be improvement in performance of the paretic hand evaluated by the Jebsen-Taylor test at end of treatment and four months after end of treatment, compared to baseline. Secondary outcomes were: 1) Compliance with the interventions, assessed through a daily written log, and oral reports of the patients; 2) safety profile of the interventions.
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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-
SP
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São Paulo、SP、巴西、55
- University of São Paulo/General Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- age 18-80 years;
- single ischemic or hemorrhagic stroke in a cerebral hemisphere, documented by computed tomography (CT) or magnetic resonance imaging (MRI);
- stroke onset at least six months before;
- hand paresis with preserved ability to perform all tasks of the Jebsen-Taylor Test (JTT).
Exclusion Criteria:
- previous strokes;
- epilepsy and other neurological conditions;
- proprioceptive or tactile anesthesia;
- shoulder or hand pain;
- severe joint deformity;
- severe chronic disease;
- inability to give provide informed consent due to severe aphasia or cognitive impairment;
- left handedness before the stroke.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Somatosensory stimulation
Active group
|
Electrical median nerve stimulation
其他名称：
|
|
安慰剂比较：Control group
Placebo stimulation
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Placebo stimulation
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
the improvement in upper extremity performance assessed using Jebsen-Taylor test
大体时间：Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment
|
Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Compliance with the interventions, assessed through a daily written log, and oral reports of the patients
大体时间：immediately after the treatment
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immediately after the treatment
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|
Adverse events
大体时间：at end of treatment
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at end of treatment
|
合作者和调查者
合作者
调查人员
- 首席研究员：Adriana Conforto, MD PhD、Hospital das Clínicas/FMUSP
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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