Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident
The lifestyle of Taiwanese people has been changed over the past decade with the improvement of economic growth, environmental sanitation and the quality of medical care. Now the investigators pay more attention to the increasing risk of people's diseases of civilization than people's malnutrition and poor quality of environmental sanitation. The cerebrovascular accident (CVA) leads to death and bio-psycho-social dysfunction. The medical care of the patient of cerebrovascular accident cause a lot of money and is a burden of our country.
Our study emphasizes that acupuncture change bio-psycho-social aspects of the patient with cerebrovascular accident. The investigators use some scales to assess efficacy of acupuncture, such as Barthel index, National Institute of Health Stroke Scale, Visual Analogue Scale, Instrumental Activities of Daily Living and Hamilton Depression Rating Scale.
Besides, the investigators notice that there are few journals about acupuncture effect of treating depression following cerebral vascular accident. The investigators may underestimate the amount of people having post-stroke depression. So the investigators use Hamilton Depression Rating Scale to Assess the post-stroke depression of cerebral vascular accident patient.
By assessing bio-psycho-social level of CVA patient, the investigators hope this study will offer them more "Holistic Health Care".
研究概览
详细说明
We want to assess the effect of acupuncture on stroke patients. The study is a double-blind randomized controlled trial. We need 80 patients altogether. The Inclusion Criteria:
(1)first time stroke(ischemic or hemorrhagic stroke) with paresis or plegia
Exclusion Criteria:
(1)transient ischemic attack (2)brain tumor, brain trauma (3)recurrent stroke (4)multiple organs failure, cancer The whole course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs.
The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen.
The investigators use Barthel index, National Institute of Health Stroke Scale, Hamilton Depression Rating Scale, Instrumental activities of daily living scale and Visual Analogue Scale to assess the effect of acupuncture on stroke patients. Four times of assessment are as below: baseline, after 8th treatment, after 16th treatment, after 24th treatment (the last time of treatment). The course of treatment should be completed within 3 months.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Taichung、台湾
- Department of Acupuncture, China Medical University 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:
- first time stroke(ischemic or hemorrhagic stroke) with paresis or plegia
Exclusion Criteria:
- transient ischemic attack
- brain tumor, brain trauma
- recurrent stroke
- multiple organs failure, cancer
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Acupuncture
The total course of the acupuncture contains 24times(about 3 months).
The acupoints are fixed and located over head and limbs.
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The whole course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs. The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen.
其他名称：
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假比较器：sham acupuncture
The total course of the acupuncture contains 24times(about 3 months).
The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen.
|
The whole course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs. The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change from baseline in Barthel index at 8 weeks
大体时间：Baseline and 8 weeks
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Baseline and 8 weeks
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Change from baseline in Barthel Index at 16 weeks
大体时间：Baseline, 16 weeks
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Baseline, 16 weeks
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Change from baseline in Barthel Index at 24 weeks
大体时间：Baseline, 24 weeks
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Baseline, 24 weeks
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Change from baseline in National Institute of Health Stroke Scale at 8 weeks
大体时间：Baseline, 8 weeks
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Baseline, 8 weeks
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Change from baseline in National Institute of Health Stroke Scale at 16 weeks
大体时间：Baseline, 16 weeks
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Baseline, 16 weeks
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Change from baseline in National Institute of Health Stroke Scale at 24 weeks
大体时间：Baseline, 24 weeks
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Baseline, 24 weeks
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Change from baseline in Instrumental Activities of Daily Living Scale at 8 weeks
大体时间：Baseline, 8 weeks
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Baseline, 8 weeks
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Change from baseline in Instrumental Activities of Daily Living Scale at 16 weeks
大体时间：Baseline, 16 weeks
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Baseline, 16 weeks
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Change from baseline in Instrumental Activities of Daily Living Scale at 24 weeks
大体时间：Baseline, 24 weeks
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Baseline, 24 weeks
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Change from baseline in Hamilton Depression Rating Scale at 8 weeks
大体时间：Baseline, 8 weeks
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Baseline, 8 weeks
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Change from baseline in Hamilton Depression Rating Scale at 16 weeks
大体时间：Baseline,16 weeks
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Baseline,16 weeks
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Change from baseline in Hamilton Depression Rating Scale at 24 weeks
大体时间：Baseline, 24 weeks
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Baseline, 24 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change from baseline in Visual Analogue Scale at 8 weeks
大体时间：Baseline, 8 weeks
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Baseline, 8 weeks
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Change from baseline in Visual Analogue Scale at 16 weeks
大体时间：Baseline,16 weeks
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Baseline,16 weeks
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Change from baseline in Visual Analogue Scale at 24 weeks
大体时间：Baseline, 24 weeks
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Baseline, 24 weeks
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合作者和调查者
调查人员
- 研究主任：Yu-Chen Lee, PHD、Department of Acupuncture, China Medical University Hospital
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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