Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident

Conditions
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Stroke

Intervention / Treatment
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* Procedure: acupuncture(44mm in length and 32-gauge)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>The total course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs. | Procedure: acupuncture(44mm in length and 32-gauge)<br>* 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.<br>* Other names: shame acupuncture(1.27 cm in length and 40-gauge);|
| Sham Comparator: sham acupuncture<br>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. | Procedure: acupuncture(44mm in length and 32-gauge)<br>* 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.<br>* Other names: shame acupuncture(1.27 cm in length and 40-gauge);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Barthel index at 8 weeks |  | Baseline and 8 weeks | 
| Change from baseline in Barthel Index at 16 weeks |  | Baseline, 16 weeks | 
| Change from baseline in Barthel Index at 24 weeks |  | Baseline, 24 weeks | 
| Change from baseline in National Institute of Health Stroke Scale at 8 weeks |  | Baseline, 8 weeks | 
| Change from baseline in National Institute of Health Stroke Scale at 16 weeks |  | Baseline, 16 weeks | 
| Change from baseline in National Institute of Health Stroke Scale at 24 weeks |  | Baseline, 24 weeks | 
| Change from baseline in Instrumental Activities of Daily Living Scale at 8 weeks |  | Baseline, 8 weeks | 
| Change from baseline in Instrumental Activities of Daily Living Scale at 16 weeks |  | Baseline, 16 weeks | 
| Change from baseline in Instrumental Activities of Daily Living Scale at 24 weeks |  | Baseline, 24 weeks | 
| Change from baseline in Hamilton Depression Rating Scale at 8 weeks |  | Baseline, 8 weeks | 
| Change from baseline in Hamilton Depression Rating Scale at 16 weeks |  | Baseline,16 weeks | 
| Change from baseline in Hamilton Depression Rating Scale at 24 weeks |  | Baseline, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Visual Analogue Scale at 8 weeks |  | Baseline, 8 weeks | 
| Change from baseline in Visual Analogue Scale at 16 weeks |  | Baseline,16 weeks | 
| Change from baseline in Visual Analogue Scale at 24 weeks |  | Baseline, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, stroke, Randomized Controlled Trial