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".
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Taichung, 대만
- Department of Acupuncture, China Medical University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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가짜 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Change from baseline in Barthel index at 8 weeks
기간: 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
기간: Baseline, 16 weeks
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Baseline, 16 weeks
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Change from baseline in Barthel Index at 24 weeks
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline, 24 weeks
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Baseline, 24 weeks
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2차 결과 측정
결과 측정 |
기간 |
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Change from baseline in Visual Analogue Scale at 8 weeks
기간: Baseline, 8 weeks
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Baseline, 8 weeks
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Change from baseline in Visual Analogue Scale at 16 weeks
기간: Baseline,16 weeks
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Baseline,16 weeks
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Change from baseline in Visual Analogue Scale at 24 weeks
기간: Baseline, 24 weeks
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Baseline, 24 weeks
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공동 작업자 및 조사자
수사관
- 연구 책임자: Yu-Chen Lee, PHD, Department of Acupuncture, China Medical University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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