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".
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Taichung、台湾
- Department of Acupuncture, China Medical University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
他の名前：
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偽コンパレータ：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Change from baseline in Barthel index at 8 weeks
時間枠：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
時間枠：Baseline, 16 weeks
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Baseline, 16 weeks
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Change from baseline in Barthel Index at 24 weeks
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline, 24 weeks
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Baseline, 24 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change from baseline in Visual Analogue Scale at 8 weeks
時間枠：Baseline, 8 weeks
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Baseline, 8 weeks
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Change from baseline in Visual Analogue Scale at 16 weeks
時間枠：Baseline,16 weeks
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Baseline,16 weeks
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Change from baseline in Visual Analogue Scale at 24 weeks
時間枠：Baseline, 24 weeks
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Baseline, 24 weeks
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協力者と研究者
捜査官
- スタディディレクター：Yu-Chen Lee, PHD、Department of Acupuncture, China Medical University Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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