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".
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Taichung, Taïwan
- Department of Acupuncture, China Medical University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
Autres noms:
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Comparateur factice: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Change from baseline in Barthel index at 8 weeks
Délai: 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
Délai: Baseline, 16 weeks
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Baseline, 16 weeks
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Change from baseline in Barthel Index at 24 weeks
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline, 24 weeks
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Baseline, 24 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Change from baseline in Visual Analogue Scale at 8 weeks
Délai: Baseline, 8 weeks
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Baseline, 8 weeks
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Change from baseline in Visual Analogue Scale at 16 weeks
Délai: Baseline,16 weeks
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Baseline,16 weeks
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Change from baseline in Visual Analogue Scale at 24 weeks
Délai: Baseline, 24 weeks
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Baseline, 24 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Yu-Chen Lee, PHD, Department of Acupuncture, China Medical University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CMUH102-REC2-015
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