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".
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Taichung, Taiwan
- Department of Acupuncture, China Medical University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Acupuncture
The total course of the acupuncture contains 24times(about 3 months).
The acupoints are fixed and located over head and limbs.
|
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.
Andre navn:
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Sham-komparator: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline in Barthel index at 8 weeks
Tidsramme: 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
Tidsramme: Baseline, 16 weeks
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Baseline, 16 weeks
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Change from baseline in Barthel Index at 24 weeks
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, 24 weeks
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Baseline, 24 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline in Visual Analogue Scale at 8 weeks
Tidsramme: Baseline, 8 weeks
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Baseline, 8 weeks
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Change from baseline in Visual Analogue Scale at 16 weeks
Tidsramme: Baseline,16 weeks
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Baseline,16 weeks
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Change from baseline in Visual Analogue Scale at 24 weeks
Tidsramme: Baseline, 24 weeks
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Baseline, 24 weeks
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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Yu-Chen Lee, PHD, Department of Acupuncture, China Medical University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CMUH102-REC2-015
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