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Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident

Primary Purpose

Stroke

Status
Terminated
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture(44mm in length and 32-gauge)
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring acupuncture, stroke, Randomized Controlled Trial

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Acupuncture, China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupuncture

sham acupuncture

Arm Description

The total course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs.

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.

Outcomes

Primary Outcome Measures

Change from baseline in Barthel index at 8 weeks
Change from baseline in Barthel Index at 16 weeks
Change from baseline in Barthel Index at 24 weeks
Change from baseline in National Institute of Health Stroke Scale at 8 weeks
Change from baseline in National Institute of Health Stroke Scale at 16 weeks
Change from baseline in National Institute of Health Stroke Scale at 24 weeks
Change from baseline in Instrumental Activities of Daily Living Scale at 8 weeks
Change from baseline in Instrumental Activities of Daily Living Scale at 16 weeks
Change from baseline in Instrumental Activities of Daily Living Scale at 24 weeks
Change from baseline in Hamilton Depression Rating Scale at 8 weeks
Change from baseline in Hamilton Depression Rating Scale at 16 weeks
Change from baseline in Hamilton Depression Rating Scale at 24 weeks

Secondary Outcome Measures

Change from baseline in Visual Analogue Scale at 8 weeks
Change from baseline in Visual Analogue Scale at 16 weeks
Change from baseline in Visual Analogue Scale at 24 weeks

Full Information

First Posted
June 8, 2014
Last Updated
October 20, 2015
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02197663
Brief Title
Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident
Official Title
Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
the numbers of drop-out patients are more than we anticipate
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
acupuncture, stroke, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
The total course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs.
Arm Title
sham acupuncture
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
acupuncture(44mm in length and 32-gauge)
Other Intervention Name(s)
acupuncture(4.4cm in length and 32-gauge), shame acupuncture(1.27 cm in length and 40-gauge)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Barthel index at 8 weeks
Time Frame
Baseline and 8 weeks
Title
Change from baseline in Barthel Index at 16 weeks
Time Frame
Baseline, 16 weeks
Title
Change from baseline in Barthel Index at 24 weeks
Time Frame
Baseline, 24 weeks
Title
Change from baseline in National Institute of Health Stroke Scale at 8 weeks
Time Frame
Baseline, 8 weeks
Title
Change from baseline in National Institute of Health Stroke Scale at 16 weeks
Time Frame
Baseline, 16 weeks
Title
Change from baseline in National Institute of Health Stroke Scale at 24 weeks
Time Frame
Baseline, 24 weeks
Title
Change from baseline in Instrumental Activities of Daily Living Scale at 8 weeks
Time Frame
Baseline, 8 weeks
Title
Change from baseline in Instrumental Activities of Daily Living Scale at 16 weeks
Time Frame
Baseline, 16 weeks
Title
Change from baseline in Instrumental Activities of Daily Living Scale at 24 weeks
Time Frame
Baseline, 24 weeks
Title
Change from baseline in Hamilton Depression Rating Scale at 8 weeks
Time Frame
Baseline, 8 weeks
Title
Change from baseline in Hamilton Depression Rating Scale at 16 weeks
Time Frame
Baseline,16 weeks
Title
Change from baseline in Hamilton Depression Rating Scale at 24 weeks
Time Frame
Baseline, 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Visual Analogue Scale at 8 weeks
Time Frame
Baseline, 8 weeks
Title
Change from baseline in Visual Analogue Scale at 16 weeks
Time Frame
Baseline,16 weeks
Title
Change from baseline in Visual Analogue Scale at 24 weeks
Time Frame
Baseline, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Chen Lee, PHD
Organizational Affiliation
Department of Acupuncture, China Medical University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Acupuncture, China Medical University Hospital
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

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Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident

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