Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident

NCT02197663 | Terminated Phase 1

• 1 other identifier: CMUH102-REC2-015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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".

Conditions

Stroke

Keywords

acupuncture; stroke; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (12)

• Change from baseline in Barthel index at 8 weeks

  Baseline and 8 weeks

• Change from baseline in Barthel Index at 16 weeks

  Baseline, 16 weeks

• Change from baseline in Barthel Index at 24 weeks

  Baseline, 24 weeks

• Change from baseline in National Institute of Health Stroke Scale at 8 weeks

  Baseline, 8 weeks

• Change from baseline in National Institute of Health Stroke Scale at 16 weeks

  Baseline, 16 weeks

• Change from baseline in National Institute of Health Stroke Scale at 24 weeks

  Baseline, 24 weeks

• Change from baseline in Instrumental Activities of Daily Living Scale at 8 weeks

  Baseline, 8 weeks

• Change from baseline in Instrumental Activities of Daily Living Scale at 16 weeks

  Baseline, 16 weeks

• Change from baseline in Instrumental Activities of Daily Living Scale at 24 weeks

  Baseline, 24 weeks

• Change from baseline in Hamilton Depression Rating Scale at 8 weeks

  Baseline, 8 weeks

• Change from baseline in Hamilton Depression Rating Scale at 16 weeks

  Baseline,16 weeks

• Change from baseline in Hamilton Depression Rating Scale at 24 weeks

  Baseline, 24 weeks

Secondary Outcomes (3)

• Change from baseline in Visual Analogue Scale at 8 weeks

  Baseline, 8 weeks

• Change from baseline in Visual Analogue Scale at 16 weeks

  Baseline,16 weeks

• Change from baseline in Visual Analogue Scale at 24 weeks

  Baseline, 24 weeks

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Procedure: acupuncture(44mm in length and 32-gauge)

sham acupuncture

SHAM COMPARATOR

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.

Procedure: acupuncture(44mm in length and 32-gauge)

Interventions

acupuncture(44mm in length and 32-gauge) PROCEDURE

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.

Also known as: acupuncture(4.4cm in length and 32-gauge), shame acupuncture(1.27 cm in length and 40-gauge)

Acupuncture; sham acupuncture

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first time stroke(ischemic or hemorrhagic stroke) with paresis or plegia

You may not qualify if:

• transient ischemic attack
• brain tumor, brain trauma
• recurrent stroke
• multiple organs failure, cancer

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Department of Acupuncture, China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Stroke

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yu-Chen Lee, PHD

  Department of Acupuncture, China Medical University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2014
• First Posted: July 23, 2014
• Study Start: April 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

TW (1)