Back to resultsAcupuncture in Stroke Rehabilitation
Primary Purpose
Stroke
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acupuncture and Strengthening
Strengthening Alone
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- After stroke (>6 months)
Exclusion Criteria:
- Other neurological diseases
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1
2
Arm Description
Acupuncture and strength training
Strength training
Outcomes
Primary Outcome Measures
Fugl-Meyer Motor Scores
Secondary Outcome Measures
Active wrist ROM
Quantitative Measure of Muscle Spasticity
Ashworth Score
Full Information
NCT ID
NCT00547690
First Posted
October 18, 2007
Last Updated
June 4, 2012
Sponsor
Wen Liu, Ph.D.
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT00547690
Brief Title
Acupuncture in Stroke Rehabilitation
Official Title
Electro-acupuncture and Strengthening Exercise for Hemiplegic Elbow and Wrist Joints
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Expired IRB approval
Study Start Date
April 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wen Liu, Ph.D.
Collaborators
American Heart Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of the study is to examine the effect of acupuncture treatment when combined with strength training on the motor functional recovery of stroke survivors
Detailed Description
In this study, we compare the effect on motor functional improvement between a combined acupuncture and strength training program and the strength training alone. The results may allow us to determine whether the acupuncture may bring in additional benefit to the motor recovery in the upper limb in stroke survivors
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Acupuncture and strength training
Arm Title
2
Arm Type
Other
Arm Description
Strength training
Intervention Type
Other
Intervention Name(s)
Acupuncture and Strengthening
Intervention Description
Acupuncture and strengthening
Intervention Type
Other
Intervention Name(s)
Strengthening Alone
Intervention Description
Strengthening training program
Primary Outcome Measure Information:
Title
Fugl-Meyer Motor Scores
Time Frame
Before and After 6 Week Treatment
Secondary Outcome Measure Information:
Title
Active wrist ROM
Time Frame
Before and After 6 Week Treatment
Title
Quantitative Measure of Muscle Spasticity
Time Frame
Before and After 6 Week Treatment
Title
Ashworth Score
Time Frame
Before and After 6 Week Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
After stroke (>6 months)
Exclusion Criteria:
Other neurological diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Liu, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acupuncture in Stroke Rehabilitation
We'll reach out to this number within 24 hrs