Back to resultsConstraint-Induced (CI) Movement Therapy for Progressive Multiple Sclerosis (MS)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Constraint-Induced Movement Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis
Eligibility Criteria
Inclusion Criteria:
- Chronic upper extremity motor deficit due to multiple sclerosis
Exclusion Criteria:
- Relapse within 3 months of planned enrollment.
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Treatment with Constraint-Induced Movement Therapy
Outcomes
Primary Outcome Measures
Improvement on the Motor Activity Log
Secondary Outcome Measures
Improvement on the Wolf Motor Function Test
Full Information
NCT ID
NCT00695084
First Posted
June 9, 2008
Last Updated
June 10, 2008
Sponsor
National Multiple Sclerosis Society
1. Study Identification
Unique Protocol Identification Number
NCT00695084
Brief Title
Constraint-Induced (CI) Movement Therapy for Progressive Multiple Sclerosis (MS)
Official Title
Constraint-Induced Movement Therapy Trial for Progressive Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Multiple Sclerosis Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial will evaluate whether progressive multiple sclerosis associated with hemiparesis may benefit from Constraint-Induced Movement Therapy.
Detailed Description
Constraint-Induced Movement Therapy was developed to treat stroke hemiparesis. Due to the similarity between multiple sclerosis and stroke in terms of chronic motor deficit, this trial will attempt to determine whether multiple sclerosis may benefit similarly from Constraint-Induced Movement Therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Treatment with Constraint-Induced Movement Therapy
Intervention Type
Behavioral
Intervention Name(s)
Constraint-Induced Movement Therapy
Other Intervention Name(s)
CI Therapy
Intervention Description
Intensive practice with the hemiparetic arm for 30 contact hours
Primary Outcome Measure Information:
Title
Improvement on the Motor Activity Log
Time Frame
One year
Secondary Outcome Measure Information:
Title
Improvement on the Wolf Motor Function Test
Time Frame
Pre to post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic upper extremity motor deficit due to multiple sclerosis
Exclusion Criteria:
Relapse within 3 months of planned enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor W Mark, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Constraint-Induced (CI) Movement Therapy for Progressive Multiple Sclerosis (MS)
We'll reach out to this number within 24 hrs