Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
66 participants
INTERVENTIONAL
2010-02-28
2016-03-31
Brief Summary
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Detailed Description
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This study will randomize persons with MS who have relatively reduced use of one of the hands to either CI therapy or CAM treatments. Treatment in either program will be for 2 consecutive weeks, 3.5 hours per day (Monday-Friday), under the direct supervision of a specially trained therapist. Before starting, participants will also undergo comprehensive medical and physical exam screening and brain MRI scan. The same evaluations will be performed after treatment to learn whether any of these have changed as a result of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CI Therapy
CI therapy involves repetitive practice with the more-affected hand on typical daily living activities (such as stacking objects, pouring, moving objects) for 3.5 hours per day, along with physical restraint of the better hand to keep it from assisting, and home practice exercises.
CI Therapy
CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
CAM treatments
CAM treatments are holistic physical treatments designed to work on the entire body to improve quality of life and overall health. This study will use yoga, relaxation exercises, aquatherapy (pool therapy), and massage.
CAM treatments
CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
Interventions
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CI Therapy
CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
CAM treatments
CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* reduced use of one of the hands because of MS
* ability to pick up and release a small object with the more-affected hand when requested
* can travel to the treatment program at the University of Alabama at Birmingham (UAB)
* can undergo treatment for 2 weeks (Monday-Friday), 3.5 hours per day
* can undergo MRI scan
* any kind of medication used for MS is allowed except spasticity medicine
Exclusion Criteria
* pregnancy
* marked pain with arm movement
* severe uncontrolled medical illness
* simultaneous treatment with another form of physical therapy
21 Years
80 Years
ALL
No
Sponsors
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National Multiple Sclerosis Society
OTHER
Responsible Party
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Victor W. Mark
Associate Professor
Principal Investigators
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Victor W Mark, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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References
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Mark VW, Taub E, Bashir K, Uswatte G, Delgado A, Bowman MH, Bryson CC, McKay S, Cutter GR. Constraint-Induced Movement therapy can improve hemiparetic progressive multiple sclerosis. Preliminary findings. Mult Scler. 2008 Aug;14(7):992-4. doi: 10.1177/1352458508090223. Epub 2008 Jun 23.
Barghi A, Allendorfer JB, Taub E, Womble B, Hicks JM, Uswatte G, Szaflarski JP, Mark VW. Phase II Randomized Controlled Trial of Constraint-Induced Movement Therapy in Multiple Sclerosis. Part 2: Effect on White Matter Integrity. Neurorehabil Neural Repair. 2018 Mar;32(3):233-241. doi: 10.1177/1545968317753073.
Mark VW, Taub E, Uswatte G, Morris DM, Cutter GR, Adams TL, Bowman MH, McKay S. Phase II Randomized Controlled Trial of Constraint-Induced Movement Therapy in Multiple Sclerosis. Part 1: Effects on Real-World Function. Neurorehabil Neural Repair. 2018 Mar;32(3):223-232. doi: 10.1177/1545968318761050.
Other Identifiers
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RG 4221-A-2
Identifier Type: -
Identifier Source: org_study_id
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