Improving Hand Use in Multiple Sclerosis
This study is currently recruiting participants.
Verified July 2011 by National Multiple Sclerosis Society
Sponsor:
National Multiple Sclerosis Society
Information provided by:
National Multiple Sclerosis Society
ClinicalTrials.gov Identifier:
NCT01081275
First received: March 4, 2010
Last updated: July 19, 2011
Last verified: July 2011
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Purpose
This study will compare two different kinds of physical therapy to improve use of the hands in individuals with multiple sclerosis (MS). One treatment will be Constraint-Induced Movement therapy (CI therapy), the other will be a set of Complementary and Alternative Medicine (CAM) treatments (yoga, relaxation exercises, aquatherapy, massage). The study will determine which of the two forms of treatment is more successful for improving hand use.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Behavioral: CI Therapy Behavioral: CAM treatments |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Rehabilitating Extremity Use After Multiple Sclerosis |
Resource links provided by NLM:
Further study details as provided by National Multiple Sclerosis Society:
Primary Outcome Measures:
- Motor Activity Log (MAL) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]The MAL is a structured interview on the amount and quality of the more-affected hand use during daily living activities.
Secondary Outcome Measures:
- Wolf Motor Function Test (WMFT) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]The WMFT evaluates how fast the more-affected hand can complete several activities that resemble those in the home (such as bringing a can to the lips).
- MSFC (Multiple Sclerosis Composite Measure) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]The MSFC evaluates memory, hand dexterity, and walking (for individuals who can walk without another person's assistance).
- SARA (Scale for the Assessment and Rating of Ataxia) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]The SARA evaluates the control of ataxia (incoordination, tremor) of hand movements.
- EDSS (Expanded Disability Status Scale) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]The EDSS is the world-wide standard to evaluate physical capability in persons with MS.
- Fatigue Severity Scale (FSS) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: Yes ]The FSS evaluates the degree of overall fatigue experienced by the person with MS.
- MSIS-29 (Multiple Sclerosis Impact Scale) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]The MSIS-29 is a questionnaire that evaluates the impact of MS on daily living activities and quality of life.
- MSSS-88 (Multiple Sclerosis Spasticity Scale) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]The MSSS-88 examines the extent of stiffness (spasticity) of the arm in persons with MS.
- Baecke Activity Questionnaire [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]The Baecke evaluates the impact of disease upon employment and leisure time activities.
| Estimated Enrollment: | 66 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.
|
Behavioral: CI Therapy
CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
Other Name: Constraint-Induced Movement therapy
|
|
Active Comparator: 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.
|
Behavioral: CAM treatments
CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
Other Name: Complementary and Alternative Medicine
|
Detailed Description:
Multiple Sclerosis (MS) frequently causes reduced use of one of the hands, and as a result, much of daily living activities are conducted only by the other hand, leaving the person effective one-handed. Nonetheless, reduced hand use can be improved for extended amounts of time with specific forms of physical therapy, as long as persons with MS have the ability to perform the training tasks.
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.
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- diagnosis of non-relapsing multiple sclerosis (primary progressive MS, secondary progressive MS)
- 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:
- disease relapse in the past 3 months
- pregnancy
- marked pain with arm movement
- severe uncontrolled medical illness
- simultaneous treatment with another form of physical therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081275
Contacts
| Contact: Victor Mark, MD | 205-966-4047 | vwmark@uab.edu |
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35249 | |
| Contact: Staci McKay, BS 205-934-9768 citherapy@uab.edu | |
| Contact: Mary Bowman, OT 205-934-9768 citherapy@uab.edu | |
| Principal Investigator: Victor W. Mark, MD | |
| Sub-Investigator: Edward Taub, PhD | |
| Sub-Investigator: Gary Cutter, PhD | |
| Sub-Investigator: Khurram Bashir, MD | |
| Sub-Investigator: Gitendra Uswatte, PhD | |
Sponsors and Collaborators
National Multiple Sclerosis Society
Investigators
| Principal Investigator: | Victor W Mark, MD | University of Alabama at Birmingham |
More Information
Additional Information:
Publications:
| Responsible Party: | Victor W. Mark, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT01081275 History of Changes |
| Other Study ID Numbers: | RG 4221-A-2 |
| Study First Received: | March 4, 2010 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by National Multiple Sclerosis Society:
|
Multiple Sclerosis MS CI Therapy CIMT Constraint-Induced Movement Therapy Complementary and Alternative Medicine CAM Physical Therapy |
Occupational Therapy Relaxation Exercise Massage Yoga Pool Therapy Aquatherapy Aquatic Therapy |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013