Improving Hand Use in Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Rehabilitating Extremity Use After Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: CI Therapy
* Behavioral: CAM treatments


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CI Therapy<br>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<br>* CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.<br>* Other names: Constraint-Induced Movement therapy;|
| Active Comparator: CAM treatments<br>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<br>* CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.<br>* Other names: Complementary and Alternative Medicine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Activity Log (MAL) | The MAL is a structured interview on the amount and quality of the more-affected hand use during daily living activities. | Before treatment, and immediately, 6 months, and 12 months after the end of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test (WMFT) | 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). | Before treatment, and immediately, 6 months, and 12 months after the end of treatment. | 
| MSFC (Multiple Sclerosis Composite Measure) | The MSFC evaluates memory, hand dexterity, and walking (for individuals who can walk without another person's assistance). | Before treatment, and immediately, 6 months, and 12 months after the end of treatment. | 
| SARA (Scale for the Assessment and Rating of Ataxia) | The SARA evaluates the control of ataxia (incoordination, tremor) of hand movements. | Before treatment, and immediately, 6 months, and 12 months after the end of treatment. | 
| EDSS (Expanded Disability Status Scale) | The EDSS is the world-wide standard to evaluate physical capability in persons with MS. | Before treatment, and immediately, 6 months, and 12 months after the end of treatment. | 
| Fatigue Severity Scale (FSS) | The FSS evaluates the degree of overall fatigue experienced by the person with MS. | Before treatment, and immediately, 6 months, and 12 months after the end of treatment. | 
| MSIS-29 (Multiple Sclerosis Impact Scale) | The MSIS-29 is a questionnaire that evaluates the impact of MS on daily living activities and quality of life. | Before treatment, and immediately, 6 months, and 12 months after the end of treatment. | 
| MSSS-88 (Multiple Sclerosis Spasticity Scale) | The MSSS-88 examines the extent of stiffness (spasticity) of the arm in persons with MS. | Before treatment, and immediately, 6 months, and 12 months after the end of treatment. | 
| Baecke Activity Questionnaire | The Baecke evaluates the impact of disease upon employment and leisure time activities. | Before treatment, and immediately, 6 months, and 12 months after the end of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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