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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CI Therapy | Active Comparator | 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. |
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| CAM treatments | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CI Therapy | Behavioral | CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks. |
|
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor W Mark, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18573826 | Background | 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. | |
| 29668401 | Derived |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000098483 | Constraint Induced Movement Therapy |
| D000529 | Complementary Therapies |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| CAM treatments | Behavioral | CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks. |
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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. |
| 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. |
| 29668399 | Derived | 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |