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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
66
CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
University of Alabama at Birmingham
Birmingham, Alabama, United States
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.
Time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
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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.
Time frame: 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.
Time frame: 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.
Time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.