Improving Hand Use in Multiple Sclerosis

National Multiple Sclerosis Society

Status and phase: Unknown; Phase 2

Conditions: Multiple Sclerosis

Treatments: Behavioral: CAM treatments; Behavioral: CI Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01081275

RG 4221-A-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

CI Therapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: CI Therapy

CAM treatments

Active Comparator group

Description:

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.

Treatment:

Behavioral: CAM treatments