Rehabilitating Extremity Use After Multiple Sclerosis

Improving Hand Use in Multiple Sclerosis

Sponsors

Lead sponsor: National Multiple Sclerosis Society

Source National Multiple Sclerosis Society
Brief Summary

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

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.

Overall Status Unknown status
Start Date February 2010
Completion Date March 2016
Primary Completion Date February 2016
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Motor Activity Log (MAL) Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Secondary Outcome
Measure Time Frame
Wolf Motor Function Test (WMFT) Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
MSFC (Multiple Sclerosis Composite Measure) Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
SARA (Scale for the Assessment and Rating of Ataxia) Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
EDSS (Expanded Disability Status Scale) Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Fatigue Severity Scale (FSS) Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
MSIS-29 (Multiple Sclerosis Impact Scale) Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
MSSS-88 (Multiple Sclerosis Spasticity Scale) Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Baecke Activity Questionnaire Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Enrollment 66
Condition
Intervention

Intervention type: Behavioral

Intervention name: CI Therapy

Description: CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.

Arm group label: CI Therapy

Other name: Constraint-Induced Movement therapy

Intervention type: Behavioral

Intervention name: CAM treatments

Description: CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.

Arm group label: CAM treatments

Other name: Complementary and Alternative Medicine

Eligibility

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

Gender: All

Minimum age: 21 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Victor W Mark, MD Principal Investigator University of Alabama at Birmingham
Location
facility University of Alabama at Birmingham
Location Countries

United States

Verification Date

April 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: National Multiple Sclerosis Society

Investigator full name: Victor W. Mark

Investigator title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: CI Therapy

Arm group type: Active Comparator

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.

Arm group label: CAM treatments

Arm group type: Active Comparator

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.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov