Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatments ci therapy, cam treatments
Phase phase 2
Sponsor National Multiple Sclerosis Society
Start date February 2010
End date February 2016
Trial size 66 participants
Trial identifier NCT01081275, RG 4221-A-2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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.
ci therapy Constraint-Induced Movement therapy
CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
(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.
cam treatments Complementary and Alternative Medicine
CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.

Primary Outcomes

Measure
Motor Activity Log (MAL)
time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

Secondary Outcomes

Measure
Wolf Motor Function Test (WMFT)
time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
MSFC (Multiple Sclerosis Composite Measure)
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)
time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
EDSS (Expanded Disability Status Scale)
time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Fatigue Severity Scale (FSS)
time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
MSIS-29 (Multiple Sclerosis Impact Scale)
time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
MSSS-88 (Multiple Sclerosis Spasticity Scale)
time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Baecke Activity Questionnaire
time frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

Eligibility Criteria

Male or female participants from 21 years up to 80 years old.

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

Additional Information

Official title Rehabilitating Extremity Use After Multiple Sclerosis
Principal investigator Victor W Mark, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by National Multiple Sclerosis Society.