Improving Hand Use in Multiple Sclerosis

Phase 2

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: CAM treatments; Behavioral: CI Therapy

• Registration Number: NCT01081275
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-03-04
• Study First Posted: 2010-03-05
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15
• Primary Completion: 2016-02
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAM treatments	CAM treatments	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.
CI Therapy	CI Therapy	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.

Primary Outcome Measures

Name	Time	Method
Motor Activity Log (MAL)	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	The MAL is a structured interview on the amount and quality of the more-affected hand use during daily living activities.

Secondary Outcome Measures

Name	Time	Method
Wolf Motor Function Test (WMFT)	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	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).
MSFC (Multiple Sclerosis Composite Measure)	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	The MSFC evaluates memory, hand dexterity, and walking (for individuals who can walk without another person's assistance).
SARA (Scale for the Assessment and Rating of Ataxia)	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	The SARA evaluates the control of ataxia (incoordination, tremor) of hand movements.
EDSS (Expanded Disability Status Scale)	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	The EDSS is the world-wide standard to evaluate physical capability in persons with MS.
Fatigue Severity Scale (FSS)	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	The FSS evaluates the degree of overall fatigue experienced by the person with MS.
MSIS-29 (Multiple Sclerosis Impact Scale)	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	The MSIS-29 is a questionnaire that evaluates the impact of MS on daily living activities and quality of life.
MSSS-88 (Multiple Sclerosis Spasticity Scale)	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	The MSSS-88 examines the extent of stiffness (spasticity) of the arm in persons with MS.
Baecke Activity Questionnaire	Before treatment, and immediately, 6 months, and 12 months after the end of treatment.	The Baecke evaluates the impact of disease upon employment and leisure time activities.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States