Improving Hand Use in Multiple Sclerosis

April 14, 2015 updated by: Victor W. Mark, National Multiple Sclerosis Society

Rehabilitating Extremity Use After Multiple Sclerosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: CI Therapy
CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
Other Names:
  • Constraint-Induced Movement therapy
Active Comparator: 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.
Behavioral: CAM treatments
CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
Other Names:
  • Complementary and Alternative Medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor Activity Log (MAL)
Time Frame: 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.
Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Multiple Sclerosis Society

Investigators

  • Principal Investigator: Victor W Mark, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

March 4, 2010

First Submitted That Met QC Criteria

March 4, 2010

First Posted (Estimate)

March 5, 2010

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG 4221-A-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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