Improving Hand Use in Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Victor W. Mark, National Multiple Sclerosis Society
ClinicalTrials.gov Identifier:
NCT01081275
First received: March 4, 2010
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Behavioral: CI Therapy
Behavioral: CAM treatments
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rehabilitating Extremity Use After Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by National Multiple Sclerosis Society:

Primary Outcome Measures:
  • Motor Activity Log (MAL) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]
    The MAL is a structured interview on the amount and quality of the more-affected hand use during daily living activities.


Secondary Outcome Measures:
  • Wolf Motor Function Test (WMFT) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]
    The SARA evaluates the control of ataxia (incoordination, tremor) of hand movements.

  • EDSS (Expanded Disability Status Scale) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]
    The EDSS is the world-wide standard to evaluate physical capability in persons with MS.

  • Fatigue Severity Scale (FSS) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: Yes ]
    The FSS evaluates the degree of overall fatigue experienced by the person with MS.

  • MSIS-29 (Multiple Sclerosis Impact Scale) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]
    The MSSS-88 examines the extent of stiffness (spasticity) of the arm in persons with MS.

  • Baecke Activity Questionnaire [ Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment. ] [ Designated as safety issue: No ]
    The Baecke evaluates the impact of disease upon employment and leisure time activities.


Estimated Enrollment: 66
Study Start Date: February 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Complementary and Alternative Medicine

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081275

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
National Multiple Sclerosis Society
Investigators
Principal Investigator: Victor W Mark, MD University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: Victor W. Mark, Associate Professor, National Multiple Sclerosis Society
ClinicalTrials.gov Identifier: NCT01081275     History of Changes
Other Study ID Numbers: RG 4221-A-2
Study First Received: March 4, 2010
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by National Multiple Sclerosis Society:
Multiple Sclerosis
MS
CI Therapy
CIMT
Constraint-Induced Movement Therapy
Complementary and Alternative Medicine
CAM
Physical Therapy
Occupational Therapy
Relaxation
Exercise
Massage
Yoga
Pool Therapy
Aquatherapy
Aquatic Therapy

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014