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Improving Hand Use in Multiple Sclerosis

N

National Multiple Sclerosis Society

Status and phase

Unknown
Phase 2

Conditions

Multiple Sclerosis

Treatments

Behavioral: CAM treatments
Behavioral: CI Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01081275
RG 4221-A-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 estimated patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 2 patient groups

CI Therapy
Active Comparator group
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.
Treatment:
Behavioral: CI Therapy
CAM treatments
Active Comparator group
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.
Treatment:
Behavioral: CAM treatments

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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