Improving Hand Use in Multiple Sclerosis

NCT ID: NCT01081275

Last Updated: 2015-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

CI Therapy

Intervention Type BEHAVIORAL

CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.

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.

Group Type ACTIVE_COMPARATOR

CAM treatments

Intervention Type BEHAVIORAL

CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.

Interventions

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CI Therapy

CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.

Intervention Type BEHAVIORAL

CAM treatments

CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.

Intervention Type BEHAVIORAL

Other Intervention Names

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Constraint-Induced Movement therapy Complementary and Alternative Medicine

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Multiple Sclerosis Society

OTHER

Sponsor Role lead

Responsible Party

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Victor W. Mark

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victor W Mark, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Mark VW, Taub E, Bashir K, Uswatte G, Delgado A, Bowman MH, Bryson CC, McKay S, Cutter GR. Constraint-Induced Movement therapy can improve hemiparetic progressive multiple sclerosis. Preliminary findings. Mult Scler. 2008 Aug;14(7):992-4. doi: 10.1177/1352458508090223. Epub 2008 Jun 23.

Reference Type BACKGROUND
PMID: 18573826 (View on PubMed)

Barghi A, Allendorfer JB, Taub E, Womble B, Hicks JM, Uswatte G, Szaflarski JP, Mark VW. Phase II Randomized Controlled Trial of Constraint-Induced Movement Therapy in Multiple Sclerosis. Part 2: Effect on White Matter Integrity. Neurorehabil Neural Repair. 2018 Mar;32(3):233-241. doi: 10.1177/1545968317753073.

Reference Type DERIVED
PMID: 29668401 (View on PubMed)

Mark VW, Taub E, Uswatte G, Morris DM, Cutter GR, Adams TL, Bowman MH, McKay S. Phase II Randomized Controlled Trial of Constraint-Induced Movement Therapy in Multiple Sclerosis. Part 1: Effects on Real-World Function. Neurorehabil Neural Repair. 2018 Mar;32(3):223-232. doi: 10.1177/1545968318761050.

Reference Type DERIVED
PMID: 29668399 (View on PubMed)

Other Identifiers

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RG 4221-A-2

Identifier Type: -

Identifier Source: org_study_id

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