Improving Hand Use in Multiple Sclerosis

NCT01081275 | Unknown Phase 2 DMC

• 1 other identifier: RG 4221-A-2
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Motor Activity Log (MAL)

  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 Outcomes (8)

• Wolf Motor Function Test (WMFT)

  Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

• MSFC (Multiple Sclerosis Composite Measure)

  Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

• SARA (Scale for the Assessment and Rating of Ataxia)

  Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

• EDSS (Expanded Disability Status Scale)

  Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

• Fatigue Severity Scale (FSS)

  Before treatment, and immediately, 6 months, and 12 months after the end of treatment.

Study Arms (2)

CI Therapy

ACTIVE COMPARATOR

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

CAM treatments

ACTIVE COMPARATOR

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

Interventions

CI Therapy BEHAVIORAL

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

Also known as: Constraint-Induced Movement therapy

CI Therapy

CAM treatments BEHAVIORAL

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

Also known as: Complementary and Alternative Medicine

CAM treatments

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Multiple Sclerosis Society: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (3)

• 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.

  PMID: 18573826 BACKGROUND

• 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.

  PMID: 29668401 DERIVED

• 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.

  PMID: 29668399 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Constraint Induced Movement Therapy; Complementary Therapies

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Victor W Mark, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

US (1)