Clinical trial NCT01081275: Improving Hand Use in Multiple Sclerosis
Official title: Rehabilitating Extremity Use After Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
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
Lead sponsor: National Multiple Sclerosis Society
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Motor Activity Log (MAL)
timeFrame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Secondary outcomes:
measure: Wolf Motor Function Test (WMFT)
timeFrame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
measure: MSFC (Multiple Sclerosis Composite Measure)
timeFrame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
measure: SARA (Scale for the Assessment and Rating of Ataxia)
timeFrame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
measure: EDSS (Expanded Disability Status Scale)
timeFrame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
measure: Fatigue Severity Scale (FSS)
timeFrame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
measure: MSIS-29 (Multiple Sclerosis Impact Scale)
timeFrame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
measure: MSSS-88 (Multiple Sclerosis Spasticity Scale)
timeFrame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
measure: Baecke Activity Questionnaire
timeFrame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Victor W Mark, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.