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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01081275 |
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Date of registration:
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04/03/2010 |
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Primary sponsor: |
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Public title:
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Improving Hand Use in Multiple Sclerosis
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Scientific title:
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Rehabilitating Extremity Use After Multiple Sclerosis |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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66 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01081275 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Staci McKay, BS |
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Address:
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Telephone:
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205-934-9768 |
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Email:
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citherapy@uab.edu |
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Affiliation:
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Name:
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Victor Mark, MD |
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Address:
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Telephone:
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205-966-4047 |
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Email:
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vwmark@uab.edu |
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Affiliation:
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Name:
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Victor W Mark, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alabama at Birmingham |
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Key inclusion & exclusion 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
Age minimum:
21 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Behavioral: CAM treatments
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Behavioral: CI Therapy
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Primary Outcome(s)
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Motor Activity Log (MAL)
[Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.]
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Secondary Outcome(s)
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Baecke Activity Questionnaire
[Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.]
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EDSS (Expanded Disability Status Scale)
[Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.]
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Fatigue Severity Scale (FSS)
[Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.]
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MSFC (Multiple Sclerosis Composite Measure)
[Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.]
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MSIS-29 (Multiple Sclerosis Impact Scale)
[Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.]
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MSSS-88 (Multiple Sclerosis Spasticity Scale)
[Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.]
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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.]
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Wolf Motor Function Test (WMFT)
[Time Frame: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.]
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Secondary ID(s)
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RG 4221-A-2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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