Physical Telerehabilitation in Veterans With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Maryland
- Enrollment
- 74
- Locations
- 2
- Primary Endpoint
- The Berg Balance Scale (BBS)
Study Overview
Brief Summary
The primary objective of this study will be to assess the feasibility and patient acceptance of a Home Automated Telemanagement (HAT) system in multiple sclerosis patients.
Our hypothesis is that home telemanagement will be effective and useful in the rehabilitation of multiple sclerosis patients. Specifically, the investigators hypothesize that home telemanagement using a daily exercise diary, monitoring of compliance with a tailored exercise program and regular assessment of strength and motor functions will: 1. Be feasible and acceptable in patients with multiple sclerosis 2. Improve patient compliance with home exercise program 3. Increase patient mobility and motor functions 4. Be a feasible and effective mechanism for affecting multiple sclerosis patient self-efficacy 5. Improve quality of life
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 18-65
- •Clinical Diagnosis of MS based on McDonald criteria
- •Functional disability defined by the PDDS in the range of 2 to 6
- •Have a working telephone line in their home or a cell phone
- •Willingness and ability to use MS HAT platform with individual modifications based on preferred user interface
- •Patient demonstrates ability to successfully perform physical therapy exercises and procedures independently or with assistance of a caregiver.
- •Ability to complete 25-foot walk test in at least 3 minutes
Exclusion Criteria
- •Age less than 18 years old
- •No diagnosis of MS
- •Other musculoskeletal diagnoses, unstable cardiovascular, respiratory, metabolic or other conditions that would interfere with this study
- •One or more exacerbations in the preceding 3 months
- •Received a course of steroids (IV or oral) within 60 days of screening
Outcomes
Primary Outcomes
The Berg Balance Scale (BBS)
Time Frame: 6 month evaluation
BBS consists of 14 activities common in daily life and is designed to measure balance in a clinical setting. The patient is asked to perform a task or to sustain a given position for a specific time. Points are deducted if the patient did not fulfill the time or activity requirements or touched an external support or received assistance from the examiner. Each item is rated from 0 to 4. Higher scores indicate a better outcome. The total score sums up to 56. A score of 45 or above implies that an individual can safely move or walk independently.
Secondary Outcomes
- Lower extremities manual muscle test (LE-MMT)(6-month evaluation)
- Functional Mobility(6-month evaluation)
- Expanded Disability Status Scale (EDSS)(6 month evaluation)
- Balance(6-month evaluation)
- Modified Fatigue Impact Scale (MFIS)(6-month evaluation)
- Range of motion(6-month evaluation)
- Gait(6-month evaluation)
- The Timed 25-Foot Walk (T25-FW)(6-month Evaluation)
- 9-Hole Peg Test(6 month evaluation)
- Paced Auditory Serial Addition Test(6-month evaluation)
- Spasticity Scale (Modified Ashworth Scale)(6-month evaluation)
- MS Self-efficacy (MSSE)(6-month evaluation)
- Patient Determined Disease Steps (PDDS)(6-month evaluation)
- Multiple Sclerosis Walking Scale (MSWS-12)(6-month evaluation)
- The Six Minute Walk Test (6MWT)(6-month evaluation)
Investigators
Walter Royal
Director, Maryland Center for Multiple Sclerosis Treatment and Research
University of Maryland