Physical Telerehabilitation in Veterans With Multiple Sclerosis
NCT ID: NCT02346734
Last Updated: 2017-05-05
Study Results
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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COMPLETED
NA
74 participants
INTERVENTIONAL
2012-07-31
2017-04-06
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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MSHAT
The study participants will receive a clinical physical therapy evaluation and a physical therapy program to do at their own pace in the home and the intervention group will receive access to the MSHAT system via a website in which they will utilize each day. The study participants in the intervention group will login to the MSHAT system, go through a pre-exercise symptom diary to determine their eligibility to exercise, perform exercise while watching a video demonstration and report results real-time. The intervention group will also be able to send and receive messages via the MSHAT system. The time to complete the daily exercises will vary from patient to patient ranging for 10-30 minutes.
Multiple Sclerosis Home Automated Telemanagement (MS HAT) system
Control
The study participants randomized to group 2 will serve as the control. The study participants will receive a clinical physical therapy evaluation and a physical therapy program to do at their own pace in the home and will be given a paper diary to report their exercise completion. The control group will bring their paper diary showing their exercise completion results to their 3 month and 6 month follow-up visits.
No interventions assigned to this group
Interventions
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Multiple Sclerosis Home Automated Telemanagement (MS HAT) system
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Baltimore VA Medical Center
FED
University of Maryland
OTHER
Responsible Party
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Walter Royal
Director, Maryland Center for Multiple Sclerosis Treatment and Research
Principal Investigators
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Walter Royal III, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland
Locations
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University of Maryland
Baltimore, Maryland, United States
Countries
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Other Identifiers
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HP-00040344
Identifier Type: -
Identifier Source: org_study_id
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