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Clinical Trials/NCT02346734
NCT02346734
Completed
N/A

Physical Telerehabilitation in Veterans With Multiple Sclerosis

University of Maryland1 site in 1 country74 target enrollmentJuly 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Maryland
Enrollment
74
Locations
1
Primary Endpoint
The Berg Balance Scale (BBS)
Status
Completed
Last Updated
8 years ago

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

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
April 6, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Walter Royal

Director, Maryland Center for Multiple Sclerosis Treatment and Research

University of Maryland

Eligibility Criteria

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, 0 indicating the lowest level of function and 4 indicating the highest level of function. 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 Six Minute Walk Test (6MWT)(6-month evaluation)
  • Multiple Sclerosis Walking Scale (MSWS-12)(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)
  • Patient Determined Disease Steps (PDDS)(6-month evaluation)
  • Spasticity Scale (Modified Ashworth Scale)(6-month evaluation)
  • MS Self-efficacy (MSSE)(6-month evaluation)

Study Sites (1)

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