Clinical trial NCT02346734: Physical Telerehabilitation in Veterans With Multiple Sclerosis
Official title: Physical Telerehabilitation in Veterans With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Telerehablitation
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Baltimore VA Medical Center
First posted: 2015-01-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: The Berg Balance Scale (BBS)
timeFrame: 6 month evaluation
Secondary outcomes:
measure: Expanded Disability Status Scale (EDSS)
timeFrame: 6 month evaluation
measure: 9-Hole Peg Test
timeFrame: 6 month evaluation
measure: Paced Auditory Serial Addition Test
timeFrame: 6-month evaluation
measure: Patient Determined Disease Steps (PDDS)
timeFrame: 6-month evaluation
measure: Range of motion
timeFrame: 6-month evaluation
measure: Lower extremities manual muscle test (LE-MMT)
timeFrame: 6-month evaluation
measure: Functional Mobility
timeFrame: 6-month evaluation
measure: Balance
timeFrame: 6-month evaluation
measure: Gait
timeFrame: 6-month evaluation
measure: Spasticity Scale (Modified Ashworth Scale)
timeFrame: 6-month evaluation
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: 6-month evaluation
measure: Multiple Sclerosis Walking Scale (MSWS-12)
timeFrame: 6-month evaluation
measure: MS Self-efficacy (MSSE)
timeFrame: 6-month evaluation
measure: The Timed 25-Foot Walk (T25-FW)
timeFrame: 6-month Evaluation
measure: The Six Minute Walk Test (6MWT)
timeFrame: 6-month evaluation
Other outcomes:
measure: The Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 6-month evaluation
measure: MOS Patient Adherence Measure
timeFrame: 6-month evaluation
measure: Patient-Provider Communication (IPC)
timeFrame: 6-month evaluation
measure: Syme's Social Networks Index (SNI)
timeFrame: 6-month evaluation
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland
name: Walter Royal III, MD
role: PRINCIPAL_INVESTIGATOR
References: