Physical Telerehabilitation in Veterans With Multiple Sclerosis

University of Maryland

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Device: Multiple Sclerosis Home Automated Telemanagement (MS HAT) system

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02346734

HP-00040344

Details and patient eligibility

About

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

Enrollment: 74 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

MSHAT

Active Comparator group

Description:

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.

Treatment:

Device: Multiple Sclerosis Home Automated Telemanagement (MS HAT) system

Control

No Intervention group

Description:

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.