Physical Telerehabilitation in Veterans With Multiple Sclerosis

NCT ID: NCT02346734

Last Updated: 2017-05-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2017-04-06

Brief Summary

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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

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type ACTIVE_COMPARATOR

Multiple Sclerosis Home Automated Telemanagement (MS HAT) system

Intervention Type DEVICE

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multiple Sclerosis Home Automated Telemanagement (MS HAT) system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baltimore VA Medical Center

FED

Sponsor Role collaborator

University of Maryland

OTHER

Sponsor Role lead

Responsible Party

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Walter Royal

Director, Maryland Center for Multiple Sclerosis Treatment and Research

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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HP-00040344

Identifier Type: -

Identifier Source: org_study_id

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