Physical Telerehabilitation in Veterans With Multiple Sclerosis

NCT02346734 | Completed Results DMC

• 1 other identifier: HP-00040344
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Telerehablitation

Outcome Measures

Primary Outcomes (1)

• The Berg Balance Scale (BBS)

  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. Higher scores indicate a better outcome. The total score sums up to 56. A score of 45 or above implies that an individual can safely move or walk independently.

  6 month evaluation

Secondary Outcomes (4)

• Patient Determined Disease Steps (PDDS)

  6-month evaluation

• The Timed 25-Foot Walk (T25-FW)

  6-month Evaluation

• Multiple Sclerosis Walking Scale (MSWS-12)

  6-month evaluation

• The Six Minute Walk Test (6MWT)

  6-month evaluation

Study Arms (2)

MSHAT

ACTIVE COMPARATOR

The intervention group will perform exercises using the MSHAT system.

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

Control

NO INTERVENTION

The non-intervention group will receive treatment in a conventional physical therapy physical therapy program to be carried out at their own pace in the home.

Interventions

Multiple Sclerosis Home Automated Telemanagement (MS HAT) system DEVICE

The HAT home unit runs on a netbook in the patient's home connected to a remote server via the internet. The system questions the patient on their condition, gives detailed step by step exercise instructions, records their daily exercise log, and informs and quizzes the patient on their knowledge of multiple sclerosis. The exercise log is transmitted to the remote HAT server where it is analyzed using decision support algorithms to facilitate MS management. The exercise logs are available on-line for review by patient providers.

MSHAT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Baltimore VA Medical Center: collaborator

Study Sites (1)

Morehouse School of Medicine

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Conroy SS, Zhan M, Culpepper WJ 2nd, Royal W 3rd, Wallin MT. Self-directed exercise in multiple sclerosis: Evaluation of a home automated tele-management system. J Telemed Telecare. 2018 Jul;24(6):410-419. doi: 10.1177/1357633X17702757. Epub 2017 Apr 25.

  PMID: 28441894 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Walter Royal III, MD
• Organization: Morehouse School of Medicine

wroyal@msm.edu

404-752-5222

Study Officials

• Walter Royal III, MD

  Morehouse School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Maryland Center for Multiple Sclerosis Treatment and Research

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: January 27, 2015
• Study Start: July 1, 2012
• Primary Completion: April 6, 2017
• Study Completion: April 6, 2017
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 24 months following publication of the study findings.
• Access Criteria: The data will be provided following approval of the request and execution of all applicable agreements (e.g., materials transfer agreement, etc.).

Locations

US (1)