Physical Telerehabilitation in Veterans With Multiple Sclerosis

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Multiple Sclerosis Home Automated Telemanagement (MS HAT) system

Detailed Description

MS is a chronic debilitating disease of the central nervous system which may result in significant damage to the neuromuscular system, vision, and affective and cognitive functions. Approximately 400,000 persons in the United States suffer from MS1, including approximately 28,000 Veterans. The annual cost of MS in the US was estimated at $6.8 billion, and a total estimated lifetime cost per case is $2.2 million. The epidemiology of MS in Veterans has been well described. Most patients with MS develop permanent neurological deficits and enter a progressive phase of the disease after the initial relapsing phase. Recent morbidity studies show that by 15 years from first symptom onset, 20% require a cane to walk. This percentage increases to 69% by 40 years after onset.8 There are four major subtypes of MS: relapsing- remitting (RR), secondary progressive (SP), primary progressive (PP) and progressive relapsing (PrR). The demographics of MS within the US Veteran population are different from those in other population-based cohorts. Firstly, the female to male ratio is 1:2, just the reverse of that seen in other MS cohorts due to the male bias in the military. Second, there is more racial diversity within the Veterans Healthcare Administration (VHA). Third, the mean age of Veterans with MS within VHA is 55 years, 5-10 years older than other comparable North American and European cohorts. Despite these demographic differences, the clinical subtypes of MS are quite comparable as are the use of standard MS medications with other cohorts. The overall neurologic disability of Veterans with MS is slightly more severe compared with other large cohorts.

MS causes functional losses and permanent impairment among a majority of patients. Lifelong rehabilitation measures, together with disease modifying medication treatment, are the major management tools for patients with MS. Physical rehabilitation (PR) is one of the few treatment options together with disease modifying pharmacological therapy for patients with MS which has been shown to be effective in clinical trials. Physical exercises have a positive impact on patient quality of life and their functional capacities. Recent studies have demonstrated that computer technology could be adapted for successful use by patients with MS and other disabling neurological conditions. Modern technology can provide tools to decrease the burden of self-care and enhance patient education and thus lead to more effective MS management. An effective, convenient, generalizable and reliable way to do this would have wide applicability and usefulness. Telerehabilitation has been rapidly developing during the last decade33, and is now in the process of moving from single-case, or small sample research, to controlled trials with larger samples. There is active discussion regarding the cost-effectiveness of telerehabilitation and its financing. For this reason, the proposed study, which evaluates the impact of an MS physical rehabilitation system delivered by telecommunications and computer technology, has the potential of making a significant contribution.

The research plan entails the performance of the following tasks: (1) based on focus group analysis, modify and enhance the HAT System to fully implement the physical therapy component to support multi-level MS physical rehabilitation and patient-provider communication tailored to Veteran-specific needs; (2) conduct a randomized controlled clinical trial to assess the impact of physical telerehabilitation on the patients' clinical and behavioral outcomes, and (3) perform data analysis of the trial and report the results. The HAT system has been implemented using a modular design. Each care component can be dynamically added or its content changed based on a particular care management program requirement without the necessity of software reprogramming. Each care component (such as computer-assisted education module, exercise support and counseling module, symptom diary, etc) is represented by a corresponding relational database structure which allows flexible content update tailored to the specifics of a particular disease management program or population. The MS HAT units will be optimized so patients with MS having motor, sensory, visual and cerebellar deficits can use it efficiently. During the pilot testing we will provide the patient several options for MS HAT enhancements using state-of-the-art technology (e.g. voice- or remote control activated interfaces, cell phone interfaces and keyboard and mouse interfaces) in the operation of the home unit. Patients can choose the best options for this interface and communications with their MS HAT device. A home web-cam option for live interviews with patients, review of exercise plans or clinical follow-ups will be integrated into MS HAT. The specifications of the remote tele-visit component will be finalized based on preferences expressed by Veterans in focus groups. To better understand the preferences and needs of Veterans with MS in terms of the home telerehabilitation program and its features, we will conduct 4 focus groups at the beginning of the study (Months 2-3). The Veteran MS population will allow a more complete evaluation of males, minorities, and individuals of older age compared to the general MS population. The four focus groups will be conducted with participants who have MS disability (Expanded Disability Status Scale or EDSS) scores from 2.0-6.5 according to the randomized controlled trial eligibility criteria. The focus groups will be stratified by gender and disability status. Two groups will be conducted in patients with mild impairment (EDSS=2.0-4.0) and two groups will be conducted in patients with more severe disability (EDSS=4.5-6.5). A secure peer-to-peer social networking component will be integrated within MS HAT. This secure internet-based network will allow text communication between patients with MS in the MS HAT intervention group. All patients in the intervention group will be encouraged to participate in this peer-to-peer component of telerehabilitation support. However, this participation will be optional.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Morehouse School Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MSHAT; The intervention group will perform exercises using the MSHAT system.	Device: Multiple Sclerosis Home Automated Telemanagement (MS HAT) system; 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.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Timed 25-Foot Walk (T25-FW)	The patient is instructed to walk 25 feet as fast and as safely as possible. Then the patient repeats the task by walking back to the starting point. If necessary. assistive devices are allowed to be used. The amount of time (in seconds) that the patient took to walk 25 feet is measured.	6-month Evaluation
Patient Determined Disease Steps (PDDS)	The PDDS is a patient-reported outcome (PRO) of disability in multiple sclerosis. It has nine ordinal levels ranging between 0 (normal) to 8 (bedridden) and can be classified to mild, moderate and severe disability. A higher score indicated a worse outcome.	6-month evaluation
Multiple Sclerosis Walking Scale (MSWS-12)	MS Walking Scale (MSWS-12). MSWS-12 is a questionnaire with 12 items, measuring self-reported walking ability in MS. The questions are on limitations to the patient's walking due to MS during the past 2 weeks. Each item ranges from 1 to 5 and the higher the sum of the scores on all 12 tests, the more severe the degree of limitation. A higher score indicates a worse outcome. The raw scores from the 12 items are summed to a total between 12 and 60. Raw scores are then transformed to a 0-100 scale.	6-month evaluation
The Six Minute Walk Test (6MWT)	The six-minute walk test (6MWT) has been widely used as a measure of functional endurance in cardiopulmonary patients and is now being used as a practical and effective outcome measure to examine functional exercise levels in other chronic diseases including MS. Patients are asked to walk along a long, flat, straight, enclosed corridor with turnaround points marked with a cone. A greater distance (measured in meters) is associated with a better outcome.	6-month evaluation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Center for Epidemiologic Studies Depression Scale (CES-D)	The Center for Epidemiologic Studies Depression Scale (CES-D) will be used to measure depressive symptoms. CES-D is one of the most common screening tests for depression. This short self-administered test measures depressive feelings and behaviors during the past week. The scale includes 20 items and taps dimensions of depressed mood, feelings of guilt and worthlessness, appetite loss, sleep disturbance, and energy level. These items are assumed to represent the major components of depressive symptoms.	6-month evaluation
MOS Patient Adherence Measure	MOS Patient Adherence Measure is used to assess a patient's tendency to adhere to a doctor's recommendations during the past 4 weeks. Each item has a 6-point Likert Scale, ranging from 1 (none of the time) to 6 (all of the time). To score general adherence, the responses are averaged after reversing the items 1 and 3. By reversing the scores for items 1 and 3, overall positive aspects of patient adherence are measured.	6-month evaluation
Patient-Provider Communication (IPC)	Patients perceptions of their patient-provider communication quality will be measured using modified items from the Interpersonal Processes of Care (IPC) questionnaire. The IPC measures multiple facets of patient-provider communication such as general clarity, explanations of conditions and prognoses, and patients' preferences for various treatment options.	6-month evaluation
Syme's Social Networks Index (SNI)	Social networks will be measured by the widely used Berkman and Syme's Social Networks Index (SNI). The SNI assesses four types of social connections: marital (married or not); sociability (number and frequency of contacts with children, close relatives, and close friends); church group membership (yes versus no); and membership in other community organizations (yes versus no).	6-month evaluation

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: Baltimore VA Medical Center
• Investigators: Principal Investigator: Walter Royal III, MD, Morehouse School Of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): April 6, 2017
• Study Completion (Actual): April 6, 2017

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: January 20, 2015
• First Posted (Estimated): January 27, 2015

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 2, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Telerehablitation
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Therapeutics; Drug Therapy; Drug Delivery Systems
• Other Study ID Numbers: HP-00040344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data, in coded form and following the removal of all PHI, may be provided to qualified researchers.
• IPD Sharing Time Frame: 24 months following publication of the study findings.
• IPD Sharing Access Criteria: The data will be provided following approval of the request and execution of all applicable agreements (e.g., materials transfer agreement, etc.).
• IPD Sharing Supporting Information Type: CSR