Multiple SclerosisNCT02346734
Physical Telerehabilitation in Veterans With Multiple Sclerosis
A study testing Multiple Sclerosis Home Automated Telemanagement (MS HAT) system in people with Multiple Sclerosis, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Multiple Sclerosis Home Automated Telemanagement (MS HAT) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 6 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Morehouse School of Medicine
Baltimore, Maryland, 21201
About this study
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
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Multiple Sclerosis Home Automated Telemanagement (MS HAT) system
- Keywords
- Multiple Sclerosis, Telerehablitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Sclerosis Home Automated Telemanagement (MS HAT) systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MSHAT | Active comparator | The intervention group will perform exercises using the MSHAT system. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month evaluation
Secondary outcomes (4)
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.
Measured: 6-month evaluation
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.
Measured: 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.
Measured: 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.
Measured: 6-month evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startJul 2012
- Primary completion6 Apr 2017
- Study completion6 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Baltimore VA Medical Center
- Responsible party
- Principal investigator, Walter Royal III MD, University of Maryland, Baltimore
- Investigators
- Walter Royal III, MD, Principal investigator, Morehouse School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346734
- Sponsor's protocol ID
- HP-00040344
- Status last verified
- Mar 2025
- First submitted
- 7 May 2014
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data, in coded form and following the removal of all PHI, may be provided to qualified researchers.
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.
PubMed 28441894
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Telerehabilitation in Veterans With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02346734
- Acronym / sponsor ID
- HP-00040344
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Telerehablitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Baltimore VA Medical Center
- Study start
- Jul 2012
- Primary completion
- 6 Apr 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSHAT | Active comparator | Device: Multiple Sclerosis Home Automated Telemanagement (MS HAT) systemThe intervention group will perform exercises using the MSHAT 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple Sclerosis Home Automated Telemanagement (MS HAT) systemThe 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. | Device | MSHAT |
Primary outcome
The Berg Balance Scale (BBS)
Time frame: 6 month evaluation
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.
4 secondary outcomes
Patient Determined Disease Steps (PDDS)
Time frame: 6-month evaluation
The Timed 25-Foot Walk (T25-FW)
Time frame: 6-month Evaluation
Multiple Sclerosis Walking Scale (MSWS-12)
Time frame: 6-month evaluation
The Six Minute Walk Test (6MWT)
Time frame: 6-month evaluation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28441894Conroy 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.
- Individual participant dataSharing planned: Yes. Data, in coded form and following the removal of all PHI, may be provided to qualified researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Royal III, MD principal investigator
Morehouse School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple Sclerosis Home Automated Telemanagement (MS HAT) system in people with Multiple Sclerosis, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Berg Balance Scale (BBS) (time frame: 6 month evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02346734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.