Trial Outcomes & Findings for Physical Telerehabilitation in Veterans With Multiple Sclerosis (NCT NCT02346734)
NCT ID: NCT02346734
Last Updated: 2026-05-05
Results Overview
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.
COMPLETED
NA
51 participants
6 month evaluation
2026-05-05
Participant Flow
Participant milestones
| Measure |
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.
Multiple Sclerosis Home Automated Telemanagement (MS HAT) system
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
|
Overall Study
COMPLETED
|
16
|
8
|
|
Overall Study
NOT COMPLETED
|
10
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physical Telerehabilitation in Veterans With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
MSHAT
n=16 Participants
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.
Multiple Sclerosis Home Automated Telemanagement (MS HAT) system
|
Control
n=8 Participants
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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=54 Participants
|
8 Participants
n=60 Participants
|
24 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 8.1 • n=54 Participants
|
54.3 years
STANDARD_DEVIATION 5.9 • n=60 Participants
|
51 years
STANDARD_DEVIATION 8.1 • n=114 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
12 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
12 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
10 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
15 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
6 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
9 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=54 Participants
|
8 participants
n=60 Participants
|
24 participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 6 month evaluationPopulation: The analysis population will consist of all control and MSHAT participants enrolled in the study.
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.
Outcome measures
| Measure |
Control
n=8 Participants
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.
|
MSHAT
n=16 Participants
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.
Multiple Sclerosis Home Automated Telemanagement (MS HAT) system
|
|---|---|---|
|
The Berg Balance Scale (BBS)
|
50 score on a scale
Standard Deviation 9.9
|
36.1 score on a scale
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: 6-month evaluationThe 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.
Outcome measures
| Measure |
Control
n=16 Participants
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.
|
MSHAT
n=8 Participants
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.
Multiple Sclerosis Home Automated Telemanagement (MS HAT) system
|
|---|---|---|
|
Patient Determined Disease Steps (PDDS)
|
4.5 score on a scale
Interval 2.0 to 6.0
|
3.0 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 6-month EvaluationThe 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.
Outcome measures
| Measure |
Control
n=16 Participants
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.
|
MSHAT
n=8 Participants
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.
Multiple Sclerosis Home Automated Telemanagement (MS HAT) system
|
|---|---|---|
|
The Timed 25-Foot Walk (T25-FW)
|
13 seconds
Standard Deviation 10.9
|
6.5 seconds
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 6-month evaluationPopulation: The analysis population will consist of all control and MSHAT participants enrolled in the study.
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.
Outcome measures
| Measure |
Control
n=16 Participants
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.
|
MSHAT
n=8 Participants
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.
Multiple Sclerosis Home Automated Telemanagement (MS HAT) system
|
|---|---|---|
|
Multiple Sclerosis Walking Scale (MSWS-12)
|
65.6 score on a scale
Standard Deviation 32.8
|
58.1 score on a scale
Standard Deviation 22.9
|
SECONDARY outcome
Timeframe: 6-month evaluationThe 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.
Outcome measures
| Measure |
Control
n=16 Participants
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.
|
MSHAT
n=8 Participants
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.
Multiple Sclerosis Home Automated Telemanagement (MS HAT) system
|
|---|---|---|
|
The Six Minute Walk Test (6MWT)
|
879.2 Meters
Standard Deviation 611.5
|
1330.8 Meters
Standard Deviation 372
|
Adverse Events
MSHAT
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place