Back to resultsPhysical Telerehabilitation in Veterans With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multiple Sclerosis Home Automated Telemanagement (MS HAT) system
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Telerehablitation
Eligibility Criteria
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
Sites / Locations
- University of Maryland
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
MSHAT
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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, 0 indicating the lowest level of function and 4 indicating the highest level of function. The total score sums up to 56. A score of 45 or above implies that an individual can safely move or walk independently.
Secondary Outcome Measures
Expanded Disability Status Scale (EDSS)
Expanded Disability Status Scale (EDSS) was developed for rating overall disability in MS. Patients are graded on the basis of presenting symptoms in eight different functional systems (FS), including pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, mental, and other functions. Scoring of the EDSS uses a 0 to 10, 20-step scale, with 0 equal to normal neurological function, 6.0 requires an assistive device for walking and 10.0 equal to death due to MS. The final score is based on grades obtained in the FS assessment.
9-Hole Peg Test
Measures finger dexterity
Administered by asking the patient to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible
Patients must then remove the pegs from the holes, one by one, and replace them back into the container
The board should be placed at the patient's midline, with the container holding the pegs oriented towards the hand being tested
Only the hand being evaluated should perform the test
Hand not being evaluated is permitted to hold the edge of the board in order to provide stability
Scores are based on the time taken to complete the test activity, recorded in seconds
Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second
Stopwatch should be started from the moment the participant touches the first peg until the moment the last peg hits the container
Paced Auditory Serial Addition Test
The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. It was developed by Gronwell in 1977 and later adapted by Rao and colleagues in 1989 for use in MS. The PASAT is presented using audio cassette tape or compact disk to ensure standardization in the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. Shorter inter-stimulus intervals, e.g., 2 seconds or less have also been used with the PASAT but tend to increase the difficulty of the task. Two alternate forms have been developed to minimize possible familiarity with the stimulus items when the PASAT is repeated over more than one occasion.
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.
Range of motion
Range of motion refers to activity aimed at improving movement of a specific joint.
Lower extremities manual muscle test (LE-MMT)
Functional Mobility
Balance
Gait
Spasticity Scale (Modified Ashworth Scale)
Modified Ashworth Scale (MAS). MAS measures the resistance encountered during passive muscle stretching. Its scale ranges from 0 to 4: 0 = No increase in muscle tone; 1 = Slight increase in tone with a catch and release; 1+ = Slight increase in tone, manifested by a catch, followed by minimal resistance; 2 = Marked increase in tone; 3 = Considerable increase in tone; 4 = Rigid in flexion or extension.
Modified Fatigue Impact Scale (MFIS)
The Modified Fatigue Impact Scale (MFIS) is used to measure fatigue. The scale consists of 21 items, with 10 items related to mental fatigue, and 11 items relating to physical and social fatigue. The scoring ranges between 0 and 82, a high score reflecting greater impact. In the literature, a cut-off value of 38 has been used to discriminate fatigued from non-fatigued patients. It has shown good validity when compared with the Fatigue Severity Scale, but also appears to be more sensitive to the cognitive and psychosocial aspects of fatigue.
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 patient's walking due to MS during the past 2 weeks. Each item ranges from 1 to 5 and the higher the sum, the more severe the degree of limitation.
MS Self-efficacy (MSSE)
MSSE is a 14-item questionnaire with a 6-point Likert scale, ranging from 1 (strongly disagree) to 6 (strongly agree). Self-efficacy is people's belief about their capabilities to overcome obstacles in life. Total score ranges from 14 to 84, a higher score indicating an elevated level of self-efficacy.
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.
The Six Minute Walk Test (6MWT)
The six minute walk test (6MWT) has been widely used as a measure of functional endurance in cadriopulmonary patients and is now being used as a practical and effective outcome measure to examine finctional exercise level 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.
Full Information
NCT ID
NCT02346734
First Posted
May 7, 2014
Last Updated
May 2, 2017
Sponsor
University of Maryland
Collaborators
Baltimore VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02346734
Brief Title
Physical Telerehabilitation in Veterans With Multiple Sclerosis
Official Title
Physical Telerehabilitation in Veterans With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 6, 2017 (Actual)
Study Completion Date
April 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland
Collaborators
Baltimore VA Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Telerehablitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MSHAT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Multiple Sclerosis Home Automated Telemanagement (MS HAT) system
Primary Outcome Measure Information:
Title
The Berg Balance Scale (BBS)
Description
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, 0 indicating the lowest level of function and 4 indicating the highest level of function. The total score sums up to 56. A score of 45 or above implies that an individual can safely move or walk independently.
Time Frame
6 month evaluation
Secondary Outcome Measure Information:
Title
Expanded Disability Status Scale (EDSS)
Description
Expanded Disability Status Scale (EDSS) was developed for rating overall disability in MS. Patients are graded on the basis of presenting symptoms in eight different functional systems (FS), including pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, mental, and other functions. Scoring of the EDSS uses a 0 to 10, 20-step scale, with 0 equal to normal neurological function, 6.0 requires an assistive device for walking and 10.0 equal to death due to MS. The final score is based on grades obtained in the FS assessment.
Time Frame
6 month evaluation
Title
9-Hole Peg Test
Description
Measures finger dexterity
Administered by asking the patient to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible
Patients must then remove the pegs from the holes, one by one, and replace them back into the container
The board should be placed at the patient's midline, with the container holding the pegs oriented towards the hand being tested
Only the hand being evaluated should perform the test
Hand not being evaluated is permitted to hold the edge of the board in order to provide stability
Scores are based on the time taken to complete the test activity, recorded in seconds
Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second
Stopwatch should be started from the moment the participant touches the first peg until the moment the last peg hits the container
Time Frame
6 month evaluation
Title
Paced Auditory Serial Addition Test
Description
The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. It was developed by Gronwell in 1977 and later adapted by Rao and colleagues in 1989 for use in MS. The PASAT is presented using audio cassette tape or compact disk to ensure standardization in the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. Shorter inter-stimulus intervals, e.g., 2 seconds or less have also been used with the PASAT but tend to increase the difficulty of the task. Two alternate forms have been developed to minimize possible familiarity with the stimulus items when the PASAT is repeated over more than one occasion.
Time Frame
6-month evaluation
Title
Patient Determined Disease Steps (PDDS)
Description
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.
Time Frame
6-month evaluation
Title
Range of motion
Description
Range of motion refers to activity aimed at improving movement of a specific joint.
Time Frame
6-month evaluation
Title
Lower extremities manual muscle test (LE-MMT)
Time Frame
6-month evaluation
Title
Functional Mobility
Time Frame
6-month evaluation
Title
Balance
Time Frame
6-month evaluation
Title
Gait
Time Frame
6-month evaluation
Title
Spasticity Scale (Modified Ashworth Scale)
Description
Modified Ashworth Scale (MAS). MAS measures the resistance encountered during passive muscle stretching. Its scale ranges from 0 to 4: 0 = No increase in muscle tone; 1 = Slight increase in tone with a catch and release; 1+ = Slight increase in tone, manifested by a catch, followed by minimal resistance; 2 = Marked increase in tone; 3 = Considerable increase in tone; 4 = Rigid in flexion or extension.
Time Frame
6-month evaluation
Title
Modified Fatigue Impact Scale (MFIS)
Description
The Modified Fatigue Impact Scale (MFIS) is used to measure fatigue. The scale consists of 21 items, with 10 items related to mental fatigue, and 11 items relating to physical and social fatigue. The scoring ranges between 0 and 82, a high score reflecting greater impact. In the literature, a cut-off value of 38 has been used to discriminate fatigued from non-fatigued patients. It has shown good validity when compared with the Fatigue Severity Scale, but also appears to be more sensitive to the cognitive and psychosocial aspects of fatigue.
Time Frame
6-month evaluation
Title
Multiple Sclerosis Walking Scale (MSWS-12)
Description
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 patient's walking due to MS during the past 2 weeks. Each item ranges from 1 to 5 and the higher the sum, the more severe the degree of limitation.
Time Frame
6-month evaluation
Title
MS Self-efficacy (MSSE)
Description
MSSE is a 14-item questionnaire with a 6-point Likert scale, ranging from 1 (strongly disagree) to 6 (strongly agree). Self-efficacy is people's belief about their capabilities to overcome obstacles in life. Total score ranges from 14 to 84, a higher score indicating an elevated level of self-efficacy.
Time Frame
6-month evaluation
Title
The Timed 25-Foot Walk (T25-FW)
Description
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.
Time Frame
6-month Evaluation
Title
The Six Minute Walk Test (6MWT)
Description
The six minute walk test (6MWT) has been widely used as a measure of functional endurance in cadriopulmonary patients and is now being used as a practical and effective outcome measure to examine finctional exercise level 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.
Time Frame
6-month evaluation
Other Pre-specified Outcome Measures:
Title
The Center for Epidemiologic Studies Depression Scale (CES-D)
Description
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.
Time Frame
6-month evaluation
Title
MOS Patient Adherence Measure
Description
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.
Time Frame
6-month evaluation
Title
Patient-Provider Communication (IPC)
Description
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.
Time Frame
6-month evaluation
Title
Syme's Social Networks Index (SNI)
Description
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).
Time Frame
6-month evaluation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Royal III, MD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Physical Telerehabilitation in Veterans With Multiple Sclerosis
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