Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Exercise, Physical activity, Telerehabilitation, Comparative effectiveness study, Social cognitive theory, Health behavior change
Brief summary
This study aims to compare the effectiveness of an exercise program delivered in a conventional facility-based format versus a telerehabilitation format, which takes place in the home. Exercise can improve mobility and perhaps decrease the rate and extent of disability in people with MS. Evidence shows that traditional, facility-based exercise training may help people with MS consistently participate in exercise or to exercise at a higher, more intense level. Despite this evidence, lack of access to facility-based exercise programs may make it difficult for people with MS to engage in exercise.Telerehabilitation (telerehab) has great potential to overcome challenges associated with facility-based programs. Telerehab can include videoconferencing, remote monitoring of signs and activity, and dissemination of specialized and individualized information via electronic mechanisms, such as smartphones and computers. Both facility-based and telerehab exercise training have yielded positive results in people with MS, but have not been compared head-to-head. The current study will fill this gap in the evidence base and compare the outcomes of delivering the same exercise interventions in a facility or in the home/community using a telerehab approach. The interventions are designed to be identical in content, with the only difference being the mode of training delivery.
Detailed description
Funded by Patient-Centered Outcomes Research Institute (PCORI), this four-year, multi-site study aims to compare the effectiveness of a 16-week telerehabilitation (telerehab) exercise program and a facility-based exercise program on Multiple Sclerosis (MS) outcomes. The research study design is a two-stage randomized choice design aimed at non-inferiority. Four hundred participants with MS who have ambulatory difficulties will be recruited from nine sites. First level randomization will assign participants to one of two groups - Choice or Random. The participants in Choice will be able to choose in which program they wish to participate (telerehab or facility-based). Individuals in the Random group, will be further randomized to either the telerehab or facility-based program. The research protocol and associated tools will be reviewed and approved by all relevant Research Review Committees before any research takes place. The study will comply with best practices in human subjects' research including following HIPAA guidelines and using strict informed consent procedures. Clinical reported outcome measures and patient reported outcome measures will be administered at baseline, immediately post-intervention (at 16 weeks), and at 12 months post-intervention. Patient reported outcomes will also be administered at 2 months and 6 months after the start of the intervention. Dr. Deborah Backus is the principal investigator (PI) and Prof. Robert Motl is the co-Principal Investigator supported by collaborating co-Investigators at the Cleveland Clinic Mellen Center, Ohio; Marquette University, Wisconsin; University of Colorado, Denver; University of North Carolina, Chapel Hill; the University of Georgia; the Tanner Center for Multiple Sclerosis, Birmingham Alabama; Massachusetts General Hospital, Boston, Massachusetts; and the iConquerMS outcomes data collaborative (Accelerated Cure Project for MS). Shepherd Center is the primary and coordinating site for all study activities under Dr. Backus. University of Alabama at Birmingham (UAB) under the leadership of Prof. Motl will oversee delivery of the training programs, and statistical analysis under the direction of Dr. Gary Cutter. This study will yield important data regarding the comparative impact of exercise programs on MS outcomes and provide information to people with MS, health providers, payers, exercise partners, and policy makers about how people with MS who have ambulatory difficulties can safely and effectively exercise.
Interventions
The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.
Sponsors
Study design
Masking description
Evaluators who assess clinical reported outcomes will be blinded to arm assignment.
Intervention model description
Two-stage randomized choice design aimed at noninferiority.
Eligibility
Inclusion criteria
* Mild to moderate MS * Has limitations in walking but can walk 25 feet * Does not participate in a rigorous exercise program * Can travel to trial site for assessments and training
Exclusion criteria
* Relapse in the past 30 days * Other neurological or musculoskeletal disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed 25 Foot Walk Test (T25FWT) | Change from baseline T25FWT at 16-weeks | The Timed 25 Foot Walk Test (T25FWT) is a measure of walking speed. Individuals are instructed to walk 25 feet as quickly and safely as possible from one marked end to the other. Higher walking speed (feet per second) indicate improved walking function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six Minute Walk Test (6MWT) | Change from baseline at 16 weeks | The six minute walk test (6MWT) assesses walking endurance and aerobic capacity. The score is the distance walked in 6 minutes. Higher scores (more distance walked in feet) indicate improved walking capacity. |
| Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire | Change from baseline at 16 weeks | The MSWS-12 is a self-reported measure of the impact of multiple sclerosis (MS) on walking ability and daily activities over the past two weeks. Items are scored from 1-5, with 1 meaning no limitation and 5 meaning extreme limitation. Scores are calculated by first adding the responses, and getting a total score of 12 - 60. This score is then transformed to a 0 - 100 scale (Nilsagard et al, 2007) by subtracting 12 from the sum, dividing by 48, and then multiplying by 100. Higher scores indicate a greater impact of MS on walking than lower scores. |
| Godin Leisure-Time Physical Activity (LTPA) Questionnaire | Change from baseline at 16 weeks | The Godin LTPA is a 4-item, self-administered questionnaire assessing leisure-time physical activity. 3 questions ask how many times the individual participated in mild/light (e.g. yoga, easy walking), moderate (e.g. tennis, fast walking), and/or strenuous (e.g. running, basketball) activities in the past 7 days. The 4th question asks how often in a typical 7-day period the individual participates in an activity long enough to break a sweat (often, sometimes, or never/rarely). More strenuous activities are more heavily weighted. Total leisure activity score is calculated by multiplying the number of strenuous activities by 9, the number of moderate activities by 5, and the number of mild activities by 3, and then adding those scores together. A higher score means that the individual participates in more and/or more vigorous leisure-time physical activity. 24 units or more = active; 14-23 units = moderately active; \< 14 units = sedentary. |
| Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Change from baseline at 16 weeks. | Domains (anxiety, depression, fatigue, upper extremity function, lower extremity function, cognitive function, emotional and behavioral dyscontrol, sleep disturbance, ability to participate in social roles and activities, satisfaction with social roles and activities, stigma) - possible score of 8-40. Positive affect domain has possible score of 9-45. Communication domain has possible score of 5-25. No clinical thresholds established. Higher scores indicate WORSE self-reported health for Anxiety, Depression, Fatigue, Emotional and Behavioral Dyscontrol, Sleep Disturbance, Stigma. Higher scores indicate BETTER self-reported health for Upper Extremity Function, Lower Extremity Function, Cognitive Function, Positive Affect & Well-Being, Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles & Activities, Communication. |
| Multiple Sclerosis Impact Scale (MSIS)-29 | Change from baseline at 16 weeks. | The MSIS measures individual's views on the impact of MS on day-to-day life during the past two weeks. It is comprised of two subscales: a 20-item physical impact scale and a 9-item psychological impact scale. The MSIS has no combined total score. Scores on the physical impact scale can range from 20 to 80 and on the psychological impact scale from 9 to 36. Lower scores indicate little impact of MS, and higher scores indicate a higher impact of MS (on either physical or psychological functioning). |
| Modified Fatigue Impact Scale (MFIS) | Change from baseline at 16 weeks | The MFIS is a 21-item questionnaire that measures the impact of fatigue on the participant's activities and lifestyle over the past four weeks. Items on the MFIS can be broken into three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. The physical subscale score can range from 0 to 36. The cognitive subscale score can range from 0 to 40. The psychosocial subscale score can range from 0 to 8. The total MFIS score is the sum total of all three subscales, and can range from 0 to 84. Higher scores indicate a greater impact of fatigue on a person's activities. |
| Expanded Disability Status Scale (EDSS) | Change from baseline at 16 weeks | The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. It characterizes disability level and determines disability progression in people with MS. Higher scores reflect greater disability due to MS. |
| Patient Determined Disease Steps (PDDS) | Change from baseline at 16 weeks | The PDDS is a patient-reported outcome of disability in MS. The scale focuses mainly on how well individuals with MS walk. Scores range from 0 (normal function) to 8 (bedridden). Higher scores reflect greater disability due to MS. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Facility-based Rehabilitation Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.
Exercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks. | 198 |
| Telerehabilitation Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.
Exercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks. | 181 |
| Total | 379 |
Baseline characteristics
| Characteristic | Total | Telerehabilitation | Facility-based Rehabilitation |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 379 Participants | 181 Participants | 198 Participants |
| Age, Continuous | 50.81 years STANDARD_DEVIATION 9.36 | 50.08 years STANDARD_DEVIATION 9.18 | 51.47 years STANDARD_DEVIATION 10.01 |
| Employment Status Employed | 133 Participants | 67 Participants | 66 Participants |
| Employment Status Other | 72 Participants | 27 Participants | 45 Participants |
| Employment Status Unemployed | 174 Participants | 87 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 8 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 355 Participants | 170 Participants | 185 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 3 Participants | 3 Participants |
| Insurance Direct purchase | 20 Participants | 10 Participants | 10 Participants |
| Insurance Employer | 158 Participants | 78 Participants | 80 Participants |
| Insurance Medicaid | 60 Participants | 31 Participants | 29 Participants |
| Insurance Medicare | 111 Participants | 52 Participants | 59 Participants |
| Insurance No insurance | 5 Participants | 3 Participants | 2 Participants |
| Insurance Other | 25 Participants | 7 Participants | 18 Participants |
| Living Arrangement Living Alone | 83 Participants | 40 Participants | 43 Participants |
| Living Arrangement Living With Others | 294 Participants | 141 Participants | 153 Participants |
| Mini Mental State Examination (MMSE) | 29.38 units on a scale STANDARD_DEVIATION 1.08 | 29.43 units on a scale STANDARD_DEVIATION 0.99 | 29.33 units on a scale STANDARD_DEVIATION 1.16 |
| MS type Primary Progressive Multiple Sclerosis (PPMS) | 38 Participants | 21 Participants | 17 Participants |
| MS type Progressive Relapsing Multiple Sclerosis (PRMS) | 6 Participants | 4 Participants | 2 Participants |
| MS type Relapsing Remitting Multiple Sclerosis (RRMS) | 255 Participants | 112 Participants | 143 Participants |
| MS type Secondary Progressive Multiple Sclerosis (SPMS) | 52 Participants | 30 Participants | 22 Participants |
| Patient-Determined Disease Steps (PDDS) Scale 1 (Mild Disability) | 1 Participants | 1 Participants | 0 Participants |
| Patient-Determined Disease Steps (PDDS) Scale 3 (Gait Disability) | 103 Participants | 48 Participants | 55 Participants |
| Patient-Determined Disease Steps (PDDS) Scale 4 (Early Cane) | 124 Participants | 57 Participants | 67 Participants |
| Patient-Determined Disease Steps (PDDS) Scale 5 (Late Cane) | 94 Participants | 49 Participants | 45 Participants |
| Patient-Determined Disease Steps (PDDS) Scale 6 (Bilateral Support) | 57 Participants | 26 Participants | 31 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 105 Participants | 50 Participants | 55 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) White | 246 Participants | 120 Participants | 126 Participants |
| Sex: Female, Male Female | 286 Participants | 142 Participants | 144 Participants |
| Sex: Female, Male Male | 92 Participants | 38 Participants | 54 Participants |
| Short Assessment of Health Literacy-English (SAHL-E) | 17.59 units on a scale STANDARD_DEVIATION 0.96 | 17.68 units on a scale STANDARD_DEVIATION 0.61 | 17.51 units on a scale STANDARD_DEVIATION 1.19 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 198 | 0 / 181 |
| other Total, other adverse events | 80 / 198 | 88 / 181 |
| serious Total, serious adverse events | 8 / 198 | 2 / 181 |
Outcome results
Timed 25 Foot Walk Test (T25FWT)
The Timed 25 Foot Walk Test (T25FWT) is a measure of walking speed. Individuals are instructed to walk 25 feet as quickly and safely as possible from one marked end to the other. Higher walking speed (feet per second) indicate improved walking function.
Time frame: Change from baseline T25FWT at 16-weeks
Population: Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Facility-based Rehabilitation | Timed 25 Foot Walk Test (T25FWT) | Walking speed at baseline | 2.88 feet per second | Standard Deviation 0.85 |
| Facility-based Rehabilitation | Timed 25 Foot Walk Test (T25FWT) | Walking speed at 16 weeks | 3.41 feet per second | Standard Deviation 1.12 |
| Telerehabilitation | Timed 25 Foot Walk Test (T25FWT) | Walking speed at baseline | 2.62 feet per second | Standard Deviation 0.94 |
| Telerehabilitation | Timed 25 Foot Walk Test (T25FWT) | Walking speed at 16 weeks | 3.26 feet per second | Standard Deviation 1.08 |
Expanded Disability Status Scale (EDSS)
The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. It characterizes disability level and determines disability progression in people with MS. Higher scores reflect greater disability due to MS.
Time frame: Change from baseline at 16 weeks
Population: Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Facility-based Rehabilitation | Expanded Disability Status Scale (EDSS) | EDSS at baseline | 5.32 score on a scale | Standard Deviation 0.95 |
| Facility-based Rehabilitation | Expanded Disability Status Scale (EDSS) | EDSS at 16 weeks | 5.02 score on a scale | Standard Deviation 1.2 |
| Telerehabilitation | Expanded Disability Status Scale (EDSS) | EDSS at baseline | 5.25 score on a scale | Standard Deviation 0.94 |
| Telerehabilitation | Expanded Disability Status Scale (EDSS) | EDSS at 16 weeks | 5.04 score on a scale | Standard Deviation 1.16 |
Godin Leisure-Time Physical Activity (LTPA) Questionnaire
The Godin LTPA is a 4-item, self-administered questionnaire assessing leisure-time physical activity. 3 questions ask how many times the individual participated in mild/light (e.g. yoga, easy walking), moderate (e.g. tennis, fast walking), and/or strenuous (e.g. running, basketball) activities in the past 7 days. The 4th question asks how often in a typical 7-day period the individual participates in an activity long enough to break a sweat (often, sometimes, or never/rarely). More strenuous activities are more heavily weighted. Total leisure activity score is calculated by multiplying the number of strenuous activities by 9, the number of moderate activities by 5, and the number of mild activities by 3, and then adding those scores together. A higher score means that the individual participates in more and/or more vigorous leisure-time physical activity. 24 units or more = active; 14-23 units = moderately active; \< 14 units = sedentary.
Time frame: Change from baseline at 16 weeks
Population: Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Facility-based Rehabilitation | Godin Leisure-Time Physical Activity (LTPA) Questionnaire | LTPA at 16 weeks | 23.09 units on a scale | Standard Deviation 17.7 |
| Facility-based Rehabilitation | Godin Leisure-Time Physical Activity (LTPA) Questionnaire | LTPA at baseline | 7.48 units on a scale | Standard Deviation 8.15 |
| Telerehabilitation | Godin Leisure-Time Physical Activity (LTPA) Questionnaire | LTPA at 16 weeks | 22.21 units on a scale | Standard Deviation 18.88 |
| Telerehabilitation | Godin Leisure-Time Physical Activity (LTPA) Questionnaire | LTPA at baseline | 7.56 units on a scale | Standard Deviation 8.01 |
Modified Fatigue Impact Scale (MFIS)
The MFIS is a 21-item questionnaire that measures the impact of fatigue on the participant's activities and lifestyle over the past four weeks. Items on the MFIS can be broken into three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. The physical subscale score can range from 0 to 36. The cognitive subscale score can range from 0 to 40. The psychosocial subscale score can range from 0 to 8. The total MFIS score is the sum total of all three subscales, and can range from 0 to 84. Higher scores indicate a greater impact of fatigue on a person's activities.
Time frame: Change from baseline at 16 weeks
Population: Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Facility-based Rehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Cognitive at baseline | 14.54 score on a scale | Standard Deviation 9.58 |
| Facility-based Rehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Cognitive at 16 weeks | 12.00 score on a scale | Standard Deviation 9.3 |
| Facility-based Rehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Physical at baseline | 20.02 score on a scale | Standard Deviation 7.81 |
| Facility-based Rehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Physical at 16 weeks | 15.57 score on a scale | Standard Deviation 8.21 |
| Facility-based Rehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Psychosocial at baseline | 3.89 score on a scale | Standard Deviation 2.2 |
| Facility-based Rehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Psychosocial at 16 weeks | 2.93 score on a scale | Standard Deviation 2.2 |
| Facility-based Rehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Total at baseline | 38.45 score on a scale | Standard Deviation 17.36 |
| Facility-based Rehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Total at 16 weeks | 30.50 score on a scale | Standard Deviation 18.02 |
| Telerehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Total at 16 weeks | 32.37 score on a scale | Standard Deviation 15.52 |
| Telerehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Cognitive at baseline | 14.96 score on a scale | Standard Deviation 9.06 |
| Telerehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Psychosocial at baseline | 3.97 score on a scale | Standard Deviation 2.2 |
| Telerehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Cognitive at 16 weeks | 11.63 score on a scale | Standard Deviation 8.36 |
| Telerehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Total at baseline | 39.91 score on a scale | Standard Deviation 16.5 |
| Telerehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Physical at baseline | 20.98 score on a scale | Standard Deviation 7.4 |
| Telerehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Psychosocial at 16 weeks | 3.07 score on a scale | Standard Deviation 2.14 |
| Telerehabilitation | Modified Fatigue Impact Scale (MFIS) | MFIS Physical at 16 weeks | 17.67 score on a scale | Standard Deviation 7.77 |
Multiple Sclerosis Impact Scale (MSIS)-29
The MSIS measures individual's views on the impact of MS on day-to-day life during the past two weeks. It is comprised of two subscales: a 20-item physical impact scale and a 9-item psychological impact scale. The MSIS has no combined total score. Scores on the physical impact scale can range from 20 to 80 and on the psychological impact scale from 9 to 36. Lower scores indicate little impact of MS, and higher scores indicate a higher impact of MS (on either physical or psychological functioning).
Time frame: Change from baseline at 16 weeks.
Population: Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Facility-based Rehabilitation | Multiple Sclerosis Impact Scale (MSIS)-29 | Baseline MSIS-29 Physical Scale | 39.63 units on a scale | Standard Deviation 19.62 |
| Facility-based Rehabilitation | Multiple Sclerosis Impact Scale (MSIS)-29 | 16 week MSIS-29 Physical Scale | 32.18 units on a scale | Standard Deviation 21.36 |
| Facility-based Rehabilitation | Multiple Sclerosis Impact Scale (MSIS)-29 | Baseline MSIS-29 Psychological Scale | 31.71 units on a scale | Standard Deviation 21.33 |
| Facility-based Rehabilitation | Multiple Sclerosis Impact Scale (MSIS)-29 | 16 week MSIS-29 Psychological Scale | 24.79 units on a scale | Standard Deviation 22.29 |
| Telerehabilitation | Multiple Sclerosis Impact Scale (MSIS)-29 | 16 week MSIS-29 Psychological Scale | 26.17 units on a scale | Standard Deviation 20.06 |
| Telerehabilitation | Multiple Sclerosis Impact Scale (MSIS)-29 | Baseline MSIS-29 Physical Scale | 41.59 units on a scale | Standard Deviation 18.24 |
| Telerehabilitation | Multiple Sclerosis Impact Scale (MSIS)-29 | Baseline MSIS-29 Psychological Scale | 33.01 units on a scale | Standard Deviation 22.16 |
| Telerehabilitation | Multiple Sclerosis Impact Scale (MSIS)-29 | 16 week MSIS-29 Physical Scale | 34.65 units on a scale | Standard Deviation 19.61 |
Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire
The MSWS-12 is a self-reported measure of the impact of multiple sclerosis (MS) on walking ability and daily activities over the past two weeks. Items are scored from 1-5, with 1 meaning no limitation and 5 meaning extreme limitation. Scores are calculated by first adding the responses, and getting a total score of 12 - 60. This score is then transformed to a 0 - 100 scale (Nilsagard et al, 2007) by subtracting 12 from the sum, dividing by 48, and then multiplying by 100. Higher scores indicate a greater impact of MS on walking than lower scores.
Time frame: Change from baseline at 16 weeks
Population: Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Facility-based Rehabilitation | Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire | MSWS at baseline | 61.36 score on a scale | Standard Deviation 21.81 |
| Facility-based Rehabilitation | Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire | MSWS at 16 weeks | 53.54 score on a scale | Standard Deviation 24.83 |
| Telerehabilitation | Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire | MSWS at baseline | 62.45 score on a scale | Standard Deviation 22.35 |
| Telerehabilitation | Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire | MSWS at 16 weeks | 58.25 score on a scale | Standard Deviation 25.14 |
Patient Determined Disease Steps (PDDS)
The PDDS is a patient-reported outcome of disability in MS. The scale focuses mainly on how well individuals with MS walk. Scores range from 0 (normal function) to 8 (bedridden). Higher scores reflect greater disability due to MS.
Time frame: Change from baseline at 16 weeks
Population: Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Facility-based Rehabilitation | Patient Determined Disease Steps (PDDS) | PDDS at baseline | 4.26 score on a scale | Standard Deviation 1.03 |
| Facility-based Rehabilitation | Patient Determined Disease Steps (PDDS) | PDDS at 16 weeks | 1.66 score on a scale | Standard Deviation 2.14 |
| Telerehabilitation | Patient Determined Disease Steps (PDDS) | PDDS at baseline | 4.28 score on a scale | Standard Deviation 1.04 |
| Telerehabilitation | Patient Determined Disease Steps (PDDS) | PDDS at 16 weeks | 2.19 score on a scale | Standard Deviation 2.31 |
Quality of Life in Neurological Disorders (Neuro-QOL) Survey
Domains (anxiety, depression, fatigue, upper extremity function, lower extremity function, cognitive function, emotional and behavioral dyscontrol, sleep disturbance, ability to participate in social roles and activities, satisfaction with social roles and activities, stigma) - possible score of 8-40. Positive affect domain has possible score of 9-45. Communication domain has possible score of 5-25. No clinical thresholds established. Higher scores indicate WORSE self-reported health for Anxiety, Depression, Fatigue, Emotional and Behavioral Dyscontrol, Sleep Disturbance, Stigma. Higher scores indicate BETTER self-reported health for Upper Extremity Function, Lower Extremity Function, Cognitive Function, Positive Affect & Well-Being, Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles & Activities, Communication.
Time frame: Change from baseline at 16 weeks.
Population: Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Upper Extremity Function Domain | 36.71 units on a scale | Standard Deviation 4.09 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Anxiety Domain | 15.41 units on a scale | Standard Deviation 6.86 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Depression Domain | 13.58 units on a scale | Standard Deviation 6.14 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Depression Domain | 12.56 units on a scale | Standard Deviation 6.2 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Fatigue Domain | 23.74 units on a scale | Standard Deviation 7.58 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Fatigue Domain | 21.44 units on a scale | Standard Deviation 7.85 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Anxiety Domain | 16.88 units on a scale | Standard Deviation 7.01 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Upper Extremity Function Domain | 37.12 units on a scale | Standard Deviation 4.08 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Lower Extremity Function Domain | 30.53 units on a scale | Standard Deviation 5.26 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Lower Extremity Function Domain | 33.04 units on a scale | Standard Deviation 5.22 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Cognitive Function Domain | 30.46 units on a scale | Standard Deviation 7.55 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Cognitive Function Domain | 31.35 units on a scale | Standard Deviation 7.52 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Emotional and Behavioral Dyscontrol Domain | 14.85 units on a scale | Standard Deviation 5.84 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Emotional and Behavioral Dyscontrol Domain | 14.27 units on a scale | Standard Deviation 6.14 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Positive Affect and Well-Being Domain | 35.20 units on a scale | Standard Deviation 7.44 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Positive Affect and Well-Being Domain | 36.55 units on a scale | Standard Deviation 7.21 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Sleep Distrubance Domain | 18.29 units on a scale | Standard Deviation 5.5 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Sleep Distrubance Domain | 16.76 units on a scale | Standard Deviation 5.88 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Ability to Participate in Social Roles and Activities Domain | 29.44 units on a scale | Standard Deviation 6.51 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Ability to Participate in Social Roles and Activities Domain | 30.77 units on a scale | Standard Deviation 6.78 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Satisfaction with Social Roles and Activities Domain | 24.69 units on a scale | Standard Deviation 7.85 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Satisfaction with Social Roles and Activities Domain | 28.02 units on a scale | Standard Deviation 7.6 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Stigma Domain | 15.28 units on a scale | Standard Deviation 6.34 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Stigma Domain | 13.74 units on a scale | Standard Deviation 5.94 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Communication Domain | 21.88 units on a scale | Standard Deviation 3.91 |
| Facility-based Rehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Communication Domain | 22.07 units on a scale | Standard Deviation 3.58 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Ability to Participate in Social Roles and Activities Domain | 30.37 units on a scale | Standard Deviation 6.48 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Anxiety Domain | 17.19 units on a scale | Standard Deviation 7.28 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Emotional and Behavioral Dyscontrol Domain | 13.19 units on a scale | Standard Deviation 4.92 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Anxiety Domain | 14.75 units on a scale | Standard Deviation 6.5 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Communication Domain | 21.76 units on a scale | Standard Deviation 3.89 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Depression Domain | 13.90 units on a scale | Standard Deviation 6.58 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Positive Affect and Well-Being Domain | 34.65 units on a scale | Standard Deviation 7.14 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Depression Domain | 12.31 units on a scale | Standard Deviation 6.1 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Satisfaction with Social Roles and Activities Domain | 24.57 units on a scale | Standard Deviation 7.37 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Fatigue Domain | 24.96 units on a scale | Standard Deviation 7.17 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Positive Affect and Well-Being Domain | 36.01 units on a scale | Standard Deviation 7.03 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Fatigue Domain | 22.31 units on a scale | Standard Deviation 7.12 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Stigma Domain | 13.68 units on a scale | Standard Deviation 5.31 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Upper Extremity Function Domain | 36.78 units on a scale | Standard Deviation 4.09 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Sleep Distrubance Domain | 19.33 units on a scale | Standard Deviation 6.11 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Upper Extremity Function Domain | 37.06 units on a scale | Standard Deviation 3.49 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Satisfaction with Social Roles and Activities Domain | 27.37 units on a scale | Standard Deviation 7.23 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Lower Extremity Function Domain | 30.17 units on a scale | Standard Deviation 5.21 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Sleep Distrubance Domain | 17.35 units on a scale | Standard Deviation 5.61 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Lower Extremity Function Domain | 31.52 units on a scale | Standard Deviation 5.72 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Communication Domain | 22.54 units on a scale | Standard Deviation 3.26 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Cognitive Function Domain | 30.41 units on a scale | Standard Deviation 7.09 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Ability to Participate in Social Roles and Activities Domain | 28.60 units on a scale | Standard Deviation 7.04 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | 16 week Cognitive Function Domain | 32.24 units on a scale | Standard Deviation 6.14 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Stigma Domain | 15.31 units on a scale | Standard Deviation 5.75 |
| Telerehabilitation | Quality of Life in Neurological Disorders (Neuro-QOL) Survey | Baseline Emotional and Behavioral Dyscontrol Domain | 14.66 units on a scale | Standard Deviation 5.65 |
Six Minute Walk Test (6MWT)
The six minute walk test (6MWT) assesses walking endurance and aerobic capacity. The score is the distance walked in 6 minutes. Higher scores (more distance walked in feet) indicate improved walking capacity.
Time frame: Change from baseline at 16 weeks
Population: Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Facility-based Rehabilitation | Six Minute Walk Test (6MWT) | Walking distance at baseline | 963.3 feet | Standard Deviation 381.1 |
| Facility-based Rehabilitation | Six Minute Walk Test (6MWT) | Walking distance at 16 weeks | 1099.6 feet | Standard Deviation 395.1 |
| Telerehabilitation | Six Minute Walk Test (6MWT) | Walking distance at baseline | 884.2 feet | Standard Deviation 392.3 |
| Telerehabilitation | Six Minute Walk Test (6MWT) | Walking distance at 16 weeks | 1027.1 feet | Standard Deviation 367 |