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Comparative Effectiveness Study Telerehab Versus Conventional

Comparative Effectiveness Study of an Exercise Intervention Delivered Via Telerehabilitation and Conventional Mode of Delivery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03468868
Enrollment
379
Registered
2018-03-19
Start date
2018-07-23
Completion date
2023-09-12
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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

BEHAVIORALExercise 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.

Sponsors

University of Alabama at Birmingham
CollaboratorOTHER
University of North Carolina, Chapel Hill
CollaboratorOTHER
University of Georgia
CollaboratorOTHER
The Cleveland Clinic
CollaboratorOTHER
University of Colorado, Denver
CollaboratorOTHER
Marquette University
CollaboratorOTHER
Accelerated Cure Project for Multiple Sclerosis
CollaboratorOTHER
Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Tanner Foundation for Multiple Sclerosis
CollaboratorOTHER
Massachusetts General Hospital
CollaboratorOTHER
Shepherd Center, Atlanta GA
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

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

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Timed 25 Foot Walk Test (T25FWT)Change from baseline T25FWT at 16-weeksThe 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

MeasureTime frameDescription
Six Minute Walk Test (6MWT)Change from baseline at 16 weeksThe 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 QuestionnaireChange from baseline at 16 weeksThe 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) QuestionnaireChange from baseline at 16 weeksThe 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) SurveyChange 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)-29Change 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 weeksThe 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 weeksThe 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 weeksThe 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

ArmCount
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
Total379

Baseline characteristics

CharacteristicTotalTelerehabilitationFacility-based Rehabilitation
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
379 Participants181 Participants198 Participants
Age, Continuous50.81 years
STANDARD_DEVIATION 9.36
50.08 years
STANDARD_DEVIATION 9.18
51.47 years
STANDARD_DEVIATION 10.01
Employment Status
Employed
133 Participants67 Participants66 Participants
Employment Status
Other
72 Participants27 Participants45 Participants
Employment Status
Unemployed
174 Participants87 Participants87 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
18 Participants8 Participants10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
355 Participants170 Participants185 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
6 Participants3 Participants3 Participants
Insurance
Direct purchase
20 Participants10 Participants10 Participants
Insurance
Employer
158 Participants78 Participants80 Participants
Insurance
Medicaid
60 Participants31 Participants29 Participants
Insurance
Medicare
111 Participants52 Participants59 Participants
Insurance
No insurance
5 Participants3 Participants2 Participants
Insurance
Other
25 Participants7 Participants18 Participants
Living Arrangement
Living Alone
83 Participants40 Participants43 Participants
Living Arrangement
Living With Others
294 Participants141 Participants153 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 Participants21 Participants17 Participants
MS type
Progressive Relapsing Multiple Sclerosis (PRMS)
6 Participants4 Participants2 Participants
MS type
Relapsing Remitting Multiple Sclerosis (RRMS)
255 Participants112 Participants143 Participants
MS type
Secondary Progressive Multiple Sclerosis (SPMS)
52 Participants30 Participants22 Participants
Patient-Determined Disease Steps (PDDS) Scale
1 (Mild Disability)
1 Participants1 Participants0 Participants
Patient-Determined Disease Steps (PDDS) Scale
3 (Gait Disability)
103 Participants48 Participants55 Participants
Patient-Determined Disease Steps (PDDS) Scale
4 (Early Cane)
124 Participants57 Participants67 Participants
Patient-Determined Disease Steps (PDDS) Scale
5 (Late Cane)
94 Participants49 Participants45 Participants
Patient-Determined Disease Steps (PDDS) Scale
6 (Bilateral Support)
57 Participants26 Participants31 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
105 Participants50 Participants55 Participants
Race (NIH/OMB)
More than one race
8 Participants3 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
16 Participants6 Participants10 Participants
Race (NIH/OMB)
White
246 Participants120 Participants126 Participants
Sex: Female, Male
Female
286 Participants142 Participants144 Participants
Sex: Female, Male
Male
92 Participants38 Participants54 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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1980 / 181
other
Total, other adverse events
80 / 19888 / 181
serious
Total, serious adverse events
8 / 1982 / 181

Outcome results

Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Facility-based RehabilitationTimed 25 Foot Walk Test (T25FWT)Walking speed at baseline2.88 feet per secondStandard Deviation 0.85
Facility-based RehabilitationTimed 25 Foot Walk Test (T25FWT)Walking speed at 16 weeks3.41 feet per secondStandard Deviation 1.12
TelerehabilitationTimed 25 Foot Walk Test (T25FWT)Walking speed at baseline2.62 feet per secondStandard Deviation 0.94
TelerehabilitationTimed 25 Foot Walk Test (T25FWT)Walking speed at 16 weeks3.26 feet per secondStandard Deviation 1.08
p-value: <0.0195% CI: [-0.14, 0.44]t-test, 2 sided
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Facility-based RehabilitationExpanded Disability Status Scale (EDSS)EDSS at baseline5.32 score on a scaleStandard Deviation 0.95
Facility-based RehabilitationExpanded Disability Status Scale (EDSS)EDSS at 16 weeks5.02 score on a scaleStandard Deviation 1.2
TelerehabilitationExpanded Disability Status Scale (EDSS)EDSS at baseline5.25 score on a scaleStandard Deviation 0.94
TelerehabilitationExpanded Disability Status Scale (EDSS)EDSS at 16 weeks5.04 score on a scaleStandard Deviation 1.16
p-value: 0.8795% CI: [-0.34, 0.29]t-test, 2 sided
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Facility-based RehabilitationGodin Leisure-Time Physical Activity (LTPA) QuestionnaireLTPA at 16 weeks23.09 units on a scaleStandard Deviation 17.7
Facility-based RehabilitationGodin Leisure-Time Physical Activity (LTPA) QuestionnaireLTPA at baseline7.48 units on a scaleStandard Deviation 8.15
TelerehabilitationGodin Leisure-Time Physical Activity (LTPA) QuestionnaireLTPA at 16 weeks22.21 units on a scaleStandard Deviation 18.88
TelerehabilitationGodin Leisure-Time Physical Activity (LTPA) QuestionnaireLTPA at baseline7.56 units on a scaleStandard Deviation 8.01
p-value: 0.795% CI: [-3.55, 5.32]t-test, 2 sided
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Facility-based RehabilitationModified Fatigue Impact Scale (MFIS)MFIS Cognitive at baseline14.54 score on a scaleStandard Deviation 9.58
Facility-based RehabilitationModified Fatigue Impact Scale (MFIS)MFIS Cognitive at 16 weeks12.00 score on a scaleStandard Deviation 9.3
Facility-based RehabilitationModified Fatigue Impact Scale (MFIS)MFIS Physical at baseline20.02 score on a scaleStandard Deviation 7.81
Facility-based RehabilitationModified Fatigue Impact Scale (MFIS)MFIS Physical at 16 weeks15.57 score on a scaleStandard Deviation 8.21
Facility-based RehabilitationModified Fatigue Impact Scale (MFIS)MFIS Psychosocial at baseline3.89 score on a scaleStandard Deviation 2.2
Facility-based RehabilitationModified Fatigue Impact Scale (MFIS)MFIS Psychosocial at 16 weeks2.93 score on a scaleStandard Deviation 2.2
Facility-based RehabilitationModified Fatigue Impact Scale (MFIS)MFIS Total at baseline38.45 score on a scaleStandard Deviation 17.36
Facility-based RehabilitationModified Fatigue Impact Scale (MFIS)MFIS Total at 16 weeks30.50 score on a scaleStandard Deviation 18.02
TelerehabilitationModified Fatigue Impact Scale (MFIS)MFIS Total at 16 weeks32.37 score on a scaleStandard Deviation 15.52
TelerehabilitationModified Fatigue Impact Scale (MFIS)MFIS Cognitive at baseline14.96 score on a scaleStandard Deviation 9.06
TelerehabilitationModified Fatigue Impact Scale (MFIS)MFIS Psychosocial at baseline3.97 score on a scaleStandard Deviation 2.2
TelerehabilitationModified Fatigue Impact Scale (MFIS)MFIS Cognitive at 16 weeks11.63 score on a scaleStandard Deviation 8.36
TelerehabilitationModified Fatigue Impact Scale (MFIS)MFIS Total at baseline39.91 score on a scaleStandard Deviation 16.5
TelerehabilitationModified Fatigue Impact Scale (MFIS)MFIS Physical at baseline20.98 score on a scaleStandard Deviation 7.4
TelerehabilitationModified Fatigue Impact Scale (MFIS)MFIS Psychosocial at 16 weeks3.07 score on a scaleStandard Deviation 2.14
TelerehabilitationModified Fatigue Impact Scale (MFIS)MFIS Physical at 16 weeks17.67 score on a scaleStandard Deviation 7.77
Comparison: MFIS Cognitivep-value: 0.7495% CI: [-1.83, 2.56]t-test, 2 sided
Comparison: MFIS Physicalp-value: 0.0495% CI: [-4.07, -0.12]t-test, 2 sided
Comparison: MFIS Psychosocialp-value: 0.5995% CI: [-0.68, 0.39]t-test, 2 sided
Comparison: MFIS Totalp-value: 0.3895% CI: [-6.05, 2.3]t-test, 2 sided
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Facility-based RehabilitationMultiple Sclerosis Impact Scale (MSIS)-29Baseline MSIS-29 Physical Scale39.63 units on a scaleStandard Deviation 19.62
Facility-based RehabilitationMultiple Sclerosis Impact Scale (MSIS)-2916 week MSIS-29 Physical Scale32.18 units on a scaleStandard Deviation 21.36
Facility-based RehabilitationMultiple Sclerosis Impact Scale (MSIS)-29Baseline MSIS-29 Psychological Scale31.71 units on a scaleStandard Deviation 21.33
Facility-based RehabilitationMultiple Sclerosis Impact Scale (MSIS)-2916 week MSIS-29 Psychological Scale24.79 units on a scaleStandard Deviation 22.29
TelerehabilitationMultiple Sclerosis Impact Scale (MSIS)-2916 week MSIS-29 Psychological Scale26.17 units on a scaleStandard Deviation 20.06
TelerehabilitationMultiple Sclerosis Impact Scale (MSIS)-29Baseline MSIS-29 Physical Scale41.59 units on a scaleStandard Deviation 18.24
TelerehabilitationMultiple Sclerosis Impact Scale (MSIS)-29Baseline MSIS-29 Psychological Scale33.01 units on a scaleStandard Deviation 22.16
TelerehabilitationMultiple Sclerosis Impact Scale (MSIS)-2916 week MSIS-29 Physical Scale34.65 units on a scaleStandard Deviation 19.61
Comparison: MSIS Physicalp-value: 0.3495% CI: [-7.55, 2.6]t-test, 2 sided
Comparison: MSIS Psychologicalp-value: 0.2495% CI: [-6.63, 3.88]t-test, 2 sided
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Facility-based RehabilitationMultiple Sclerosis Walking Scale (MSWS)-12 QuestionnaireMSWS at baseline61.36 score on a scaleStandard Deviation 21.81
Facility-based RehabilitationMultiple Sclerosis Walking Scale (MSWS)-12 QuestionnaireMSWS at 16 weeks53.54 score on a scaleStandard Deviation 24.83
TelerehabilitationMultiple Sclerosis Walking Scale (MSWS)-12 QuestionnaireMSWS at baseline62.45 score on a scaleStandard Deviation 22.35
TelerehabilitationMultiple Sclerosis Walking Scale (MSWS)-12 QuestionnaireMSWS at 16 weeks58.25 score on a scaleStandard Deviation 25.14
p-value: 0.1395% CI: [-10.84, 1.41]t-test, 2 sided
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Facility-based RehabilitationPatient Determined Disease Steps (PDDS)PDDS at baseline4.26 score on a scaleStandard Deviation 1.03
Facility-based RehabilitationPatient Determined Disease Steps (PDDS)PDDS at 16 weeks1.66 score on a scaleStandard Deviation 2.14
TelerehabilitationPatient Determined Disease Steps (PDDS)PDDS at baseline4.28 score on a scaleStandard Deviation 1.04
TelerehabilitationPatient Determined Disease Steps (PDDS)PDDS at 16 weeks2.19 score on a scaleStandard Deviation 2.31
p-value: 0.0595% CI: [-1.08, 0]t-test, 2 sided
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Upper Extremity Function Domain36.71 units on a scaleStandard Deviation 4.09
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Anxiety Domain15.41 units on a scaleStandard Deviation 6.86
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Depression Domain13.58 units on a scaleStandard Deviation 6.14
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Depression Domain12.56 units on a scaleStandard Deviation 6.2
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Fatigue Domain23.74 units on a scaleStandard Deviation 7.58
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Fatigue Domain21.44 units on a scaleStandard Deviation 7.85
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Anxiety Domain16.88 units on a scaleStandard Deviation 7.01
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Upper Extremity Function Domain37.12 units on a scaleStandard Deviation 4.08
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Lower Extremity Function Domain30.53 units on a scaleStandard Deviation 5.26
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Lower Extremity Function Domain33.04 units on a scaleStandard Deviation 5.22
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Cognitive Function Domain30.46 units on a scaleStandard Deviation 7.55
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Cognitive Function Domain31.35 units on a scaleStandard Deviation 7.52
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Emotional and Behavioral Dyscontrol Domain14.85 units on a scaleStandard Deviation 5.84
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Emotional and Behavioral Dyscontrol Domain14.27 units on a scaleStandard Deviation 6.14
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Positive Affect and Well-Being Domain35.20 units on a scaleStandard Deviation 7.44
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Positive Affect and Well-Being Domain36.55 units on a scaleStandard Deviation 7.21
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Sleep Distrubance Domain18.29 units on a scaleStandard Deviation 5.5
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Sleep Distrubance Domain16.76 units on a scaleStandard Deviation 5.88
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Ability to Participate in Social Roles and Activities Domain29.44 units on a scaleStandard Deviation 6.51
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Ability to Participate in Social Roles and Activities Domain30.77 units on a scaleStandard Deviation 6.78
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Satisfaction with Social Roles and Activities Domain24.69 units on a scaleStandard Deviation 7.85
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Satisfaction with Social Roles and Activities Domain28.02 units on a scaleStandard Deviation 7.6
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Stigma Domain15.28 units on a scaleStandard Deviation 6.34
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Stigma Domain13.74 units on a scaleStandard Deviation 5.94
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Communication Domain21.88 units on a scaleStandard Deviation 3.91
Facility-based RehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Communication Domain22.07 units on a scaleStandard Deviation 3.58
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Ability to Participate in Social Roles and Activities Domain30.37 units on a scaleStandard Deviation 6.48
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Anxiety Domain17.19 units on a scaleStandard Deviation 7.28
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Emotional and Behavioral Dyscontrol Domain13.19 units on a scaleStandard Deviation 4.92
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Anxiety Domain14.75 units on a scaleStandard Deviation 6.5
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Communication Domain21.76 units on a scaleStandard Deviation 3.89
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Depression Domain13.90 units on a scaleStandard Deviation 6.58
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Positive Affect and Well-Being Domain34.65 units on a scaleStandard Deviation 7.14
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Depression Domain12.31 units on a scaleStandard Deviation 6.1
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Satisfaction with Social Roles and Activities Domain24.57 units on a scaleStandard Deviation 7.37
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Fatigue Domain24.96 units on a scaleStandard Deviation 7.17
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Positive Affect and Well-Being Domain36.01 units on a scaleStandard Deviation 7.03
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Fatigue Domain22.31 units on a scaleStandard Deviation 7.12
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Stigma Domain13.68 units on a scaleStandard Deviation 5.31
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Upper Extremity Function Domain36.78 units on a scaleStandard Deviation 4.09
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Sleep Distrubance Domain19.33 units on a scaleStandard Deviation 6.11
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Upper Extremity Function Domain37.06 units on a scaleStandard Deviation 3.49
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Satisfaction with Social Roles and Activities Domain27.37 units on a scaleStandard Deviation 7.23
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Lower Extremity Function Domain30.17 units on a scaleStandard Deviation 5.21
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Sleep Distrubance Domain17.35 units on a scaleStandard Deviation 5.61
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Lower Extremity Function Domain31.52 units on a scaleStandard Deviation 5.72
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Communication Domain22.54 units on a scaleStandard Deviation 3.26
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Cognitive Function Domain30.41 units on a scaleStandard Deviation 7.09
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Ability to Participate in Social Roles and Activities Domain28.60 units on a scaleStandard Deviation 7.04
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) Survey16 week Cognitive Function Domain32.24 units on a scaleStandard Deviation 6.14
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Stigma Domain15.31 units on a scaleStandard Deviation 5.75
TelerehabilitationQuality of Life in Neurological Disorders (Neuro-QOL) SurveyBaseline Emotional and Behavioral Dyscontrol Domain14.66 units on a scaleStandard Deviation 5.65
Comparison: NeuroQOL Anxiety Domainp-value: 0.4395% CI: [-0.97, 2.3]t-test, 2 sided
Comparison: NeuroQOL Depression Domainp-value: 0.7595% CI: [-1.26, 1.74]t-test, 2 sided
Comparison: NeuroQOL Fatigue Domainp-value: 0.3595% CI: [-2.71, 0.97]t-test, 2 sided
Comparison: NeuroQOL Upper Extremity Function Domainp-value: 0.9195% CI: [-0.88, 0.99]t-test, 2 sided
Comparison: NeuroQOL Lower Extremity Function Domainp-value: 0.0295% CI: [0.2, 2.85]t-test, 2 sided
Comparison: NeuroQOL Cognitive Function Domainp-value: 0.2995% CI: [-2.54, 0.76]t-test, 2 sided
Comparison: NeuroQOL Emotional and Behavioral Dyscontrol Domainp-value: 0.1195% CI: [-0.26, 2.42]t-test, 2 sided
Comparison: NeuroQOL Positive Affect and Well-Being Domainp-value: 0.5495% CI: [-1.19, 2.28]t-test, 2 sided
Comparison: NeuroQOL Sleep Disturbance Domainp-value: 0.4195% CI: [-2, 0.81]t-test, 2 sided
Comparison: NeuroQOL Ability to Participate in Social Roles and Activities Domainp-value: 0.6395% CI: [-1.22, 2.02]t-test, 2 sided
Comparison: NeuroQOL Satisfaction with Social Roles and Activities Domainp-value: 0.4895% CI: [-1.16, 2.47]t-test, 2 sided
Comparison: NeuroQOL Stigma Domainp-value: 0.9295% CI: [-1.32, 1.45]t-test, 2 sided
Comparison: NeuroQOL Communication Domainp-value: 0.2895% CI: [-1.31, 0.37]t-test, 2 sided
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Facility-based RehabilitationSix Minute Walk Test (6MWT)Walking distance at baseline963.3 feetStandard Deviation 381.1
Facility-based RehabilitationSix Minute Walk Test (6MWT)Walking distance at 16 weeks1099.6 feetStandard Deviation 395.1
TelerehabilitationSix Minute Walk Test (6MWT)Walking distance at baseline884.2 feetStandard Deviation 392.3
TelerehabilitationSix Minute Walk Test (6MWT)Walking distance at 16 weeks1027.1 feetStandard Deviation 367
p-value: 0.1695% CI: [-29.56, 174.5]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026