Multiple SclerosisNCT03468868
Comparative Effectiveness Study Telerehab Versus Conventional
A study testing Exercise program for people with MS in people with Multiple Sclerosis, run by Shepherd Center, Atlanta GA at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Exercise program for people with MS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 9 sitesUnited States
- Study dates
- 23 Jul 2018to 12 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Relapse in the past 30 days
- Other neurological or musculoskeletal disorders
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Georgia
Athens, Georgia, 30602
Shepherd Center
Atlanta, Georgia, 30309
The Tanner Center for Multiple Sclerosis
Birmingham, Alabama, 35209
University of Alabama
Birmingham, Alabama, 35209
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic
Cleveland, Ohio, 44195
University of Colorado
Denver, Colorado, 80045
Marquette University
Milwaukee, Wisconsin, 53233
University of North Carolina
Raleigh, North Carolina, 27599
About this study
Official title: Comparative Effectiveness Study of an Exercise Intervention Delivered Via Telerehabilitation and Conventional Mode of Delivery
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Exercise program for people with MS
- Keywords
- Multiple sclerosis, Exercise, Physical activity, Telerehabilitation, Comparative effectiveness study, Social cognitive theory, Health behavior change
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise program for people with MSBehavioural
The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Facility-based rehabilitation | Active comparator | 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. Receives: Behavioral: Exercise program for people with MS |
| Telerehabilitation | Active comparator | Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions. Receives: Behavioral: Exercise program for people with MS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline T25FWT at 16-weeks
Secondary outcomes (8)
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.
Measured: Change from baseline at 16 weeks
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.
Measured: Change from baseline at 16 weeks
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.
Measured: Change from baseline at 16 weeks
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.
Measured: Change from baseline at 16 weeks.
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).
Measured: Change from baseline at 16 weeks.
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.
Measured: Change from baseline at 16 weeks
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.
Measured: Change from baseline at 16 weeks
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.
Measured: Change from baseline at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start23 Jul 2018
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-stage randomized choice design aimed at noninferiority.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of North Carolina, Chapel Hill, University of Georgia, The Cleveland Clinic, University of Colorado, Denver, Marquette University, Accelerated Cure Project for Multiple Sclerosis, Patient-Centered Outcomes Research Institute, Tanner Foundation for Multiple Sclerosis, Massachusetts General Hospital
- Responsible party
- Principal investigator, Deborah Backus, Shepherd Center, Atlanta GA
- Investigators
- Deborah Backus, PT, PhD, Principal investigator, Shepherd Center, Atlanta GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468868
- Sponsor's protocol ID
- MS-1610-36999
- Status last verified
- Jan 2025
- First submitted
- 6 Mar 2018
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Motl RW, Backus D, Neal WN, Cutter G, Palmer L, McBurney R, Schmidt H, Bethoux F, Hebert J, Ng A, McCully KK, Plummer P. Rationale and design of the STEP for MS Trial: Comparative effectiveness of Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis. Contemp Clin Trials. 2019 Jun;81:110-122. doi: 10.1016/j.cct.2019.04.013. Epub 2019 Apr 22.
PubMed 31022481Neal WN, Moldavskiy M, Truax B, Ithurburn A, Ware M, Hebert JR, Opielinski L, Penko AL, Kern K, Palmer L, Backus D, Motl RW. Intervention fidelity and adaptation in a multi-site exercise training intervention for adults with multiple sclerosis. Contemp Clin Trials. 2023 Oct;133:107320. doi: 10.1016/j.cct.2023.107320. Epub 2023 Aug 24.
PubMed 37633458Palmer LC, Neal WN, Motl RW, Backus D. The Impact of COVID-19 Lockdown Restrictions on Exercise Behavior Among People With Multiple Sclerosis Enrolled in an Exercise Trial: Qualitative Interview Study. JMIR Rehabil Assist Technol. 2022 Nov 22;9(4):e42157. doi: 10.2196/42157.
PubMed 36269870Motl RW, Plummer P, Backus D, Hebert JR, Neal WN, Ng A, Lowman J, Bethoux F, Schmidt H, McBurney R, McCully KK, Cutter G. Validation of scores from a telephone administered multiple sclerosis walking scale-12 in persons with multiple sclerosis. Mult Scler Relat Disord. 2024 Aug;88:105715. doi: 10.1016/j.msard.2024.105715. Epub 2024 Jun 9.
PubMed 38889558Motl RW, Backus D, Hebert JR, Ng AV, McCully KK, Neal WN, Schmidt H, McBurney R, Plummer P, Bethoux F, Lowman J, Cutter G. Walking performance is worse in black than white people with multiple sclerosis. Mult Scler Relat Disord. 2025 Mar;95:106343. doi: 10.1016/j.msard.2025.106343. Epub 2025 Feb 18.
PubMed 39986137Motl R, Neal W, Backus D, Hebert J, McCully K, Bethoux F, Plummer P, Ng A, Lowman J, Schmidt H, McBurney R, Cutter G. Middle-range scores from the patient determined disease steps scale reflect varying levels of walking dysfunction in multiple sclerosis. BMC Neurol. 2024 Oct 10;24(1):383. doi: 10.1186/s12883-024-03871-1.
PubMed 39390466
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Study of an Exercise Intervention Delivered Via Telerehabilitation and Conventional Mode of Delivery
- ClinicalTrials.gov ID
- NCT03468868
- Acronym / sponsor ID
- MS-1610-36999
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Exercise, Physical activity, Telerehabilitation, Comparative effectiveness study, Social cognitive theory, Health behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of North Carolina, Chapel Hill, University of Georgia, The Cleveland Clinic, University of Colorado, Denver, Marquette University, Accelerated Cure Project for Multiple Sclerosis, Patient-Centered Outcomes Research Institute, Tanner Foundation for Multiple Sclerosis, Massachusetts General Hospital
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-stage randomized choice design aimed at noninferiority.
| Arm | Type | Receives |
|---|---|---|
| Facility-based rehabilitation | Active comparator | Behavioral: Exercise program for people with MSParticipants 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. |
| Telerehabilitation | Active comparator | Behavioral: Exercise program for people with MSParticipants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Relapse in the past 30 days
- Other neurological or musculoskeletal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise program for people with MSThe intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks. | Behavioural | Facility-based rehabilitation, Telerehabilitation |
Primary outcome
Timed 25 Foot Walk Test (T25FWT)
Time frame: 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.
8 secondary outcomes
Six Minute Walk Test (6MWT)
Time frame: Change from baseline at 16 weeks
Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire
Time frame: Change from baseline at 16 weeks
Godin Leisure-Time Physical Activity (LTPA) Questionnaire
Time frame: Change from baseline at 16 weeks
Quality of Life in Neurological Disorders (Neuro-QOL) Survey
Time frame: Change from baseline at 16 weeks.
Multiple Sclerosis Impact Scale (MSIS)-29
Time frame: Change from baseline at 16 weeks.
Modified Fatigue Impact Scale (MFIS)
Time frame: Change from baseline at 16 weeks
Expanded Disability Status Scale (EDSS)
Time frame: Change from baseline at 16 weeks
Patient Determined Disease Steps (PDDS)
Time frame: Change from baseline at 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31022481Motl RW, Backus D, Neal WN, Cutter G, Palmer L, McBurney R, Schmidt H, Bethoux F, Hebert J, Ng A, McCully KK, Plummer P. Rationale and design of the STEP for MS Trial: Comparative effectiveness of Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis. Contemp Clin Trials. 2019 Jun;81:110-122. doi: 10.1016/j.cct.2019.04.013. Epub 2019 Apr 22.
- Background: PubMed 37633458Neal WN, Moldavskiy M, Truax B, Ithurburn A, Ware M, Hebert JR, Opielinski L, Penko AL, Kern K, Palmer L, Backus D, Motl RW. Intervention fidelity and adaptation in a multi-site exercise training intervention for adults with multiple sclerosis. Contemp Clin Trials. 2023 Oct;133:107320. doi: 10.1016/j.cct.2023.107320. Epub 2023 Aug 24.
- Background: PubMed 36269870Palmer LC, Neal WN, Motl RW, Backus D. The Impact of COVID-19 Lockdown Restrictions on Exercise Behavior Among People With Multiple Sclerosis Enrolled in an Exercise Trial: Qualitative Interview Study. JMIR Rehabil Assist Technol. 2022 Nov 22;9(4):e42157. doi: 10.2196/42157.
- Background: PubMed 38889558Motl RW, Plummer P, Backus D, Hebert JR, Neal WN, Ng A, Lowman J, Bethoux F, Schmidt H, McBurney R, McCully KK, Cutter G. Validation of scores from a telephone administered multiple sclerosis walking scale-12 in persons with multiple sclerosis. Mult Scler Relat Disord. 2024 Aug;88:105715. doi: 10.1016/j.msard.2024.105715. Epub 2024 Jun 9.
- Derived from this study: PubMed 39986137Motl RW, Backus D, Hebert JR, Ng AV, McCully KK, Neal WN, Schmidt H, McBurney R, Plummer P, Bethoux F, Lowman J, Cutter G. Walking performance is worse in black than white people with multiple sclerosis. Mult Scler Relat Disord. 2025 Mar;95:106343. doi: 10.1016/j.msard.2025.106343. Epub 2025 Feb 18.
- Derived from this study: PubMed 39390466Motl R, Neal W, Backus D, Hebert J, McCully K, Bethoux F, Plummer P, Ng A, Lowman J, Schmidt H, McBurney R, Cutter G. Middle-range scores from the patient determined disease steps scale reflect varying levels of walking dysfunction in multiple sclerosis. BMC Neurol. 2024 Oct 10;24(1):383. doi: 10.1186/s12883-024-03871-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Backus, PT, PhD principal investigator
Shepherd Center, Atlanta GA
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program for people with MS in people with Multiple Sclerosis, run by Shepherd Center, Atlanta GA at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed 25 Foot Walk Test (T25FWT) (time frame: Change from baseline T25FWT at 16-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03468868, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.