Multiple SclerosisTRAIN-BWNCT04091464
TRAIN-BW: Backward Walking Training in Multiple Sclerosis
A study testing Backward Walking Training and Forward Walking Training in people with Multiple Sclerosis and Gait Disorders, Neurologic, run by Wayne State University at 1 site in United States.
Trial summary
Individuals with multiple sclerosis (MS) experience in impairments in mobility and cognition that increase the risk for accidental falls. More than 50% of individuals with MS experience injurious falls within a 6-month period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Gait Disorders, Neurologic, Accidental Fall
- What is being tested?
- Backward Walking Training and Forward Walking Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MS
- PDDS <6, indicating ability to ambulate with or without an assistive device >/= 50% of the time
- Self-reported walking dysfunction as evidenced by a score of >/= 30 on MSWS-12 OR reports of 2 or more falls in the prior 6 months, indicating a frequent faller.
Who cannot join
- MS relapse within the past 30 days
- comorbid neurological disorder
- acute orthopedic disorder/injury
- unable to follow study-related commands
Trial locations and contacts
1 site in 1 country.
About this study
Individuals with multiple sclerosis (MS) experience in impairments in mobility and cognition that increase the risk for accidental falls. More than 50% of individuals with MS experience injurious falls within a 6-month period. Current interventions to improve fall risk have focused on forward walking (FW) and balance training, resulting in small declines in the relative risk for falls with a large degree of variability. Interestingly, motor differences between MS and healthy controls are more pronounced in backward walking (BW), yet no studies have investigated BW training as an intervention to reduce fall risk in persons with MS. This study will investigate the feasibility, acceptability and impact of BW training compared to forward walking training on motor function and fall risk in persons with MS.
- Being tested
- Backward Walking Training, Forward Walking Training
- Keywords
- Backward Walking, Neurorehabilitation
- Medical subject headings
- Multiple Sclerosis, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backward Walking TrainingBehavioural
Training will consist of BW training on both a treadmill and overground. All participants will receive 1x/week training with a trained member of the research team, who will progress the participant week-to-week and ensure safety. Treadmill speed will be determined by baseline BW walking speed and incrementally increased with each training week to subject tolerance. Participants will follow a home exercise program for the remainder of the week that includes BW, backward stepping, and functional exercises that incorporate BW movements.
Forward Walking TrainingBehavioural
Training will consist of FW training on both treadmill and overground. All participants will receive 1x/week training with a trained member of the research team, who will progress the participant week-to-week and ensure safety. Treadmill speed will be determined by baseline FW walking speed and incrementally increased with each training week to subject tolerance. Participants will follow a home exercise program for the remainder of the week that includes FW, forward stepping, and functional exercises that incorporate FW movements.
| Study group | Role | What they receive |
|---|---|---|
| TRAIN-BW | Experimental | 1x/week for 8 weeks + home exercise program Receives: Behavioral: Backward Walking Training |
| TRAIN-FW | Active comparator | 1x/week for 8 weeks + home exercise program Receives: Behavioral: Forward Walking Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sway during quiet stance
Measured with APDM Sensors
Measured: Change in sway at 8 weeks
Stepping latency on push-and-release test
Measured with APDM Sensors
Measured: Change in stepping latency at 8 weeks
Secondary outcomes (6)
Client Satisfaction Questionnaire (CSQ-8)
Scores range from 8-32, with high scores indicating greater satisfaction with the intervention
Measured: 8 weeks
Patient Global Impression of Change
Perceived Treatment Effect; scores range from 1-7 with higher scores indicating greater perception of improvement related to the intervention.
Measured: 8 weeks
Number of Active Minutes
Measured with Accelerometry, passively collected for a 1 week period prior to the intervention and again after the intervention concludes 8 weeks later.
Measured: Change in Physical Activity measures at 8 weeks
Number of Falls
Number of falls reported in 6 month period after the intervention ends
Measured: 6 months
Forward and Backward Velocity and Double Support Time
Walking speed and double support time (spatiotemporal measures of gait)
Measured: Change in velocity and double support time at 8 weeks
ABC Scale
Balance confidence
Measured: Change in balance confidence at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start1 Jan 2020
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Fritz, Wayne State University
- Investigators
- Nora Fritz, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091464
- Sponsor's protocol ID
- URG20192020
- Acronym
- TRAIN-BW
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2019
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
VanNostrand M, Monaghan PG, Daugherty AM, Fritz NE. Study protocol of a randomized controlled trial comparing backward walking to forward walking training on balance in multiple sclerosis: The TRAIN-MS trial. Contemp Clin Trials. 2024 Sep;144:107621. doi: 10.1016/j.cct.2024.107621. Epub 2024 Jul 5.
PubMed 38971304
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRAIN-BW: Backward Walking Training in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04091464
- Acronym / sponsor ID
- TRAIN-BW / URG20192020
- Keywords
- Backward Walking, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with multiple sclerosis (MS) experience in impairments in mobility and cognition that increase the risk for accidental falls. More than 50% of individuals with MS experience injurious falls within a 6-month period. Current interventions to improve fall risk have focused on forward walking (FW) and balance training, resulting in small declines in the relative risk for falls with a large degree of variability. Interestingly, motor differences between MS and healthy controls are more pronounced in backward walking (BW), yet no studies have investigated BW training as an intervention to reduce fall risk in persons with MS. This study will investigate the feasibility, acceptability and impact of BW training compared to forward walking training on motor function and fall risk in persons with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRAIN-BW | Experimental | Behavioral: Backward Walking Training1x/week for 8 weeks + home exercise program |
| TRAIN-FW | Active comparator | Behavioral: Forward Walking Training1x/week for 8 weeks + home exercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of MS
- PDDS <6, indicating ability to ambulate with or without an assistive device >/= 50% of the time
- Self-reported walking dysfunction as evidenced by a score of >/= 30 on MSWS-12 OR reports of 2 or more falls in the prior 6 months, indicating a frequent faller.
Key exclusion criteria (4 listed)
- MS relapse within the past 30 days
- comorbid neurological disorder
- acute orthopedic disorder/injury
- unable to follow study-related commands
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 |
|---|---|---|
| Backward Walking TrainingTraining will consist of BW training on both a treadmill and overground. All participants will receive 1x/week training with a trained member of the research team, who will progress the participant week-to-week and ensure safety. Treadmill speed will be determined by baseline BW walking speed and incrementally increased with each training week to subject tolerance. Participants will follow a home exercise program for the remainder of the week that includes BW, backward stepping, and functional exercises that incorporate BW movements. | Behavioural | TRAIN-BW |
| Forward Walking TrainingTraining will consist of FW training on both treadmill and overground. All participants will receive 1x/week training with a trained member of the research team, who will progress the participant week-to-week and ensure safety. Treadmill speed will be determined by baseline FW walking speed and incrementally increased with each training week to subject tolerance. Participants will follow a home exercise program for the remainder of the week that includes FW, forward stepping, and functional exercises that incorporate FW movements. | Behavioural | TRAIN-FW |
Primary outcome
Sway during quiet stance
Time frame: Change in sway at 8 weeks
Measured with APDM Sensors
Stepping latency on push-and-release test
Time frame: Change in stepping latency at 8 weeks
Measured with APDM Sensors
6 secondary outcomes
Client Satisfaction Questionnaire (CSQ-8)
Time frame: 8 weeks
Patient Global Impression of Change
Time frame: 8 weeks
Number of Active Minutes
Time frame: Change in Physical Activity measures at 8 weeks
Number of Falls
Time frame: 6 months
Forward and Backward Velocity and Double Support Time
Time frame: Change in velocity and double support time at 8 weeks
ABC Scale
Time frame: Change in balance confidence at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 38971304VanNostrand M, Monaghan PG, Daugherty AM, Fritz NE. Study protocol of a randomized controlled trial comparing backward walking to forward walking training on balance in multiple sclerosis: The TRAIN-MS trial. Contemp Clin Trials. 2024 Sep;144:107621. doi: 10.1016/j.cct.2024.107621. Epub 2024 Jul 5.
- 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.
Nora Fritz, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backward Walking Training and Forward Walking Training in people with Multiple Sclerosis and Gait Disorders, Neurologic, run by Wayne State University at 1 site 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 3 inclusion and 4 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sway during quiet stance (time frame: Change in sway at 8 weeks). The study lists 2 primary outcomes in all. 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 NCT04091464, which also lists 1 linked publication.
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 19 Aug 2026.