- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06919900
Motor Learning of Fall Resistant Skills Through Slip and Trip Exposure in Multiple Sclerosis (STRES-MS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Falls present a significant health risk for people with multiple sclerosis (PwMS). Perturbation training has emerged as a promising strategy to prevent falls. This type of training, which is based on sensorimotor adaptation and motor learning, capitalizes on the central nervous system's (CNS) ability to develop new motor skills. With repeated exposure to large-scale slip or trip perturbations, participants can quickly learn how to better respond to falls. The primary benefits of this training include improved dynamic stability control, both proactively and reactively, by adjusting the body's center of mass (COM) relative to its base of support (BOS).
Sixty-four individuals with relapsing-remitting multiple sclerosis (MS) will be randomly assigned to one of two groups: Group A (training) and Group B (control). Both groups will first participate in an acquisition session. Group A will undergo a training procedure blending slips, trips, and unperturbed walking on a treadmill. In contrast, Group B will walk on the treadmill for the same duration without any perturbations. Immediately following the acquisition session, both groups will experience an unexpected slip and trip while walking over ground (with the order of the slip and trip randomized). Three and six months later, both groups will complete two retention sessions. Each retention session will involve experiencing a treadmill slip and trip (treadmill reslip and retrip) and an overground slip and trip (overground reslip and retrip), with the order randomized. Responses to these perturbations will be measured using the outcomes of fall or non-fall, dynamic stability, leg muscle reaction times, and recovery step length. Additionally, real-life prospective falls and near falls will be monitored for both groups over the six months following the acquisition session.
This project will advance our understanding of learning new motor skills from exposure to external perturbations. If it is proven that people with MS can learn motor skills from perturbation training, the findings from this study will pave a theoretical foundation for applying perturbation training as a promising fall prevention intervention for people with MS.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Feng Yang, Ph.D.
- Phone Number: 404-413-8357
- Email: fyang@gsu.edu
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30303
- Recruiting
- Georgia State University Biomechanics Lab
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Contact:
- Feng Yang, PhD
- Phone Number: 404-413-8357
- Email: fyang@gsu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinically confirmed multiple sclerosis
- At least 45 years old
- Able to walk independently at least 25 feet
- Able to stand independently for at least 30 seconds
- Patient Determined Disability Steps score between 0 and 4
- Free from pregnancy
- Montreal Cognitive Assessment score of 23 or higher
Exclusion Criteria:
- Previous experience with perturbation training
- T-score from the dual x-ray absorptiometry (DXA) scan of less than -2.5
- Coexisting psychiatric disorders or other neurological conditions, severe medical illness, or cardiovascular diseases
- Participants have had a relapse in the past 8 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Training Group
During the acquisition session, this group will undergo perturbation training on the treadmill while wearing a safety harness.
Then, they will experience an unexpected slip and trip while wearing a safety harness and walking overground.
During the 3-month and 6-month retention sessions, they will experience a slip and trip during treadmill walking and a slip and trip during overground walking.
|
Unexpected slips blended with trips and unperturbed walking trials on a treadmill.
A safety harness will be worn at all times.
|
|
Active Comparator: Control Group
During the acquisition session, this group will walk on the treadmill without perturbations for the same amount of time as the training group.
Then, they will experience an unexpected slip and trip while wearing a safety harness and walking overground.
During the 3-month and 6-month retention sessions, they will experience a slip and trip during treadmill walking and a slip and trip during overground walking.
|
Treadmill walking for the same amount of time as the training group without perturbation.
A safety harness will be worn at all times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perturbation Outcome (Fall or Non-Fall) on the Treadmill or Overground
Time Frame: Baseline (acquisition session), 3-month retention session, 6-month retention session.
|
A loadcell will be connected to the safety harness (above the participant's head) and will measure the force exerted on the safety harness during each perturbation trial.
Perturbation outcomes will be classified as falls if the peak loadcell force exceeds 30% of the body weight.
Otherwise, perturbation outcomes will be classified as non-falls.
|
Baseline (acquisition session), 3-month retention session, 6-month retention session.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Gait Stability as defined by the Feasible Stability Region (FSR) Theory
Time Frame: Baseline (acquisition session), 3-month retention session, 6-month retention session.
|
FSR-based dynamic gait stability considers both the center of mass position and velocity during the slip or trip recovery process.
Dynamic stability will be calculated at the foot touchdown before and after the perturbation onset.
For slip-falls (or trip-falls), the larger (or smaller) the stability value, the more stable one is in resisting slip-related backward (or trip-induced forward) falling.
|
Baseline (acquisition session), 3-month retention session, 6-month retention session.
|
|
Leg Muscle Reaction Time
Time Frame: Baseline (acquisition session), 3-month retention session, 6-month retention session.
|
The reaction times will be determined as the duration from the perturbation onset to the instant when the respective muscle is activated.
|
Baseline (acquisition session), 3-month retention session, 6-month retention session.
|
|
Recovery Step Length
Time Frame: Baseline (acquisition session), 3-month retention session, 6-month retention session.
|
Recovery step length will be calculated as the distance between the heels at recovery foot touchdown and normalized to body height.
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Baseline (acquisition session), 3-month retention session, 6-month retention session.
|
|
Prospective Real-Life Falls and Near Falls
Time Frame: 6 month period after the acquisition session
|
Both groups will report their fall or near-fall incidents through an online survey weekly.
|
6 month period after the acquisition session
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Yang F, Bhatt T, Pai YC. Generalization of treadmill-slip training to prevent a fall following a sudden (novel) slip in over-ground walking. J Biomech. 2013 Jan 4;46(1):63-9. doi: 10.1016/j.jbiomech.2012.10.002. Epub 2012 Nov 8.
- Yang F, Pai YC. Automatic recognition of falls in gait-slip training: Harness load cell based criteria. J Biomech. 2011 Aug 11;44(12):2243-9. doi: 10.1016/j.jbiomech.2011.05.039. Epub 2011 Jun 21.
- Yang F, Su X, Wen PS, Lazarus J. Adaptation to repeated gait-slip perturbations among individuals with multiple sclerosis. Mult Scler Relat Disord. 2019 Oct;35:135-141. doi: 10.1016/j.msard.2019.07.019. Epub 2019 Jul 23.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H25443
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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