Clinical trial NCT06919900: Motor Learning of Fall Resistant Skills Through Slip and Trip Exposure in Multiple Sclerosis
Official title: Motor Learning of Fall Resistant Skills Through Slip and Trip Exposure in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis (Relapsing Remitting)
Keywords: Falls
Fall prevention
Slips
Trips
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2025-04-09
Enrollment: 64
Sex: ALL
Minimum age (years): 45
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this interventional study is to examine the overall motor learning capacity from exposure to repeated perturbations among ambulatory people with multiple sclerosis (MS). 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Clinically confirmed multiple sclerosis
2. At least 45 years old
3. Able to walk independently at least 25 feet
4. Able to stand independently for at least 30 seconds
5. Patient Determined Disability Steps score between 0 and 4
6. Free from pregnancy
7. Montreal Cognitive Assessment score of 23 or higher

Exclusion Criteria:

1. Previous experience with perturbation training
2. T-score from the dual x-ray absorptiometry (DXA) scan of less than -2.5
3. Coexisting psychiatric disorders or other neurological conditions, severe medical illness, or cardiovascular diseases
4. Participants have had a relapse in the past 8 weeks

Primary outcomes:
measure: Perturbation Outcome (Fall or Non-Fall) on the Treadmill or Overground
timeFrame: Baseline (acquisition session), 3-month retention session, 6-month retention session.
Secondary outcomes:
measure: Dynamic Gait Stability as defined by the Feasible Stability Region (FSR) Theory
timeFrame: Baseline (acquisition session), 3-month retention session, 6-month retention session.
measure: Leg Muscle Reaction Time
timeFrame: Baseline (acquisition session), 3-month retention session, 6-month retention session.
measure: Recovery Step Length
timeFrame: Baseline (acquisition session), 3-month retention session, 6-month retention session.
measure: Prospective Real-Life Falls and Near Falls
timeFrame: 6 month period after the acquisition session
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University Biomechanics Lab
state: Georgia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.