Motor Learning of Fall Resistant Skills Through Slip and Trip Exposure in Multiple Sclerosis

NCT ID: NCT06919900

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-12-31

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.

Conditions

Multiple Sclerosis (Relapsing Remitting)

Keywords

Falls; Fall prevention; Slips; Trips

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Perturbation Training

Intervention Type: BEHAVIORAL

Unexpected slips blended with trips and unperturbed walking trials on a treadmill. A safety harness will be worn at all times.

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.

Group Type: ACTIVE_COMPARATOR

Treadmill Walking

Intervention Type: BEHAVIORAL

Treadmill walking for the same amount of time as the training group without perturbation. A safety harness will be worn at all times.

Interventions

Perturbation Training

Unexpected slips blended with trips and unperturbed walking trials on a treadmill. A safety harness will be worn at all times.

Intervention Type: BEHAVIORAL

Treadmill Walking

Treadmill walking for the same amount of time as the training group without perturbation. A safety harness will be worn at all times.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

Georgia State University

OTHER

Sponsor Role: lead

Responsible Party

Feng Yang, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Georgia State University Biomechanics Lab

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Feng Yang, Ph.D.

Role: CONTACT

Phone: 404-413-8357

Email: fyang@gsu.edu

Facility Contacts

Feng Yang, PhD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 21696744 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23141636 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31376685 (View on PubMed)

Other Identifiers

H25443

Identifier Type: -

Identifier Source: org_study_id