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

NCT06919900 | Recruiting

• 1 other identifier: H25443
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis (Relapsing Remitting)

Keywords

Falls; Fall prevention; Slips; Trips

Outcome Measures

Primary Outcomes (1)

• Perturbation Outcome (Fall or Non-Fall) on the Treadmill or Overground

  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 Outcomes (4)

• Dynamic Gait Stability as defined by the Feasible Stability Region (FSR) Theory

  Baseline (acquisition session), 3-month retention session, 6-month retention session.

• Leg Muscle Reaction Time

  Baseline (acquisition session), 3-month retention session, 6-month retention session.

• Recovery Step Length

  Baseline (acquisition session), 3-month retention session, 6-month retention session.

• Prospective Real-Life Falls and Near Falls

  6 month period after the acquisition session

Study Arms (2)

Training Group

EXPERIMENTAL

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.

Behavioral: Perturbation Training

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Treadmill Walking

Interventions

Perturbation Training BEHAVIORAL

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

Training Group

Treadmill Walking BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 45 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgia State University: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Georgia State University Biomechanics Lab

Atlanta, Georgia, 30303, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 21696744 BACKGROUND

• 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.

  PMID: 23141636 BACKGROUND

• 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.

  PMID: 31376685 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Feng Yang, Ph.D.

CONTACT

404-413-8357; fyang@gsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both the participants and outcome assessors will be blinded to each participant's group assignment. However, the researchers who conduct the training will not be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)