Motor Learning of Fall Resistant Skills Through Slip and Trip Exposure in Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-89
SponsorGeorgia State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Perturbation Training
BehavioralUnexpected slips blended with trips and unperturbed walking trials on a treadmill. A safety harness will be worn at all times.
Treadmill Walking
BehavioralTreadmill walking for the same amount of time as the training group without perturbation. A safety harness will be worn at all times.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Training GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (acquisition session), 3-month retention session, 6-month retention session.Secondary outcomes
1
Dynamic Gait Stability as defined by the Feasible Stability Region (FSR) Theory
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.
Time frame
Baseline (acquisition session), 3-month retention session, 6-month retention session.2
Leg Muscle Reaction Time
The reaction times will be determined as the duration from the perturbation onset to the instant when the respective muscle is activated.
Time frame
Baseline (acquisition session), 3-month retention session, 6-month retention session.3
Recovery Step Length
Recovery step length will be calculated as the distance between the heels at recovery foot touchdown and normalized to body height.
Time frame
Baseline (acquisition session), 3-month retention session, 6-month retention session.4
Prospective Real-Life Falls and Near Falls
Both groups will report their fall or near-fall incidents through an online survey weekly.
Time frame
6 month period after the acquisition sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Georgia State University
Lead sponsor
National Multiple Sclerosis Society
Collaborator
Source ClinicalTrials.gov