The Neural Mechanisms of Split-belt Treadmill Adaptation in People With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: Split-belt TreadmillDevice: Transcutaneous Electrical Nerve Stimulation (TENS)
- Registration Number
- NCT05878873
- Lead Sponsor
- Colorado State University
- Brief Summary
Majority of people with multiple sclerosis experience difficulty with balance and mobility, leading to an increased risk of falls. The goal of this clinical trial is to learn about brain activity during walking adaptation in people with multiple sclerosis. Also, this clinical trial will test a form of nerve stimulation to see if it can improve walking performance.
The main questions it aims to answer are:
* What areas of the brain are the most active during walking adaptation?
* Can nerve stimulation make walking adaptation more effective?
Participants will walk on a treadmill where each leg will go a different speed which will create walking adaptation. At the same time, brain scans will occur. There will be two sessions of walking adaptation, one with nerve stimulation, and one without nerve stimulation. Researchers will compare people with multiple sclerosis to healthy young adults to see if there are differences in brain activity.
- Detailed Description
Most people with MS (PwMS) experience significant gait asymmetries between the two legs leading to an increased risk of falls and musculoskeletal injury. The objective of this study is to investigate the neural mechanisms of gait adaptation and the effects of transcutaneous electrical nerve stimulation (TENS) on adaptability during split-belt treadmill training in PwMS. Our hypothesis is that TENS will strengthen sensorimotor integration via amplified afferent signaling, thereby enhancing adaptation, and further improving gait symmetry chronically. Functional near-infrared spectroscopy (fNIRS) will be used during a split-belt treadmill training paradigm to assess cortical activation during gait adaptation. Additionally, the effect of split-belt treadmill training coupled with TENS on gait adaptability in PwMS will be tested with experimental and a sham TENS split-belt treadmill sessions. Cortical activation and the effect of TENS on gait adaptability will be compared between young neurotypical adults and PwMS to assess differences that can be attributed to multiple sclerosis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- A diagnosis of relapsing remitting multiple sclerosis OR a neurotypical adult (ages 18-86)
- Not experiencing an active relapse
- Able to stand and walk without an assistive device
- Able to walk for three tenths of a mile without stopping to rest
- Unable to walk for three tenths of a mile without assistance
- Musculoskeletal injury in past 6 months
- Lower extremity surgery in past 6 months
- Unable to abstain from medications that impair balance
- Currently pregnant
- History of traumatic brain injury
- History of vestibular disease
- History of any other balance impairment unrelated to multiple sclerosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Split-belt Treadmill Training without TENS Split-belt Treadmill During this arm, participants will perform split-belt treadmill training with sensory stimulation equipment outfitted but not active during all adaptation sessions. Split-belt Treadmill Training with TENS Transcutaneous Electrical Nerve Stimulation (TENS) During this arm, participants will perform split-belt treadmill training with active sensory stimulation occuring simultaneously during all adaptation sessions. Split-belt Treadmill Training with TENS Split-belt Treadmill During this arm, participants will perform split-belt treadmill training with active sensory stimulation occuring simultaneously during all adaptation sessions.
- Primary Outcome Measures
Name Time Method Change in Cortical Hemodynamics Baseline session 1 (day 1), training session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), training session 2, and post-training session 2 (day 14) The changes of oxygenated hemoglobin in the cortex, a proxy for neuronal activity.
Change in Step Length Asymmetry Baseline session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), and post-training session 2 (day 14) The difference in the distance covered by each step, a common measure of gait asymmetry, measured using three-dimensional motion capture and force plates.
Rate of Step Length Asymmetry Adaptation Adaptation session 1 (day 1), and adaptation session 2 (day 14) The number of steps that it takes to reach steady state walking from when the adaptation period begins
- Secondary Outcome Measures
Name Time Method Change in Double Support Percent Baseline session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), and post-training session 2 (day 14) The percentage of time spent with both feet on the ground during walking, measured using three-dimensional motion capture and force plates.
Change in Phase Coordination Index Baseline session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), and post-training session 2 (day 14) The accuracy and consistency of step time compared to stride time, measured using three-dimensional motion capture and force plates.
Trial Locations
- Locations (1)
The Sensorimotor Neuroimaging Laboratory
🇺🇸Fort Collins, Colorado, United States