The Neural Mechanisms of Split-belt Treadmill Adaptation in People With Multiple Sclerosis
Part of paid clinical trials in Fort Collins, Colorado.
- Sponsor
- Colorado State University
- Study ID
- NCT05878873
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 86 Years
- Healthy Volunteers
- Accepted
Interventions
- Split-belt Treadmill — BEHAVIORALSplit-belt treadmill training, where the speed of each leg is controlled independently has been shown to create gait adaptation where the coordination of each leg is altered, creating improved gait symmetry for people with walking impairments.
- Transcutaneous Electrical Nerve Stimulation (TENS) — DEVICETENS is a form of nerve stimulation that stimulates at a frequency below motor threshold, targeting activation of sensory receptors, such as muscle spindles. Electrodes that create this stimulation will be placed on the skin superficial to the muscle bellies of the tibialis anterior and rectus femoris.
Study Details
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.
Key Dates
- Start date
- Nov 28, 2023
- Status verified
- Jun 2025
- Primary completion
- Jun 30, 2024
- Completion
- Jun 30, 2024
Study Design
- Enrollment
- 51 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Sham Comparator: Split-belt Treadmill Training without TENSDuring this arm, participants will perform split-belt treadmill training with sensory stimulation equipment outfitted but not active during all adaptation sessions.
- Experimental: Split-belt Treadmill Training with TENSDuring this arm, participants will perform split-belt treadmill training with active sensory stimulation occuring simultaneously during all adaptation sessions.
Primary Outcome Measure
Change in Cortical Activation [ Time Frame: Training session 1 (day 1), training session 2 (day 28) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Sensorimotor Neuroimaging Laboratory | Fort Collins | Colorado | 80523 | - |
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