NCT06430164

AB Gait Estim Neurophysiology

Effects of Gait Training Strategies and Noninvasive Stimulation on Neurophysiology and Walking Performance in Able-Bodied Adults- A Preliminary Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is being done to answer the question: What are the effects of electrical stimulation and stepping practice on connections between the brain and muscles? The long-term goal of this project is to develop novel, effective, and personalized rehabilitation protocols founded on an understanding of neurobiological mechanisms that combine electrical stimulation with gait training to improve gait performance in older adults and stroke survivors. The rationale of this project is to explore and generate preliminary data regarding how electrical stimulation-based strategies modulate cortical and spinal circuits in able-bodied individuals. The researchers will evaluate the effects of short treadmill walking bouts or single gait training sessions with and without electrical stimulation on somatosensory, spinal-reflex, corticospinal circuit neurophysiology, and/or gait performance. The study will provide important preliminary and normative data that can explain how brain circuits change with stimulation or stepping practice and inform future rehabilitation studies on patients. The study population is able-bodied individuals.

Detailed description

This study is being done to determine the effects of electrical stimulation and walking practice on connections between the brain and muscles. This study consists of 1-5 study visits lasting up to 5 hours each. Participants will complete stepping training with or without electrical stimulation delivered to their leg muscles; noninvasive stimulation will be delivered to the participants' brain or nerves in the leg to measure the strength of connections within their brain and between their brain / spinal cord and their muscles. The number of sessions for each participant will depend on whether the same participant completes only 1 or more than 1 study aim.

Conditions

• Gait

Interventions

Type	Name	Description
OTHER	Gait Training	Gait training: One or multiple short bouts of stepping practice on a treadmill at self-selected or fast speeds will be delivered without FES.
DEVICE	Functional electrical stimulation (FES)	Electrical stimulation involving the parameters and settings proposed here is commonly used in clinical practice and research for pain relief and other applications also referred to as neuromuscular or transcutaneous electrical nerve stimulation. The FES will be delivered using the UDel Stimulator, a custom-designed FES system from the University of Delaware FES lab. Researchers will use a customized, real-time system to control the stimulator and deliver stimulation during appropriate phases of the gait cycle. Stimulation will be delivered to the ankle dorsiflexors when the subject's foot is in the air (swing phase). Stimulation will be delivered to the ankle plantarflexors during the terminal stance phase of gait. 30-Hz variable frequency stimulation trains will be delivered during gait.
DEVICE	Peripheral electrical stimulation paired with cortical magnetic stimulation pulses	The paired associative stimulation (PAS) will be conducted in a static posture (seated or standing), to evaluate effects on somatosensory, spinal-reflex, and/or corticospinal neurophysiology delivered with different stimulation parameters. One or multiple short bouts of stepping practice on a treadmill at self-selected or fast speeds may be completed before and/or after PAS to evaluate gait performance

Timeline

• Start date: 2024-02-12
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-05-28
• Last updated: 2025-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study