Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:20 PM
Study NCT ID:
NCT07492602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis
Sponsor:
Casa Colina Hospital and Centers for Healthcare
Organization:
Study Overview
Official Title:
Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis Before and After Functional Electrical Stimulation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People with neurological conditions often have difficulty walking, including problems such as foot drop. Functional electrical stimulation (FES) is a treatment that uses electrical signals to activate muscles and support walking. The L300 device is designed to help lift the foot during each step.
This study will evaluate how using the L300 affects walking performance. Researchers will measure walking speed, step length, and walking symmetry using objective gait assessment tools. The study will also explore whether people with different neurological conditions respond differently to FES.
The goal of this research is to improve understanding of how FES influences walking and to support more personalized rehabilitation approaches.
This study will evaluate how using the L300 affects walking performance. Researchers will measure walking speed, step length, and walking symmetry using objective gait assessment tools. The study will also explore whether people with different neurological conditions respond differently to FES.
The goal of this research is to improve understanding of how FES influences walking and to support more personalized rehabilitation approaches.
Detailed Description:
Functional Electrical Stimulation (FES) is an established therapeutic approach that applies electrical currents to peripheral nerves to elicit muscle contractions, thereby facilitating movement in individuals with neurological impairments. FES has demonstrated benefits for improving motor function and gait in populations such as stroke survivors, individuals with spinal cord injury, and those with multiple sclerosis. By activating muscles during walking, FES can enhance gait parameters including speed, stride length, and symmetry, ultimately supporting greater independence and mobility.
Despite these documented benefits, comparative data across neurological conditions remain limited, and the degree to which FES influences specific gait metrics is not fully understood. Furthermore, most prior studies have relied on basic clinical assessments, which may not capture the nuanced changes in gait mechanics that occur with FES intervention.
The L300 system is a widely used FES device designed to address foot drop by stimulating the peroneal nerve to facilitate ankle dorsiflexion during the swing phase of gait. This targeted approach can improve walking efficiency and reduce compensatory movements. However, the integration of advanced gait analysis technologies-such as wearable sensors and instrumented walkways-offers an opportunity to obtain objective, high-resolution data on spatiotemporal and kinematic parameters. These tools enable a more comprehensive evaluation of gait before and after FES intervention, providing insights into both functional outcomes and underlying biomechanical changes.
Despite these documented benefits, comparative data across neurological conditions remain limited, and the degree to which FES influences specific gait metrics is not fully understood. Furthermore, most prior studies have relied on basic clinical assessments, which may not capture the nuanced changes in gait mechanics that occur with FES intervention.
The L300 system is a widely used FES device designed to address foot drop by stimulating the peroneal nerve to facilitate ankle dorsiflexion during the swing phase of gait. This targeted approach can improve walking efficiency and reduce compensatory movements. However, the integration of advanced gait analysis technologies-such as wearable sensors and instrumented walkways-offers an opportunity to obtain objective, high-resolution data on spatiotemporal and kinematic parameters. These tools enable a more comprehensive evaluation of gait before and after FES intervention, providing insights into both functional outcomes and underlying biomechanical changes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: