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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FES | Experimental | Participants will undergo a single supervised session involving:
This component will establish feasibility and inform protocol refinements for the randomized controlled trial. |
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| FES - RCT | Experimental | A prospective, randomized, controlled trial will be conducted with N = 90 participants, stratified into three diagnostic groups (30 per group):
Procedures:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Electrical Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gait speed | Measuring changes in gait speed | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go | The Timed Up and Go test measures basic mobility and balance. Participants start seated in a chair, stand up, walk a short distance (3 meters), turn around, walk back to the chair, and sit down. The time it takes to complete the task is recorded in seconds. Shorter times indicate better mobility and functional walking ability. | Baseline and 12-week Follow-Up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Rosario, PhD | Contact | 909-596-7733 | 3036 | erosario@casacolina.org |
| Dan Humphrey, PT, DPT, NCS | Contact | 909-596-7733 | 3500 | dhumphrey@casacolina.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casa Colina Hospital and Centers for Healthcare | Pomona | California | 91767 | United States |
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| Normal care | Device | No device, no FES |
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| 10-Meter Walk Test | The 10-Meter Walk Test measures walking speed over a short distance. Participants are asked to walk 10 meters at their normal walking pace. The time to walk the distance is recorded and used to calculate walking speed. Faster walking speeds indicate better walking ability. | Baseline and 12-Week Follow-Up |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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