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NCT Number: NCT07492602

Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18-80 years.
  • Diagnosis of stroke, traumatic brain injury, or multiple sclerosis confirmed by medical records.
  • Presence of foot drop or impaired ankle dorsiflexion during gait.
  • Ability to ambulate at least 10 meters with or without assistive devices.
  • Cognitive ability to follow simple instructions and provide informed consent.

Exclusion criteria

  • Severe lower limb contractures or orthopedic conditions that limit gait.
  • Implanted electrical devices (e.g., pacemaker) contraindicating FES use.
  • Uncontrolled medical conditions (e.g., severe cardiac disease).
  • Pregnancy.
  • Skin integrity issues preventing electrode placement.
  • Participation in other interventional gait studies within the past 3 months.

Treatment and study plan

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.

Normal care

Device

No device, no FES

Primary outcomes

  1. Changes in gait speed

    Time frame: From enrollment to the end of treatment at 12 weeks

    Measuring changes in gait speed

Secondary outcomes

  1. Timed Up and Go

    Time frame: Baseline and 12-week Follow-Up

    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.

  2. 10-Meter Walk Test

    Time frame: Baseline and 12-Week Follow-Up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Humphrey, PT, DPT, NCS

CONTACT

[email protected]

909-596-7733 ext. 3500

Emily Rosario, PhD

CONTACT

[email protected]

909-596-7733 ext. 3036

Sponsors and collaborators

Lead sponsor

Casa Colina Hospital and Centers for Healthcare

Other

Registry information

Official study title

Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis Before and After Functional Electrical Stimulation

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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