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

Casa Colina Hospital and Centers for Healthcare

Status: Not yet enrolling

Conditions: Traumatic Brain Injury; Stroke; Multiple Sclerosis

Treatments: Device: Functional Electrical Stimulation; Device: Normal care

Study type: Interventional

Funder types: Other

Identifiers

NCT07492602

GAIT2026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

FES

Experimental group

Description:

Participants will undergo a single supervised session involving: 1. Baseline gait assessment using the Baliston Health Gait System and the OneStep Gait Measurement Application. 2. FES intervention with the L300 system (e.g., Bioness L300 Go), titrated to individual needs to facilitate ankle dorsiflexion. 3. Immediate post-intervention gait assessment to evaluate changes in gait parameters with the L300. This component will establish feasibility and inform protocol refinements for the randomized controlled trial.

Treatment:

Device: Functional Electrical Stimulation

FES - RCT

Experimental group

Description:

A prospective, randomized, controlled trial will be conducted with N = 90 participants, stratified into three diagnostic groups (30 per group): * Group 1: Stroke * Group 2: Traumatic Brain Injury * Group 3: Multiple Sclerosis (or other specified neurological condition) Procedures: * Baseline Assessment: Comprehensive gait evaluation using Baliston Health and OneStep systems. * Intervention: Participants will receive FES via the L300 Go device during supervised sessions over 4 weeks. Stimulation parameters will be individualized and adjusted to optimize gait performance. Gait will be assessed each week for the 4 weeks. * Post-Intervention Assessment: Repeat gait evaluation immediately following the intervention period. * Follow-Up: A 12-week post-intervention assessment will be conducted to evaluate retention of gait improvements.

Treatment:

Device: Normal care

Device: Functional Electrical Stimulation