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

NCT07492602 | Not Yet Recruiting FDA Device

• 1 other identifier: GAIT2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Traumatic Brain Injury; Multiple Sclerosis

Keywords

FES; Gait; Stroke; TBI; MS

Outcome Measures

Primary Outcomes (1)

• Changes in gait speed

  Measuring changes in gait speed

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (2)

• Timed Up and Go

  Baseline and 12-week Follow-Up

• 10-Meter Walk Test

  Baseline and 12-Week Follow-Up

Study Arms (2)

FES

EXPERIMENTAL

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.

Device: Functional Electrical Stimulation

FES - RCT

EXPERIMENTAL

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.

Device: Functional Electrical Stimulation; Device: Normal care

Interventions

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.

FES; FES - RCT

Normal care DEVICE

No device, no FES

FES - RCT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Casa Colina Hospital and Centers for Healthcare: lead

Study Sites (1)

Casa Colina Hospital and Centers for Healthcare

Pomona, California, 91767, United States

Location

MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Emily Rosario, PhD

CONTACT

909-596-7733; erosario@casacolina.org

Dan Humphrey, PT, DPT, NCS

CONTACT

909-596-7733; dhumphrey@casacolina.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director, Casa Colina Research Institute

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 25, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)