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

Part of paid clinical trials in Pomona, California.

Sponsor
Casa Colina Hospital and Centers for Healthcare
Study ID
NCT07492602
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • Normal care — DEVICE
    No device, no FES

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FES
    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.
  • Experimental: FES - RCT
    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.

Primary Outcome Measure

Changes in gait speed [ Time Frame: From enrollment to the end of treatment at 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Casa Colina Hospital and Centers for HealthcarePomonaCalifornia91767-

Find similar trials in Pomona, CA

By condition
Multiple sclerosisStroke
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Casa Colina Hospital and Centers for Healthcare· Pomona, CA

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