Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Functional Electrical Stimulation, Normal care.
- Who it may be relevant to
- Registry conditions: Stroke, Traumatic Brain Injury, Multiple Sclerosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis Before and After Functional Electrical Stimulation
Overview
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.
Detailed 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.
Interventions
- Device Functional Electrical Stimulation
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 - Device Normal care
No device, no FES
Primary outcome measures
- Changes in gait speed [Time frame: From enrollment to the end of treatment at 12 weeks]
Secondary outcome measures (2)
- Timed Up and Go [Time frame: Baseline and 12-week Follow-Up]
- 10-Meter Walk Test [Time frame: Baseline and 12-Week Follow-Up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Casa Colina Hospital and Centers for Healthcare — Pomona
Identifiers
NCT: NCT07492602 · GAIT2026