StrokeNCT07492602
Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis
A study testing Functional Electrical Stimulation and Normal care in people with Stroke and Traumatic Brain Injury, run by Casa Colina Hospital and Centers for Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Traumatic Brain Injury, Multiple Sclerosis
- What is being tested?
- Functional Electrical Stimulation and Normal care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Casa Colina Hospital and Centers for Healthcare
Pomona, California, 91767
About this study
Official title: Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis Before and After Functional Electrical Stimulation
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.
Read the 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.
- Conditions
- Stroke, Traumatic Brain Injury, Multiple Sclerosis
- Being tested
- Functional Electrical Stimulation, Normal care
- Keywords
- FES, Gait, Stroke, TBI, MS
- Medical subject headings
- Stroke, Brain Injuries, Traumatic, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical StimulationDevice
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 careDevice
No device, no FES
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Functional Electrical Stimulation; Device: Normal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gait speed
Measuring changes in gait speed
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (2)
Timed Up and Go
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.
Measured: Baseline and 12-week Follow-Up
10-Meter Walk Test
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.
Measured: Baseline and 12-Week Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa Colina Hospital and Centers for Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Rosario, Casa Colina Hospital and Centers for Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492602
- Sponsor's protocol ID
- GAIT2026
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis Before and After Functional Electrical Stimulation
- ClinicalTrials.gov ID
- NCT07492602
- Acronym / sponsor ID
- GAIT2026
- Conditions
- Stroke, Traumatic Brain Injury, Multiple Sclerosis
- Keywords
- FES, Gait, Stroke, TBI, MS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Casa Colina Hospital and Centers for HealthcareUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES | Experimental | Device: Functional Electrical StimulationParticipants 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. |
| FES - RCT | Experimental | Device: Functional Electrical Stimulation, Device: Normal careA 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Electrical StimulationFunctional 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. | Device | FES, FES - RCT |
| Normal careNo device, no FES | Device | FES - RCT |
Primary outcome
Changes in gait speed
Time frame: From enrollment to the end of treatment at 12 weeks
Measuring changes in gait speed
2 secondary outcomes
Timed Up and Go
Time frame: Baseline and 12-week Follow-Up
10-Meter Walk Test
Time frame: Baseline and 12-Week Follow-Up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation and Normal care in people with Stroke and Traumatic Brain Injury, run by Casa Colina Hospital and Centers for Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Rosario, PhD (909-596-7733 ext. 3036, erosario@casacolina.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gait speed (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.