Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis Before and After Functional Electrical Stimulation
New study tests electrical stimulation to improve walking in stroke, TBI, MS patients
Plain English Summary
Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis is a Not Applicable clinical trial sponsored by Casa Colina Hospital and Centers for Healthcare studying Stroke, Traumatic Brain Injury, Multiple Sclerosis. This study tests if a device called Functional Electrical Stimulation (FES) can help people with stroke, traumatic brain injury, or multiple sclerosis walk better. It is for adults aged 18-80 who have been diagnosed with stroke, TBI, or MS and have difficulty lifting their foot when walking. Participants will use the L300 FES device for 12 weeks and have their walking measured before and after. The alternative is standard care without the FES device. The trial aims to enroll 90 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18-80 years old and have a confirmed diagnosis of stroke, traumatic brain injury, or multiple sclerosis. You must have trouble lifting your foot while walking and be able to walk at least 10 meters. You cannot join if you have severe leg stiffness, certain implanted devices like pacemakers, uncontrolled serious health issues, or are pregnant. This trial is studying Stroke, Traumatic Brain Injury, Multiple Sclerosis, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how much participants' walking speed changes after using the electrical stimulation device, indicating if it makes them walk faster. The specific primary outcome measures are: Changes in gait speed (From enrollment to the end of treatment at 12 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to improve walking for people with neurological conditions, addressing a common challenge like foot drop and potentially leading to more personalized treatment. This research targets Stroke, Traumatic Brain Injury, Multiple Sclerosis, where improved treatment options are needed.
Investor Insight
This trial explores a non-invasive device for a large patient population with gait impairments, potentially offering a new treatment option and signaling interest in innovative rehabilitation technolo
Is This Trial Right for Me?
Ask your doctor if this FES device is right for you and what potential risks are involved. Participation involves using the L300 device for 12 weeks, with regular visits to measure your walking. You will be randomly assigned to either use the device or receive normal care. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 90 participants
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 Outcomes
- Changes in gait speed (From enrollment to the end of treatment at 12 weeks)
Secondary Outcomes
- Timed Up and Go (Baseline and 12-week Follow-Up)
- 10-Meter Walk Test (Baseline and 12-Week Follow-Up)
Trial Locations
- Casa Colina Hospital and Centers for Healthcare, Pomona, California, United States
Frequently Asked Questions
What is clinical trial NCT07492602?
NCT07492602 is a Not Applicable INTERVENTIONAL study titled "Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis." It is currently not yet recruiting and is sponsored by Casa Colina Hospital and Centers for Healthcare. The trial targets enrollment of 90 participants.
What conditions does NCT07492602 study?
This trial investigates treatments for Stroke, Traumatic Brain Injury, Multiple Sclerosis. The primary condition under study is Stroke.
What treatments are being tested in NCT07492602?
The interventions being studied include: Functional Electrical Stimulation (DEVICE), Normal care (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
What does Not Applicable mean for NCT07492602?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07492602?
This trial is currently "Not Yet Recruiting." It started on 2026-04-01. The estimated completion date is 2027-02-01.
Who is sponsoring NCT07492602?
NCT07492602 is sponsored by Casa Colina Hospital and Centers for Healthcare. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07492602?
The trial aims to enroll 90 participants. The trial has not yet started recruiting.
How is NCT07492602 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07492602?
The primary outcome measures are: Changes in gait speed (From enrollment to the end of treatment at 12 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07492602 being conducted?
This trial is being conducted at 1 site, including Pomona, California (United States).
Where can I find official information about NCT07492602?
The official record for NCT07492602 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07492602. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07492602 testing in simple terms?
This study tests if a device called Functional Electrical Stimulation (FES) can help people with stroke, traumatic brain injury, or multiple sclerosis walk better. It is for adults aged 18-80 who have been diagnosed with stroke, TBI, or MS and have difficulty lifting their foot when walking.
Why is this trial significant?
This trial matters because it aims to improve walking for people with neurological conditions, addressing a common challenge like foot drop and potentially leading to more personalized treatment.
What are the potential risks of participating in NCT07492602?
The most common side effects of FES can include skin irritation where the electrodes are placed. There is a small risk of muscle discomfort or pain during stimulation. Individuals with certain implanted electronic devices may not be able to participate due to potential interference. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07492602?
Ask your doctor if this FES device is right for you and what potential risks are involved. Participation involves using the L300 device for 12 weeks, with regular visits to measure your walking. You will be randomly assigned to either use the device or receive normal care. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07492602 signal from an investment perspective?
This trial explores a non-invasive device for a large patient population with gait impairments, potentially offering a new treatment option and signaling interest in innovative rehabilitation technolo This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will use the L300 FES device for 12 weeks and have their walking measured before and after. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.