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BCI-FES Therapy for Stroke Rehabilitation
Study Summary
This trial is testing whether BCI-FES systems can improve foot movement and walking ability in people who have had a stroke.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have been diagnosed with severe depression.I have had a stroke or brain tumor in the past.I can walk more than 10 meters, even if I need a cane, walker, or AFO.I experience significant pain, chest pain, or shortness of breath when walking.I do not have a major medical condition that could stop me from safely completing the study.I have had a new stroke during the screening process.I do not have any major health issues affecting my ability to walk.You have trouble with thinking and memory, as shown by a test score below 22.I am unable or unwilling to follow the study's required procedures or treatments.I can move my ankle upwards to a flat position without help.I have had or plan to have Botox in my legs within the next 6 months.I am not taking medications like antidepressants that can affect seizure risk.You have a pacemaker or metal implant in your skull.You are not expected to live for more than 6 months.I have skin damage where electrical treatments were applied.I use a FES device to help me walk.Your blood pressure is very high when measured while you are resting.I have migraines that aren't controlled by my current treatment.I am between 18 and 80 years old.I have been diagnosed with seizures or epilepsy before.I can handle electrical stimulation with minimal pain and my foot lifts properly.I walk slower than 0.8 meters per second.Your foot muscles are not very stiff, scoring less than 3 on a muscle stiffness scale.I am not getting any leg physical therapy during or up to 1 month after the study.I had a stroke confirmed by imaging at least 26 weeks ago.My health conditions are stable.You have metal implants in your head, like clips or mesh.I have foot-drop in my limb, with limited movement.You have implanted medication pumps, a line inside your heart, or a catheter in a large vein.You have trouble communicating or paying attention, which makes it hard for you to take part in the study.I have had brain surgery in the past.
- Group 1: BCI-FES dorsiflexion therapy with physiotherapy
- Group 2: Dose-and intensity-matched physiotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this trial open to individuals who are of advanced age?
"The requirements for being eligible to participate in this trial stipulate that suitable candidates must be between 18 and 80 years of age. There are 40 studies looking at minors, while 1058 focus on those over 65."
Are there currently any enrollment openings for this clinical experiment?
"Yes, the clinicaltrials.gov website affirms that this medical study is in the process of recruiting participants. The first recruitment post was published on May 15th 2020 and has been updated as recently as September 15th 2022; it seeks to enrol 80 patients from a single centre."
What is the projected sample size of participants for this clinical trial?
"Affirmative. The clinical trial listing hosted on clinicaltrials.gov indicates that the study is actively seeking participants, with 80 individuals required at a single site since it was posted on May 15th 2020 and updated most recently in September 2022."
Are my qualifications sufficient to participate in this investigation?
"Participants aged 18 to 80 with a recent wake-up stroke are being recruited for this clinical trial. This research is seeking out individuals who have radiologically confirmed strokes, spasticity scores of less than three on the modified Ashworth Scale, pain tolerance no greater than four on an analog scale, adequate muscle response in dorsiflexion of at least 10 degrees or more and passive range of motion (PROM) at 0 degrees or higher in subtalar neutral when using FES technology. Additionally all participants must be able to walk over 10m without ankle foot orthosis (AFO), canes and/or walkers permitted but"
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