Brain-Based biofeedback could rewire walking after stroke
NCT ID NCT06099444
First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time
Summary
This study compares standard high-intensity gait training and gait training with electrical stimulation against a new approach that uses real-time feedback on how muscles work together (muscle synergies). The goal is to see if this biofeedback method helps people with chronic stroke walk more naturally. Participants will undergo 18 treadmill sessions, and researchers will measure changes in muscle coordination and walking speed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- high-intensity gait training with functional electrical stimulation and muscle synergy biofeedback
- What this could lead to
- If successful, this approach could offer a more effective way to restore natural walking patterns in people with chronic stroke.
- What could go wrong
- This is an early-stage study with a moderate sample size, and the benefits of the novel biofeedback method may not exceed those of existing gait training.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Healthy participants: Inclusion Criteria: * Age 18-80 years, inclusive * Normal hearing and vision, can be corrected * Able to understand and give informed consent * Able to understand and speak English Exclusion Criteria: * Reduced cognitive function or inability to perform study tasks * Any neurological disorder or history of neurological injuries (e.g., Parkinson's disease or other neurodegenerative disorder, dementia, brain injury, spinal cord injury, multiple sclerosis, peripheral nerve injury, or cancer of the central nervous system) * Presence of pathology that could cause abnormal movements of extremities (e.g., epilepsy, marked arthritis, chronic pain, musculoskeletal injuries) * Recent fracture or osteoporosis (as reported by subject) * Lesions or wounds on the legs * Medical (cardiac, renal, hepatic, or oncological) or psychiatric disease that would interfere with study procedures * Pregnancy * Prisoners Patients: Inclusion Criteria: * Age 18-80 years, inclusive * Normal hearing and vision, can be corrected * History of a single unilateral, supratentorial ischemic or hemorrhagic stroke at least six months prior * Reduced ambulation but able to walk \>10m independently on level ground (with assistive device if needed) * Medical clearance from medical team (signed Medical Clearance form) * Able to understand and give informed consent * Able to understand and speak English * Able to passively move all joints (i.e., hip, knee, ankle) through the range of motion of a typical gait cycle Exclusion Criteria: * Reduced cognitive function and inability to perform study tasks * Severe aphasia * Co-existence of other neurological diseases (e.g., Parkinson's disease or other neurodegenerative disorder, dementia, brain injury, spinal cord injury, multiple sclerosis, or cancer of the central nervous system) * History of peripheral nerve injury * Severe hip, knee, or ankle arthritis * Recent fracture or osteoporosis (as reported by subject) * Medical (cardiac, renal, hepatic, or oncological) or psychiatric disease that would interfere with study procedures * Significant spasticity or contracture in the lower limbs (Modified Ashworth Scale score of 3 or higher) * Use of pacemakers, defibrillators, electrical implants, or metallic implants * Lesions or wounds on the paretic leg * Botox (botulinum toxin) injection to lower limbs within the prior 3 months, or planned injection during study period * Pregnancy * Prisoners * Concurrent or planned participation in surgeries, significant medical treatments, other lower limb research studies, or physical therapy during the study timeline Therapists: Inclusion Criteria: * Licensed physical therapist at SRALab * At least 1 year of experience as a physical therapist * Regularly treats people with stroke, at minimum once per week * Able to give informed consent * Active CITI training certification, or willing to complete this online CITI training Exclusion Criteria: * Inability to interact safety with the technologies * Unwillingness to try to use the technologies * Unable to complete at least 1 competency session and deliver at least 6 intervention sessions
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Effects of transcranial direct current stimulation and pelvic proprioceptive neuromuscular facilitation on trunk control, balance and functional mobility in stroke patients
- Correlation of visual and motor deficits in stroke patients
- Pilot study on the effects induced by an electromyographic-controlled functional electrical stimulator (FitFES) for upper limb rehabilitation in post-stroke patients
- Brazilian version of a behavior change intervention to support healthy lifestyle adoption after stroke - iVIDAVC: protocol for a pilot randomized study
- Determination of efficacy of sustained motor contraction generated using StimWave peripheral nerve stimulator
- Can a PET tracer reveal hidden brain inflammation?