Brain-Based biofeedback could rewire walking after stroke

NCT ID NCT06099444

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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Contacts and locations

Locations

  • Shirley Ryan AbilityLab

    Chicago, Illinois, 60611, United States

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