This Study Evaluates the Use of a Data-driven Lower Limb Exoskeleton Controller for Stroke Rehabi… (NCT07616167) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
This Study Evaluates the Use of a Data-driven Lower Limb Exoskeleton Controller for Stroke Rehabilitation.
United States20 participantsStarted 2026-10-01
Plain-language summary
The goal of this clinical trial is to test a new, impairment-aware robotic control software framework to see if its smart adaptation can improve walking recovery in healthy adults and chronic stroke survivors. .
The main questions it aims to answer are:
Can the new control software safely use sensors and machine learning to predict and instantly adapt to a user's specific walking needs?
Does training with a robotic device driven by this new adaptive control framework improve walking speed and overall mobility in stroke survivors?
Researchers will compare a lower-limb orthosis operating under the new "smart" control software (which adapts to the user's impairment) to the same device operating under a standard, non-adaptive controller (which uses rigid or fixed assistance) to see if the new control approach leads to greater improvements in walking ability.
Participants will:
Walk on treadmills, flat walkways, or stairs while wearing a robotic leg orthosis driven by the different control software systems being tested.
Wear small tracking tools (like reflective motion-capture markers and muscle activity sensors) so researchers can precisely measure how their movements interact with each control program.
Complete standard walking tests to measure their walking speed and overall mobility under each software condition.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Cohort 1: Able-Bodied Participants (Initial Validation)
* Healthy young adults.
* No history of neurological, orthopedic, or cardiovascular impairments affecting gait or balance.
* Able to walk independently without assistive devices.
Cohort 2: Stroke Survivors (Clinical Efficacy Pilot)
* Individuals with a documented history of chronic stroke.
* Persistent unilateral lower-limb motor impairment resulting in a pathological gait pattern (heterogeneous gait deficits).
* Stable medical condition allowing for participation in intensive physical rehabilitation tasks.
* Able to provide informed consent.
Exclusion Criteria:
* Severe cognitive or communication impairments that prevent the participant from following safety instructions or reporting discomfort.
* Co-existing neurological conditions (other than stroke) that independently impair locomotion (e.g., Parkinson's disease, Multiple Sclerosis).
* Severe lower-limb joint contractures or orthopedic conditions that mechanically restrict the safe range of motion of the robotic orthosis.
* Skin breakdowns, open wounds, or severe unhealed lesions at the contact points where the powered orthosis interfaces with the lower limbs.
* Any medical contraindication to intensive walking exercise or treadmill training (e.g., unstable angina, severe unmanaged cardiovascular disease).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.