By InvitationPhase 1

Robotic Exoskeleton Assisted Gait Post Stroke

United States75 participantsStarted 2020-01-30

Plain-language summary

The current investigation takes advantage of both a progressive and adaptive assist-as-needed massed practice and time-sensitive neuroplasticity through exoskeleton assisted walking in order to induce greater recovery-oriented CNS plasticity and consequent gains in more independent walking.

Who can participate

Age range

21 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: * Stroke survivors \< 4 weeks from most recent stroke. * Age: 21- 80 years * Unilateral hemiparesis * Medical clearance by the Medical Director * Be able to physically fit into the exoskeleton device. * Have joint range of motion within normal functional limits for ambulation. * Have sufficient strength to use the hemiwalker, cane or walker (etc. assistive device) while wearing the RE. * Patient cognitive status and ability to communicate in English must be at a level consistent with that required to participate in standard motor rehabilitation, e.g. can follow directions. * Adequate cognitive function to give informed consent, understand the training, instructions, use investigational devices and give adequate feedback. * No history of injury or pathology to the unaffected limb. * physically fit within the RE: Height below 60" or above 76" and weight above 220 lbs. Exclusion Criteria: * Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity). * Skin issues that would prevent wearing the device. * Pre-existing condition that caused exercise intolerance.(Documented uncontrolled hypertension, coronary artery disease, cardiac arrhythmia, or congestive heart failure) * Hospitalization for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study. * Severe cognitive or psychiatric problems as well as incontinence might be contraindications to start training with a…

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.

What they're measuring

Functional Independence Measure (FIM) (aim 1)

Timeframe: Change from Baseline FIM at 10 weeks

Within-brain functional connectivity (aim 2)

Timeframe: Change from Baseline Within-brain functional connectivity at 10 weeks

TMS recruitment curve slope (aim 3)

Timeframe: Change from Baseline TMS recruitment curve slope at 10 weeks

electroencephalogram (EEG) (aim 3)

Timeframe: Change from Baseline EEG at 10 weeks

electromyography (EMG) (aim 3)

Timeframe: Change from Baseline EMG at 10 weeks

10MWT (aims 1-3)

Timeframe: Change from Baseline 10MWT at 10 weeks

6MWT (aims 1-3)

Timeframe: Change from Baseline 6MWT at 10 weeks

Trial details

NCT IDNCT04309305

SponsorKessler Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-01

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