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Wearable robot aims to rewire the brain after severe stroke

NCT ID NCT06404268

Disease control Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 24, 2026 · Updated 4 times

Summary

This study tests a wearable rehabilitation robot designed for stroke survivors with severe leg paralysis. The robot guides patients through motor relearning and passive stretching exercises while they are still in bed during the early acute phase after a stroke. The goal is to see if this early, intensive therapy can improve leg function and promote brain recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
wearable rehabilitation robot
What this could lead to
If successful, this approach could improve motor recovery and quality of life for stroke survivors with severe paralysis.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply broadly. The robot-assisted therapy may not lead to significant functional gains.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 68 people

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

Started

Jun 2025

Expected to finish

Aug 2028

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

30 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Inclusion Criteria: * Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment) * Hemiplegia or hemiparesis * 0≤Manual Muscle Testing (MMT)\<=2 * Age 30-85 * Ankle impairments including stiff calf muscles and/or inadequate dorsiflexion Exclusion Criteria: * Medically not stable * Associated acute medical illness that interferes with ability to training and exercise * No impairment or very mild ankle impairment of ankle * Severe cardiovascular problems that interfere with ability to perform moderate movement exercises * Cognitive impairment or aphasia with inability to follow instructions * Severe pain in legs * Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion) * Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee

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Conditions

The condition(s) this trial relates to.

paraplegia stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • TIRR Memorial Hermann

    RECRUITING

    Houston, Texas, 77030, United States

  • UMROI

    RECRUITING

    Baltimore, Maryland, 21207, United States

  • University of Maryland Baltimore

    RECRUITING

    Baltimore, Maryland, 21201, United States

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