Wearable in-bed robot to boost early leg and ankle recovery after stroke.
Official title: Facilitating Neuroplastic Changes of Acute Stroke Survivors With Severe Hemiplegia
Run by University of Maryland, Baltimore · NCT06404268 · Data updated 2026-11-12
This trial will test a wearable in-bed robot to help people with a recent unilateral stroke — including those with little or no leg movement — retrain ankle and lower-limb function using passive and active training.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 30 Years to 85 Years |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 3 sites (Baltimore, Maryland and 2 other locations) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | August 31, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT06404268 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 30–85 with a first-time unilateral ischemic or hemorrhagic stroke 24 hours to one month prior who have hemiparesis or hemiplegia, ankle impairment, and Manual Muscle Testing scores of 0–2.
✕Probably not a fit
Patients who are medically unstable, have severe cardiovascular disease, severe ankle contracture (>15°), significant cognitive impairment or aphasia, active lower-leg wounds, or other conditions that prevent exercise are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1–2 interventional trial tests a novel wearable rehabilitation robot designed for in‑bed use during the acute post-stroke period. The device provides guided motor relearning through passive stretching, passive and active movement, and game-based active movement training targeting ankle and lower-limb function. Participants are acute first-time unilateral stroke patients enrolled 24 hours after admission up to one month post-stroke, including those with minimal or no voluntary motor output (MMT 0–2). The trial will evaluate safety, feasibility, and early signals of functional recovery during the hospital stay.
Why it matters
Potential benefit: If successful, the device could speed early motor recovery, improve ankle and walking function, and reduce long-term disability.
How similar studies have gone: Robot-assisted and early intensive sensorimotor rehabilitation have shown promise for post-stroke motor gains, but wearable in‑bed devices focused on acutely paralyzed patients remain relatively novel and less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University of Maryland Baltimore
Baltimore, Maryland, United States Recruiting -
Umroi
Baltimore, Maryland, United States Recruiting -
TIRR Memorial Hermann
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Li-Qun Zhang — University of Maryland
- Study coordinator: Peiwen Fu, BS
- Email: Peiwen.Fu@som.umaryland.edu
- Phone: 410 706-8625
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.
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Remote Ischaemic Conditioning for Fatigue After Stroke 2
Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.