Wearable in-bed robot to boost early leg and ankle recovery after stroke.
Facilitating Neuroplastic Changes of Acute Stroke Survivors With Severe Hemiplegia
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 |
| Enrollment | 68 (estimated) |
| Ages | 30 Years to 85 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT06404268 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Baltimore, Maryland and 1 other locations
- University of Maryland Baltimore — Baltimore, Maryland, United States (Recruiting)
- Umroi — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Li-Qun Zhang — University of Maryland
- Study coordinator: Soh-Hyun Hur
- Email: SoHur@som.umaryland.edu
- Phone: 410 706-8625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.