NCT06404268 Facilitating Neuroplastic Changes of Acute Stroke Survivors
| NCT ID | NCT06404268 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Maryland, Baltimore |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 68 participants in total. It began in 2025-06-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.
Eligibility 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
Contact & Investigator
Li-Qun Zhang
PRINCIPAL INVESTIGATOR
University of Maryland
Frequently Asked Questions
Who can join the NCT06404268 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06404268 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06404268 currently recruiting?
Yes, NCT06404268 is actively recruiting participants. Contact the research team at Peiwen.Fu@som.umaryland.edu for enrollment information.
Where is the NCT06404268 trial being conducted?
This trial is being conducted at Baltimore, United States, Baltimore, United States, Houston, United States.
Who is sponsoring the NCT06404268 clinical trial?
NCT06404268 is sponsored by University of Maryland, Baltimore. The principal investigator is Li-Qun Zhang at University of Maryland. The trial plans to enroll 68 participants.
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