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Promoting Neuroplastic Changes of Patients With TBI

RecruitingNAAges 30 Years - 85 YearsAllUniversity of Maryland, Baltimore
NCT06465290 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-TBI including patients who are paralyzed with no motor output. The early acute TBI rehabilitation device will be evaluated in this clinical trial.

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📋 Eligibility rules (as published)
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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What it tests

  • Motor relearning training with wearable ankle robot
  • Passive stretching with wearable ankle robot
  • Gamed-based active movement training with wearable ankle robot
  • Passive movement with limited wearable ankle robot
  • Active movement training with limited wearable ankle robot
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Where

1 site
Li-Qun Zhang
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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