Wearable ankle robot to promote neuroplasticity after traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized clinical trial tests a wearable ankle rehabilitation device combined with motor relearning, sensory stimulation, and real-time feedback to promote neuroplastic changes in the acute phase after traumatic brain injury. The approach uses EMG and potentially EEG signals to detect early motor intent and guide robot-assisted therapy, including game-based active movement and assisted/passive therapies. The study aims to determine if early intensive sensorimotor training with this device can reduce sensorimotor impairments in patients with hemiparesis or hemiplegia within the first month post-injury. The intervention sequence includes motor relearning, passive stretching, and active movement training through a wearable ankle robot, with adjustments based on feedback signals. The trial will assess safety, feasibility, and preliminary efficacy in promoting functional recovery.

Why it matters

Who can join: the full rules

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

• Li-Qun Zhang
  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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.