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Hybrid Robot+FES Stroke Rehabilitation

RecruitingPhase 1, Phase 2Ages 18 Years - 85 YearsAllUniversity of Maryland, Baltimore
NCT04550728 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The investigators have developed a novel robot-guided stretching under intelligent control and combine it with active movement training, which helped increase joint ROM, reduce spasticity and joint stiffness, increase muscle force output, and improve locomotion. However, for stroke survivors with sensorimotor impairment, their peripheral muscle may not sufficiently be recruited. Functional electrical stimulation (FES), has been shown its advantage to activate the peripheral muscles for people with neurological conditions. The investigators thus make a hybrid robot-FES rehabilitation system, combining the advantage of robot and FES technologies for stroke motor recovery. The investigators further would like to translate the technologies from lab to home-based training. Thus, the investigators will conduct a randomized, controlled, primarily home-based clinical trial using an ankle robot a

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18-85; * Able to ambulate at least 10 meters without human assistance, with or without an assistive device * ≥ 6 months post stroke; * having a caregiver to assist in training at home. Exclusion Criteria: * having expressive and receptive aphasia; * an inability to follow multi-step commands; * enrolled in another lower limb rehabilitation program; * having severe pain in the paralyzed lower-limb; * \>30º ankle plantar flexion contracture; * Having implanted electronic device such as a pacemaker, spinal cord, or deep brain stimulator because FES may potentially interfere with their functions.
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What it tests

  • Ankle robot training group
  • Ankle robot training and functional electrical stimulation(FES) group
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Where

1 site
University of Maryland School of Medicine
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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