NCT04550728 Hybrid Robot+FES Stroke Rehabilitation
| NCT ID | NCT04550728 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Maryland, Baltimore |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2026-10-01 |
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 60 participants in total. It began in 2021-08-01 with a primary completion date of 2026-10-01.
⚠ 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
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 alone or combined with functional electrical stimulation (FES) to treat sensorimotor and locomotion impairments post-stroke.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04550728 clinical trial?
This trial is open to participants of all sexes, aged 18 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 NCT04550728 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 NCT04550728 currently recruiting?
Yes, NCT04550728 is actively recruiting participants. Contact the research team at L-Zhang@som.umaryland.edu for enrollment information.
Where is the NCT04550728 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT04550728 clinical trial?
NCT04550728 is sponsored by University of Maryland, Baltimore. The trial plans to enroll 60 participants.
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