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NCT04550728RecruitingPhase 1/2

Hybrid Robot+FES Stroke Rehabilitation

Assessment Followed by Home-based Hybrid Robot + FES Rehabilitation Post-stroke

Source: ClinicalTrials.gov · Last updated 18 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
3 Sept 2020
Start date
1 Aug 2021
Primary completion date
1 Oct 2026
Lead sponsor
University of Maryland, Baltimore
Diseases
Stroke
NCT number
NCT04550728

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 60
  • From 1 Aug 2021 to the primary completion date, 1 Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Maryland School of Medicine
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.