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NCT04550728 · ClinicalTrials.gov registry record · Phase 1

Hybrid Robot+FES Stroke Rehabilitation

A Phase 1 study of Stroke, sponsored by University of Maryland, Baltimore.

Recruiting
Registry status
Phase 1
Development phase
60
Enrollment target
1
Study location

NCT04550728 is a Phase 1 study of Stroke that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 60 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04550728, a Phase 1 study of Stroke, is actively recruiting participants, sponsored by University of Maryland, Baltimore.

RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

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

Study Locations (1)

Maryland

  • University of Maryland School of Medicine - Baltimore

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-08-01
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

University of Maryland, Baltimore

560 total trials

What the Registry Record Tells You About NCT04550728

The ClinicalTrials.gov registry entry for NCT04550728 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Ankle robot training group is the first listed.

NCT04550728 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT04550728 about?

NCT04550728 is a clinical study titled "Hybrid Robot+FES Stroke Rehabilitation". 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 se...

What is the current status of trial NCT04550728?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2021-08-01. Estimated completion is 2026-12-31.

What conditions does trial NCT04550728 study?

This clinical trial studies the following conditions: Stroke.

What interventions are being tested in trial NCT04550728?

The interventions under investigation include: Ankle robot training group (COMBINATION_PRODUCT), Ankle robot training and functional electrical stimulation(FES) group (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT04550728?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04550728 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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