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Innovative Closed-loop Functional Electrical Stimulation Control System for Augmenting Post-stroke Gait

NCT07189819 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-25

No results posted yet for this study

Summary

This study will compare the performance of a novel data-driven model-predictive controller (MPC) based functional electrical stimulation (FES) system versus a conventional FES system for footdrop correction during treadmill and overground walking tasks in people post-stroke.

Conditions

  • Post-stroke Hemiparesis

Interventions

DEVICE

Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES)

The model-predictive controller (MPC) determines the timing and intensity of electrical stimulation delivered for FES. MPC combined with real-time ultrasound-based feedback delivers optimal FES intensities and minimizes fatigue. FES is delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator.

DEVICE

Conventional Functional Electrical Stimulation (FES)

For functional electrical stimulation, surface electrodes are placed on the paretic leg on skin overlying the tibialis anterior (TA) muscle, with intensity pre-set to elicit dorsiflexion to neutral against gravity. FES will be delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Trisha Kesar, PT, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-08-01
Completion
2026-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07189819 on ClinicalTrials.gov