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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07189819
Status
Not Yet Recruiting

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Conditions

  • Post-stroke Hemiparesis

Eligibility Criteria

Sex
ALL
Age
40 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES) — DEVICE
    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.
  • Conventional Functional Electrical Stimulation (FES) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Aug 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: MPC FES Followed by Conventional FES
    Post-stroke participants participating in both treadmill and overground walking trials with the novel model-predictive controller (MPC) functional electrical stimulation (FES) system first and with a conventional functional electrical stimulation (FES) system second.
  • Experimental: Conventional FES Followed by MPC FES
    Post-stroke participants participating in both treadmill and overground walking trials with a conventional functional electrical stimulation (FES) system first and the novel model-predictive controller (MPC) functional electrical stimulation (FES) system second.

Primary Outcome Measure

Number of Adverse Events [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory Rehabilitation HospitalAtlantaGeorgia30322-

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By research site
Emory Rehabilitation Hospital· Atlanta, GA

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