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

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

First listed

Sep 24, 2025

Start date

Jul 7, 2026

Status verified

Jul 2026

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

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

• Trisha Kesar, PT, PhD
  (404) 712-5803
  [email protected]

Locations (1)

Find similar trials in Atlanta, GA

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