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

NCT07189819 | Not Yet Recruiting FDA Device

• 2 other identifiers: STUDY000101021R21HD116484
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

post-stroke gait

Outcome Measures

Primary Outcomes (6)

• Number of Adverse Events

  Safety is assessed as the number of adverse events experienced by study participants.

  Day 1

• Count of Risks

  Safety is assessed as the count of risks, including falling, discomfort, pain, skin problems, fatigue, and soreness.

  Day 1

• Participant Perception of Comfort

  Participant perception of comfort is measured on an 10-point Likert scale ranging from 1 to 10, where 10 is the most comfortable.

  Day 1

• Participant Perception of Acceptability

  Participant perception of acceptability is measured on an 10-point Likert scale ranging from 1 to 10, where 10 is the most acceptable.

  Day 1

• Percent of Gait Cycles with Footdrop Correction

  Feasibility of the FES control system is assessed as the percentage of gait cycles with footdrop correction. The FES control system is considered effective if greater than 80% of gait cycles have footdrop correction.

  Day 1

• Number of Participants Completing Gait Bouts

  Feasibility of the FES control system is assessed as the number of participants who are able to complete gait bouts with the MPC FES system. The FES control system is considered effective if greater than 80% of participants are able to complete gait bouts.

  Day 1

Secondary Outcomes (3)

• Peak Ankle Dorsiflexion Angle During Swing

  Day 1

• Overground Walking Distance

  Day 1

• FES Intensity

  Day 1

Study Arms (2)

MPC FES Followed by Conventional FES

EXPERIMENTAL

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.

Device: Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES); Device: Conventional Functional Electrical Stimulation (FES)

Conventional FES Followed by MPC FES

EXPERIMENTAL

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.

Device: Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES); Device: Conventional Functional Electrical Stimulation (FES)

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 FES Followed by MPC FES; MPC FES Followed by Conventional FES

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.

Conventional FES Followed by MPC FES; MPC FES Followed by Conventional FES

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>6 months since stroke
• cortical or subcortical stroke
• able to walk 10-meters with or without an assistive device
• sufficient cardiovascular health and ankle stability to walk on treadmill without ankle orthosis
• passive ankle range of motion to benefit from dorsiflexor FES assistance
• resting heart rate 40-100 bpm

You may not qualify if:

• cerebellar signs
• score \>1 on question 1b (does not know the current month and age) and \>0 on question 1c (can not blink eyes and squeeze hands) on NIH Stroke Scale
• inability to communicate with investigators
• neglect/hemianopia
• unexplained dizziness in past 6 months
• sensory loss in paretic leg
• musculoskeletal or medical conditions limiting walking
• neurologic diagnoses other than stroke

Sponsors & Collaborators

• Emory University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Emory Rehabilitation Hospital

Atlanta, Georgia, 30322, United States

Location

Study Officials

• Trisha Kesar, PT, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trisha Kesar, PT, PhD

CONTACT

(404) 712-5803; trisha.m.kesar@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are randomized to the order of the test conditions.

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available for sharing beginning 9 months and for 2 years after publication of the manuscript presenting the study primary results.
• Access Criteria: Data will be made available for sharing with researchers who provide a methodologically sound proposal to achieve the aims proposed by the requestor. Proposed purposes for using the shared data include replication studies, meta-analyses or systematic reviews, and other special requests. Researchers wanting to use data from this study should direct their requests to tkesar@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)