Recruiting

MPC vs. FES

Sponsor:

Emory University

Code:

NCT07189819

Conditions

Post-stroke Hemiparesis

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Conventional Functional Electrical Stimulation (FES)

Study Details

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

Study ID

NCT07189819

Start date

Jul 7, 2026

Status verified date

Jul, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • >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

Exclusion Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

  • Number of Adverse Events [ Time Frame: Day 1 ]
  • Count of Risks [ Time Frame: Day 1 ]
  • Participant Perception of Comfort [ Time Frame: Day 1 ]
  • Participant Perception of Acceptability [ Time Frame: Day 1 ]
  • Percent of Gait Cycles with Footdrop Correction [ Time Frame: Day 1 ]
  • Number of Participants Completing Gait Bouts [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Trisha Kesar, PT, PhD

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

Locations

Emory Rehabilitation Hospital

Recruiting

Atlanta, Georgia, United States, 30322

More Information

Sponsor

Emory University

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • post-stroke gait

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-07-16.