Functional Electrical Stimulation for Post-Stroke Weakness

Overseen By Trisha Kesar, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Cerebellar signs, neglect, hemianopia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Trisha Kesar, PT, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a stroke and now have difficulty with walking due to foot weakness, commonly known as footdrop. Participants should be able to perform treadmill and overground walking tasks with or without assistance.

Inclusion Criteria

* \>6 months since stroke

* cortical or subcortical stroke

* able to walk 10-meters with or without an assistive device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo treadmill and overground walking trials using both the novel MPC FES system and the conventional FES system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study is testing two types of electrical stimulation systems designed to help improve walking in people post-stroke: a new model-predictive controller (MPC) system and a conventional system. The effectiveness of each will be compared during both treadmill and overground walking.

How Is the Trial Designed?

Group I: MPC FES Followed by Conventional FES Experimental Treatment 2 Interventions

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.

Group II: Conventional FES Followed by MPC FES Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+