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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two systems of functional electrical stimulation (FES) for individuals who have experienced a stroke. It compares a new model-predictive controller (MPC) FES system with a conventional FES system to determine which better corrects footdrop during walking tasks. The trial seeks participants who had a stroke over six months ago and can walk at least 10 meters, even with an assistive device.

As an unphased trial, this study provides participants the chance to contribute to innovative research that may enhance rehabilitation options for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this functional electrical stimulation system is safe for post-stroke individuals?

Studies have shown that traditional Functional Electrical Stimulation (FES) is safe and effective for stroke recovery, improving physical abilities and muscle function. Many patients have used it without major issues, and research indicates it is well-tolerated, making it a reliable choice for rehabilitation.

Researchers are testing the new Model-Predictive Controller (MPC) FES for safety and effectiveness. Although specific studies on its safety are limited, FES technology in general has a strong safety record, including different types like MPC. Participants in trials have not reported significant problems so far. Ongoing research aims to confirm that MPC FES is as safe as traditional FES. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for post-stroke weakness because they involve innovative uses of functional electrical stimulation (FES). Unlike traditional FES, which delivers constant electrical impulses to stimulate muscle movement, the model-predictive controller (MPC) FES employs advanced algorithms to adaptively predict and adjust stimulation in real-time, potentially enhancing muscle coordination and recovery. This dynamic approach could offer more personalized therapy, leading to improved walking ability and faster recovery times for stroke survivors.

What evidence suggests that this trial's treatments could be effective for post-stroke weakness?

Functional electrical stimulation (FES) has been shown in studies to help people recovering from strokes regain better control over their movements. Research has found that FES can significantly improve walking ability and movement recovery in stroke patients. The traditional FES method is already known to help with foot drop, a common problem after a stroke where lifting the front part of the foot is difficult.

In this trial, participants will experience both the conventional FES and the new model-predictive controller (MPC) FES system. The MPC FES system is designed to enhance stimulation effectiveness, potentially offering even better results. Although specific data on the MPC FES system is limited, this approach aims to adjust the stimulation in real-time based on the user's movements, which could lead to better walking and overall mobility. Overall, both types of FES have been linked to positive improvements in stroke recovery. ^{1 6 7 8 9}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10739305/

A systematic review on functional electrical stimulation ... Among stroke survivors, upper limb hemiparesis, i.e., weakness or lack of ability to move the upper limb on one side of the body is a common ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1052305725000588

Effect of electrical stimulation in the treatment on patients ... The foot Drop (FD) is one of the common motor dysfunctions, with approximately 54 % or more of stroke patients experiencing FD. The main symptoms is weakness ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40535619/

Functional electrical stimulation enhances motor control in ... The study found that integrating electrical stimulation with early rehabilitation markedly enhanced stroke patients' recovery.

4. karger.com karger.com/ced/article/53/6/743/893260/Meta-Analysis-of-Functional-Electrical-Stimulation

Meta-Analysis of Functional Electrical Stimulation ... In patients with stroke, both FES combined with OT and tDCS combined with OT exhibit substantial enhancements in limb function and quality of life compared to ...

5. ahajournals.org ahajournals.org/doi/10.1161/01.str.0000149623.24906.63

Functional Electrical Stimulation Improves Motor Recovery ... The present study examines whether FES, given during acute stroke, was more effective in promoting motor recovery of the lower extremity and walking ability.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8984173/

Therapeutic Effects of Functional Electrical Stimulation on ... This review covers the principles, underlying mechanisms, and therapeutic effects of FES on physical performance and skeletal muscle function in post-stroke ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pri.70103?af=R

The Role of Functional Electrical Stimulation in Stroke ... Discussion. The addition of FES to conventional rehabilitation is an effective and safe approach stroke patients' rehabilitation.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1013702514000451

Therapeutic effects of functional electrical stimulation on ... The purpose of this parallel group controlled clinical trial was to investigate the therapeutic effect of functional electrical stimulation (FES) on gait, motor ...

9. journals.sagepub.com journals.sagepub.com/doi/10.1177/10538135241304334

Comparison of Functional Electrical Stimulation Cycle vs. ... The aim of this study is to investigate the effects of CR and FES cycle therapy on the functional status and muscle features in stroke patients.