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Behavioural Intervention

FES + Treadmill Training for Post-Stroke Gait Improvement

N/A

Recruiting

Led By Trisha Kesar, PT, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Single cortical or subcortical ischemic stroke

Able to walk 10-meters with or without assistive device

Must not have

Cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements)

Lack of sensation in lower limb affected by stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 1 (after 3 training sessions), week 2 (after 6 training sessions), week 4 (after 12 training sessions), 3 weeks post-training, 6 weeks post-training

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well two different types of treatments, Fast and FastFES, help improve walking for people with different types of injuries.

Who is the study for?

This trial is for individuals who've had a single ischemic stroke at least 6 months ago, can walk 10 meters with or without help, and have stable cardiovascular health. They must be able to use a treadmill without an orthosis and have a resting heart rate of 40-100 bpm. People with hemorrhagic stroke, severe coordination issues, certain NIH Stroke Scale scores, inability to communicate with researchers, conditions affecting walking ability other than stroke, lack of sensation in the affected limb or medical issues preventing trial completion are excluded.

What is being tested?

The study is testing how fast treadmill walking alone (Fast) and combined with functional electrical stimulation (FastFES) can improve walking quality and function after a stroke. The goal is to understand these methods' biomechanical and neural effects better so that future treatments can be more personalized.

What are the potential side effects?

Potential side effects may include muscle fatigue due to exercise on the treadmill or skin irritation from the functional electrical stimulation electrodes. There might also be discomfort associated with increased physical activity levels during rehabilitation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had one stroke affecting the surface or deep parts of my brain.

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I can walk 10 meters with or without help.

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I can walk on a treadmill for 2 minutes at my own pace without support.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have difficulty walking steadily or coordinating my movements quickly.

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I cannot feel my leg that was affected by a stroke.

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I have had a bleeding stroke.

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I have not experienced unexplained dizziness or vision loss on one side in the last 6 months.

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I don't have seizures, metal in my head, severe headaches, recent skull issues, or recent dizziness.

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I have a neurological condition that is not a stroke.

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I have a condition or pain that makes it hard for me to walk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 1 (after 3 training sessions), week 2 (after 6 training sessions), week 4 (after 12 training sessions), 3 weeks post-training, 6 weeks post-training

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 1 (after 3 training sessions), week 2 (after 6 training sessions), week 4 (after 12 training sessions), 3 weeks post-training, 6 weeks post-training

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1 (after 3 training sessions), week 2 (after 6 training sessions), week 4 (after 12 training sessions), 3 weeks post-training, 6 weeks post-training for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 10-Meter Walk Test at Fast Walking Speed

Change in 10-Meter Walk Test at Self-selected Walking Speed

Change in 6-Minute Walk Test

+6 more

Secondary study objectives

Soleus muscle structure

Ankle

Change in ankle power during gait

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Fast treadmill walking with functional electrical stimulation (FastFES)Experimental Treatment2 Interventions

Participants with post-stroke hemiparesis who are randomized to receive 12 sessions of FastFES. FastFES is a targeted intervention that provides motor level stimulation-induced cues to improve ankle propulsion. FES is delivered only to the paretic ankle muscles, enhancing afferent ascending as well as descending corticomotor drive. Increased corticomotor drive in lesioned corticomotor circuits in turn promotes improved timing and intensity of muscle activation in the paretic plantar- and dorsi-flexor muscles, increasing plantarflexor moment and propulsion from the paretic ankle.

Group II: Fast treadmill walking (Fast)Active Control1 Intervention

Participants with post-stroke hemiparesis who are randomized to receive 12 sessions of Fast. Fast is a non-targeted intervention that provides similar structure, dose, and intensity of stepping practice as FastFES, but does not include FES, and no specific instructions are provided to target practice to the paretic leg or specific ankle deficits

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Functional electrical stimulation (FES)

2015

Completed Phase 2

~30

0 / 10Eligibility criteria met