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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
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

Study 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.Check my eligibility
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.See study design
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.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Soleus muscle structure
Ankle
Change in ankle power during gait
+2 more

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

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,645 Previous Clinical Trials
2,564,490 Total Patients Enrolled
30 Trials studying Stroke
349,972 Patients Enrolled for Stroke
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,977 Previous Clinical Trials
2,680,737 Total Patients Enrolled
79 Trials studying Stroke
5,327 Patients Enrolled for Stroke
Trisha Kesar, PT, PhDPrincipal Investigator - Emory University
Emory University
3 Previous Clinical Trials
83 Total Patients Enrolled
3 Trials studying Stroke
83 Patients Enrolled for Stroke

Media Library

Fast Treadmill Walking (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04380454 — N/A
Stroke Research Study Groups: Fast treadmill walking with functional electrical stimulation (FastFES), Fast treadmill walking (Fast)
Stroke Clinical Trial 2023: Fast Treadmill Walking Highlights & Side Effects. Trial Name: NCT04380454 — N/A
Fast Treadmill Walking (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04380454 — N/A
~18 spots leftby Sep 2025
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