Your session is about to expire
← Back to Search
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 belowSelect...
I have had one stroke affecting the surface or deep parts of my brain.
Select...
I can walk 10 meters with or without help.
Select...
I can walk on a treadmill for 2 minutes at my own pace without support.
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
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 moreSecondary outcome measures
Soleus muscle structure
Ankle
Change in ankle power during gait
+2 moreTrial 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
1,638 Previous Clinical Trials
2,560,472 Total Patients Enrolled
29 Trials studying Stroke
347,972 Patients Enrolled for Stroke
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,670 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had one stroke affecting the surface or deep parts of my brain.I have difficulty walking steadily or coordinating my movements quickly.It has been over 6 months since my stroke.I cannot feel my leg that was affected by a stroke.You cannot talk to the researchers.I can walk 10 meters with or without help.I have had a bleeding stroke.I can walk on a treadmill for 2 minutes at my own pace without support.I have not experienced unexplained dizziness or vision loss on one side in the last 6 months.I have a neurological condition that is not a stroke.I don't have seizures, metal in my head, severe headaches, recent skull issues, or recent dizziness.You have a score higher than 1 on question 1b and higher than 0 on question 1c on the NIH Stroke Scale.Your heart beats between 40 and 100 times per minute when you are at rest.I have a condition or pain that makes it hard for me to walk.
Research Study Groups:
This trial has the following groups:- Group 1: Fast treadmill walking with functional electrical stimulation (FastFES)
- Group 2: Fast treadmill walking (Fast)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is the optimal candidate for this medical experiment?
"This clinical trial seeks 60 participants with a medical history of stroke, aged between 40 and 90 years old."
Answered by AI
What aims is this research endeavor aiming to accomplish?
"This experiment, analyzed over Baseline, Week 1 (after 3 lessons), Week 2 (after 6 sessions), Week 4 (following 12 educationals) and a Six-Weeks Post Training period, endeavors to monitor the Change in 10-Meter Walk Test at Self-selected Walking Speed. Secondary goals include measuring any alterations in ankle peak plantarflexor moment during gait with motion analysis technology via 7 cameras; ground reaction forces while on the treadmill using force platforms; intracortical facilitation through transcranial magnetic stimulation of motor cortex; and energy cost changes due to activity intolerance, sedentary living or physical decond"
Answered by AI
Is it still possible to participate in this experimental research?
"Clinicaltrials.gov indicates that this medical trial is still recruiting participants, having been posted for the first time on March 16th 2021 and last edited on October 18th 2022."
Answered by AI
Are the requirements for this research project open to those under 25 years old?
"Patients aged 40 or above, yet below 90 years of age are eligible for this clinical trial."
Answered by AI
What is the ceiling for enrollment in this investigation?
"Yes, the data hosted on clinicaltrials.gov confirms this trial is actively recruiting patients. The study was first published on 16th March 2021 and most recently updated on 18th October 2022, with a goal of enrolling 60 volunteers across 1 site."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger