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Behavioural Intervention

Electrical Stimulation and Gait Training for Improved Walking

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
18-65 years
Ability to walk >10m overground and for 1 minute on a treadmill
Must not have
Uncontrolled hypertension
Severe uncontrolled medical problems (e.g., hypertension, cardiovascular disease, rheumatoid arthritis, active cancer or renal disease, epilepsy) that may interfere with study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)
Awards & highlights

Summary

This trial aims to understand how electrical stimulation and stepping practice can improve connections between the brain and muscles. The goal is to create better rehabilitation protocols for older adults and stroke survivors by combining these two approaches.

Who is the study for?
This trial is for able-bodied individuals aged 18-65 who can walk and follow commands. They must not have any physical disabilities, neurological disorders, or medical conditions that affect walking or participation in the study protocol.Check my eligibility
What is being tested?
The study tests how electrical stimulation combined with gait training affects brain-muscle connections. It involves treadmill walking and single gait training sessions with various types of electrical stimulation to improve gait performance.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, skin irritation, muscle fatigue from exercise, and possible mild headaches or dizziness related to cortical stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I can walk more than 10 meters and use a treadmill for at least 1 minute.
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I can understand and follow detailed instructions.
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I am healthy and can walk without assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is not well-controlled.
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I do not have severe health issues that could affect my participation.
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I don't have metal implants, take certain medications, or had unexplained dizziness recently.
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I have a physical disability or orthopedic issue.
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I have a history of neurological issues.
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I have a history of brain or nerve problems.
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I have skin conditions that prevent the use of electrical stimulation.
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I have reduced feeling in my left arm.
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I have a physical disability that may affect my participation in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Corticospinal excitability
Gait Performance
Spinal circuit excitability
Other outcome measures
Muscle activity during gait
Somatosensory excitability

Trial Design

3Treatment groups
Experimental Treatment
Group I: Paired stimulation of the cortex and peripheral nervous systemExperimental Treatment2 Interventions
Participants will participate in a single session of peripheral electrical stimulation paired with cortical stimulation pulses (i.e. paired associative stimulation(PAS)) on somatosensory, spinal-reflex, and corticospinal neurophysiology.
Group II: Gait without functional electrical stimulationExperimental Treatment1 Intervention
Participants will participate in 2 to 5 sessions over 2-8 weeks. Each session will comprise gait or stepping practice on a treadmill without functional electrical stimulation, and non-invasive measurement of neural circuit excitability. Participants will complete multiple 30-second to 4-minute bouts of walking on the treadmill or overground at speeds ranging from self-selected to fast speeds (faster than comfortable self-selected speed), with rest breaks between bouts. For gait training, participants may complete up to six 6-minute bouts of walking with rest breaks between bouts (30-36 minutes walking).
Group III: Gait with functional electrical stimulationExperimental Treatment2 Interventions
Participants will participate in 2 to 5 sessions over 2-8 weeks. Each session will comprise gait or stepping practice on a treadmill with functional electrical stimulation, and non-invasive measurement of neural circuit excitability. Participants will complete multiple 30-second to 4-minute bouts of walking on the treadmill or overground at speeds ranging from self-selected to fast speeds (faster than comfortable self-selected speed), with rest breaks between bouts. For gait training, participants may complete up to six 6-minute bouts of walking with rest breaks between bouts (30-36 minutes walking).
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
1,655 Previous Clinical Trials
2,572,433 Total Patients Enrolled
Trisha Kesar, PT, PhDPrincipal InvestigatorEmory University
4 Previous Clinical Trials
143 Total Patients Enrolled
~33 spots leftby Dec 2026