RECRUITING

AB Gait Estim Neurophysiology

Conditions

Gait Corticospinal excitability Non-invasive stimulation Functional electrical stimulation (FES)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is being done to answer the question: What are the effects of electrical stimulation and stepping practice on connections between the brain and muscles? The long-term goal of this project is to develop novel, effective, and personalized rehabilitation protocols founded on an understanding of neurobiological mechanisms that combine electrical stimulation with gait training to improve gait performance in older adults and stroke survivors. The rationale of this project is to explore and generate preliminary data regarding how electrical stimulation-based strategies modulate cortical and spinal circuits in able-bodied individuals. The researchers will evaluate the effects of short treadmill walking bouts or single gait training sessions with and without electrical stimulation on somatosensory, spinal-reflex, corticospinal circuit neurophysiology, and/or gait performance. The study will provide important preliminary and normative data that can explain how brain circuits change with stimulation or stepping practice and inform future rehabilitation studies on patients. The study population is able-bodied individuals.

Official Title

Effects of Gait Training Strategies and Noninvasive Stimulation on Neurophysiology and Walking Performance in Able-Bodied Adults- A Preliminary Study

Quick Facts

Study Start:2024-02-12

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06430164

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 18-65 years * Able-bodied (healthy without any physical disability, neurological, orthopedic, or other medical disorder affecting walking or study protocol participation) * Ability to walk \>10m overground and for 1 minute on a treadmill * Ability to follow 3-stage commands and provide informed consent.	* Self-reported history or evidence of orthopedic or physical disability * History or evidence of neurological pathology * Pregnancy (female) * Uncontrolled hypertension * Cardiac pacemaker or other implanted electronic system * Presence of skin conditions preventing electrical stimulation setup * Impaired sensation in the left upper limb. * Bruises or cuts at the stimulation electrode placement site * Concurrent enrollment in rehabilitation or another investigational study. * History or evidence of orthopedic or physical disability interfering with study procedures * History or evidence of neurological pathology or disorder * Severe uncontrolled medical problems (e.g., hypertension, cardiovascular disease, rheumatoid arthritis, active cancer or renal disease, epilepsy) that may interfere with study procedures * Contraindications to TMS such as metal implants, medications that can increase cortical excitability, unexplained dizziness in the past 6 months

Inclusion Criteria

Exclusion Criteria

* 18-65 years
* Able-bodied (healthy without any physical disability, neurological, orthopedic, or other medical disorder affecting walking or study protocol participation)
* Ability to walk \>10m overground and for 1 minute on a treadmill
* Ability to follow 3-stage commands and provide informed consent.

* Self-reported history or evidence of orthopedic or physical disability
* History or evidence of neurological pathology
* Pregnancy (female)
* Uncontrolled hypertension
* Cardiac pacemaker or other implanted electronic system
* Presence of skin conditions preventing electrical stimulation setup
* Impaired sensation in the left upper limb.
* Bruises or cuts at the stimulation electrode placement site
* Concurrent enrollment in rehabilitation or another investigational study.
* History or evidence of orthopedic or physical disability interfering with study procedures
* History or evidence of neurological pathology or disorder
* Severe uncontrolled medical problems (e.g., hypertension, cardiovascular disease, rheumatoid arthritis, active cancer or renal disease, epilepsy) that may interfere with study procedures
* Contraindications to TMS such as metal implants, medications that can increase cortical excitability, unexplained dizziness in the past 6 months

Contacts and Locations

Study Contact

Trisha Kesar, PT, PhD

CONTACT

404-712-5803

tkesar@emory.edu

Principal Investigator

Trisha Kesar, PT, PhD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory University

Atlanta, Georgia, 30329

United States

Collaborators and Investigators

Sponsor: Emory University

Trisha Kesar, PT, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-12

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-02-12

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Corticospinal excitability
Non-invasive stimulation
Functional electrical stimulation (FES)

Additional Relevant MeSH Terms

Gait