Cortical Processes During Walking Post-stroke

Sponsor

University of Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT05710029

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to use novel mobile imaging techniques with high-density electroencephalography (EEG) to quantify cortical processes synchronized to the biomechanics of walking. Here, the study has two aims - the primary aim is to quantify the cortical processes that contribute to gait dysfunction early post-stroke, and the second aim is to determine how cortical processes are mediated by mechanical assistance during early gait training post-stroke.

Participants will wear an electroencephalography (EEG) cap to measure brain activity and other non-invasive physiological sensors. Participants will be asked to perform different tasks, such as walking at different speeds and walking with different levels of body weight support.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute Walking, Difficulty

Detailed Description

This study will recruit 15 subacute post-stroke individuals and 15 age-matched neurotypical individuals between the age of 18-80 years old.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Cortical Processes During Walking Post-stroke

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

Brain activity during walking measured by EEG [through study study completion, an average of 2 years]
Changes in brain activity during walking with different levels of weight support
Brain activity during walking measured by EEG [through study study completion, an average of 2 years]
Differences in brain activity during walking between people post-stroke and neurotypical individuals

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria for post-stroke patients:

Participants will have a unilateral brain lesion within six months prior to participation in this project;
Paresis confined to one side;
Ability to walk for 10 meters continuously;
Absence of severe cognitive dysfunction as demonstrated by a Mini-Mental score greater than 24;
Absence of severe concurrent medical problems;
Ability to provide informed consent.

Exclusion Criteria for age-matched adults:

Any major neurological, cardiovascular, orthopedic, and psychiatric diagnoses

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Chang Liu, PhD, University of Florida
Principal Investigator: Daniel Ferris, PhD, University of Florida
Principal Investigator: Dorian Rose, PT, PhD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chang Liu, Postdoctoral associate, University of Florida

ClinicalTrials.gov Identifier:

NCT05710029

Other Study ID Numbers:

PRO00048585

First Posted:

Feb 2, 2023

Last Update Posted:

Feb 2, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chang Liu, Postdoctoral associate, University of Florida

Additional relevant MeSH terms:

Stroke

Mobility Limitation

Study Results

No Results Posted as of Feb 2, 2023