Cortical Processes During Walking Post-stroke

Stroke, Acute Clinical Trial

Official title:

Cortical Processes During Walking Post-stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710029
• Other study ID #: PRO00048585
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: University of Florida
• Contact: Chang Liu, PhD
• Phone: 352-294-1281
• Email: liu.chang1[@]ufl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Mobility Limitation
• Stroke
• Stroke, Acute
• Walking, Difficulty

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activity during walking measured by EEG	Changes in brain activity during walking with different levels of weight support	through study study completion, an average of 2 years
Primary	Brain activity during walking measured by EEG	Differences in brain activity during walking between people post-stroke and neurotypical individuals	through study study completion, an average of 2 years