NCT05710029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

January 10, 2023

Last Update Submit

March 26, 2025

Conditions

Keywords

WalkingStrokeEEGAssistance

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Post-stroke participants (age 18-80), age-matched adults (age 18-80)

You may qualify if:

  • 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.

You may not qualify if:

  • Any major neurological, cardiovascular, orthopedic, and psychiatric diagnoses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

StrokeMobility LimitationHelping Behavior

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Study Officials

  • Chang Liu, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR
  • Daniel Ferris, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR
  • Dorian Rose, PT, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

February 2, 2023

Study Start

May 1, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

April 1, 2025

Record last verified: 2025-03

Locations