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OpenTrials
Completed

NCT Number: NCT05710029

Cortical Processes During Walking Post-stroke

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Brain activity during walking measured by EEG

    Time frame: through study study completion, an average of 2 years

    Changes in brain activity during walking with different levels of weight support

  2. Brain activity during walking measured by EEG

    Time frame: through study study completion, an average of 2 years

    Differences in brain activity during walking between people post-stroke and neurotypical individuals

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 2, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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