Stroke, AcuteNCT05710029
Cortical Processes During Walking Post-stroke
An observational study of Stroke, Acute and Walking, Difficulty, run by University of Florida at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute, Walking, Difficulty
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Post-stroke participants (age 18-80), age-matched adults (age 18-80)
Who may be able to join
- 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.
Who cannot join
- Any major neurological, cardiovascular, orthopedic, and psychiatric diagnoses
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke, Acute, Walking, Difficulty
- Keywords
- Walking, Stroke, EEG, Assistance
- Medical subject headings
- Stroke, Mobility Limitation, Helping Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity during walking measured by EEG
Changes in brain activity during walking with different levels of weight support
Measured: 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
Measured: through study study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 May 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chang Liu, PhD, Principal investigator, University of FloridaDaniel Ferris, PhD, Principal investigator, University of FloridaDorian Rose, PT, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710029
- Sponsor's protocol ID
- IRB202202100
- Status last verified
- Mar 2025
- First submitted
- 10 Jan 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Share deidentified data on an online repository
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Processes During Walking Post-stroke
- ClinicalTrials.gov ID
- NCT05710029
- Acronym / sponsor ID
- IRB202202100
- Conditions
- Stroke, Acute, Walking, Difficulty
- Keywords
- Walking, Stroke, EEG, Assistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Post-stroke participants (age 18-80), age-matched adults (age 18-80)
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- Any major neurological, cardiovascular, orthopedic, and psychiatric diagnoses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: Undecided. Share deidentified data on an online repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Liu, PhD principal investigator
University of Florida
Daniel Ferris, PhD principal investigator
University of Florida
Dorian Rose, PT, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Walking, Difficulty, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity during walking measured by EEG (time frame: through study study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.