StrokeNCT06234618
The Effect of Covered Eye Walking on Electroencephalogram in Stroke Patients Compared With Open Eye Walking
An observational study of Stroke, run by Nanjing Medical University at 1 site in China.
Trial summary
Post-stroke walking abnormalities present significant rehabilitation challenges. Visual deprivation training has been shown to be more effective than open-eye training. The investigators intend to examine the changes in electroencephalography patterns in stroke patients during visually deprived walking tasks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- visual deprivation
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2024to 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stroke patients in a hospital inpatient unit
Who may be able to join
- Clinical diagnosis of stroke
- Disease duration of more than 14 days
- Ability to walk at least 10 m without assistance,
Who cannot join
- Visual impairment
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Visual Deprivation on EEG Signal in Stroke Patients
Post-stroke walking abnormalities present significant rehabilitation challenges. Visual deprivation training has been shown to be more effective than open-eye training. The investigators intend to examine the changes in electroencephalography patterns in stroke patients during visually deprived walking tasks.
The stroke participants will be fitted with a brain cap. The participants will walk with their eyes open for 60 seconds, and then their eyes will be blindfolded as they continue walking for another 60 seconds. Electroencephalography will monitor the signals in real-time during both walks.
Read the detailed description
The electroencephalography data collection will be conducted in the Rehabilitation Department of Geriatric Hospital Affiliated with Nanjing Medical University. Upon commencing the experiment, participants will walk at a comfortable pace with their eyes open for a duration of 60 seconds. Following this initial test, a rest period of five minutes will be provided. For the visual deprivation walking trial, participants will be instructed to keep their eyes open throughout the trial. Investigators will apply an adequately sized blindfold to ensure complete visual deprivation, and the participants will proceed to walk for 60 seconds. During both trials, one investigator will remain one step behind the participant at all times to ensure safety.
- Conditions
- Stroke
- Being tested
- visual deprivation
- Keywords
- Electroencephalography, walking, visual deprivation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual deprivationOther
A group of patients walking with eyes open and walking with visual deprivation.
| Study group | Role | What they receive |
|---|---|---|
| stroke patients | Stroke patients who can walk without assistance in their daily life. Receives: Other: visual deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
phase locking value
used to evaluate the phase synchronization relationship between two signals.
Measured: Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.
phase lag Index
evaluate the degree of phase synchronization and the symmetry of neural oscillatory
Measured: Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start28 Feb 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Why it stopped: The researchers would like to conduct a larger study and cover the contents of this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Jing, Nanjing Medical University
- Investigators
- Xia Li Zhang, doctor, Study director, Geriatric Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234618
- Sponsor's protocol ID
- ZD2022065
- Status last verified
- Apr 2024
- First submitted
- 9 Jan 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication.
Publications
Oliveira AS, Schlink BR, Hairston WD, Konig P, Ferris DP. Restricted vision increases sensorimotor cortex involvement in human walking. J Neurophysiol. 2017 Oct 1;118(4):1943-1951. doi: 10.1152/jn.00926.2016. Epub 2017 Jul 5.
PubMed 28679843
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Visual Deprivation on EEG Signal in Stroke Patients
- ClinicalTrials.gov ID
- NCT06234618
- Acronym / sponsor ID
- ZD2022065
- Conditions
- Stroke
- Keywords
- Electroencephalography, walking, visual deprivation
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: The researchers would like to conduct a larger study and cover the contents of this study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 31 Jan 2024 (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.
Post-stroke walking abnormalities present significant rehabilitation challenges. Visual deprivation training has been shown to be more effective than open-eye training. The investigators intend to examine the changes in electroencephalography patterns in stroke patients during visually deprived walking tasks.
The stroke participants will be fitted with a brain cap. The participants will walk with their eyes open for 60 seconds, and then their eyes will be blindfolded as they continue walking for another 60 seconds. Electroencephalography will monitor the signals in real-time during both walks.
Detailed description
The electroencephalography data collection will be conducted in the Rehabilitation Department of Geriatric Hospital Affiliated with Nanjing Medical University. Upon commencing the experiment, participants will walk at a comfortable pace with their eyes open for a duration of 60 seconds. Following this initial test, a rest period of five minutes will be provided. For the visual deprivation walking trial, participants will be instructed to keep their eyes open throughout the trial. Investigators will apply an adequately sized blindfold to ensure complete visual deprivation, and the participants will proceed to walk for 60 seconds. During both trials, one investigator will remain one step behind the participant at all times to ensure safety.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke patients | – | Other: visual deprivationStroke patients who can walk without assistance in their daily life. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stroke patients in a hospital inpatient unit
Key inclusion criteria (3 listed)
- Clinical diagnosis of stroke
- Disease duration of more than 14 days
- Ability to walk at least 10 m without assistance,
Key exclusion criteria (2 listed)
- Visual impairment
- Severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visual deprivationA group of patients walking with eyes open and walking with visual deprivation. | Other | stroke patients |
Primary outcome
phase locking value
Time frame: Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.
used to evaluate the phase synchronization relationship between two signals.
phase lag Index
Time frame: Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.
evaluate the degree of phase synchronization and the symmetry of neural oscillatory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Background: PubMed 28679843Oliveira AS, Schlink BR, Hairston WD, Konig P, Ferris DP. Restricted vision increases sensorimotor cortex involvement in human walking. J Neurophysiol. 2017 Oct 1;118(4):1943-1951. doi: 10.1152/jn.00926.2016. Epub 2017 Jul 5.
- In this paper, the electroencephalography changes of normal people during visual deprivation walking were studiedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication.
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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.
Xia Li Zhang, doctor study director
Geriatric Hospital of Nanjing Medical University
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, run by Nanjing Medical University at 1 site in China.
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 3 inclusion and 2 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: paused, as of the sponsor's last update on 12 Apr 2024. 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 China. 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?
Results are not available in the source record.
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?
phase locking value (time frame: Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.). 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?
On the ClinicalTrials.gov record for NCT06234618, which also lists 1 linked publication.
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 12 Apr 2024.