The Effect of Covered Eye Walking on Electroencephalogram in Stroke Patients Compared With Open Eye Walking

April 10, 2024 updated by: Zhao Jing, Nanjing Medical University

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Geriatric Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

stroke patients in a hospital inpatient unit

Description

Inclusion Criteria:

  • Clinical diagnosis of stroke
  • Disease duration of more than 14 days
  • Ability to walk at least 10 m without assistance,

Exclusion Criteria:

  • Visual impairment
  • Severe cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
stroke patients
Stroke patients who can walk without assistance in their daily life.
Other: visual deprivation
A group of patients walking with eyes open and walking with visual deprivation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Investigators

  • Study Director: Xia Li Zhang, doctor, Geriatric Hospital of Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 28, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZD2022065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication.

IPD Sharing Time Frame

Three months after publication.

IPD Sharing Access Criteria

Request from the researchers by email.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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