Clinical trial NCT06234618: The Effect of Covered Eye Walking on Electroencephalogram in Stroke Patients Compared With Open Eye Walking
Official title: Study of Visual Deprivation on EEG Signal in Stroke Patients
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Stroke
Keywords: Electroencephalography
walking
visual deprivation
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stroke patients in a hospital inpatient unit

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: phase locking value
timeFrame: 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.
measure: phase lag Index
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Geriatric Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Geriatric Hospital of Nanjing Medical University
name: Xia Li Zhang, doctor
role: STUDY_DIRECTOR
References:
citation: 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.