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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT06234618
Other study ID # ZD2022065
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date February 28, 2024
Est. completion date June 30, 2024

Study information

Verified date April 2024
Source Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 5
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
visual deprivation
A group of patients walking with eyes open and walking with visual deprivation.

Locations

Country Name City State
China Geriatric Hospital of Nanjing Medical University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary phase locking value 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.
Primary phase lag Index 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.
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