NCT06234618

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

February 28, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

January 9, 2024

Last Update Submit

April 10, 2024

Conditions

Keywords

Electroencephalographywalkingvisual deprivation

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (1)

stroke patients

Stroke patients who can walk without assistance in their daily life.

Other: visual deprivation

Interventions

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

stroke patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

stroke patients in a hospital inpatient unit

You may qualify if:

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

You may not qualify if:

  • Visual impairment
  • Severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Related 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.

    PMID: 28679843BACKGROUND

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Xia Li Zhang, doctor

    Geriatric Hospital of Nanjing Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior physiotherapist

Study Record Dates

First Submitted

January 9, 2024

First Posted

January 31, 2024

Study Start

February 28, 2024

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Three months after publication.
Access Criteria
Request from the researchers by email.

Locations