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Trial registered on ANZCTR
Registration number
ACTRN12620001100987
Ethics application status
Approved
Date submitted
19/08/2020
Date registered
22/10/2020
Date last updated
6/04/2022
Date data sharing statement initially provided
22/10/2020
Date results information initially provided
6/04/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
Reliability Of Oculomotor Tests Used To Assess Mild Traumatic Brain Injury (mTBI)
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Scientific title
Reliability Of Oculomotor Tests Used To Assess mTBI in healthy adults
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Secondary ID [1]
302070
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None
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Universal Trial Number (UTN)
U1111-1233-0051
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Trial acronym
ROMT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Oculomotor dysfunction
318668
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Mild traumatic brain injury
318669
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Condition category
Condition code
Neurological
316687
316687
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0
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Other neurological disorders
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Injuries and Accidents
317043
317043
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0
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Other injuries and accidents
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Eye
317044
317044
0
0
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Computerised eye tracking tests that consist of ~10-15minutes of different tests. The tests centre around watching a target presented on a computer screen. Tests include fixation, pursuits, ocular following, vestibulo-ocular test, saccades and the Stroop test. The participants will do the tests once (the tests are presented in a random order), wait at least 5 minutes and then repeat the eye tests again (also in a random order)
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Intervention code [1]
318368
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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This a composite primary outcome (Oculomotor outcomes, including saccades, anti-saccades, fixations, smooth pursuits, ocular following, Vestibulo-ocular reflex, Stroop test and egocentric localisation) . All outcomes are determined from computerised eye tracking record record by an infra-red camera.
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Assessment method [1]
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Timepoint [1]
324814
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during one-off eye-tracking session where the participant performs all tests twice
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Secondary outcome [1]
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Nil
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Assessment method [1]
385836
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Timepoint [1]
385836
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Nil
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Eligibility
Key inclusion criteria
Adults over the age of 18 years that have normal (or corrected to normal) vision and no visual issues that affect eye movements (such as; ADHD, loss of vision in one eye, stroke or cranial nerve palsy).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Non other than what is specified in the inclusion criteria
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
Twenty-five adults will be recruited A sample size of 25 was selected based on an expected intraclass correlation coefficient of 0.8 and a 95% confidence interval that excluded 0.61, which was predefined as the lowest acceptable level of test-retest reliability based on the recommendations made by Shrout (1998) (Barch & Yarkoni, 2013; Koo & Li, 2016; Shrout, 1998; Walter, Eliasziw, & Donner, 1998). All adults over the age of 18 would be eligible to participate, but an attempt was made to recruit young adults where possible. A convenience sampling frame was used.
To assess test-retest reliability of the primary outcome measures intraclass correlation coefficients will be calculated using two way mixed models with consistency as the type and single measurements. Spearman’s correlation coefficients will also be calculated to account for the non-parametric nature of some of the data. Scatter plots will also be created to visually assess the data. Bland-Altman plots will also be presented as an alternative measure of validity.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
10/07/2020
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Date of last participant enrolment
Anticipated
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Actual
1/10/2021
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Date of last data collection
Anticipated
30/11/2020
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Actual
31/10/2021
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Sample size
Target
35
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Accrual to date
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Final
35
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Recruitment outside Australia
Country [1]
22861
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New Zealand
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State/province [1]
22861
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Auckand
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Funding & Sponsors
Funding source category [1]
305476
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University
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Name [1]
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University of Auckland
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Address [1]
305476
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85 Park Road, Grafton, Auckland 1023
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Country [1]
305476
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
85 Park Road, Grafton, Auckland 1023
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Country
New Zealand
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Secondary sponsor category [1]
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Other
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Name [1]
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New Zealand College of Chiropractic
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Address [1]
305874
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6 Harrison Road,
Mt Wellington 1060
Auckland
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Country [1]
305874
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305792
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Health and Disabilities Ethics Committee New Zealand
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Ethics committee address [1]
305792
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Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
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Ethics committee country [1]
305792
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New Zealand
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Date submitted for ethics approval [1]
305792
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21/05/2019
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Approval date [1]
305792
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21/08/2019
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Ethics approval number [1]
305792
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19/CEN/130
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Summary
Brief summary
This first study aims to test the reliability and validity of computerised eye tracking tests in young adults. This study includes the refinement of eye-tracking procedures in order to minimise test-retest differences in tests for eye movement function, integrating multiple senses and participant perceived body midline
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Phil Turnbull
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Address
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University of Auckland, School of Optometry and Vision Science, 85 Park Road, Grafton, Auckland 1023
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Country
101610
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New Zealand
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Phone
101610
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+64 9 373 7599
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Alice Cade
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Address
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University of Auckland, School of Optometry and Vision Science, 85 Park Road, Grafton, Auckland 1023
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Country
101611
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New Zealand
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Phone
101611
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+64 21 400 739
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Fax
101611
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Email
101611
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[email protected]
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Contact person for scientific queries
Name
101612
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Ms Alice Cade
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Address
101612
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University of Auckland, School of Optometry and Vision Science, 85 Park Road, Grafton, Auckland 1023
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Country
101612
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New Zealand
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Phone
101612
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+64 21 400 739
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Fax
101612
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Email
101612
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Analytical code (R language) which is used to analyse the raw files of eye tracking data that can be recorded during the eye tracking tests
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When will data be available (start and end dates)?
Starts date - some code is available now (16/09/2020)
End date - code will be available in perpetuity
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Available to whom?
Public
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Available for what types of analyses?
Reproducing results in similar studies
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How or where can data be obtained?
By contacting the principal investigator:
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
3879
Basic results
No
379638-(Uploaded-10-01-2023-12-37-42)-Basic results summary.docx
4146
Plain language summary
No
Mild traumatic brain injury (mTBI) is a common and...
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