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Trial registered on ANZCTR


Registration number
ACTRN12624001291572
Ethics application status
Approved
Date submitted
7/10/2024
Date registered
24/10/2024
Date last updated
24/10/2024
Date data sharing statement initially provided
24/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Validating a measure of eye movements after concussion
Scientific title
Validating a measure of eye movements after concussion in healthy and mild Traumatic Brain Injury (mTBI) participants aged between 18 - 40 years old.
Secondary ID [1] 312916 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild traumatic brain injury 335079 0
Concussion 335080 0
Condition category
Condition code
Neurological 331583 331583 0 0
Other neurological disorders
Injuries and Accidents 332050 332050 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
- Participants will complete the Hart Strings test. This assesses vestibular and oculomotor function through three standardised, timed conditions and is currently used in clinical practice by physiotherapists. These are an adaptation of the Hart Chart Rock exercise, and Saccade grids exercise, commonly used as treatments for oculomotor dysfunction. The third condition challenges the Vestibulo-Ocular Reflex as per the Dynamic Visual Acuity Test. Participants stand with feet together, 90cm from a wall, with two Hart charts (10cm x 10cm grid of letters) on the wall at eye level, 30cm apart. Participants will complete each condition as fast as possible for 30 seconds in a set pattern. The position of the last completed letter on the grid provides the score. Participants will complete two repetitions of the Hart Strings test, separated by five minutes of rest. These tests will be administered by a member of the research team who will observe participants and monitor adherence.
- During the Hart Strings testing, participants will wear SensoMotoricInstruments (SMI) eye-tracking glasses to enable concurrent data collection through gold-standard SMI BeGaze software. The SMI eye tracking glasses are portable and are worn like a regular pair of reading glasses. They employ infrared light to enhance the contrast between the pupil and the iris, facilitating detection by the camera on the principle of pupil centre corneal reflection. It’s scene camera offers resolution of 1280 x 690 pixels at 24 frames per second (FPS) and 960 x 720 pixels at 30 FPS. With a gaze position accuracy of 0.5° for all distances, SMI glasses provide a gaze-tracking range of 80° horizontally and 60° vertically. The SMI BeGaze software conducts a frame-by-frame analysis of gaze data. This involves identifying the nature and location of gaze behaviour, including duration of eye movements, saccades, fixations, and blinks. The glasses need to be calibrated prior to testing; this takes approximately 30 seconds.
Intervention code [1] 329449 0
Diagnosis / Prognosis
Comparator / control treatment
Healthy (non-injured) controls.
Control group
Active

Outcomes
Primary outcome [1] 339318 0
Oculomotor performance
Timepoint [1] 339318 0
Single timepoint, two repetitions of test separated by 5 min
Secondary outcome [1] 439447 0
Oculomotor performance
Timepoint [1] 439447 0
Single timepoint, concurrent data collection during Hart Strings test

Eligibility
Key inclusion criteria
Healthy participants
Inclusion criteria:
i: 18-40 years old.

mTBI participants
Inclusion criteria:
i: 18-40 years old.
ii: have ongoing symptoms from a diagnosis of mTBI (mild traumatic brain injury) within the last six months.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Healthy group:
Exclusion criteria:
i: a self-reported history of mTBI in the previous 12 months or complaining of residual symptoms from a previous mTBI at any point.
ii: diagnosed peripheral vestibular conditions such as BPPV, and/or oculomotor or visual problems that are not mitigated with wearing corrective lenses.
iii: self-reported acute illness; or a positive response to any of the COVID-19 screening questions indicating risk of potential infection.
iiii: musculoskeletal issues or medical conditions that would limit the ability to safely and consistently perform the outcome measure (e.g. neck injuries, an ankle sprain limited standing).

mTBI group:
Exclusion criteria:
i: a diagnosis of moderate/severe TBI
ii: diagnosed peripheral vestibular conditions such as BPPV, and/or oculomotor or visual problems prior to the mTBI that are not mitigated with wearing corrective lenses.
iii: self-reported acute illness; or a positive response to any of the COVID-19 screening questions indicating risk of potential infection.
iiii: musculoskeletal issues or medical conditions that would limit the ability to safely and consistently perform the outcome measure (e.g. neck injuries, an ankle sprain limiting standing).

Study design
Purpose
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Research questions:
1) Is the novel Hart Strings measure valid compared with a gold-standard eye-tracking measure? Acceptable validity defined as r = 0.5.
2) Is the novel Hart Strings measure reliable within a session? Acceptable reliability is defined as intra-class coefficient = 0.75.
Based on an anticipated correlation coefficient of = 0.4, 15 subjects would allow the planned validation correlation analysis at a statistical power of 80%, with a significance level of 0.05 (two-tailed). 15 healthy, and 15 mTBI participants will therefore be recruited to allow for the measure to be validated in both populations. This sample size will also allow the planned analysis for within-session reliability for ICC = 0.75 with the same power and significance level.
Pearson correlation coefficients will be calculated to examine criterion validity of the Hart
Strings test in comparison to the SMI eye-tracking data. The metrics of interest from the SMI data will be ‘dwell time’ (duration of fixations) in milliseconds, number of fixations, number of saccades, and total task time in milliseconds. Intraclass correlation coefficients will be calculated to investigate the within-session reliability of the Hart Strings outcomes. The research team will review the results of this study to inform potential future use of the measure.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/06/2025
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26548 0
New Zealand
State/province [1] 26548 0
Auckland

Funding & Sponsors
Funding source category [1] 317348 0
Government body
Name [1] 317348 0
Health Research Council of NZ
Country [1] 317348 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Country
New Zealand
Secondary sponsor category [1] 319636 0
None
Name [1] 319636 0
Address [1] 319636 0
Country [1] 319636 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316078 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 316078 0
https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
Ethics committee country [1] 316078 0
New Zealand
Date submitted for ethics approval [1] 316078 0
11/07/2024
Approval date [1] 316078 0
02/09/2024
Ethics approval number [1] 316078 0
2024 FULL 19505
Ethics committee name [2] 316079 0
Auckland University of Technology Ethics Committee
Ethics committee address [2] 316079 0
https://www.aut.ac.nz/research/researchethics
Ethics committee country [2] 316079 0
New Zealand
Date submitted for ethics approval [2] 316079 0
06/09/2024
Approval date [2] 316079 0
04/10/2024
Ethics approval number [2] 316079 0
24/291

Summary
Brief summary
This study's primary aim is validating a clinical measure of eye movements 'Hart Strings' for use in further research. Participants will complete the Hart Strings measure twice, while wearing gold-standard SensoMotoric Instruments (SMI) eye-tracking glasses. This will allow exploration of validity, through the correlation between Hart Strings and eye-tracking outcomes such as fixations, latency and mean saccade error, and the within-session reliability of the Hart Strings test. Additional data on Hart Strings reliability (within- and between-session) will be collected during a separate clinical trial of cross-over design. The study hypothesis is that the Hart Strings will identify (characterised by a lower score) poorer oculomotor performance where the eye-tracking outcomes are also poor (characterised by increased latency, fixations and/or saccade error).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136710 0
Ms Katherine Forch
Address 136710 0
Auckland University of Technology North Campus, 90 Akoranga Drive, Northcote, Auckland 0627
Country 136710 0
New Zealand
Phone 136710 0
+64 274450595
Fax 136710 0
Email 136710 0
[email protected]
Contact person for public queries
Name 136711 0
Katherine Forch
Address 136711 0
Auckland University of Technology North Campus, 90 Akoranga Drive, Northcote, Auckland 0627
Country 136711 0
New Zealand
Phone 136711 0
+64 274450595
Fax 136711 0
Email 136711 0
[email protected]
Contact person for scientific queries
Name 136712 0
Katherine Forch
Address 136712 0
Auckland University of Technology North Campus, 90 Akoranga Drive, Northcote, Auckland 0627
Country 136712 0
New Zealand
Phone 136712 0
+64 274450595
Fax 136712 0
Email 136712 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.