RecruitingACTRN12624001291572

Validating a measure of eye movements after concussion

Validating a measure of eye movements after concussion in healthy and mild Traumatic Brain Injury (mTBI) participants aged between 18 - 40 years old.


Sponsor

Auckland University of Technology

Enrollment

30 participants

Start Date

Apr 17, 2025

Study Type

Observational

Conditions

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 Tobii Eye Tracker 3 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).


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

After a concussion (also called mild traumatic brain injury, or mTBI), many people experience ongoing symptoms including difficulties with balance, dizziness, and eye movement problems. Assessing how the eyes move and focus is one important way to measure recovery, but existing clinical tools do not always have strong scientific validation. This study is testing the accuracy and reliability of a clinical eye movement test called 'Hart Strings,' comparing it to a high-tech eye-tracking device. Participants complete the Hart Strings test twice while wearing specialised glasses that precisely record eye movements. Researchers will check whether the results of the simple clinical test match the detailed eye-tracking data — and whether the test gives consistent results when performed twice in the same session. You may be eligible if you are aged 18 to 40 and either have ongoing symptoms from a concussion in the past six months, or are a healthy person with no history of concussion in the past year. People with balance conditions like BPPV, unmanaged vision problems, or musculoskeletal issues that would affect standing and performing the test are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

- 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 physioth

- 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 Tobii Eye Tracker 3 eye-tracking glasses to enable concurrent data collection. The 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 1920 x 1080 pixels at 25 frames per second (FPS). With a gaze position accuracy of 0.6° for all distances, the glasses provide a gaze-tracking range of 95° horizontally and 63° vertically. The 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.


Locations(1)

Auckland, New Zealand

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