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NCT Number: NCT07806994

Wearable Eye Tracking During Bimanual Tasks in Children With Cerebral Palsy

This observational pilot study will include 40 children and adolescents aged 6 to 12 years: 20 with cerebral palsy and 20 with typical development. The main purpose is to determine whether Pupil Labs Neon wearable eye-tracking glasses can be used reliably while participants perform structured tasks using both hands.

Each participant will attend one study visit. After assessments of near vision, hand function, visual perception, visual-motor function, and attention-related characteristics, participants will wear the eye-tracking glasses. They will view an instruction card, find target objects, and place the objects into boxes using both hands. The tasks will be completed under three conditions that vary visual-search and sequencing demands, with breaks provided as needed.

Researchers will evaluate whether the planned procedures can be completed and whether the recordings provide usable eye-tracking data. Exploratory analyses will examine how gaze and hand actions are coordinated and whether these patterns differ between the cerebral palsy and typical-development groups or across task conditions. No treatment will be provided, and the study is not designed to evaluate treatment effectiveness. The findings will be used to improve the measurement protocol and quality-control procedures for future research.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Location status: Recruiting

Location contact

Jeong Yi Kwon, PhD

PRINCIPAL_INVESTIGATOR

Youngsub Hwang, Ph.D

CONTACT

[email protected]

+821065292034

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

General Inclusion Criteria

Children aged 6-12 years

  • Ability to understand simple instructions required for the study procedures and perform structured visual and bimanual tasks
  • For children who routinely wear glasses or contact lenses, ability to view near visual stimuli and task materials with their habitual vision correction
  • Written informed consent provided by a parent or legally authorized representative, with the child providing assent after receiving an age- and developmentally appropriate explanation of the study

Cerebral Palsy Group

  • Diagnosis of cerebral palsy confirmed by a pediatric physiatrist
  • Manual Ability Classification System (MACS) level I-III
  • Ability to grasp or manipulate task materials with at least one hand and attempt bimanual task performance

Typically Developing Group

  • Typical developmental history based on parent report and confirmation by the research team
  • No history of neurological disorders, including cerebral palsy, or musculoskeletal conditions affecting upper-limb function
  • No diagnosis of a neurodevelopmental disorder that may affect task performance, such as attention-deficit/hyperactivity disorder, autism spectrum disorder, or intellectual disability

Exclusion criteria

  • Visual impairment that prevents the child from adequately viewing near visual stimuli or task materials, even with habitual vision correction
  • Severe strabismus, nystagmus, or another ophthalmologic condition judged likely to substantially compromise stable eye-tracking data collection
  • Severe cognitive, communication, or behavioral difficulties that prevent adequate understanding or performance of the study tasks
  • Severe upper-limb joint contracture, pain, fracture, or another musculoskeletal condition that prevents safe performance of the bimanual tasks
  • Uncontrolled epilepsy, acute illness, unstable medical condition, or any other condition judged to make study participation unsafe

Treatment and study plan

Wearable Eye-Tracking Assessment During Structured Bimanual Tasks

Other

Participants wear the Pupil Neon eye-tracking system during one study visit while performing structured visual-search and goal-directed bimanual tasks under a standard condition, an increased visual-search-demand condition, and an increased sequencing-demand condition. The order of conditions is counterbalanced. The system records two-dimensional gaze coordinates and egocentric scene video to evaluate protocol feasibility, data quality, and exploratory gaze-behavior measures. The assessment is research-specific and does not provide treatment, rehabilitation training, visual cues, stimulation, or performance feedback and does not alter clinical care.

Primary outcomes

  1. Successful Gaze-Position Verification Rate

    Time frame: Day 1, before structured task recording

    Percentage of participants for whom gaze position is successfully verified at predefined central and task-relevant locations before task recording, after offset correction when needed. The rate will be calculated as the number with successful verification divided by the number attempting eye-tracker setup, multiplied by 100. Reasons for unsuccessful verification will be recorded.

  2. Wearable Eye-Tracking Protocol Completion Rates

    Time frame: Day 1, during the single study visit (up to 180 minutes)

    Three completion percentages will be calculated separately: (1) participants successfully fitted with the Pupil Neon and starting recording divided by all enrolled participants; (2) participants completing all three planned task conditions divided by those starting the wearable eye-tracking assessment; and (3) participants completing each condition divided by those scheduled for that condition. Each value will be multiplied by 100. Reasons for noncompletion will be categorized.

  3. Mean Valid Gaze Data Proportion

    Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)

    Percentage of sampled time points within each predefined analysis interval for which a valid two-dimensional gaze coordinate is available. Values range from 0 to 100, with higher values indicating more complete gaze data. Results will be summarized by task condition and study group. Trials with less than 70 percent valid gaze data will be flagged for quality control but retained in the feasibility denominator.

  4. Analyzable Eye-Tracking Trial Rate

    Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)

    Percentage of attempted trials with synchronized scene video, gaze coordinates, and task-event annotations sufficient to derive the predefined area-of-interest and event measures. The rate will be calculated as the number of analyzable trials divided by all attempted trials, multiplied by 100. Reasons for non-analyzability will be categorized as device slippage, field-of-view occlusion, lighting problems, signal loss, missing data streams, synchronization failure, or other.

  5. Mean Total Study Assessment Duration

    Time frame: Day 1, from initiation of the first study assessment through completion or discontinuation of the final planned assessment (up to 180 minutes)

    Elapsed time in minutes from initiation of the first study assessment after consent to completion or discontinuation of the final planned assessment, including rest breaks. Duration will be summarized separately for each study group.

  6. Number of Participants With Assessment-Related Discomfort or Protocol Interruption

    Time frame: Day 1, from the start of the study visit through the immediate post-assessment period (up to 180 minutes)

    Number and percentage of participants experiencing fatigue, eye strain, pressure from the eye-tracking glasses, headache, dizziness, upper-limb fatigue, distress or refusal, or other discomfort, and participants requiring a pause, device adjustment, or early discontinuation. Events will be summarized by type, severity, action taken, and resolution.

Secondary outcomes

  1. Mean Overall and Phase-Specific Task Performance Time

    Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)

    Mean time in seconds from task onset to task completion and for the predefined phases of instruction-card viewing, visual search, object selection, transport, insertion, and phase transition. Each timing measure will be reported separately by task condition and study group.

  2. Mean Number of Task Errors and Instruction-Card Rechecks per Trial

    Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)

    Mean number per trial of incorrect object selections, sequence errors, and returns to the instruction card. Each event type will be reported separately by task condition and study group. Higher counts indicate more frequent task-performance disruptions.

  3. Mean Time to First Target Fixation

    Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)

    Mean time in seconds from the trial-start event to the onset of the first valid fixation within the target area of interest. Longer times indicate slower visual identification of the target.

  4. Mean Area-of-Interest-Specific Fixation-Time Proportion

    Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)

    Percentage of total valid fixation duration within the analysis interval allocated to each predefined area of interest, including the target, non-target items, and distractors. Each area-of-interest proportion will be reported separately by task condition and study group.

Study contacts

Contact information is provided by the study sponsor or research team.

Youngsub Hwang, PhD

CONTACT

[email protected]

+821065292034

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Official study title

Establishing a Wearable Eye-Tracking Protocol and Candidate Gaze-Action Metrics for Goal-Directed Bimanual Task Performance in Children With Cerebral Palsy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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