Wearable Eye Tracking During Bimanual Tasks in Children With Cerebral Palsy

ConditionCerebral Palsy (CP)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-12

SponsorSamsung Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Diagnosis of cerebral palsy confirmed by a pediatric physiatrist

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Wearable Eye-Tracking Assessment During Structured Bimanual Tasks
Other intervention
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Children With Unilateral Cerebral PalsyExperimental treatment 1 intervention

Group B: Typically Developing ChildrenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Successful Gaze-Position Verification Rate

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.

Time frame

Day 1, before structured task recording

Wearable Eye-Tracking Protocol Completion Rates

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.

Time frame

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

Mean Valid Gaze Data Proportion

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.

Time frame