Wearable Eye Tracking During Bimanual Tasks in Children With Cerebral Palsy

Establishing a Wearable Eye-Tracking Protocol and Candidate Gaze-Action Metrics for Goal-Directed Bimanual Task Performance 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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy (CP)
• Intervention / Treatment: Other: Wearable Eye-Tracking Assessment During Structured Bimanual Tasks

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youngsub Hwang, PhD; Phone Number: +821065292034; Email: hys2034@skku.edu

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 06351
      • Recruiting
      • Samsung Medical Center
      • Contact: Youngsub Hwang, Ph.D; Phone Number: +821065292034; Email: hys2034@skku.edu
      • Principal Investigator: Jeong Yi Kwon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Children With Unilateral Cerebral Palsy; Children with unilateral cerebral palsy complete one study visit involving wearable eye tracking during 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 task conditions is counterbalanced. The same assessment protocol is administered to the typically developing comparison arm. The procedure is conducted for research measurement only and does not provide treatment or alter clinical care.	Other: Wearable Eye-Tracking Assessment During Structured Bimanual Tasks; 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.
Experimental: Typically Developing Children; Typically developing children complete the same single-visit wearable eye-tracking and structured task-assessment protocol as the cerebral palsy arm. Participants perform 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 task conditions is counterbalanced. This arm serves as the pre-specified comparison arm. The procedure does not provide treatment or alter clinical care.	Other: Wearable Eye-Tracking Assessment During Structured Bimanual Tasks; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Analyzable Eye-Tracking Trial Rate	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.	Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Mean Total Study Assessment Duration	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.	Day 1, from initiation of the first study assessment through completion or discontinuation of the final planned assessment (up to 180 minutes)
Number of Participants With Assessment-Related Discomfort or Protocol Interruption	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.	Day 1, from the start of the study visit through the immediate post-assessment period (up to 180 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Overall and Phase-Specific Task Performance Time	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.	Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Mean Number of Task Errors and Instruction-Card Rechecks per Trial	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.	Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Mean Time to First Target Fixation	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.	Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Mean Area-of-Interest-Specific Fixation-Time Proportion	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.	Day 1, during the structured eye-tracking task assessment (up to 180 minutes)

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: National Research Foundation of Korea
• Investigators: Principal Investigator: Jeong-Yi Kwon, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: August 27, 2026
• First Submitted That Met QC Criteria: September 2, 2026
• First Posted (Actual): September 8, 2026

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: SMC 2026-07-120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study involves minors and includes potentially identifiable eye-tracking recordings and linked clinical assessment data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No