Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Wearable Eye Tracking During Bimanual Tasks in Children With Cerebral Palsy

2 september 2026 bijgewerkt door: Jeong Yi Kwon, Samsung Medical Center

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Youngsub Hwang, PhD
  • Telefoonnummer: +821065292034
  • E-mail: hys2034@skku.edu

Studie Locaties

  • Zuid -Korea
    • Seoul
      • Seoul, Seoul, Zuid -Korea, 06351
        • Werving
        • Samsung Medical Center
        • Contact:
        • Hoofdonderzoeker:
          • Jeong Yi Kwon, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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.
Experimenteel: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Successful Gaze-Position Verification Rate
Tijdsspanne: 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.
Day 1, before structured task recording
Wearable Eye-Tracking Protocol Completion Rates
Tijdsspanne: 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.
Day 1, during the single study visit (up to 180 minutes)
Mean Valid Gaze Data Proportion
Tijdsspanne: 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.
Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Analyzable Eye-Tracking Trial Rate
Tijdsspanne: 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.
Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Mean Total Study Assessment Duration
Tijdsspanne: 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.
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
Tijdsspanne: 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.
Day 1, from the start of the study visit through the immediate post-assessment period (up to 180 minutes)

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Samsung Medical Center

Medewerkers

National Research Foundation of Korea

Onderzoekers

  • Hoofdonderzoeker: Jeong-Yi Kwon, PhD, Samsung Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

31 augustus 2026

Primaire voltooiing (Geschat)

30 juli 2027

Studie voltooiing (Geschat)

30 augustus 2027

Studieregistratiedata

Eerst ingediend

27 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 september 2026

Eerst geplaatst (Werkelijk)

8 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 september 2026

Laatste update ingediend die voldeed aan QC-criteria

2 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SMC 2026-07-120

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared because the study involves minors and includes potentially identifiable eye-tracking recordings and linked clinical assessment data.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren