Wearable Eye Tracking During Bimanual Tasks in Children With Cerebral Palsy
2 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Youngsub Hwang, PhD
- Numéro de téléphone: +821065292034
- E-mail: hys2034@skku.edu
Lieux d'étude
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Seoul
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Seoul, Seoul, Corée du Sud, 06351
- Recrutement
- Samsung Medical Center
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Contact:
- Youngsub Hwang, Ph.D
- Numéro de téléphone: +821065292034
- E-mail: hys2034@skku.edu
-
Chercheur principal:
- Jeong Yi Kwon, PhD
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Expérimental: 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.
|
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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Successful Gaze-Position Verification Rate
Délai: 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.
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Day 1, before structured task recording
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Wearable Eye-Tracking Protocol Completion Rates
Délai: Day 1, during the single study visit (up to 180 minutes)
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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.
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Day 1, during the single study visit (up to 180 minutes)
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Mean Valid Gaze Data Proportion
Délai: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
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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.
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Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
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Analyzable Eye-Tracking Trial Rate
Délai: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
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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.
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Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
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Mean Total Study Assessment Duration
Délai: Day 1, from initiation of the first study assessment through completion or discontinuation of the final planned assessment (up to 180 minutes)
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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.
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Day 1, from initiation of the first study assessment through completion or discontinuation of the final planned assessment (up to 180 minutes)
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Number of Participants With Assessment-Related Discomfort or Protocol Interruption
Délai: Day 1, from the start of the study visit through the immediate post-assessment period (up to 180 minutes)
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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.
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Day 1, from the start of the study visit through the immediate post-assessment period (up to 180 minutes)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean Overall and Phase-Specific Task Performance Time
Délai: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
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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.
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Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
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Mean Number of Task Errors and Instruction-Card Rechecks per Trial
Délai: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
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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.
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Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
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Mean Time to First Target Fixation
Délai: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
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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.
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Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
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Mean Area-of-Interest-Specific Fixation-Time Proportion
Délai: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
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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.
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Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jeong-Yi Kwon, PhD, Samsung Medical Center
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
31 août 2026
Achèvement primaire (Estimé)
30 juillet 2027
Achèvement de l'étude (Estimé)
30 août 2027
Dates d'inscription aux études
Première soumission
27 août 2026
Première soumission répondant aux critères de contrôle qualité
2 septembre 2026
Première publication (Réel)
8 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SMC 2026-07-120
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be shared because the study involves minors and includes potentially identifiable eye-tracking recordings and linked clinical assessment data.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .