Wearable Eye Tracking During Bimanual Tasks in Children With Cerebral Palsy
2 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Youngsub Hwang, PhD
- Número de teléfono: +821065292034
- Correo electrónico: hys2034@skku.edu
Ubicaciones de estudio
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Seoul
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Seoul, Seoul, Corea del Sur, 06351
- Reclutamiento
- Samsung Medical Center
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Contacto:
- Youngsub Hwang, Ph.D
- Número de teléfono: +821065292034
- Correo electrónico: hys2034@skku.edu
-
Investigador principal:
- Jeong Yi Kwon, PhD
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Successful Gaze-Position Verification Rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Overall and Phase-Specific Task Performance Time
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jeong-Yi Kwon, PhD, Samsung Medical Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
31 de agosto de 2026
Finalización primaria (Estimado)
30 de julio de 2027
Finalización del estudio (Estimado)
30 de agosto de 2027
Fechas de registro del estudio
Enviado por primera vez
27 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Publicado por primera vez (Actual)
8 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SMC 2026-07-120
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .