Establishing a Wearable Eye-Tracking Protocol and Candidate Gaze-Action Metrics for Goal-Directed Bimanual Task Performance in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Successful Gaze-Position Verification Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Wearable Eye-Tracking Assessment During Structured Bimanual Tasks (Other)
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.
干预措施: Wearable Eye-Tracking Assessment During Structured Bimanual Tasks (Other)
结局指标
主要结局
Successful Gaze-Position Verification Rate
时间窗: 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.
Wearable Eye-Tracking Protocol Completion Rates
时间窗: 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.
Mean Valid Gaze Data Proportion
时间窗: 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.
Analyzable Eye-Tracking Trial Rate
时间窗: 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.
Mean Total Study Assessment Duration
时间窗: 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.
Number of Participants With Assessment-Related Discomfort or Protocol Interruption
时间窗: 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.
次要结局
- Mean Area-of-Interest-Specific Fixation-Time Proportion(Day 1, during the structured eye-tracking task assessment (up to 180 minutes))
- Mean Overall and Phase-Specific Task Performance Time(Day 1, during the structured eye-tracking task assessment (up to 180 minutes))
- Mean Number of Task Errors and Instruction-Card Rechecks per Trial(Day 1, during the structured eye-tracking task assessment (up to 180 minutes))
- Mean Time to First Target Fixation(Day 1, during the structured eye-tracking task assessment (up to 180 minutes))
研究者
Jeong Yi Kwon
Professor
Samsung Medical Center