Wearable Eye Tracking During Bimanual Tasks in Children With Cerebral Palsy
2026年9月2日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Youngsub Hwang, PhD
- 電話番号：+821065292034
- メール：hys2034@skku.edu
研究場所
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Seoul
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Seoul、Seoul、韓国、06351
- 募集
- Samsung Medical Center
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コンタクト：
- Youngsub Hwang, Ph.D
- 電話番号：+821065292034
- メール：hys2034@skku.edu
-
主任研究者：
- Jeong Yi Kwon, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Successful Gaze-Position Verification Rate
時間枠：Day 1, before structured task recording
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Overall and Phase-Specific Task Performance Time
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Jeong-Yi Kwon, PhD、Samsung Medical Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年8月31日
一次修了 (推定)
2027年7月30日
研究の完了 (推定)
2027年8月30日
試験登録日
最初に提出
2026年8月27日
QC基準を満たした最初の提出物
2026年9月2日
最初の投稿 (実際)
2026年9月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月8日
QC基準を満たした最後の更新が送信されました
2026年9月2日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data will not be shared because the study involves minors and includes potentially identifiable eye-tracking recordings and linked clinical assessment data.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。