Cerebral Palsy (CP)NCT07806994
Wearable Eye Tracking During Bimanual Tasks in Children With Cerebral Palsy
A study testing Wearable Eye-Tracking Assessment During Structured Bimanual Tasks in people with Cerebral Palsy (CP), run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Wearable Eye-Tracking Assessment During Structured Bimanual Tasks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Aug 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Seoul, 06351
Youngsub Hwang, Ph.D, +821065292034, hys2034@skku.edu
Jeong Yi Kwon, PhD
About this study
Official title: 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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Wearable Eye-Tracking Assessment During Structured Bimanual Tasks
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Eye-Tracking Assessment During Structured Bimanual TasksOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Children With Unilateral Cerebral Palsy | Experimental | 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. Receives: Other: Wearable Eye-Tracking Assessment During Structured Bimanual Tasks |
| Typically Developing Children | Experimental | 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. Receives: Other: Wearable Eye-Tracking Assessment During Structured Bimanual Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Gaze-Position Verification Rate
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.
Measured: Day 1, before structured task recording
Wearable Eye-Tracking Protocol Completion Rates
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.
Measured: Day 1, during the single study visit (up to 180 minutes)
Mean Valid Gaze Data Proportion
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.
Measured: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Analyzable Eye-Tracking Trial Rate
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.
Measured: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Mean Total Study Assessment Duration
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.
Measured: 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
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.
Measured: Day 1, from the start of the study visit through the immediate post-assessment period (up to 180 minutes)
Secondary outcomes (4)
Mean Overall and Phase-Specific Task Performance Time
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.
Measured: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Mean Number of Task Errors and Instruction-Card Rechecks per Trial
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.
Measured: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Mean Time to First Target Fixation
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.
Measured: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Mean Area-of-Interest-Specific Fixation-Time Proportion
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.
Measured: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start31 Aug 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are enrolled into one of two parallel groups based on pre-existing clinical status: unilateral cerebral palsy or typical development. Both groups complete the same single-visit wearable eye-tracking and structured bimanual task-assessment protocol. Group assignment is non-randomized; no therapeutic treatment is assigned. The order of the three task conditions is counterbalanced within each participant.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Jeong Yi Kwon, Samsung Medical Center
- Investigators
- Jeong-Yi Kwon, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806994
- Sponsor's protocol ID
- SMC 2026-07-120
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves minors and includes potentially identifiable eye-tracking recordings and linked clinical assessment data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Wearable Eye-Tracking Protocol and Candidate Gaze-Action Metrics for Goal-Directed Bimanual Task Performance in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07806994
- Acronym / sponsor ID
- SMC 2026-07-120
- Conditions
- Cerebral Palsy (CP)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are enrolled into one of two parallel groups based on pre-existing clinical status: unilateral cerebral palsy or typical development. Both groups complete the same single-visit wearable eye-tracking and structured bimanual task-assessment protocol. Group assignment is non-randomized; no therapeutic treatment is assigned. The order of the three task conditions is counterbalanced within each participant.
| Arm | Type | Receives |
|---|---|---|
| Children With Unilateral Cerebral Palsy | Experimental | Other: Wearable Eye-Tracking Assessment During Structured Bimanual TasksChildren 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. |
| Typically Developing Children | Experimental | Other: Wearable Eye-Tracking Assessment During Structured Bimanual TasksTypically 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Eye-Tracking Assessment During Structured Bimanual TasksParticipants 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. | Other | Children With Unilateral Cerebral Palsy, Typically Developing Children |
Primary outcome
Successful Gaze-Position Verification Rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Mean Overall and Phase-Specific Task Performance Time
Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Mean Number of Task Errors and Instruction-Card Rechecks per Trial
Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Mean Time to First Target Fixation
Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Mean Area-of-Interest-Specific Fixation-Time Proportion
Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves minors and includes potentially identifiable eye-tracking recordings and linked clinical assessment data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeong-Yi Kwon, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Eye-Tracking Assessment During Structured Bimanual Tasks in people with Cerebral Palsy (CP), run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youngsub Hwang, PhD (+821065292034, hys2034@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Gaze-Position Verification Rate (time frame: Day 1, before structured task recording). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.