ClinicalTrials.gg
RecruitingNCT07806994Updated Sep 8, 2026

Wearable Eye Tracking During Bimanual Tasks in Children With Cerebral Palsy

An interventional study of Wearable Eye-Tracking Assessment During Structured Bimanual Tasks in Cerebral Palsy (CP), sponsored by Samsung Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
6 Years to 12 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 56 studies in Cerebral Palsy with a site in Korea, Republic of — 7 open to participants now, 8 under way, none of them phase 3. Cerebral Palsy · Korea, Republic of.

Planned enrollment
17th of 46
40 · median 31
Started
2026
with 2 others
No phase
31 of 56
4 open now
Registered
54th of 56
by date
Lead sponsor
5 of 56
Samsung Medical Center

Among the 56 studies in Cerebral Palsy with a site in Korea, Republic of, this one is the 17th largest by planned enrollment of the 46 interventional ones that give a count, is one of 3 that started in 2026, is one of 31 with no phase, and was the 54th registered.

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

Browse Cerebral Palsy studies →

Open to participants now

7 of the 56 studies in Cerebral Palsy with a site in Korea, Republic of are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 270 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 235 (87%) stop at 75 or younger; 255 take children under 18; 51 take healthy volunteers.

This study: 6 Years to 12 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 56 studies in Cerebral Palsy with a site in Korea, Republic of, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Cerebral Palsy (CP)

Browse trials for

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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.

    Other: Wearable Eye-Tracking Assessment During Structured Bimanual Tasks

  • 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.

    Other: Wearable Eye-Tracking Assessment During Structured Bimanual Tasks

Interventions

  • OtherWearable Eye-Tracking Assessment During Structured Bimanual Tasks

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1, before structured task recording

  2. 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.

    Time frame: Day 1, during the single study visit (up to 180 minutes)

  3. 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.

    Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)

  4. 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.

    Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)

  5. 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.

    Time frame: Day 1, from initiation of the first study assessment through completion or discontinuation of the final planned assessment (up to 180 minutes)

  6. 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.

    Time frame: Day 1, from the start of the study visit through the immediate post-assessment period (up to 180 minutes)

Secondary outcomes

  1. 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.

    Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)

  2. 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.

    Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)

  3. 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.

    Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)

  4. 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.

    Time frame: Day 1, during the structured eye-tracking task assessment (up to 180 minutes)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jul 2027, 10 months after the start.

Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 10 months is below that.

Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2026
First posted
Sep 8, 2026
StartActual
Aug 31, 2026
Primary completionEst.
Jul 30, 2027
CompletionEst.
Aug 30, 2027
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07806994
Collaborators
National Research Foundation of Korea
Responsible party
Jeong Yi Kwon (Professor, Samsung Medical Center) — Principal investigator
First posted
Sep 8, 2026
Start date
Aug 31, 2026
Primary completion
Jul 30, 2027 (estimated)
Completion
Aug 30, 2027 (estimated)
Last update
Sep 8, 2026

Study contacts

Youngsub Hwang, PhD
Contact
hys2034@skku.edu
+821065292034
Jeong-Yi Kwon, PhD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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