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Cerebral PalsyNCT07824531

Feasibility of Vision-Language Models for Detecting Physical Assistance as an Observable Criterion Defining GMFCS Levels in Children Aged 2 to 6 Years With Cerebral Palsy

An observational study of Cerebral Palsy, run by Samsung Medical Center at 2 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The GMFCS sorts children with cerebral palsy into five levels of gross motor function. What mainly separates one level from the next is two things an observer can see: whether another person has to physically help the child move, and whether the child has to bear weight on something external, such as a walker, a… Read more about this study

Who is it for?
Ages 2 to 6 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Vision-language model assessment of movement video
How many people
26 participants
Where
2 sitesSouth Korea
Study dates
30 May 2025to Dec 2026
Phase
Observational
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 2 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children with cerebral palsy aged 2 to 6 years under the care of the department of physical and rehabilitation medicine at Samsung Medical Center or Asan Medical Center, each with a GMFCS level assigned by the treating clinician. All five GMFCS levels are represented. Children were enrolled as they attended, without random selection.

Who may be able to join

  • Clinical diagnosis of cerebral palsy
  • Aged 2 to 6 years at the time of video recording
  • Under the care of the department of physical and rehabilitation medicine at Samsung Medical Center or Asan Medical Center
  • A GMFCS level assigned by the treating clinician
  • Written informed consent from a parent or legal guardian for video recording

Who cannot join

  • Consent for video recording is not given
  • GMFCS level cannot be clearly assessed
  • The child or the parent or legal guardian declines to take part in the study
  • Withdrawal Criteria:
  • The child or the parent or legal guardian requests withdrawal during the study
  • The collected video is not of adequate quality for analysis
  • The participant's health status changes substantially during the study period

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites
  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

Official title: Feasibility of a Self-Hosted Vision-Language Model for Detecting Caregiver Contact and External Support, the Observable Criteria That Define GMFCS Levels, From Multi-View Movement Video in Children Aged 2 to 6 Years With Cerebral Palsy: A Two-Center Diagnostic Accuracy Study

The GMFCS sorts children with cerebral palsy into five levels of gross motor function. What mainly separates one level from the next is two things an observer can see: whether another person has to physically help the child move, and whether the child has to bear weight on something external, such as a walker, a support stand, or furniture. Scoring these takes an experienced clinician, and it is hardest between the ages of 2 and 6.

This study asks a narrow question. Can a vision-language model, meaning an artificial-intelligence model that looks at images and answers questions about them, detect those two things from short video clips of a child moving?

Read more

Twenty-six children with cerebral palsy aged 2 to 6 years were filmed at two hospitals. Each child performed everyday movements, including walking, crawling, rolling sideways, rising from the floor to standing, and lowering back to the floor, and up to three cameras recorded every attempt at the same time. Sixteen still frames were taken from each recorded attempt, always sixteen, and shown to the model without the child's identity, the name of the movement, or the child's GMFCS level.

The model answers two yes-or-no questions and nothing else: did an adult touch the child, and did the child bear weight on an external object. A fixed rule, not the model, turns those answers into one determination per attempt, namely whether the child performed the movement unaided. These determinations are compared with what a human annotator recorded for the same clips while blind to clinical information.

All rating is done with open-weight models running on hardware the investigators control, and every reported figure is tied to the specific model version that produced it.

The study does not assign a GMFCS level, and it is not built to. It tests whether the two observations the GMFCS itself relies on can be read from video reliably. If they can, they can be placed in front of a clinician as evidence, which is where later work on supporting GMFCS assessment would start.

Read the detailed description

BACKGROUND

The GMFCS-E\&R separates its five levels mainly by two things: what a child cannot do without help from another person, and what a child cannot do without a hand-held mobility device. The wording is explicit in the age bands relevant here. At Level I a child moves in and out of floor sitting and standing "without adult assistance." At Level III a child "may require adult assistance to assume sitting" and needs "adult assistance for steering and turning" when walking with a walker. Adult contact and external support are therefore not proxies chosen for convenience. They are part of the definition.

Scoring them is another matter. It takes an experienced clinician, it is slow, and between 2 and 6 years of age the assignment is known to be difficult.

STUDY DESIGN

This is a two-center feasibility study of a determination made from video. The index test is a binary determination produced by an open-weight vision-language model. The reference standard is a human annotator's record of the same clips. No clinical grade is requested from the model at any point.

Four elements define the design.

First, analyses are stratified by participant and by movement class. Summary statistics are computed within a stratum and pooled afterward, so movement class cannot vary with the outcome.

Second, each movement attempt is reduced to exactly 16 frames, 8 from each of two camera views. The count is fixed and is never scaled to clip duration.

Third, the model receives the frames with no identifier, no movement name and no GMFCS level, and answers two questions: was the child touched by an adult, and did the child bear load through an external object.

Fourth, a deterministic rule combines the two answers. An attempt counts as performed unaided when both answers are negative.

BLINDING

No masking of intervention assignment applies, because the study has a single group and no assignment step. What is masked is the reading of the data, and it is masked on both sides.

The rater model sees only the extracted image frames. It is given no participant identifier, no movement name, no GMFCS level and no other clinical information, and it is never shown what the reference standard recorded for that attempt. Each request carries one attempt and nothing else, so nothing learned from one attempt can be carried into the next.

The human annotator who produced the reference standard worked from the clips alone, blind to clinical information, and recorded the two features before any model output existed. The stimulus set was fingerprinted and sealed before rating began, and the rating files are recorded as absent in that seal, which is positive evidence that no model output existed at the time the stimuli were fixed.

The index test and the reference standard were therefore read independently of each other. Neither reader saw the other's output.

PARTICIPANTS AND RECORDINGS

Twenty-six children with cerebral palsy were enrolled, 15 at Samsung Medical Center and 11 at Asan Medical Center. Ages ranged from 25 to 72 months, median 48.5 months. Fifteen were male and 11 female. All five GMFCS levels are represented: 8 children at Level I, 4 at Level II, 3 at Level III, 3 at Level IV and 8 at Level V.

Five movement classes were filmed: walking, crawling, side-rolling, floor sit-to-stand and stand-to-floor-sit. The unit of annotation is the movement attempt, filmed by up to three cameras at once. The dataset holds 536 annotated attempts across 1,554 clip files, recorded at 1920 x 1080 and 30 frames per second.

REFERENCE STANDARD

One annotator, blind to clinical information, recorded two features for every attempt: whether a caregiver physically assisted the child, and whether the child used an acrylic support stand or a walker.

ANALYSIS AND IMAGE-INDEPENDENT CONTROLS

A clinical video dataset carries the answer in places that have nothing to do with the images, so every reported figure is set against baselines that read no image content at all: majority class, movement repertoire alone, a clip-duration threshold and scene composition alone.

Two of these baselines are strong in this dataset, and they are the reason the design takes the form it does. The set of movement classes a clinician chose to film for a child recovers the dichotomized GMFCS group in 25 of 26 children, which is why analyses are stratified by movement class. Mean clip duration alone recovers it in 25 of 26, which is why the frame count per attempt is fixed. For the same reason the primary reporting level is the two video-derived determinations rather than a participant-level grade. Participant-level aggregates are always reported beside their image-independent control.

RATER MODELS

Rating uses open-weight vision-language models run on hardware controlled by the investigators. Each model is identified by name and version, and no accuracy figure is carried beyond the version that produced it. Whether one rater model can be substituted for another is treated as something to measure rather than assume, and agreement between raters on identical image inputs is reported.

SCOPE

The study is designed to show whether adult contact and external support can be read from video by an open-weight vision-language model closely enough to a human annotator to be useful. It does not assign a GMFCS level.

Those two features are part of how the GMFCS defines its levels, so reading them reliably from video contributes to GMFCS assessment directly rather than alongside it. If the feasibility holds, the same two determinations can be put in front of a clinician as video-derived evidence for criteria that are at present judged by eye, and can serve as the input layer for later work on supporting GMFCS assessment between 2 and 6 years of age, the range in which that assessment is most difficult.

Conditions
Cerebral Palsy
Being tested
Vision-language model assessment of movement video
Keywords
GMFCS, Gross Motor Function Classification System, Vision-Language Model, Artificial Intelligence, Video Analysis, Motor Function Assessment, Pediatric Rehabilitation, Diagnostic Accuracy
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vision-language model assessment of movement videoDiagnostic test

    Standardized multi-view video recording of five prescribed gross motor tasks, followed by automated reading of the recordings. From each recorded attempt, 16 frames are extracted, 8 from each of two camera views, and presented to an open-weight vision-language model. The model answers two binary questions: whether an adult touched the child during the attempt, and whether the child bore load through an external object. A fixed rule combines the two answers into a determination of whether the attempt was performed unaided. The model is given no participant identifier, no movement name and no GMFCS level, and is never asked for a clinical grade. All models run on hardware controlled by the investigators.

Study groups in NCT07824531
Study groupRoleWhat they receive
Standardized Video AssessmentAll 26 enrolled children. Each child performed five prescribed gross motor tasks (walking, crawling, side-rolling, floor sit-to-stand, stand-to-floor-sit) while being recorded simultaneously by up to three cameras. Every recorded attempt was submitted to the index test, in which 16 extracted frames are read by an open-weight vision-language model. There is no comparison group.
Receives: Diagnostic Test: Vision-language model assessment of movement video

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of the model-determined adult-contact call against the human annotator's record

    For each movement attempt in the 178-attempt floor-transition set, the rater model's binary determination of whether an adult touched the child is compared with the human annotator's blind record for the same attempt. Accuracy is the proportion of attempts in agreement, reported as a count out of 178. Sensitivity and specificity against the same reference are reported alongside. Every rater model is evaluated on identical image inputs, so accuracies are directly comparable, and comparisons between rater models use McNemar's paired test. The human record is the sole reference.

    Measured: Single video assessment per participant; recordings collected May 2025 to June 2026

  2. Accuracy of the model-determined external-support call against the human annotator's record

    For each movement attempt in the same 178-attempt set, the rater model's binary determination of whether the child bore load through an external object is compared with the human annotator's blind record of acrylic support stand or walker use. Accuracy is reported as a count out of 178, with sensitivity and specificity against the same reference.

    Measured: Single video assessment per participant; recordings collected May 2025 to June 2026

Secondary outcomes (3)
  1. Stratified concordance between model and human contact determinations within participant and movement strata

    Concordance is computed inside each (participant, movement class) stratum and pooled across strata, so that neither participant identity nor movement class can contribute to the statistic. The null value is 0.5. The statistic is reported separately for floor transitions and for non-floor movement classes (walking, side-rolling), using an exact stratified conditional test.

    Measured: Single video assessment per participant; recordings collected May 2025 to June 2026

  2. Agreement between independent rater models on identical image inputs

    Two rater models that share no developer organization, no language-model backbone and no vision encoder are run on identical image inputs. Their agreement with each other, and the difference in their accuracy against the human record, are reported. Between-model comparison uses McNemar's paired test.

    Measured: Single video assessment per participant; recordings collected May 2025 to June 2026

  3. Accuracy of image-independent baselines on the same attempts

    Four baselines that read no image content are computed on the same attempts: majority class, movement repertoire alone, a clip-duration threshold, and scene composition alone. Each reported model accuracy is presented beside these baselines, so that any accuracy attributable to properties of the dataset rather than to the images is visible.

    Measured: Single video assessment per participant; recordings collected May 2025 to June 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2026
  2. Study start30 May 2025
  3. Primary completion23 Jun 2026
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07824531
Sponsor's protocol ID
2025-05-096
Other IDs
2025-0826
Status last verified
Sep 2026
First submitted
11 Sep 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data in this study are video recordings of identifiable children and cannot be shared.

Publications

  • Jewell AT, Stokes AI, Bartlett DJ. Correspondence of classifications between parents of children with cerebral palsy aged 2 to 6 years and therapists using the Gross Motor Function Classification System. Dev Med Child Neurol. 2011 Apr;53(4):334-7. doi: 10.1111/j.1469-8749.2010.03853.x. Epub 2010 Dec 17.

    PubMed 21166672
  • Park EY. Stability of the gross motor function classification system in children with cerebral palsy for two years. BMC Neurol. 2020 May 6;20(1):172. doi: 10.1186/s12883-020-01721-4.

    PubMed 32375677
  • Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.

    PubMed 17370477
  • Zhao P, Alencastre-Miranda M, Shen Z, O'Neill C, Whiteman D, Gervas-Arruga J, Igo Krebs H. Computer Vision for Gait Assessment in Cerebral Palsy: Metric Learning and Confidence Estimation. IEEE Trans Neural Syst Rehabil Eng. 2024;32:2336-2345. doi: 10.1109/TNSRE.2024.3416159. Epub 2024 Jul 1.

    PubMed 38889045
  • Kidzinski L, Yang B, Hicks JL, Rajagopal A, Delp SL, Schwartz MH. Deep neural networks enable quantitative movement analysis using single-camera videos. Nat Commun. 2020 Aug 13;11(1):4054. doi: 10.1038/s41467-020-17807-z.

    PubMed 32792511

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy, run by Samsung Medical Center at 2 sites 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of the model-determined adult-contact call against the human annotator's record (time frame: Single video assessment per participant; recordings collected May 2025 to June 2026). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07824531, which also lists 5 linked publications.

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 2 Nov 2026.

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