- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07824531
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
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?
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 of the design are fixed in advance.
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: 6 children at Level I, 5 at Level II, 4 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 24 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 reported as descriptive only and always 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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Seoul, Korea Południowa, 05505
- Asan Medical Center
-
Seoul, Korea Południowa, 06351
- Samsung Medical Center
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
Standardized Video Assessment
All 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.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Accuracy of the model-determined adult-contact call against the human annotator's record
Ramy czasowe: Single video assessment per participant; recordings collected May 2025 to June 2026
|
For each movement attempt in the fixed 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.
|
Single video assessment per participant; recordings collected May 2025 to June 2026
|
|
Accuracy of the model-determined external-support call against the human annotator's record
Ramy czasowe: Single video assessment per participant; recordings collected May 2025 to June 2026
|
For each movement attempt in the same fixed 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.
|
Single video assessment per participant; recordings collected May 2025 to June 2026
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Stratified concordance between model and human contact determinations within participant and movement strata
Ramy czasowe: Single video assessment per participant; recordings collected May 2025 to June 2026
|
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.
|
Single video assessment per participant; recordings collected May 2025 to June 2026
|
|
Agreement between independent rater models on identical image inputs
Ramy czasowe: Single video assessment per participant; recordings collected May 2025 to June 2026
|
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.
|
Single video assessment per participant; recordings collected May 2025 to June 2026
|
|
Accuracy of image-independent baselines on the same attempts
Ramy czasowe: Single video assessment per participant; recordings collected May 2025 to June 2026
|
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.
|
Single video assessment per participant; recordings collected May 2025 to June 2026
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Jeong Yi Kwon, M.D., Ph.D., Samsung Medical Center
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025-05-096
- 2025-0826 (Inny identyfikator: Asan Medical Center Institutional Review Board)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .