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Motor DisordersNCT05456126

Artificial Intelligence for Infant Motor Screening: Development and Validation

An observational study of Motor Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this three-year study is therefore three-fold: (1) Model Development- to apply pose estimation model and tracking recognition model on the movements of a large sample of term and preterm infants under a motor assessment in the laboratory to examine the accuracy of the AI algorithms in identifying… Read more about this study

Who is it for?
Ages 4 to 18 monthsHealthy volunteers can take part
Conditions the study is for
Motor Disorders
How many people
122 participants
Where
1 siteTaiwan
Study dates
1 Aug 2021to 17 May 2025
Phase
Observational
Are there results?
None posted in the registry

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 4 to 18 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: This study will prospectively recruit term and preterm infants from National Taiwan University Children's Hospital, Taipei, Taiwan. Infants will be recruited from the neonatal and well-baby follow-up clinic of the hospital. The proportion of boys and girls in the sample will be balanced. The parents will be informed of the study and will sign a written consent form before participation in the study. This study is currently under human right review by National Taiwan University Hospital.

Who may be able to join

  • The inclusion criteria for term infants are: gestational age 37-42 weeks, birth weight >2,500 grams, aged 2-4 months, and no congenital/genetic abnormalities.
  • The inclusion criteria for preterm infants are: gestational age <37 weeks, birth weight <2,500 grams, aged 2-4 months (corrected for prematurity), and no congenital/genetic abnormalities.
  • Their mothers are older than 20 years of age, have no history of alcohol or drug abuse, and are married or live with fathers.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Taiwan University

    Taipei, 100

Other trials in Taiwan

About this study

The purpose of this three-year study is therefore three-fold: (1) Model Development- to apply pose estimation model and tracking recognition model on the movements of a large sample of term and preterm infants under a motor assessment in the laboratory to examine the accuracy of the AI algorithms in identifying individual movements using physical therapists' results as gold standards; (2) Model Validation- to examine the performance of the AI algorithms on the same term and preterm infants' movements when video recorded by the parents at home between the laboratory assessment ages using physical therapists' results as gold standards; and (3) Concurrent and Predictive Validity of AI Movement Sets- to select the identifiable movement classes into AI movement sets for individual ages to examine their concurrent validity with physical therapists' results and predictive validity on developmental outcomes at 18 months of age in these infants.

Read the detailed description

Background and Purpose. Although the number of children with developmental disorders reported for early intervention in Taiwan increases in the recent decade, the prevalence estimate of children with developmental disorders is lower than the global data particularly among those aged under 2 years or in remote areas. Artificial Intelligence (AI), based on machine learning of big data, has been successfully used for medical image classification and prediction in certain diseases; however, its application in child developmental screening is rare. The purpose of this three-year study is therefore three-fold: (1) Model Development- to apply pose estimation model and tracking recognition model on the movements of a large sample of term and preterm infants under a motor assessment in the laboratory to examine the accuracy of the AI algorithms in identifying individual movements using physical therapists' results as gold standards; (2) Model Validation- to examine the performance of the AI algorithms on the same term and preterm infants' movements when video recorded by the parents at home between the laboratory assessment ages using physical therapists' results as gold standards; and (3) Concurrent and Predictive Validity of AI Movement Sets- to select the identifiable movement classes into AI movement sets for individual ages to examine their concurrent validity with physical therapists' results and predictive validity on developmental outcomes at 18 months of age in these infants. Method. A total of 125 term and preterm infants will be recruited from National Taiwan University Children's Hospital and will be randomly split into the training (N=101), tuning (N=12), and testing sets (N=12) with 8:1:1 ratio for Model Development. All infants will be prospectively administered the Alberta Infant Motor Assessment in prone, supine, sitting and standing positions at 4, 6, 8, 10, 12 and 14 months of age (corrected for prematurity) in the laboratory with movements recorded by 5 cameras. For Model Validation, the same 125 infants will be video recorded their movements by the parents using cell phones at home at 5, 7, 9, 11 and 13 months of age from at least 2 camera views, with the movement records uploaded to a prototype of Mobile APP "Baby Go." The data processing of movement video records will include: selection of movement records, establishment of a pose estimation model, and establishment of an action recognition model. The accuracy of the AI model in identifying infants' individual movements will be examined using physical therapist's results as gold standards. The movements identifiable through machine learning will be selected to establish AI movement sets for each age. Concurrent and Predictive Validity of the AI movement sets will be respectively examined using physical therapist's results and developmental outcomes at 18 months of age as the criteria (age of walking attainment and the Peabody Developmental Motor Scale- 2nd edition). Significance. The results will help establish the best and appropriate AI model for infant motor screening in Taiwan. The established AI model may be incorporated into clinical procedure to assist pediatricians and physical therapists in planning for further diagnostic assessment.

Conditions
Motor Disorders
Keywords
Artificial intelligence, Infant, Machine Learning, Motor Development, Screening
Medical subject headings
Motor Disorders

What participants receive

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

Study groups in NCT05456126
Study groupRoleWhat they receive
Term infantsThe inclusion criteria for term infants are: gestational age 37-42 weeks, birth weight >2,500 grams, aged 2-4 months, and no congenital/genetic abnormalities. Their mothers are older than 20 years of age, have no history of alcohol or drug abuse, and are married or live with fathers.
Preterm infantsThe inclusion criteria for preterm infants are: gestational age <37 weeks, birth weight <2,500 grams, aged 2-4 months (corrected for prematurity), and no congenital/genetic abnormalities. Their mothers are older than 20 years of age, have no history of alcohol or drug abuse, and are married or live with fathers.

What is being measured

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

  1. Alberta Infant Motor Scale (AIMS)

    motor function in supine, prone, sitting and standing position

    Measured: 4-18 months of age

  2. Age of walking attainment

    Age of attaining independent walking for at least five steps

    Measured: 10-18 months of age

  3. Peabody Developmental Motor Scale- 2nd edition (PDMS-II)

    The motor scale is composed of gross and fine motor items

    Measured: 18 months of age

Timeline

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

  1. First posted13 Jul 2022
  2. Study start1 Aug 2021
  3. Primary completion17 May 2025
  4. Study completion17 May 2025

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
Prospective
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05456126
Sponsor's protocol ID
202012089RINB
Status last verified
Sep 2025
First submitted
11 Jul 2022
Last updated
18 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lin SC, Chandra E, Tsao PN, Liao WC, Chen WJ, Yen TA, Hsu JY, Jeng SF. Application of Artificial Intelligence in Infant Movement Classification: A Reliability and Validity Study in Infants Who Were Full-Term and Preterm. Phys Ther. 2024 Feb 1;104(2):pzad176. doi: 10.1093/ptj/pzad176.

    PubMed 38245806

Questions about this trial

What is this clinical trial studying?

An observational study of Motor Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.

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 3 inclusion and 0 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: finished, as of the sponsor's last update on 18 Nov 2025. 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 Taiwan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Alberta Infant Motor Scale (AIMS) (time frame: 4-18 months of age). The study lists 3 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 NCT05456126, which also lists 1 linked publication.

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 18 Nov 2025.

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