NCT05456126

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2025

Completed
Last Updated

November 18, 2025

Status Verified

September 1, 2025

Enrollment Period

3.8 years

First QC Date

July 11, 2022

Last Update Submit

November 17, 2025

Conditions

Keywords

Artificial intelligenceInfantMachine LearningMotor DevelopmentScreening

Outcome Measures

Primary Outcomes (3)

  • Alberta Infant Motor Scale (AIMS)

    motor function in supine, prone, sitting and standing position

    4-18 months of age

  • Age of walking attainment

    Age of attaining independent walking for at least five steps

    10-18 months of age

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

    The motor scale is composed of gross and fine motor items

    18 months of age

Study Arms (2)

Term infants

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. 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 infants

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.

Eligibility Criteria

Age4 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Their mothers are older than 20 years of age, have no history of alcohol or drug abuse, and are married or live with fathers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Motor Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Suh-Fang Jeng, Professor

    School and Graduate Institute of Physical Therapy, National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 13, 2022

Study Start

August 1, 2021

Primary Completion

May 17, 2025

Study Completion

May 17, 2025

Last Updated

November 18, 2025

Record last verified: 2025-09

Locations