NCT04684173

Brief Summary

The purpose of this preliminary study is to apply AI technology on a sample of infants aged 4 to 18 months to develop an action tracking and recognition algorithm for infant motor screening and to determine the accuracy of the captured movements during the Alberta Infant Motor Scale (AIMS) assessment using an experienced physical therapists' assessment results as the reference.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 14, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

December 21, 2020

Last Update Submit

September 12, 2022

Conditions

Motor Disorders

Keywords

AIInfantMotorScreening

Outcome Measures

Primary Outcomes (1)

  • gross motor development

    motor function in supine, prone, sitting and standing position

    4-18 months of age

Secondary Outcomes (1)

  • age of walking attainment

    10-18 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, 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, 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 MethodProbability Sample
Study Population

The inclusion criteria for preterm infants are: gestational age \<37 weeks, birth weight \<2,500 grams, 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.

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)

School and Graduate Institute of Physical Therapy, 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
Target Duration
14 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 24, 2020

Study Start

November 17, 2020

Primary Completion

March 30, 2021

Study Completion

December 31, 2021

Last Updated

September 14, 2022

Record last verified: 2022-01

Locations

TW(1)