- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04684173
A Preliminary Study on Artificial Intelligence for Infant Motor Screening
September 12, 2022 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Background and Purpose.
Although there is an increase in the public awareness of early intervention for children with developmental disorder in Taiwan, the number of children reported for early intervention by the Ministry of Health and Welfare is limited, particularly for those aged under two years, outside of hospital settings, and in remote areas.
This has highlighted the need of early screening for infants who are at risk or have developmental disorders.
While motor development has a potential impact on the emergence of abilities in other domains in children at later age, motor screening may serve as the cornerstone to help detect signs of developmental dysfunction.
Artificial Intelligence (AI), based on machine learning of big data, may be an alternative for assisting healthcare professionals to efficiently screen children's development and to help plan for further diagnostic assessment.
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.
Method.
This study will recruit 50 infants (40 preterm infants and 10 term infants age 4-18 months (corrected age for preterm infants) from the National Taiwan University Children's Hospital.
Each infant will be evaluated by a physical therapist for their gross motor development during prone, spine, sitting and standing positions using the AIMS assessment.
The whole assessment procedure will be video recorded by five cameras.
The data processing of movement video records will consist of selection of movement records, establishment of a pose estimation model, and establishment of an action recognition model.
The accuracy of the pose and action recognition model in identifying infants' movements will be examined using the physical therapist's results as the gold standard.
The results of this study will provide preliminary data to help establish the best and appropriate action recognition model of infant motor screening for future validation on a large sample.
Study Type
Observational
Enrollment (Actual)
47
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan, 100
- School and Graduate Institute of Physical Therapy, National Taiwan University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 1 year (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability 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.
Description
Inclusion Criteria:
- The inclusion criteria for term infants are: gestational age 37-42 weeks, birth weight >2,500 grams, and no congenital/genetic abnormalities.
- 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.
Exclusion Criteria:
- No
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gross motor development
Time Frame: 4-18 months of age
|
motor function in supine, prone, sitting and standing position
|
4-18 months of age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
age of walking attainment
Time Frame: 10-18 months of age
|
age of attaining independent walking for at least five steps
|
10-18 months of age
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 17, 2020
Primary Completion (Actual)
March 30, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
December 21, 2020
First Submitted That Met QC Criteria
December 21, 2020
First Posted (Actual)
December 24, 2020
Study Record Updates
Last Update Posted (Actual)
September 14, 2022
Last Update Submitted That Met QC Criteria
September 12, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202010031RINB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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