Motor DisordersNCT04684173
A Preliminary Study on Artificial Intelligence for Infant Motor Screening
An observational study of Motor Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… 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
- 47 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Nov 2020to 31 Dec 2021
- How long will I take part?
- 14 Months
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School and Graduate Institute of Physical Therapy, National Taiwan University
Taipei, 100
About this study
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.
Read the 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.
- Conditions
- Motor Disorders
- Keywords
- AI, Infant, Motor, 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 group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
gross motor development
motor function in supine, prone, sitting and standing position
Measured: 4-18 months of age
Secondary outcomes (1)
age of walking attainment
age of attaining independent walking for at least five steps
Measured: 10-18 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start17 Nov 2020
- Primary completion30 Mar 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor DisordersStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 47 participants (actual)
- Target duration
- 14 Months
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suh-Fang Jeng, Professor, Principal investigator, School and Graduate Institute of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684173
- Sponsor's protocol ID
- 202010031RINB
- Status last verified
- Jan 2022
- First submitted
- 21 Dec 2020
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study on Artificial Intelligence for Infant Motor Screening
- ClinicalTrials.gov ID
- NCT04684173
- Acronym / sponsor ID
- 202010031RINB
- Conditions
- Motor Disorders
- Keywords
- AI, Infant, Motor, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 4 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
gross motor development
Time frame: 4-18 months of age
motor function in supine, prone, sitting and standing position
1 secondary outcome
age of walking attainment
Time frame: 10-18 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suh-Fang Jeng, Professor principal investigator
School and Graduate Institute of Physical Therapy, National Taiwan University
1 site in 1 country: see every site and its status.
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 1 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 14 Sep 2022. 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?
gross motor development (time frame: 4-18 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2022.