Gross Motor Development DelayNCT07054437
Video-based Assessment of Preschool Children's Gross Motor Development
An observational study of Gross Motor Development Delay, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Artificial intelligence (AI) is currently one of the global focal points for industrial development, with its applications in healthcare steadily increasing, such as in disease prediction, image diagnosis, and drug development. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Gross Motor Development Delay
- What is being tested?
- Gross Motor Development Screening Tool
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jun 2025to 31 Aug 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 6 years
- All sexes
- Child
Study population: Participants will be recruited from individuals referred for early intervention assessments at hospitals.
Who may be able to join
- Legal guardian willing to provide written informed consent.
- Males and females aged 1 to 6 years old.
- Capable of independent walking.
Who cannot join
- Non-native Chinese speakers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan
yijing li, +886-920226108, yjl9528@gmail.com
About this study
Official title: Video-based Assessment of Preschool Children's Gross Motor Development for Early Intervention Screening
Artificial intelligence (AI) is currently one of the global focal points for industrial development, with its applications in healthcare steadily increasing, such as in disease prediction, image diagnosis, and drug development. AI assists healthcare professionals in clinical decision-making by training relevant models through algorithms, thereby enhancing medical efficiency and quality.
Currently, standardized tools are used in clinical settings to screen and assess various aspects of child development. Children's motor development levels are determined by comparing their performance against established norms. However, the current assessment methods primarily rely on on-site visual observation and recording by evaluators, which demands significant time and human resources.
This research aims to establish an automated screening tool for gross motor development in early intervention, suitable for independently walking children aged one to six years old in Taiwan. The goal is to reduce the time cost of manual assessment and enable remote healthcare applications.
- Conditions
- Gross Motor Development Delay
- Being tested
- Gross Motor Development Screening Tool
- Keywords
- artificial intelligence, machine learning, neural networks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gross Motor Development Screening ToolOther
This intervention is an automated gross motor development screening tool specifically designed for independently walking children aged one to six years old in Taiwan. What sets it apart is its use of artificial intelligence (AI) algorithms to analyze motion data, enabling early identification of potential gross motor developmental delays.
Unlike traditional methods that rely on manual, visual observation and subjective recording by healthcare professionals, this tool aims to significantly reduce assessment time and human resource costs. Furthermore, its automated nature makes it uniquely suited for telemedicine applications, allowing for remote screenings and overcoming geographical barriers to access early intervention services. The tool will be developed and validated against established developmental norms relevant to the Taiwanese population.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of AI-based gross motor development screening model compared to pediatric therapist's CDIIT gross motor subscale assessment
Accuracy will be calculated by comparing the AI model's classification results to pediatric therapists' assessments based on the CDIIT gross motor subscale.
The accuracy formula is: (True Positive + True Negative) / Total number of cases.
Measured: Day 1 (single assessment at enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start11 Jun 2025
- Primary completion11 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gross Motor Development DelayStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan Normal University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054437
- Sponsor's protocol ID
- 2501160032
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-based Assessment of Preschool Children's Gross Motor Development for Early Intervention Screening
- ClinicalTrials.gov ID
- NCT07054437
- Acronym / sponsor ID
- 2501160032
- Conditions
- Gross Motor Development Delay
- Keywords
- artificial intelligence, machine learning, neural networks
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Taiwan Normal University
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 11 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 8 Jul 2025 (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.
Artificial intelligence (AI) is currently one of the global focal points for industrial development, with its applications in healthcare steadily increasing, such as in disease prediction, image diagnosis, and drug development. AI assists healthcare professionals in clinical decision-making by training relevant models through algorithms, thereby enhancing medical efficiency and quality.
Currently, standardized tools are used in clinical settings to screen and assess various aspects of child development. Children's motor development levels are determined by comparing their performance against established norms. However, the current assessment methods primarily rely on on-site visual observation and recording by evaluators, which demands significant time and human resources.
This research aims to establish an automated screening tool for gross motor development in early intervention, suitable for independently walking children aged one to six years old in Taiwan. The goal is to reduce the time cost of manual assessment and enable remote healthcare applications.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- Participants will be recruited from individuals referred for early intervention assessments at hospitals.
Key inclusion criteria (3 listed)
- Legal guardian willing to provide written informed consent.
- Males and females aged 1 to 6 years old.
- Capable of independent walking.
Key exclusion criteria (1 listed)
- Non-native Chinese speakers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gross Motor Development Screening ToolThis intervention is an automated gross motor development screening tool specifically designed for independently walking children aged one to six years old in Taiwan. What sets it apart is its use of artificial intelligence (AI) algorithms to analyze motion data, enabling early identification of potential gross motor developmental delays. Unlike traditional methods that rely on manual, visual observation and subjective recording by healthcare professionals, this tool aims to significantly reduce assessment time and human resource costs. Furthermore, its automated nature makes it uniquely suited for telemedicine applications, allowing for remote screenings and overcoming geographical barriers to access early intervention services. The tool will be developed and validated against established developmental norms relevant to the Taiwanese population. | Other | – |
Primary outcome
Accuracy of AI-based gross motor development screening model compared to pediatric therapist's CDIIT gross motor subscale assessment
Time frame: Day 1 (single assessment at enrollment).
Accuracy will be calculated by comparing the AI model's classification results to pediatric therapists' assessments based on the CDIIT gross motor subscale. The accuracy formula is: (True Positive + True Negative) / Total number of cases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: Yes
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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.
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 Gross Motor Development Delay, run by Chang Gung Memorial 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: looking for participants now, as of the sponsor's last update on 8 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yijing li (+886-920226108, yjl9528@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of AI-based gross motor development screening model compared to pediatric therapist's CDIIT gross motor subscale assessment (time frame: Day 1 (single assessment at enrollment).). 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 8 Jul 2025.