Clinical trial NCT06521918: Combined Artificial Intelligence and Mobile Application for Remote Infant Motor Screening: Development and Validation
Official title: Combined Artificial Intelligence and Mobile Application for Remote Infant Motor Screening: Development and Validation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Motor Disorders
Keywords: AI, infant motor assessment, APP, validation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2024-07-26
Enrollment: 242
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit preterm and term infants from National Taiwan University Children's Hospital (NTUCH), Taipei, Taiwan, with the former recruited from the neonatal follow-up clinic and the latter from the well-baby follow-up clinic.

Two pediatric physiotherapists providing early intervention to the participating infants will be invited to complete a feedback questionnaire about the APP "Baby Go."

Brief summary: The purpose of this study is therefore five-fold: (1) designation of an APP "Baby Go" version 3.0 to include the assessment, follow-up, and education functions for parental use at home, (2) development and validation of the AI algorithm for infant motor assessment based on home videos obtained from term and preterm infants, (3) comparison of parental perception and report with AI-driven assessment results, (4) examination of the predictive validity of the AI algorithm for infant motor assessment on subsequent outcome, and (5) investigation of the usability of the APP "Baby Go" version 3.0 in parents and clinicians.

Detailed description: Background and Purpose: Early identification and intervention of infants who are at risk of developmental disorders (such as preterm infants) is an important global health policy and action. The number of children with developmental disorders referred for early intervention in Taiwan has increased in the last ten years. Yet, they are more likely diagnosed and referred for intervention at an age beyond two years. Existing developmental diagnostic tests are frequently accessible at hospitals, whereas screening tests are often based on parental reports that are influenced by parents' knowledge and interpretation. Although the emerging artificial intelligence (AI) technology and deep learning have enabled the tracking and recognition of human movements in standardized laboratory settings, whether its incorporation with mobile application (APP) is feasible and accurate for infant motor assessment at home has rarely been investigated. Therefore, this study continues our previous endeavors that applied AI and machine learning to classify several infant movements at standardized laboratory. This study aims to combine the AI algorithm and machine learning with an APP for infant motor assessment in home setup. The specific purposes are (1) designation of an APP "Baby Go" version 3.0 to include the assessment, follow-up, and education functions for parental use at home, (2) development and validation of the AI algorithm for infant motor assessment based on home videos obtained from term and preterm infants, (3) comparison of parental perception and report with AI-driven assessment results, (4) examination of the predictive validity of the AI algorithm for infant motor assessment on subsequent outcome, and (5) investigation of the usability of the APP "Baby Go" version 3.0 in parents and clinicians. Method: This study will recruit 100 preterm infants, 20 term infants aged 2 to 18 months (corrected for prematurity), 120 infants' parents, and 2 clinicians at National Taiwan University Children's Hospital. The APP "Baby Go" version 3.0 will contain the features of age-based motor assessment with 2 to 5 movements at each age, follow-up, and education module. The parents will be asked to video record their baby's movements in prone, supine, sitting, and standing at home biweekly and to simultaneously upload the video files via the APP during the age period of 2 to 18 months, followed by recording their infant's age of walking attainment. Trained physiotherapists will annotate all video files and the results will serve as the gold standards for validation of the data of the AI model and parental perception. The video data will be randomly split into the training and testing set with an 8:2 ratio for model development and validation. The AI model of infant motor assessment will be examined for its predictive validity on age of walking attainment. The parents and clinicians will fill out the APP usability survey. Innovation and Significance: This study is an incremental AI model advancement in tracking and recognizing infant movements from a laboratory-based classification system to a home-based assessment system. The automatic AI-driven infant motor assessment via the APP "Baby Go" will provide parents and healthcare providers in Taiwan with innovative and feasible developmental resources in remote communities. The results are insightful to assist pediatricians and physiotherapists in planning diagnostic assessment and early intervention for infants at risk of neuromotor disorders.

Eligibility criteria: The inclusion criterion is:

Preterm infants: gestational age \< 37 weeks, birth body weight \< 2,500 grams, and corrected age of 2-18 months.

Term infants: gestational age 37-42 weeks, birth body weight \>2,500 grams, and age of 2-18 months.

Clinicians: who provide early intervention to the participating infants in this study.

The exclusion criterion is:

Infants: parents can not read Chinese. Clinicians: can not read Chinese

Primary outcomes:
measure: Alberta Infant Motor Scale (AIMS)
timeFrame: 3 - 18 months of age
measure: Age of walking attainment
timeFrame: 9 - 18 months of age
measure: User experience from parents
timeFrame: When the infant approached 6 months, 12 months, and 18 months
measure: User experience from clinicians
timeFrame: When the infant 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei, Taiwan, 100
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: School and Graduate Institute of Physical Therapy, National Taiwan University
name: Suh-Fang Jeng, Professor
role: PRINCIPAL_INVESTIGATOR
References: