Combined Artificial Intelligence and Mobile Application for Remote Infant Motor Screening: Development and Validation

NCT06521918 | Recruiting

• 1 other identifier: 202311095RIND
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Motor Disorders

Keywords

AI, infant motor assessment, APP, validation

Outcome Measures

Primary Outcomes (4)

• Alberta Infant Motor Scale (AIMS)

  motor function in supine, prone, sitting and standing position

  3 - 18 months of age

• Age of walking attainment

  Age of attaining independent walking for at least five steps

  9 - 18 months of age

• User experience from parents

  Parents' perspectives on the use of the APP "Baby Go" were collected using Google Forms (For parents: https://forms.gle/BPL7CWopaB7qk3388). The questionnaire for parents was customized for the APP "Baby Go" in this study and adapted from a survey used in the "Baby Moves" APP previously described by Kwong et al. The questionnaire for the parents consisted of three sections: (1) frequency of the APP use, (2) benefits of the APP use, and (3) user's experience. Questionnaires contained three types of measures: (1) multiple choice, (2) five-point Likert scale, and (3) open-ended questions.

  When the infant approached 6 months, 12 months, and 18 months

• User experience from clinicians

  Clinicians' perspectives on the use of the APP "Baby Go" were collected using Google Forms (for clinicians: https://forms.gle/3L7nGKe2ZTT39t7n6). The questionnaire for clinicians is customized for the APP "Baby Go" in this study and adapted from a healthcare professional interview previously described by AlMahadin et al. 44 The questionnaire for clinicians contains two sections: (1) perspectives of the APP use and (2) recommendations of APP use. Each questionnaire contains three types of measures: (1) multiple choice, (2) five-point Likert scale, and (3) open-ended questions.

  When the infant 18 months

Study Arms (3)

Term infants

The inclusion criterion is: gestational age 37-42 weeks, birth body weight \>2,500 grams, and age at 2-18 months. The exclusion criterion is: parents can not read Chinese.

Preterm infants

The inclusion criterion is: gestational age \< 37 weeks, birth body weight \< 2,500 grams, and corrected age of 2-18 months. The exclusion criterion is: parents can not read Chinese.

Clinicians

The inclusion criterion is: who provide early intervention to the participating infants in this study. The exclusion criterion is: can not read Chinese

Eligibility Criteria

• Age: 2 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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."

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Health Research Institutes, Taiwan: collaborator

Study Sites (1)

National Taiwan University

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Motor Disorders; Alzheimer Disease

Condition Hierarchy (Ancestors)

Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• Suh-Fang Jeng, Professor

  School and Graduate Institute of Physical Therapy, National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suh-Fang Jeng, Professor

CONTACT

886-2-33668132; jeng@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 26, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 13, 2025

Record last verified: 2024-12

Locations

TW (1)