Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04684173
Other study ID # 202010031RINB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 17, 2020
Est. completion date December 31, 2021

Study information

Verified date January 2022
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 experienced physical therapists' assessment results as the reference.


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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date December 31, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Months to 18 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan School and Graduate Institute of Physical Therapy, National Taiwan University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary gross motor development motor function in supine, prone, sitting and standing position 4-18 months of age
Secondary age of walking attainment age of attaining independent walking for at least five steps 10-18 months of age
See also
  Status Clinical Trial Phase
Recruiting NCT04899830 - Study of the Acceptability and Psychosocial Impact of Using a Telepresence Robot in the Living Space of Inpatients N/A
Recruiting NCT06086951 - Pai.ACT - An Artificial Intelligence Driven Chatbot Assisted ACT N/A
Completed NCT04681235 - Virtual Reality Training Affects on Motor Functions and Mental Health in Stroke Patients N/A
Completed NCT04361149 - Motor Unit Abnormalities After Experimentally Induced Sensitization Phase 4
Recruiting NCT04620707 - RGS@Home: Personalized 24/7 Home Care Post-stroke N/A
Completed NCT04619953 - Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis N/A
Recruiting NCT05637775 - DiSCIoser: Improving Arm Sensorimotor Functions After Spinal Cord Injury Via Brain-Computer Interface Training N/A
Active, not recruiting NCT03114748 - Electroencephalographic Monitoring in Patients Treated by Deep Brain Stimulation N/A
Completed NCT05373394 - Evaluation of Cognitive and Motor Neurological Disorders in the Short and Long Term After Surgery for the Removal of a Diffuse Low-grade Glioma of the Supplementary Motor Area
Recruiting NCT05511207 - Clinical Validation of a Hybrid BCI-controlled FES for Upper Limb Rehabilitation After Stroke N/A
Recruiting NCT06392802 - Effectiveness of a Rehabilitation Exercise Plan at Home to Treat Post-stroke Patients in the Chronic Phase N/A
Recruiting NCT05872737 - FAB Programme for Parents of Children With NDD N/A
Not yet recruiting NCT05900310 - Linus Health CDS Retrospective Validation Study
Completed NCT02821598 - Effects of the Proprioceptive Neuromuscular Facilitation for Promoting Muscular Irradiation N/A
Completed NCT02828813 - Neural Mechanisms of Motor and Cognitive Networks
Recruiting NCT05183152 - Non-invasive BCI-controlled Assistive Devices N/A
Recruiting NCT05349539 - Instrumental Assessment of Motor Symptoms by Means of Wearable Sensors in Patients With Parkinson's Disease
Terminated NCT05316519 - Transcutaneous Auricular Vagus Nerve Stimulation to Enhance Motor Learning N/A
Completed NCT04203589 - Explorer Babies Early Intervention Program N/A
Completed NCT02816541 - Effects of Pilates-based Therapeutic Exercises on the Postural Control N/A