Clinical trial NCT02813889: SmarToyGym: Smart Detection of Atypical Toy-oriented Actions in At-risk Infants
Official title: SmarToyGym: Smart Detection of Atypical Toy-oriented Actions in At-risk Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Developmental Delay
Stroke
Fine Motor Delay
Infant Development
Other Development Delays
Keywords: infant
baby
developmental delay
robotics
cerebral palsy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-06-27
Enrollment: 36
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to develop a SmarToyGym where sensitized, wireless toys are strategically hung and placed within reach of infants to elicit toy-oriented body and arm/hand movements. Each toy will be equipped with sensors capable of measuring the infant's grasping actions such as squeezing, pinching, tilting, etc.

A low-cost 3D motion capture system will be used to collect video data and the infants' reaching and body kinematics in response to the toys. A pressure mat will be used to measure postural changes to detect weight shifts, rolling, crawling and other movements away from the initial posture. By capitalizing on these wireless and low-cost technologies, it will permit the regular and non-invasive monitoring of infants, which can lead to detailed, non-obtrusive, quantitative evaluation of motor development. In this vein, the investigators also aim to conduct proof-of-concept testing of the SmarToyGym with atypical and typical developing infants. The investigators will include infants' ages 3 to 11 months who are categorized as high-risk or low-risk using the Bayley Infant Neurodevelopmental Screener.

Detailed description: The proposed research is specifically designed to investigate the ability of a novel tool to identify atypically developing infants from their typically developing peers. Twenty-four infants will be recruited to participate, including 12 who are developing typically and 12 who are identified as at-risk for neuromotor delay. Infants with typical development will be at least 3 months and less than 11 months of age, score in the low-risk category on the Bayley Infant Neurodevelopmental Screener (BINS), score a greater than 85 on all sub-scales of the Bayley Scale of Infant Development (BSID-II), have no history of significant cardiac, orthopedic, or neurological condition, and gestational age at least 37 weeks. Infants at risk for neuromotor delay will be at least 3 months and less than 11 months of age (corrected for preterm birth if applicable), score in the moderate or high risk categories on the BINS, and score an 85 or less on the motor sub-scales of the Bayley Scale of Infant Development (BSID-II). In an effort to decrease variability of the data, infants in each group will be further stratified into an older group (8-10+ months) and a younger group (3-5 months).

Eligibility criteria: Inclusion Criteria:

* Infants exhibiting typical development between 3 months and 11 months of age who score in the low-risk category on the Bayley Infant Neurodevelopment Screener (BINS), score greater than 85 on all sub-scales of the Bayley Scale of Infant Development (BSID-II), have no history of significant cardiac, orthopedic or neurological condition and have a gestational age at least 37 weeks.
* Infants exhibiting atypical development (at-risk for neuromotor delay) between 3 months and 11 months of age, score in the moderate or high risk categories on the BINS, and score an 85 or less on the motor sub-scales of the BSID-II.
* Exclusion Criteria:
* Infants outside age range of 3-11 months

Primary outcomes:
measure: Center of Pressure, Path Length Per Second - No Toy (Birth Status)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Path Length Per Second - Elephant Toy (Birth Status)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Path Length Per Second - Orangutan Toy (Birth Status)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Path Length Per Second - Lion Toy (Birth Status)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Path Length Per Second - No Toy (Motor Control Outcome)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Path Length Per Second - Elephant Toy (Motor Control Outcome)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Path Length Per Second - Orangutan Toy (Motor Control Outcome)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Path Length Per Second - Lion Toy (Motor Control Outcome)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Standard Deviation (Y) - No Toy (Birth Status)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Standard Deviation (Y) - Elephant Toy (Birth Status)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Standard Deviation (Y) - Orangutan Toy (Birth Status)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Standard Deviation (Y) - Lion Toy (Birth Status)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Standard Deviation (Y) - No Toy (Motor Control Outcome)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Standard Deviation (Y) - Elephant Toy (Motor Control Outcome)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Standard Deviation (Y) - Orangutan Toy (Motor Control Outcome)
timeFrame: 1 session, about 1 hour in length
measure: Center of Pressure, Standard Deviation (Y) - Lion Toy (Motor Control Outcome)
timeFrame: 1 session, about 1 hour in length
measure: Toy Interaction (Elephant Toy) - Grasp/Touch/Kick/Mouth Time
timeFrame: 1 session, approximately 120 seconds during session 1 for the Elephant toy
measure: Toy Interaction (Orangutan Toy) - Grasp/Touch/Kick/Mouth Time
timeFrame: 1 session, approximately 120 seconds during session 1 for the Orangutan toy
measure: Toy Interaction (Lion Toy) - Grasp/Touch/Kick/Mouth Time
timeFrame: 1 session, approximately 120 seconds during session 1 for the Lion toy
measure: Toy Interaction (Elephant Toy) - Gaze Time
timeFrame: 1 session, approximately 120 seconds during session 1 for the Elephant toy
measure: Toy Interaction (Orangutan Toy) - Gaze Time
timeFrame: 1 session, approximately 120 seconds during session 1 for the Orangutan toy
measure: Toy Interaction (Lion Toy) - Gaze Time
timeFrame: 1 session, approximately 120 seconds during session 1 for the Lion toy
measure: Number of Occurrences of Elephant Toy Interactions
timeFrame: 1 session, approximately 120 seconds during session 1 for the Elephant toy
measure: Number of Occurrences of Orangutan Toy Interactions
timeFrame: 1 session, approximately 120 seconds during session 1 for the Orangutan toy
measure: Number of Occurrences of Lion Toy Interactions
timeFrame: 1 session, approximately 120 seconds during session 1 for the Lion toy
Secondary outcomes:
measure: Wrist Position
timeFrame: 1 session, about 1 hour in length
measure: Ankle Position
timeFrame: 1 session, about 1 hour in length
measure: Wrist Velocity
timeFrame: 1 session, about 1 hour in length
measure: Ankle Velocity
timeFrame: 1 session, about 1 hour in length
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Childrens Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Michelle J Johnson, PhD
state: Pennsylvania
Study officials:
affiliation: Penn Medicine Rittenhouse
name: Michelle J Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Laura Prosser, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lysenko S, Seethapathi N, Prosser L, Kording K, Johnson MJ. Towards Automated Emotion Classification of Atypically and Typically Developing Infants. Proc IEEE RAS EMBS Int Conf Biomed Robot Biomechatron. 2020 Nov-Dec;2020:503-508. doi: 10.1109/BioRob49111.2020.9224271. Epub 2020 Oct 15.
citation: Goyal V, Torres W, Rai R, Shofer F, Bogen D, Bryant P, Prosser L, Johnson MJ. Quantifying infant physical interactions using sensorized toys in a natural play environment. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:882-887. doi: 10.1109/ICORR.2017.8009360.
citation: Shivakumar SS, Loeb H, Bogen DK, Shofer F, Bryant P, Prosser L, Johnson MJ. Stereo 3D tracking of infants in natural play conditions. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:841-846. doi: 10.1109/ICORR.2017.8009353.
citation: Prosser LA, Aguirre MO, Zhao S, Bogen DK, Pierce SR, Nilan KA, Zhang H, Shofer FS, Johnson MJ. Infants at risk for physical disability may be identified by measures of postural control in supine. Pediatr Res. 2022 Apr;91(5):1215-1221. doi: 10.1038/s41390-021-01617-0. Epub 2021 Jun 26.
citation: Chambers C, Seethapathi N, Saluja R, Loeb H, Pierce SR, Bogen DK, Prosser L, Johnson MJ, Kording KP. Computer Vision to Automatically Assess Infant Neuromotor Risk. IEEE Trans Neural Syst Rehabil Eng. 2020 Nov;28(11):2431-2442. doi: 10.1109/TNSRE.2020.3029121. Epub 2020 Nov 6.
citation: Kather C, Shofer FS, Park JI, Bogen D, Pierce SR, Kording K, Nilan KA, Zhang H, Prosser LA, Johnson MJ. Quantifying interaction with robotic toys in pre-term and full-term infants. Front Pediatr. 2023 Oct 19;11:1153841. doi: 10.3389/fped.2023.1153841. eCollection 2023.