SmarToyGym: Smart Detection of Atypical Toy-oriented Actions in At-risk Infants

NCT02813889 | Completed Results

• 2 other identifiers: 8224871R21HD084327-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy; Developmental Delay; Stroke; Fine Motor Delay; Infant Development; Other Development Delays

Keywords

infant; baby; developmental delay; robotics; cerebral palsy

Outcome Measures

Primary Outcomes (25)

• Center of Pressure, Path Length Per Second - No Toy (Birth Status)

  Body movement (center of pressure) on a mat, in terms of average path length per second. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes without a toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Path Length Per Second - Elephant Toy (Birth Status)

  Body movement (center of pressure) on a mat, in terms of average path length per second. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with elephant toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Path Length Per Second - Orangutan Toy (Birth Status)

  Body movement (center of pressure) on a mat, in terms of average path length per second. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with orangutan toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Path Length Per Second - Lion Toy (Birth Status)

  Body movement (center of pressure) on a mat, in terms of average path length per second. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with lion toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Path Length Per Second - No Toy (Motor Control Outcome)

  Body movement (center of pressure) on a mat, in terms of path length per minute. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes without a toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Path Length Per Second - Elephant Toy (Motor Control Outcome)

  Body movement (center of pressure) on a mat, in terms of path length per minute. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with elephant toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Path Length Per Second - Orangutan Toy (Motor Control Outcome)

  Body movement (center of pressure) on a mat, in terms of path length per minute. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with orangutan toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Path Length Per Second - Lion Toy (Motor Control Outcome)

  Body movement (center of pressure) on a mat, in terms of path length per minute. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with lion toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Standard Deviation (Y) - No Toy (Birth Status)

  Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes without a toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Standard Deviation (Y) - Elephant Toy (Birth Status)

  Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with elephant toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Standard Deviation (Y) - Orangutan Toy (Birth Status)

  Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with orangutan toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Standard Deviation (Y) - Lion Toy (Birth Status)

  Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with lion toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Standard Deviation (Y) - No Toy (Motor Control Outcome)

  Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes without a toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Standard Deviation (Y) - Elephant Toy (Motor Control Outcome)

  Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with elephant toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Standard Deviation (Y) - Orangutan Toy (Motor Control Outcome)

  Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with orangutan toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Center of Pressure, Standard Deviation (Y) - Lion Toy (Motor Control Outcome)

  Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with lion toy. Path length was measured in distance with time normalized to 1 minute.

  1 session, about 1 hour in length

• Toy Interaction (Elephant Toy) - Grasp/Touch/Kick/Mouth Time

  Time duration (in seconds) of infant interaction with the Elephant toy. Time spent in voluntary motor (feet and hand) interactions with the toy, analyzing grasp/touch/kick/mouth time. The data analyzed was the condition where the elephant toy was suspended within arm reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of seconds the infant spent interacting with the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time interacting with the toy. Toy interaction time ranged from 0-120 seconds.

  1 session, approximately 120 seconds during session 1 for the Elephant toy

• Toy Interaction (Orangutan Toy) - Grasp/Touch/Kick/Mouth Time

  Time duration (in seconds) of infant interaction with the Orangutan toy. Time spent in voluntary motor (feet and hand) interactions with the toy, analyzing grasp/touch/kick/mouth time. The data analyzed was the condition where the orangutan toy was suspended within arm reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of seconds the infant spent interacting with the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time interacting with the toy. Toy interaction time ranged from 0-120 seconds.

  1 session, approximately 120 seconds during session 1 for the Orangutan toy

• Toy Interaction (Lion Toy) - Grasp/Touch/Kick/Mouth Time

  Time duration (in seconds) of infant interaction with the Lion toy. Time spent in voluntary motor (feet and hand) interactions with the toy, analyzing grasp/touch/kick/mouth time. The data analyzed was the condition where the lion toy was suspended within foot reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of seconds the infant spent interacting with the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time interacting with the toy. Toy interaction time ranged from 0-120 seconds.

  1 session, approximately 120 seconds during session 1 for the Lion toy

• Toy Interaction (Elephant Toy) - Gaze Time

  Time duration (in seconds) of infant interaction with the Elephant toy. Time spent gazing at the toy. The data analyzed was the condition where the elephant toy was suspended within arm reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of seconds the infant spent gazing at the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time gazing at the toy. Toy interaction time ranged from 0-120 seconds.

  1 session, approximately 120 seconds during session 1 for the Elephant toy

• Toy Interaction (Orangutan Toy) - Gaze Time

  Time duration (in seconds) of infant interaction with the Orangutan toy. Time spent gazing at the toy. The data analyzed was the condition where the orangutan toy was suspended within arm reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of seconds the infant spent gazing at the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time gazing at the toy. Toy interaction time ranged from 0-120 seconds.

  1 session, approximately 120 seconds during session 1 for the Orangutan toy

• Toy Interaction (Lion Toy) - Gaze Time

  Time duration (in seconds) of infant interaction with the Lion toy. Time spent gazing at the toy. The data analyzed was the condition where the lion toy was suspended within foot reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of seconds the infant spent gazing at the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time gazing at the toy. Toy interaction time ranged from 0-120 seconds.

  1 session, approximately 120 seconds during session 1 for the Lion toy

• Number of Occurrences of Elephant Toy Interactions

  Frequency of infant interactions with the Elephant toy. Frequency of mouthing, grasping, hand touch, foot touch, and kicking with the toy. The data analyzed was the condition where the elephant toy was suspended within arm reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of occurrences the infant had interacting with the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time interacting with the toy.

  1 session, approximately 120 seconds during session 1 for the Elephant toy

• Number of Occurrences of Orangutan Toy Interactions

  Frequency of infant interactions with the Orangutan toy. Frequency of mouthing, grasping, hand touch, foot touch, and kicking with the toy. The data analyzed was the condition where the orangutan toy was suspended within arm reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of occurrences the infant had interacting with the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time interacting with the toy.

  1 session, approximately 120 seconds during session 1 for the Orangutan toy

• Number of Occurrences of Lion Toy Interactions

  Frequency of infant interactions with the Lion toy. Frequency of mouthing, grasping, hand touch, foot touch, and kicking with the toy. The data analyzed was the condition where the lion toy was suspended within foot reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of occurrences the infant had interacting with the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time interacting with the toy.

  1 session, approximately 120 seconds during session 1 for the Lion toy

Secondary Outcomes (4)

• Wrist Position

  1 session, about 1 hour in length

• Ankle Position

  1 session, about 1 hour in length

• Wrist Velocity

  1 session, about 1 hour in length

• Ankle Velocity

  1 session, about 1 hour in length

Study Arms (1)

Infants

EXPERIMENTAL

Two populations will be involved in testing in the SmarToyGym: 1. Infants exhibiting typical development between 3 months and 11 months of age 2 . Infants exhibiting atypical development (at-risk for neuromotor delay) between 3 months and 11 months of age.

Device: SmarToyGym

Interventions

SmarToyGym DEVICE

We aim 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.

Infants

Eligibility Criteria

• Age: 3 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Infants outside age range of 3-11 months

Sponsors & Collaborators

• University of Pennsylvania: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Michelle J Johnson, PhD

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (6)

• 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.

  PMID: 33959406 BACKGROUND

• 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.

  PMID: 28813932 BACKGROUND

• 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.

  PMID: 28813925 BACKGROUND

• 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.

  PMID: 34175891 RESULT

• 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.

  PMID: 33021933 RESULT

• 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.

  PMID: 37928351 RESULT

MeSH Terms

Conditions

Cerebral Palsy; Learning Disabilities; Stroke

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Michelle J. Johnson
• Organization: Penn Medicine Center for Physical Medicine and Rehabilitation

johnmic@pennmedicine.upenn.edu

4148130128

Study Officials

• Michelle J Johnson, PhD

  Penn Medicine Rittenhouse

  PRINCIPAL INVESTIGATOR

• Laura Prosser, PT, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 27, 2016
• Study Start: May 1, 2015
• Primary Completion: August 30, 2019
• Study Completion: December 30, 2022
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)