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

Not Applicable

Completed

• Conditions: Developmental Delay; Stroke; Other Development Delays; Infant Development; Cerebral Palsy; Fine Motor Delay
• Interventions: Device: SmarToyGym

• Registration Number: NCT02813889
• Lead Sponsor: University of Pennsylvania

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).

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-27
• Primary Completion: 2019-08-30
• Study Completion: 2022-12-30
• Results First Submitted: 2023-02-22
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Results First Posted: 2024-08-06
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

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Exclusion Criteria

• Infants outside age range of 3-11 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infants	SmarToyGym	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.

Primary Outcome Measures

Name	Time	Method
Toy Interaction (Orangutan Toy) - Grasp/Touch/Kick/Mouth Time	1 session, approximately 120 seconds during session 1 for the Orangutan toy	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.
Center of Pressure, Path Length Per Second - No Toy (Birth Status)	1 session, about 1 hour in length	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.
Center of Pressure, Path Length Per Second - Elephant Toy (Birth Status)	1 session, about 1 hour in length	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.
Center of Pressure, Path Length Per Second - Orangutan Toy (Birth Status)	1 session, about 1 hour in length	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.
Center of Pressure, Path Length Per Second - No Toy (Motor Control Outcome)	1 session, about 1 hour in length	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.
Center of Pressure, Path Length Per Second - Orangutan Toy (Motor Control Outcome)	1 session, about 1 hour in length	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.
Center of Pressure, Path Length Per Second - Lion Toy (Birth Status)	1 session, about 1 hour in length	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.
Center of Pressure, Path Length Per Second - Lion Toy (Motor Control Outcome)	1 session, about 1 hour in length	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.
Center of Pressure, Standard Deviation (Y) - No Toy (Motor Control Outcome)	1 session, about 1 hour in length	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.
Number of Occurrences of Elephant Toy Interactions	1 session, approximately 120 seconds during session 1 for the Elephant toy	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.
Number of Occurrences of Lion Toy Interactions	1 session, approximately 120 seconds during session 1 for the Lion toy	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.
Center of Pressure, Standard Deviation (Y) - No Toy (Birth Status)	1 session, about 1 hour in length	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.
Center of Pressure, Standard Deviation (Y) - Elephant Toy (Birth Status)	1 session, about 1 hour in length	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.
Center of Pressure, Standard Deviation (Y) - Orangutan Toy (Birth Status)	1 session, about 1 hour in length	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.
Center of Pressure, Standard Deviation (Y) - Elephant Toy (Motor Control Outcome)	1 session, about 1 hour in length	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.
Center of Pressure, Standard Deviation (Y) - Lion Toy (Motor Control Outcome)	1 session, about 1 hour in length	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.
Center of Pressure, Path Length Per Second - Elephant Toy (Motor Control Outcome)	1 session, about 1 hour in length	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.
Center of Pressure, Standard Deviation (Y) - Lion Toy (Birth Status)	1 session, about 1 hour in length	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.
Center of Pressure, Standard Deviation (Y) - Orangutan Toy (Motor Control Outcome)	1 session, about 1 hour in length	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.
Toy Interaction (Lion Toy) - Grasp/Touch/Kick/Mouth Time	1 session, approximately 120 seconds during session 1 for the Lion toy	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.
Toy Interaction (Elephant Toy) - Gaze Time	1 session, approximately 120 seconds during session 1 for the Elephant toy	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.
Toy Interaction (Orangutan Toy) - Gaze Time	1 session, approximately 120 seconds during session 1 for the Orangutan toy	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.
Toy Interaction (Lion Toy) - Gaze Time	1 session, approximately 120 seconds during session 1 for the Lion toy	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.
Toy Interaction (Elephant Toy) - Grasp/Touch/Kick/Mouth Time	1 session, approximately 120 seconds during session 1 for the Elephant toy	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.
Number of Occurrences of Orangutan Toy Interactions	1 session, approximately 120 seconds during session 1 for the Orangutan toy	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.

Secondary Outcome Measures

Name	Time	Method
Wrist Position	1 session, about 1 hour in length	Kinematic planar (x, y) representation of wrist position (in l) based on pose captured from a single camera and through machine learning. Right and left arm wrist position were measured. Wrist position is reported in pixels from the camera data and normalization of data (units of measure is represented as pixels per length of trunk, normalized units with respect to trunk length). A positive value indicates the movement of arm upwards, and a negative value indicates the movement of arm downwards, with respect to the baseline.; The camera data analyzed was the condition where infant supine movement on the mat for up to two minutes (without a toy). The camera was in a fixed position above the infant.
Ankle Position	1 session, about 1 hour in length	Kinematic planar (x, y) representation of ankle position (in l) based on pose captured from a single camera and through machine learning. Right and left arm ankle position were measured. Ankle position is reported in pixels from the camera data and normalization of data (units of measure is represented as pixels per length of trunk, normalized units with respect to trunk length). A positive value indicates the movement of leg upwards, and a negative value indicates the movement of leg downwards, with respect to the baseline.; The camera data analyzed was the condition where infant supine movement on the mat for up to two minutes (without a toy). The camera was in a fixed position above the infant.
Ankle Velocity	1 session, about 1 hour in length	Kinematic (x, y) representation of ankle movement (in l/s) based on pose captured from a single camera and through machine learning. Right and left ankle movement were measured. Ankle movement is reported in pixels from the camera data and normalization of data (units of measure is represented as pixels per length of trunk, normalized units with respect to trunk length). A positive value indicates the movement of leg upwards, and a negative value indicates the movement of leg downwards, with respect to the baseline.; The camera data analyzed was the condition where infant supine movement on the mat for up to two minutes (without a toy). The camera was in a fixed position above the infant.
Wrist Velocity	1 session, about 1 hour in length	Kinematic (x, y) representation of wrist movement (in l/s) based on pose captured from a single camera and through machine learning. Right and left arm wrist movement were measured. Wrist movement is reported in pixels from the camera data and normalization of data (units of measure is represented as pixels per length of trunk, normalized units with respect to trunk length). A positive value indicates the movement of arm upwards, and a negative value indicates the movement of arm downwards, with respect to the baseline.; The camera data analyzed was the condition where infant supine movement on the mat for up to two minutes (without a toy). The camera was in a fixed position above the infant.

Trial Locations

Locations (2)

Childrens Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Michelle J Johnson, PhD; 🇺🇸 Philadelphia, Pennsylvania, United States