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Completed

NCT Number: NCT02813889

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  20. Toy Interaction (Elephant Toy) - Gaze Time

    Time frame: 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.

  21. Toy Interaction (Orangutan Toy) - Gaze Time

    Time frame: 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.

  22. Toy Interaction (Lion Toy) - Gaze Time

    Time frame: 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.

  23. Number of Occurrences of Elephant Toy Interactions

    Time frame: 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.

  24. Number of Occurrences of Orangutan Toy Interactions

    Time frame: 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.

  25. Number of Occurrences of Lion Toy Interactions

    Time frame: 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.

Secondary outcomes

  1. Wrist Position

    Time frame: 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.

  2. Ankle Position

    Time frame: 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.

  3. Wrist Velocity

    Time frame: 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.

  4. Ankle Velocity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2022
First posted
Jun 27, 2016
Registry last updated
Aug 6, 2024

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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