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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02813889
Enrollment
36
Registered
2016-06-27
Start date
2015-05-31
Completion date
2022-12-30
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

infant, baby, developmental delay, robotics, cerebral palsy

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).

Interventions

DEVICESmarToyGym

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.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Months to 11 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Center of Pressure, Standard Deviation (Y) - Elephant Toy (Birth Status)1 session, about 1 hour in lengthBody 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, Path Length Per Second - Elephant Toy (Motor Control Outcome)1 session, about 1 hour in lengthBody 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, Path Length Per Second - Orangutan Toy (Motor Control Outcome)1 session, about 1 hour in lengthBody 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 (Motor Control Outcome)1 session, about 1 hour in lengthBody 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 (Birth Status)1 session, about 1 hour in lengthBody 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) - Orangutan Toy (Birth Status)1 session, about 1 hour in lengthBody 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) - Lion Toy (Birth Status)1 session, about 1 hour in lengthBody 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) - No Toy (Motor Control Outcome)1 session, about 1 hour in lengthBody 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 (Motor Control Outcome)1 session, about 1 hour in lengthBody 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 (Motor Control Outcome)1 session, about 1 hour in lengthBody 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) - Lion Toy (Motor Control Outcome)1 session, about 1 hour in lengthBody 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.
Toy Interaction (Elephant Toy) - Grasp/Touch/Kick/Mouth Time1 session, approximately 120 seconds during session 1 for the Elephant toyTime 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.
Toy Interaction (Orangutan Toy) - Grasp/Touch/Kick/Mouth Time1 session, approximately 120 seconds during session 1 for the Orangutan toyTime 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.
Toy Interaction (Lion Toy) - Grasp/Touch/Kick/Mouth Time1 session, approximately 120 seconds during session 1 for the Lion toyTime 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 Time1 session, approximately 120 seconds during session 1 for the Elephant toyTime 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 Time1 session, approximately 120 seconds during session 1 for the Orangutan toyTime 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 Time1 session, approximately 120 seconds during session 1 for the Lion toyTime 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.
Number of Occurrences of Elephant Toy Interactions1 session, approximately 120 seconds during session 1 for the Elephant toyFrequency 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 Orangutan Toy Interactions1 session, approximately 120 seconds during session 1 for the Orangutan toyFrequency 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.
Number of Occurrences of Lion Toy Interactions1 session, approximately 120 seconds during session 1 for the Lion toyFrequency 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, Path Length Per Second - No Toy (Birth Status)1 session, about 1 hour in lengthBody 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 lengthBody 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 lengthBody 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 - Lion Toy (Birth Status)1 session, about 1 hour in lengthBody 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 - No Toy (Motor Control Outcome)1 session, about 1 hour in lengthBody 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.

Secondary

MeasureTime frameDescription
Ankle Position1 session, about 1 hour in lengthKinematic 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.
Wrist Velocity1 session, about 1 hour in lengthKinematic (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.
Ankle Velocity1 session, about 1 hour in lengthKinematic (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 Position1 session, about 1 hour in lengthKinematic 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.

Countries

United States

Participant flow

Recruitment details

The same group of infants were analyzed throughout the study and for all outcome measures. The number differs for each outcome measure because data for some infants were excluded, the number varying for each study due to the specific outcome measure. These exclusions are specifically explained for each outcome measure in the outcome measures section. Infants #35 and #36 were consented, but no data was collected for them regarding any outcome measure.

Participants by arm

ArmCount
Full-Term and Pre-Term Infants
Two populations will be involved in testing in the SmarToyGym: 1. Full-term infants (born at a gestational age of \> 37 weeks) between 3 months and 11 months of age. 2. Pre-term infants (born at a gestational age \< 36 weeks) between 3 months and 11 months of age. Infants were also categorized by typical and atypical (at-risk for neuromotor delay or physical disability) development, and by low, moderate, and high risk. SmarToyGym: 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.
36
Total36

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyExcluded 7 due to protocol adjustments. Specific exclusions listed under each outcome measure.70

Baseline characteristics

CharacteristicFull-Term and Pre-Term Infants
Age, Categorical
<=18 years
36 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous6 month
STANDARD_DEVIATION 2
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
3 Participants
Race (NIH/OMB)
Black or African American
11 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
21 Participants
Sex: Female, Male
Female
24 Participants
Sex: Female, Male
Male
12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 260 / 10
other
Total, other adverse events
0 / 260 / 10
serious
Total, serious adverse events
0 / 260 / 10

Outcome results

Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Path Length Per Second - Elephant Toy (Birth Status)0.0311 centimeters per second (cm/sec)Standard Deviation 0.0171
Pre-Term InfantsCenter of Pressure, Path Length Per Second - Elephant Toy (Birth Status)0.0508 centimeters per second (cm/sec)Standard Deviation 0.0206
p-value: 0.000595% CI: [-0.0331, -0.007]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Path Length Per Second - Elephant Toy (Motor Control Outcome)0.0312 centimeters per second (cm/sec)Standard Deviation 0.0153
Pre-Term InfantsCenter of Pressure, Path Length Per Second - Elephant Toy (Motor Control Outcome)0.0617 centimeters per second (cm/sec)Standard Deviation 0.0181
p-value: <0.000195% CI: [0.0138, 0.048]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Path Length Per Second - Lion Toy (Birth Status)0.0342 centimeters per second (cm/sec)Standard Deviation 0.0123
Pre-Term InfantsCenter of Pressure, Path Length Per Second - Lion Toy (Birth Status)0.0421 centimeters per second (cm/sec)Standard Deviation 0.0126
p-value: 0.762495% CI: [-0.018, 0.0062]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Path Length Per Second - Lion Toy (Motor Control Outcome)0.0335 centimeters per second (cm/sec)Standard Deviation 0.0113
Pre-Term InfantsCenter of Pressure, Path Length Per Second - Lion Toy (Motor Control Outcome)0.0416 centimeters per second (cm/sec)Standard Deviation 0.0025
p-value: 0.678295% CI: [-0.0059, 0.0191]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Path Length Per Second - No Toy (Birth Status)0.0282 centimeters per second (cm/sec)Standard Deviation 0.0116
Pre-Term InfantsCenter of Pressure, Path Length Per Second - No Toy (Birth Status)0.0428 centimeters per second (cm/sec)Standard Deviation 0.0144
p-value: 0.005495% CI: [-0.0261, -0.0031]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Path Length Per Second - No Toy (Motor Control Outcome)0.0287 centimeters per second (cm/sec)Standard Deviation 0.011
Pre-Term InfantsCenter of Pressure, Path Length Per Second - No Toy (Motor Control Outcome)0.0416 centimeters per second (cm/sec)Standard Deviation 0.0035
p-value: 0.032695% CI: [0.0007, 0.0251]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Path Length Per Second - Orangutan Toy (Birth Status)0.0251 centimeters per second (cm/sec)Standard Deviation 0.105
Pre-Term InfantsCenter of Pressure, Path Length Per Second - Orangutan Toy (Birth Status)0.0417 centimeters per second (cm/sec)Standard Deviation 0.0115
p-value: 0.008895% CI: [-0.0267, -0.0026]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Path Length Per Second - Orangutan Toy (Motor Control Outcome)0.0260 centimeters per second (cm/sec)Standard Deviation 0.01
Pre-Term InfantsCenter of Pressure, Path Length Per Second - Orangutan Toy (Motor Control Outcome)0.0445 centimeters per second (cm/sec)Standard Deviation 0.007
p-value: 0.002595% CI: [0.0045, 0.0295]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Standard Deviation (Y) - Elephant Toy (Birth Status)1.520 centimeters per minute (cm/min)Standard Deviation 0.71
Pre-Term InfantsCenter of Pressure, Standard Deviation (Y) - Elephant Toy (Birth Status)1.159 centimeters per minute (cm/min)Standard Deviation 1.001
p-value: 0.994795% CI: [-0.921, 1.477]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Standard Deviation (Y) - Elephant Toy (Motor Control Outcome)1.3491 centimeters per second (cm/sec)Standard Deviation 0.7232
Pre-Term InfantsCenter of Pressure, Standard Deviation (Y) - Elephant Toy (Motor Control Outcome)1.6428 centimeters per second (cm/sec)Standard Deviation 1.7433
p-value: 0.96695% CI: [-1.1243, 2.1739]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Standard Deviation (Y) - Lion Toy (Birth Status)2.046 centimeters per minute (cm/min)Standard Deviation 0.658
Pre-Term InfantsCenter of Pressure, Standard Deviation (Y) - Lion Toy (Birth Status)0.738 centimeters per minute (cm/min)Standard Deviation 0.285
p-value: 0.031495% CI: [0.066, 2.286]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Standard Deviation (Y) - Lion Toy (Motor Control Outcome)1.8048 centimeters per second (cm/sec)Standard Deviation 0.7578
Pre-Term InfantsCenter of Pressure, Standard Deviation (Y) - Lion Toy (Motor Control Outcome)0.6503 centimeters per second (cm/sec)Standard Deviation 0.2535
p-value: 0.112995% CI: [-2.2785, 0.1375]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureGroupValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Standard Deviation (Y) - No Toy (Birth Status)*StdDevY (Full-Term)1.863 centimeters per minute (cm/min)Standard Deviation 0.92
Pre-Term InfantsCenter of Pressure, Standard Deviation (Y) - No Toy (Birth Status)*StdDevY (Pre-Term)0.799 centimeters per minute (cm/min)Standard Deviation 0.502
p-value: 0.047995% CI: [0.006, 2.122]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Standard Deviation (Y) - No Toy (Motor Control Outcome)1.6920 centimeters per second (cm/sec)Standard Deviation 0.9442
Pre-Term InfantsCenter of Pressure, Standard Deviation (Y) - No Toy (Motor Control Outcome)0.6177 centimeters per second (cm/sec)Standard Deviation 0.3032
p-value: 0.095895% CI: [-2.255, 0.1059]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Standard Deviation (Y) - Orangutan Toy (Birth Status)1.857 centimeters per minute (cm/min)Standard Deviation 0.981
Pre-Term InfantsCenter of Pressure, Standard Deviation (Y) - Orangutan Toy (Birth Status)0.890 centimeters per minute (cm/min)Standard Deviation 0.54
p-value: 0.261495% CI: [-0.274, 1.945]ANOVA
Primary

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.

Time frame: 1 session, about 1 hour in length

Population: 21 excluded from enrolled 36: 7 infants were excluded from Center of Pressure analysis due to procedural adjustments.~11 infants were excluded from Center of Pressure analysis due to unusable data (infants either rolled or crawled on the mat, or they were fussy and were not able to be calmed while laying supine without being touched).~3 infants were excluded from Center of Pressure analysis due to technical issues (with the mat on the day of testing).

ArmMeasureValue (MEAN)Dispersion
Full-Term InfantsCenter of Pressure, Standard Deviation (Y) - Orangutan Toy (Motor Control Outcome)1.5857 centimeters per second (cm/sec)Standard Deviation 1.0106
Pre-Term InfantsCenter of Pressure, Standard Deviation (Y) - Orangutan Toy (Motor Control Outcome)1.0820 centimeters per second (cm/sec)Standard Deviation 0.6662
p-value: 0.946295% CI: [-1.6278, 0.7882]ANOVA
Primary

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.

Time frame: 1 session, approximately 120 seconds during session 1 for the Elephant toy

Population: 13 excluded from enrolled 36: 2 infants were excluded from Toy Interaction analysis due to procedural adjustments.~5 were excluded from Toy Interaction analysis due to procedural inconsistencies.~6 were excluded from Toy Interaction analysis from unusable data (infants were either crying or crawling/rolling off the gym).

ArmMeasureValue (MEDIAN)
Full-Term InfantsNumber of Occurrences of Elephant Toy Interactions22.5 occurrences
Pre-Term InfantsNumber of Occurrences of Elephant Toy Interactions0 occurrences
Primary

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.

Time frame: 1 session, approximately 120 seconds during session 1 for the Lion toy

Population: 13 excluded from enrolled 36: 2 infants were excluded from Toy Interaction analysis due to procedural adjustments.~5 were excluded from Toy Interaction analysis due to procedural inconsistencies.~6 were excluded from Toy Interaction analysis from unusable data (infants were either crying or crawling/rolling off the gym).

ArmMeasureValue (MEDIAN)
Full-Term InfantsNumber of Occurrences of Lion Toy Interactions1 occurrences
Pre-Term InfantsNumber of Occurrences of Lion Toy Interactions0 occurrences
Primary

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.

Time frame: 1 session, approximately 120 seconds during session 1 for the Orangutan toy

Population: 13 excluded from enrolled 36: 2 infants were excluded from Toy Interaction analysis due to procedural adjustments.~5 were excluded from Toy Interaction analysis due to procedural inconsistencies.~6 were excluded from Toy Interaction analysis from unusable data (infants were either crying or crawling/rolling off the gym).

ArmMeasureValue (MEDIAN)
Full-Term InfantsNumber of Occurrences of Orangutan Toy Interactions7 occurrences
Pre-Term InfantsNumber of Occurrences of Orangutan Toy Interactions7 occurrences
Primary

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.

Time frame: 1 session, approximately 120 seconds during session 1 for the Elephant toy

Population: 13 excluded from enrolled 36: 2 infants were excluded from Toy Interaction analysis due to procedural adjustments.~5 were excluded from Toy Interaction analysis due to procedural inconsistencies.~6 were excluded from Toy Interaction analysis from unusable data (infants were either crying or crawling/rolling off the gym).

ArmMeasureValue (MEDIAN)
Full-Term InfantsToy Interaction (Elephant Toy) - Gaze Time59.6 seconds (s)
Pre-Term InfantsToy Interaction (Elephant Toy) - Gaze Time0 seconds (s)
Primary

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.

Time frame: 1 session, approximately 120 seconds during session 1 for the Elephant toy

Population: 13 excluded from enrolled 36: 2 infants were excluded from Toy Interaction analysis due to procedural adjustments.~5 were excluded from Toy Interaction analysis due to procedural inconsistencies.~6 were excluded from Toy Interaction analysis from unusable data (infants were either crying or crawling/rolling off the gym).

ArmMeasureValue (MEDIAN)
Full-Term InfantsToy Interaction (Elephant Toy) - Grasp/Touch/Kick/Mouth Time90.7 second (s)
Pre-Term InfantsToy Interaction (Elephant Toy) - Grasp/Touch/Kick/Mouth Time0 second (s)
Primary

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.

Time frame: 1 session, approximately 120 seconds during session 1 for the Lion toy

Population: 13 excluded from enrolled 36: 2 infants were excluded from Toy Interaction analysis due to procedural adjustments.~5 were excluded from Toy Interaction analysis due to procedural inconsistencies.~6 were excluded from Toy Interaction analysis from unusable data (infants were either crying or crawling/rolling off the gym).

ArmMeasureValue (MEDIAN)
Full-Term InfantsToy Interaction (Lion Toy) - Gaze Time21.7 seconds (s)
Pre-Term InfantsToy Interaction (Lion Toy) - Gaze Time0 seconds (s)
Primary

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.

Time frame: 1 session, approximately 120 seconds during session 1 for the Lion toy

Population: 13 excluded from enrolled 36: 2 infants were excluded from Toy Interaction analysis due to procedural adjustments.~5 were excluded from Toy Interaction analysis due to procedural inconsistencies.~6 were excluded from Toy Interaction analysis from unusable data (infants were either crying or crawling/rolling off the gym).

ArmMeasureValue (MEDIAN)
Full-Term InfantsToy Interaction (Lion Toy) - Grasp/Touch/Kick/Mouth Time2.2 seconds (s)
Pre-Term InfantsToy Interaction (Lion Toy) - Grasp/Touch/Kick/Mouth Time0 seconds (s)
Primary

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.

Time frame: 1 session, approximately 120 seconds during session 1 for the Orangutan toy

Population: 13 excluded from enrolled 36: 2 infants were excluded from Toy Interaction analysis due to procedural adjustments.~5 were excluded from Toy Interaction analysis due to procedural inconsistencies.~6 were excluded from Toy Interaction analysis from unusable data (infants were either crying or crawling/rolling off the gym).

ArmMeasureValue (MEDIAN)
Full-Term InfantsToy Interaction (Orangutan Toy) - Gaze Time83.5 seconds (s)
Pre-Term InfantsToy Interaction (Orangutan Toy) - Gaze Time44.8 seconds (s)
Primary

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.

Time frame: 1 session, approximately 120 seconds during session 1 for the Orangutan toy

Population: 13 excluded from enrolled 36: 2 infants were excluded from Toy Interaction analysis due to procedural adjustments.~5 were excluded from Toy Interaction analysis due to procedural inconsistencies.~6 were excluded from Toy Interaction analysis from unusable data (infants were either crying or crawling/rolling off the gym).

ArmMeasureValue (MEDIAN)
Full-Term InfantsToy Interaction (Orangutan Toy) - Grasp/Touch/Kick/Mouth Time69.3 seconds (s)
Pre-Term InfantsToy Interaction (Orangutan Toy) - Grasp/Touch/Kick/Mouth Time27.9 seconds (s)
Secondary

Ankle Position

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.

Time frame: 1 session, about 1 hour in length

Population: 13 full-term, 6 pre-term. 17 excluded from enrolled 36: 5 were excluded from wrist/ankle analysis due to procedural adjustments. 7 were excluded from wrist/ankle analysis due to missing BINS score data. 2 were excluded from wrist/ankle analysis due to unusable data (infants were sitting during the video, which prevented successful pose estimation).~3 were excluded from wrist/ankle analysis due to missing video data.

ArmMeasureGroupValue (MEDIAN)Dispersion
Full-Term InfantsAnkle PositionAnkle Position, x-0.018 pixels per normalized trunk lengthStandard Deviation 0.19
Full-Term InfantsAnkle PositionAnkle Position, y1.580 pixels per normalized trunk lengthStandard Deviation 0.076
Pre-Term InfantsAnkle PositionAnkle Position, x0.017 pixels per normalized trunk lengthStandard Deviation 0.176
Pre-Term InfantsAnkle PositionAnkle Position, y1.472 pixels per normalized trunk lengthStandard Deviation 0.094
High-Risk InfantsAnkle PositionAnkle Position, x-0.056 pixels per normalized trunk lengthStandard Deviation 0.097
High-Risk InfantsAnkle PositionAnkle Position, y1.348 pixels per normalized trunk lengthStandard Deviation 0.389
Secondary

Ankle Velocity

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.

Time frame: 1 session, about 1 hour in length

Population: 13 full-term, 6 pre-term. 17 excluded from enrolled 36: 5 were excluded from wrist/ankle analysis due to procedural adjustments. 7 were excluded from wrist/ankle analysis due to missing BINS score data. 2 were excluded from wrist/ankle analysis due to unusable data (infants were sitting during the video, which prevented successful pose estimation).~3 were excluded from wrist/ankle analysis due to missing video data.

ArmMeasureGroupValue (MEDIAN)Dispersion
Full-Term InfantsAnkle VelocityAnkle Velocity, x0.052 pixels (per trunk length) per secondStandard Deviation 0.02
Full-Term InfantsAnkle VelocityAnkle Velocity, y0.041 pixels (per trunk length) per secondStandard Deviation 0.018
Pre-Term InfantsAnkle VelocityAnkle Velocity, x0.072 pixels (per trunk length) per secondStandard Deviation 0.029
Pre-Term InfantsAnkle VelocityAnkle Velocity, y0.067 pixels (per trunk length) per secondStandard Deviation 0.039
High-Risk InfantsAnkle VelocityAnkle Velocity, x0.067 pixels (per trunk length) per secondStandard Deviation 0.042
High-Risk InfantsAnkle VelocityAnkle Velocity, y0.062 pixels (per trunk length) per secondStandard Deviation 0.046
Secondary

Wrist Position

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.

Time frame: 1 session, about 1 hour in length

Population: 13 full-term, 6 pre-term. 17 excluded from enrolled 36: 5 were excluded from wrist/ankle analysis due to procedural adjustments. 7 were excluded from wrist/ankle analysis due to missing BINS score data. 2 were excluded from wrist/ankle analysis due to unusable data (infants were sitting during the video, which prevented successful pose estimation).~3 were excluded from wrist/ankle analysis due to missing video data.

ArmMeasureGroupValue (MEDIAN)Dispersion
Full-Term InfantsWrist PositionWrist Position, x0.008 pixels per normalized trunk lengthStandard Deviation 0.031
Full-Term InfantsWrist PositionWrist Position, y0.370 pixels per normalized trunk lengthStandard Deviation 0.229
Pre-Term InfantsWrist PositionWrist Position, x0.088 pixels per normalized trunk lengthStandard Deviation 0.239
Pre-Term InfantsWrist PositionWrist Position, y0.268 pixels per normalized trunk lengthStandard Deviation 0.217
High-Risk InfantsWrist PositionWrist Position, x-0.044 pixels per normalized trunk lengthStandard Deviation 0.146
High-Risk InfantsWrist PositionWrist Position, y0.224 pixels per normalized trunk lengthStandard Deviation 0.185
Secondary

Wrist Velocity

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.

Time frame: 1 session, about 1 hour in length

Population: 13 full-term, 6 pre-term. 17 excluded from enrolled 36: 5 were excluded from wrist/ankle analysis due to procedural adjustments. 7 were excluded from wrist/ankle analysis due to missing BINS score data. 2 were excluded from wrist/ankle analysis due to unusable data (infants were sitting during the video, which prevented successful pose estimation).~3 were excluded from wrist/ankle analysis due to missing video data.

ArmMeasureGroupValue (MEDIAN)Dispersion
Full-Term InfantsWrist VelocityWrist Velocity, x0.034 pixels (per trunk length) per secondStandard Deviation 0.014
Full-Term InfantsWrist VelocityWrist Velocity, y0.035 pixels (per trunk length) per secondStandard Deviation 0.016
Pre-Term InfantsWrist VelocityWrist Velocity, x0.048 pixels (per trunk length) per secondStandard Deviation 0.017
Pre-Term InfantsWrist VelocityWrist Velocity, y0.045 pixels (per trunk length) per secondStandard Deviation 0.019
High-Risk InfantsWrist VelocityWrist Velocity, x0.048 pixels (per trunk length) per secondStandard Deviation 0.023
High-Risk InfantsWrist VelocityWrist Velocity, y0.054 pixels (per trunk length) per secondStandard Deviation 0.023

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026