Cerebral PalsyNCT02813889
SmarToyGym: Smart Detection of Atypical Toy-oriented Actions in At-risk Infants
A study testing SmarToyGym in people with Cerebral Palsy and Developmental Delay, run by University of Pennsylvania at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Developmental Delay, Stroke
- What is being tested?
- SmarToyGym
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Infants outside age range of 3-11 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Michelle J Johnson, PhD
Philadelphia, Pennsylvania, 19146
About this study
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.
Read the 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).
- Conditions
- Cerebral Palsy, Developmental Delay, Stroke, Fine Motor Delay, Infant Development, Other Development Delays
- Being tested
- SmarToyGym
- Keywords
- infant, baby, developmental delay, robotics, cerebral palsy
- Medical subject headings
- Cerebral Palsy, Learning Disabilities, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmarToyGymDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Infants | Experimental | Two populations will be involved in testing in the SmarToyGym: 1. Infants exhibiting typical development between 3 months and 11 months of age 2 . Infants exhibiting atypical development (at-risk for neuromotor delay) between 3 months and 11 months of age. Receives: Device: SmarToyGym |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 session, about 1 hour in length
Center of Pressure, Path Length Per Second - Elephant Toy (Birth Status)
Body movement (center of pressure) on a mat, in terms of average path length per second. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with elephant toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Center of Pressure, Path Length Per Second - Orangutan Toy (Birth Status)
Body movement (center of pressure) on a mat, in terms of average path length per second. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with orangutan toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Center of Pressure, Path Length Per Second - Lion Toy (Birth Status)
Body movement (center of pressure) on a mat, in terms of average path length per second. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with lion toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Center of Pressure, Path Length Per Second - No Toy (Motor Control Outcome)
Body movement (center of pressure) on a mat, in terms of path length per minute. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes without a toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Center of Pressure, Path Length Per Second - Elephant Toy (Motor Control Outcome)
Body movement (center of pressure) on a mat, in terms of path length per minute. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with elephant toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Center of Pressure, Path Length Per Second - Orangutan Toy (Motor Control Outcome)
Body movement (center of pressure) on a mat, in terms of path length per minute. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with orangutan toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Center of Pressure, Path Length Per Second - Lion Toy (Motor Control Outcome)
Body movement (center of pressure) on a mat, in terms of path length per minute. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with lion toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Center of Pressure, Standard Deviation (Y) - No Toy (Birth Status)
Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes without a toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Center of Pressure, Standard Deviation (Y) - Elephant Toy (Birth Status)
Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with elephant toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Center of Pressure, Standard Deviation (Y) - Orangutan Toy (Birth Status)
Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with orangutan toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Center of Pressure, Standard Deviation (Y) - Lion Toy (Birth Status)
Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with lion toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Center of Pressure, Standard Deviation (Y) - No Toy (Motor Control Outcome)
Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes without a toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Center of Pressure, Standard Deviation (Y) - Elephant Toy (Motor Control Outcome)
Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with elephant toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Center of Pressure, Standard Deviation (Y) - Orangutan Toy (Motor Control Outcome)
Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with orangutan toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Center of Pressure, Standard Deviation (Y) - Lion Toy (Motor Control Outcome)
Body movement (center of pressure) on a mat, in terms of standard deviation Y. Early postural control (measured by center of pressure) was investigated to distinguish infants with future impairment in motor control from their typically developing peers. Lower path length is representative of greater postural control. The data analyzed was the condition where infant supine movement on the mat for up to two minutes with lion toy. Path length was measured in distance with time normalized to 1 minute.
Measured: 1 session, about 1 hour in length
Toy Interaction (Elephant Toy) - Grasp/Touch/Kick/Mouth Time
Time duration (in seconds) of infant interaction with the Elephant toy. Time spent in voluntary motor (feet and hand) interactions with the toy, analyzing grasp/touch/kick/mouth time. The data analyzed was the condition where the elephant toy was suspended within arm reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of seconds the infant spent interacting with the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time interacting with the toy. Toy interaction time ranged from 0-120 seconds.
Measured: 1 session, approximately 120 seconds during session 1 for the Elephant toy
Toy Interaction (Orangutan Toy) - Grasp/Touch/Kick/Mouth Time
Time duration (in seconds) of infant interaction with the Orangutan toy. Time spent in voluntary motor (feet and hand) interactions with the toy, analyzing grasp/touch/kick/mouth time. The data analyzed was the condition where the orangutan toy was suspended within arm reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of seconds the infant spent interacting with the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time interacting with the toy. Toy interaction time ranged from 0-120 seconds.
Measured: 1 session, approximately 120 seconds during session 1 for the Orangutan toy
Toy Interaction (Lion Toy) - Grasp/Touch/Kick/Mouth Time
Time duration (in seconds) of infant interaction with the Lion toy. Time spent in voluntary motor (feet and hand) interactions with the toy, analyzing grasp/touch/kick/mouth time. The data analyzed was the condition where the lion toy was suspended within foot reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of seconds the infant spent interacting with the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time interacting with the toy. Toy interaction time ranged from 0-120 seconds.
Measured: 1 session, approximately 120 seconds during session 1 for the Lion toy
Toy Interaction (Elephant Toy) - Gaze Time
Time duration (in seconds) of infant interaction with the Elephant toy. Time spent gazing at the toy. The data analyzed was the condition where the elephant toy was suspended within arm reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of seconds the infant spent gazing at the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time gazing at the toy. Toy interaction time ranged from 0-120 seconds.
Measured: 1 session, approximately 120 seconds during session 1 for the Elephant toy
Toy Interaction (Orangutan Toy) - Gaze Time
Time duration (in seconds) of infant interaction with the Orangutan toy. Time spent gazing at the toy. The data analyzed was the condition where the orangutan toy was suspended within arm reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of seconds the infant spent gazing at the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time gazing at the toy. Toy interaction time ranged from 0-120 seconds.
Measured: 1 session, approximately 120 seconds during session 1 for the Orangutan toy
Toy Interaction (Lion Toy) - Gaze Time
Time duration (in seconds) of infant interaction with the Lion toy. Time spent gazing at the toy. The data analyzed was the condition where the lion toy was suspended within foot reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of seconds the infant spent gazing at the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time gazing at the toy. Toy interaction time ranged from 0-120 seconds.
Measured: 1 session, approximately 120 seconds during session 1 for the Lion toy
Number of Occurrences of Elephant Toy Interactions
Frequency of infant interactions with the Elephant toy. Frequency of mouthing, grasping, hand touch, foot touch, and kicking with the toy. The data analyzed was the condition where the elephant toy was suspended within arm reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of occurrences the infant had interacting with the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time interacting with the toy.
Measured: 1 session, approximately 120 seconds during session 1 for the Elephant toy
Number of Occurrences of Orangutan Toy Interactions
Frequency of infant interactions with the Orangutan toy. Frequency of mouthing, grasping, hand touch, foot touch, and kicking with the toy. The data analyzed was the condition where the orangutan toy was suspended within arm reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of occurrences the infant had interacting with the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time interacting with the toy.
Measured: 1 session, approximately 120 seconds during session 1 for the Orangutan toy
Number of Occurrences of Lion Toy Interactions
Frequency of infant interactions with the Lion toy. Frequency of mouthing, grasping, hand touch, foot touch, and kicking with the toy. The data analyzed was the condition where the lion toy was suspended within foot reach above the supine infant for approximately 120 seconds. The median and IQR measure the number of occurrences the infant had interacting with the toy. For numbers that were reported (0,0), those infants had no reaction and spent no time interacting with the toy.
Measured: 1 session, approximately 120 seconds during session 1 for the Lion toy
Secondary outcomes (4)
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.
Measured: 1 session, about 1 hour in length
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.
Measured: 1 session, about 1 hour in length
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.
Measured: 1 session, about 1 hour in length
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.
Measured: 1 session, about 1 hour in length
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startMay 2015
- Primary completion30 Aug 2019
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Michelle J Johnson, PhD, Principal investigator, Penn Medicine RittenhouseLaura Prosser, PT, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813889
- Sponsor's protocol ID
- 822487
- Other IDs
- 1R21HD084327-01
- Status last verified
- Jul 2024
- First submitted
- 16 Jun 2016
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lysenko S, Seethapathi N, Prosser L, Kording K, Johnson MJ. Towards Automated Emotion Classification of Atypically and Typically Developing Infants. Proc IEEE RAS EMBS Int Conf Biomed Robot Biomechatron. 2020 Nov-Dec;2020:503-508. doi: 10.1109/BioRob49111.2020.9224271. Epub 2020 Oct 15.
PubMed 33959406Goyal V, Torres W, Rai R, Shofer F, Bogen D, Bryant P, Prosser L, Johnson MJ. Quantifying infant physical interactions using sensorized toys in a natural play environment. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:882-887. doi: 10.1109/ICORR.2017.8009360.
PubMed 28813932Shivakumar SS, Loeb H, Bogen DK, Shofer F, Bryant P, Prosser L, Johnson MJ. Stereo 3D tracking of infants in natural play conditions. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:841-846. doi: 10.1109/ICORR.2017.8009353.
PubMed 28813925Prosser LA, Aguirre MO, Zhao S, Bogen DK, Pierce SR, Nilan KA, Zhang H, Shofer FS, Johnson MJ. Infants at risk for physical disability may be identified by measures of postural control in supine. Pediatr Res. 2022 Apr;91(5):1215-1221. doi: 10.1038/s41390-021-01617-0. Epub 2021 Jun 26.
PubMed 34175891Chambers C, Seethapathi N, Saluja R, Loeb H, Pierce SR, Bogen DK, Prosser L, Johnson MJ, Kording KP. Computer Vision to Automatically Assess Infant Neuromotor Risk. IEEE Trans Neural Syst Rehabil Eng. 2020 Nov;28(11):2431-2442. doi: 10.1109/TNSRE.2020.3029121. Epub 2020 Nov 6.
PubMed 33021933Kather C, Shofer FS, Park JI, Bogen D, Pierce SR, Kording K, Nilan KA, Zhang H, Prosser LA, Johnson MJ. Quantifying interaction with robotic toys in pre-term and full-term infants. Front Pediatr. 2023 Oct 19;11:1153841. doi: 10.3389/fped.2023.1153841. eCollection 2023.
PubMed 37928351
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmarToyGym: Smart Detection of Atypical Toy-oriented Actions in At-risk Infants
- ClinicalTrials.gov ID
- NCT02813889
- Acronym / sponsor ID
- 822487
- Conditions
- Cerebral Palsy, Developmental Delay, Stroke, Fine Motor Delay, Infant Development, Other Development Delays
- Keywords
- infant, baby, developmental delay, robotics, cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2015 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Posted 6 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to develop a SmarToyGym where sensitized, wireless toys are strategically hung and placed within reach of infants to elicit toy-oriented body and arm/hand movements. Each toy will be equipped with sensors capable of measuring the infant's grasping actions such as squeezing, pinching, tilting, etc.
A low-cost 3D motion capture system will be used to collect video data and the infants' reaching and body kinematics in response to the toys. A pressure mat will be used to measure postural changes to detect weight shifts, rolling, crawling and other movements away from the initial posture. By capitalizing on these wireless and low-cost technologies, it will permit the regular and non-invasive monitoring of infants, which can lead to detailed, non-obtrusive, quantitative evaluation of motor development. In this vein, the investigators also aim to conduct proof-of-concept testing of the SmarToyGym with atypical and typical developing infants. The investigators will include infants' ages 3 to 11 months who are categorized as high-risk or low-risk using the Bayley Infant Neurodevelopmental Screener.
Detailed description
The proposed research is specifically designed to investigate the ability of a novel tool to identify atypically developing infants from their typically developing peers. Twenty-four infants will be recruited to participate, including 12 who are developing typically and 12 who are identified as at-risk for neuromotor delay. Infants with typical development will be at least 3 months and less than 11 months of age, score in the low-risk category on the Bayley Infant Neurodevelopmental Screener (BINS), score a greater than 85 on all sub-scales of the Bayley Scale of Infant Development (BSID-II), have no history of significant cardiac, orthopedic, or neurological condition, and gestational age at least 37 weeks. Infants at risk for neuromotor delay will be at least 3 months and less than 11 months of age (corrected for preterm birth if applicable), score in the moderate or high risk categories on the BINS, and score an 85 or less on the motor sub-scales of the Bayley Scale of Infant Development (BSID-II). In an effort to decrease variability of the data, infants in each group will be further stratified into an older group (8-10+ months) and a younger group (3-5 months).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants | Experimental | Device: SmarToyGymTwo populations will be involved in testing in the SmarToyGym: 1. Infants exhibiting typical development between 3 months and 11 months of age 2 . Infants exhibiting atypical development (at-risk for neuromotor delay) between 3 months and 11 months of age. |
Who may qualify
- Ages
- 3 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Infants outside age range of 3-11 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmarToyGymWe 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. | Device | Infants |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Wrist Position
Time frame: 1 session, about 1 hour in length
Ankle Position
Time frame: 1 session, about 1 hour in length
Wrist Velocity
Time frame: 1 session, about 1 hour in length
Ankle Velocity
Time frame: 1 session, about 1 hour in length
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33959406Lysenko S, Seethapathi N, Prosser L, Kording K, Johnson MJ. Towards Automated Emotion Classification of Atypically and Typically Developing Infants. Proc IEEE RAS EMBS Int Conf Biomed Robot Biomechatron. 2020 Nov-Dec;2020:503-508. doi: 10.1109/BioRob49111.2020.9224271. Epub 2020 Oct 15.
- Background: PubMed 28813932Goyal V, Torres W, Rai R, Shofer F, Bogen D, Bryant P, Prosser L, Johnson MJ. Quantifying infant physical interactions using sensorized toys in a natural play environment. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:882-887. doi: 10.1109/ICORR.2017.8009360.
- Background: PubMed 28813925Shivakumar SS, Loeb H, Bogen DK, Shofer F, Bryant P, Prosser L, Johnson MJ. Stereo 3D tracking of infants in natural play conditions. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:841-846. doi: 10.1109/ICORR.2017.8009353.
- Results publication: PubMed 34175891Prosser LA, Aguirre MO, Zhao S, Bogen DK, Pierce SR, Nilan KA, Zhang H, Shofer FS, Johnson MJ. Infants at risk for physical disability may be identified by measures of postural control in supine. Pediatr Res. 2022 Apr;91(5):1215-1221. doi: 10.1038/s41390-021-01617-0. Epub 2021 Jun 26.
- Results publication: PubMed 33021933Chambers C, Seethapathi N, Saluja R, Loeb H, Pierce SR, Bogen DK, Prosser L, Johnson MJ, Kording KP. Computer Vision to Automatically Assess Infant Neuromotor Risk. IEEE Trans Neural Syst Rehabil Eng. 2020 Nov;28(11):2431-2442. doi: 10.1109/TNSRE.2020.3029121. Epub 2020 Nov 6.
- Results publication: PubMed 37928351Kather C, Shofer FS, Park JI, Bogen D, Pierce SR, Kording K, Nilan KA, Zhang H, Prosser LA, Johnson MJ. Quantifying interaction with robotic toys in pre-term and full-term infants. Front Pediatr. 2023 Oct 19;11:1153841. doi: 10.3389/fped.2023.1153841. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle J Johnson, PhD principal investigator
Penn Medicine Rittenhouse
Laura Prosser, PT, PhD principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmarToyGym in people with Cerebral Palsy and Developmental Delay, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of Pressure, Path Length Per Second - No Toy (Birth Status) (time frame: 1 session, about 1 hour in length). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02813889, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.