SmarToyGym: Smart Detection of Atypical Toy-oriented Actions in At-risk Infants
Primary Purpose
Cerebral Palsy, Developmental Delay, Stroke
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SmarToyGym
Sponsored by
About this trial
This is an interventional diagnostic trial for Cerebral Palsy focused on measuring infant, baby, developmental delay, robotics, cerebral palsy
Eligibility Criteria
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
Sites / Locations
- Childrens Hospital of Philadelphia
- Michelle J Johnson, PhD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Infants
Arm Description
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.
Outcomes
Primary Outcome Measures
Toy contact
Accelerometer and inertial sensor
Secondary Outcome Measures
Grasp
Force grip
Hand Kinematics
Motion capture of hand reach movements
Center of Pressure
body movement on a mat
Leg kinematics
Motion capture of leg movements
Full Information
NCT ID
NCT02813889
First Posted
June 16, 2016
Last Updated
September 29, 2022
Sponsor
University of Pennsylvania
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT02813889
Brief Title
SmarToyGym: Smart Detection of Atypical Toy-oriented Actions in At-risk Infants
Official Title
SmarToyGym: Smart Detection of Atypical Toy-oriented Actions in At-risk Infants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2015 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Developmental Delay, Stroke, Fine Motor Delay, Infant Development, Other Development Delays
Keywords
infant, baby, developmental delay, robotics, cerebral palsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SmarToyGym
Intervention Description
We aim to develop a SmarToyGym where sensitized, wireless toys are strategically hung and placed within reach of infants to elicit toy-oriented body and arm/hand movements. Each toy will be equipped with sensors capable of measuring the infant's grasping actions such as squeezing, pinching, tilting, etc.
A low-cost 3D motion capture system will be used to collect video data and the infants' reaching and body kinematics in response to the toys. A pressure mat will be used to measure postural changes to detect weight shifts, rolling, crawling and other movements away from the initial posture.
Primary Outcome Measure Information:
Title
Toy contact
Description
Accelerometer and inertial sensor
Time Frame
1 session, about 1 hour in length
Secondary Outcome Measure Information:
Title
Grasp
Description
Force grip
Time Frame
1 session, about 1 hour in length
Title
Hand Kinematics
Description
Motion capture of hand reach movements
Time Frame
1 session, about 1 hour in length
Title
Center of Pressure
Description
body movement on a mat
Time Frame
1 session, about 1 hour in length
Title
Leg kinematics
Description
Motion capture of leg movements
Time Frame
1 session, about 1 hour in length
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
11 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle J Johnson, PhD
Organizational Affiliation
Penn Medicine Rittenhouse
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Prosser, PT, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Michelle J Johnson, PhD
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34175891
Citation
Prosser LA, Aguirre MO, Zhao S, Bogen DK, Pierce SR, Nilan KA, Zhang H, Shofer FS, Johnson MJ. Infants at risk for physical disability may be identified by measures of postural control in supine. Pediatr Res. 2022 Apr;91(5):1215-1221. doi: 10.1038/s41390-021-01617-0. Epub 2021 Jun 26.
Results Reference
background
PubMed Identifier
33959406
Citation
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.
Results Reference
background
PubMed Identifier
33021933
Citation
Chambers C, Seethapathi N, Saluja R, Loeb H, Pierce SR, Bogen DK, Prosser L, Johnson MJ, Kording KP. Computer Vision to Automatically Assess Infant Neuromotor Risk. IEEE Trans Neural Syst Rehabil Eng. 2020 Nov;28(11):2431-2442. doi: 10.1109/TNSRE.2020.3029121. Epub 2020 Nov 6.
Results Reference
background
PubMed Identifier
28813932
Citation
Goyal V, Torres W, Rai R, Shofer F, Bogen D, Bryant P, Prosser L, Johnson MJ. Quantifying infant physical interactions using sensorized toys in a natural play environment. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:882-887. doi: 10.1109/ICORR.2017.8009360.
Results Reference
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SmarToyGym: Smart Detection of Atypical Toy-oriented Actions in At-risk Infants
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