SmarToyGym: Smart Detection of Atypical Toy-oriented Actions in At-risk Infants
Phase: NA
Conditions: Cerebral Palsy, Developmental Delay, Stroke, Fine Motor Delay, Infant Development, Other Development Delays
Sponsor: University of Pennsylvania

 
 
  
 
 
SmarToyGym: Smart Detection 
of Atypical Toy-Oriented 
Actions in At-Risk Infants 
(Protocol) 
NCT #02813889 
MAY 19, 2021 

Page 1 of 13
Protocol Details
Basic Info
Conﬁrmation Number:
cigajiii
Protocol Number:
822487
Created By:
VIVIO, NICHOLAS
Principal Investigator:
JOHNSON, MICHELLE J
Protocol Title:
SmarToyGym: Smart detection of atypical toy-oriented actions in at-risk infants
Short Title:
SmarToyGym
Protocol Description:
This project develops a SmarToyGym where sensorized, wireless toys are placed within the reach 
of infants to elicit body, arm/hand and leg movements. The objective is to conduct pilot testing of 
the SmartToyGm with atypical and typical infants. A battery of metrics will be identiﬁed to 
discriminate between high and low risk infants, thus allowing for earlier neurodevelopmental 
intervention.
Submission Type:
Biomedical Research
Application Type:
EXEMPT Category 2
Resubmission*
Yes
Hospital Sites
Will any research activities and/or services be conducted at a Penn Medicine afﬁliated hospital site?
No
Study Personnel
Principal Investigator
Name:
JOHNSON, MICHELLE J
Dept / School / Div:
4482 - RM-Rehabilitation Medicine
Campus Address
Mail Code
4283
Address:
PENN MEDICINE RITTENHOUSE
1800 LOMBARD ST., 1ST FLR.
City State Zip:
PHILADELPHIA PA 19146-8400
Phone:
215-893-2665
Fax:
215-893-2686
Pager:
Email:
johnmic@pennmedicine.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
09/07/2015
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA

Page 2 of 13
Study Contacts
Name:
LIMA, KRISTINE S
Dept / School / Div:
4482 - RM-Rehabilitation Medicine
Campus Address
Mail Code
4283
Address:
1800 Lombard St 
Penn Medicine Rittenhouse 
City State Zip:
PHILADELPHIA PA 19146-0000
Phone:
215-893-2679
Fax:
-
Pager:
Email:
kristine.lima@uphs.upenn.edu
HS Training Completed:
No
Training Expiration Date:
Name of course completed :
Other Investigator
Name:
PROSSER, LAURA
Dept / School / Div:
4392 - PE-Pediatrics
Campus Address
Mail Code
4399
Address:
CHOP 
3401 Civic Center Boulevard
City State Zip:
PHILADELPHIA PA 19104-4399
Phone:
215-590-2495
Fax:
215-590-9162
Pager:
Email:
prosserl@email.chop.edu
HS Training Completed:
No
Training Expiration Date:
Name of course completed :
Responsible Org (Department/School/Division):
4482 - RM-Rehabilitation Medicine
Key Study Personnel
Name:
OYERINDE, ESTHER
Department/School/Division:
DM-Department of Medicine
HS Training Completed:
Yes
Training Expiration Date:
03/13/2021
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA

Page 3 of 13
Name:
HO, ELAINE S
Department/School/Division:
PH-Pharmacology
HS Training Completed:
Yes
Training Expiration Date:
10/17/2020
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
SALUJA, RACHIT
Department/School/Division:
School of Engineering
HS Training Completed:
No
Training Expiration Date:
Name of course completed:
Name:
GAARDSMOE, SAMUEL
Department/School/Division:
Health System
HS Training Completed:
Yes
Training Expiration Date:
05/31/2018
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
TORRES, WILSON
Department/School/Division:
Health System
HS Training Completed:
Yes
Training Expiration Date:
04/17/2019
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
PATEL, ANIKET C
Department/School/Division:
School of Engineering
HS Training Completed:
Yes
Training Expiration Date:
01/27/2021
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
BOGEN, DANIEL K
Department/School/Division:
Research Services
HS Training Completed:
Yes
Training Expiration Date:
04/07/2017
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
FREGENE, NICOLE
Department/School/Division:
Health System
HS Training Completed:
No
Training Expiration Date:
Name of course completed:

Page 4 of 13
Name:
SANDERS, OZELL P
Department/School/Division:
Regulatory Affairs
HS Training Completed:
No
Training Expiration Date:
Name of course completed:
Name:
LYSENKO, SOFIYA
Department/School/Division:
Health System
HS Training Completed:
Yes
Training Expiration Date:
06/19/2020
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
LOEB, HELEN
Department/School/Division:
Regulatory Affairs
HS Training Completed:
No
Training Expiration Date:
Name of course completed:
Name:
GIBBS, KATHLEEN A
Department/School/Division:
PE-Pediatrics
HS Training Completed:
Yes
Training Expiration Date:
09/27/2020
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
SEETHAPATHI, NIDHI
Department/School/Division:
Bioengineering
HS Training Completed:
No
Training Expiration Date:
Name of course completed:
Name:
KORDING, KONRAD P
Department/School/Division:
Bioengineering
HS Training Completed:
Yes
Training Expiration Date:
07/13/2020
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
SOBREPERA, MICHAEL
Department/School/Division:
Health System
HS Training Completed:
Yes
Training Expiration Date:
09/02/2019
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA

Page 5 of 13
Name:
ZHAO, SUSAN
Department/School/Division:
Health System
HS Training Completed:
Yes
Training Expiration Date:
09/17/2019
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
MORRIS, HEIDI
Department/School/Division:
Health System
HS Training Completed:
No
Training Expiration Date:
Name of course completed:
Name:
CHAMBERS, CLAIRE
Department/School/Division:
Bioengineering
HS Training Completed:
Yes
Training Expiration Date:
10/24/2020
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
SHOFER, FRANCES S
Department/School/Division:
EG-Emergency Medicine
HS Training Completed:
No
Training Expiration Date:
Name of course completed:
Name:
CHEN, YUDAN
Department/School/Division:
School of Engineering
HS Training Completed:
Yes
Training Expiration Date:
05/13/2021
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
KONG, GAIQING
Department/School/Division:
Bioengineering
HS Training Completed:
Yes
Training Expiration Date:
10/29/2020
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Disclosure of Signiﬁcant Financial Interests*
Does any person who is responsible for the design, conduct, or reporting of this research protocol have 
a FINANCIAL INTEREST?
No
Penn Intellectual Property*
To the best of the Principal Investigator's knowledge, does this protocol involve the testing, 
development or evaluation of a drug, device, product, or other type of intellectual property (IP) that is 
owned by or assigned to the University of Pennsylvania?
Yes

Page 6 of 13
If yes, please provide any readily available information on such IP. For example, a brief description of 
the IP, any relevant docket number (if disclosed to the Penn Center for Innovation (PCI), patent 
application or patent numbers, inventor's names, and/or other relevant details.*
Michelle Johnson is one of the inventors.
Certiﬁcation
I have reviewed the Financial Disclosure and Presumptively Prohibited Conﬂicts for Faculty 
Participating in Clinical Trials and the Financial Disclosure Policy for Research and Sponsored 
Projects  with all persons who are responsible for the design, conduct, or reporting of this research; and 
all required Disclosures have been attached to this application.
Yes
Biomedical Research
Human Source Material*
Does this research include collection or use of human source material (i.e., human blood, blood 
products, tissues or body ﬂuids)?
No
Medical Information Disclosure*
Does the research proposal involve the use and disclosure of research subject's medical information for 
research purposes?
Yes
If the answer is YES, indicate which items is is provided with this submission:
Modiﬁed research informed consent document that incorporates HIPAA requirements
CTRC Resources*
Does the research involve CTRC resources?
No
Pathology and Laboratory Medicine Resources*
Will samples be collected by hospital phlebotomy and/or processed or analyzed by any of the clinical 
laboratories of the University of Pennsylvania Health System?
No
Research Involves Apheresis, Cell Collection, and/or Blood Product Collection*
Does this research involve collection of blood products in the Penn Donor Center and/or the use of 
apheresis for treatment or collection of cells or other blood components?
No
Research involving blood transfusion or drug infusions*
Will your research involve blood transfusion or infusion of study drug in 3 Ravdin Apheresis Unit for 
research purposes?
No
Trial in Radiation Oncology
Is this research a prospective trial being done in Radiation Oncology, and if so, has this protocol been 
approved by the Radiation Oncology Protocol committee?
No
Study in Radiation Oncology
Is this research a retrospective study being done in Radiation Oncology, and if so, has this project been 
reviewed by the Radiation Oncology Clinical Research Group?
No

Page 7 of 13
Use of UPHS services*
Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or 
procedures*, whether considered routine care or strictly for research purposes?
No
Primary Focus*
Other
Protocol Interventions
Sociobehavioral (i.e. cognitive or behavioral therapy)
Drug
Device - therapeutic
x Device - diagnostic (assessing a device for sensitivity or speciﬁcity in disease diagnosis)
Surgical
x Diagnostic test/procedure (research-related diagnostic test or procedure)
Obtaining human tissue for basic research or biospecimen bank
Survey instrument
None of the above
The following documents are currently attached to this item:
There are no documents attached for this item.
Department budget code
None
Protocol
Objectives
Overall objectives
We aim to develop a Gym 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, we also aim to conduct proof-of-concept testing of the Gym with atypical and typical developing 
infants. We will include infants' ages 3 to 11 months who are categorized as high-risk or low-risk using 
the Bayley Infant Neurodevelopmental Screener.
Background
An estimated 5 to 10 percent of children have developmental disabilities (Rydz 2005), and an increase 
in survival rates of medically fragile infants has led to an increased number of children with functional 
impairments later in life (Vohr et al 2003). Particularly, pre-term and low birth weight infants as well as 
those exposed to brain injuries due to a central nervous injury insults such as asphyxia, neonatal 
seizures, prenatal drug use, or maternal infections are at increased risk for developmental delays and 
neurologic impairment.  Successful early detection of delay or impairment in at-risk infants depends on 
the effectiveness of standard clinical scales, many of which are not sufﬁciently sensitive to screen 
infants younger than 6 months (Leonard et al 2001). For example, one popular scale was reported to 
have a positive predictive value of 67 percent for motor or cognitive impairment, i.e., high risk infants 
identiﬁed at 6 months using the screening tool were 67 percent likely to have a cognitive impairment at 

Page 8 of 13
12 months. The same scale is even less predictive for infants deemed moderate risk. While an infant 
ages, these scales do become more accurate and can better predict which infants will develop 
disabilities at 2 and 3 years old (Aylward and Verhust 2000). However, currently there is no tool that is 
deﬁnitively predictive of functional impairment for infants less than one year. The earlier detection of 
motor delays or impairments provides the opportunity for earlier treatment, thus leading to better health 
outcomes over the lifespan (McIntyre et al 2011). Recognizing this, primary care pediatric physicians 
now recommend that infants at risk for delayed achievement of developmental milestones have a 
developmental evaluation at least two times during their ﬁrst year of life (Spittle et al 2008). 
Unfortunately, while the physicians' recommendation is well intended, the current screening tools 
provide them with much less than perfect information. Note: For complete bibliography see grant 
attached to this submission. References directly related to the above background information can be 
found below.  Aylward G, Verhulst S. Predictive utility of the bayley infant neurodevelopmental 
screener (BINS) risk status classiﬁcations: Clinical interpretation and application. Dev Medicine & 
Child Neurology 2000; 42:25 31. Leonard C, Piecuch R, Cooper B. Use of the bayley infant 
neurodevelopmental screener with low birth weight infants. Journal of Pediatric Psychology. 2001; 26
(1):33 40. McIntyre S, Morgan C, Walker K, Novak I. Cerebral palsy--don't delay. Dev Disabil Res Rev. 
2011 Nov; 17(2):114-29. PMID:23362031 Rydz D, Shevell MI, Majnemer A, Oskoui M. 
Developmental Screening, Journal of Child Neurology. 2005; 20(1): 4-21 Spittle A, Doyle L, Boyd R. A 
Systematic review of the clinimetric properties of neuromotor assessments for preterm infants during 
the ﬁrst year of life. Developmental Medicine & Child Neurology. 2008;50:254 266. Vohr B, OShea M, 
Wright LL, Longitudinal multicenter follow-up of high-risk Infants: why, who, when, and what to 
Assess, Seminars in Perinatology. Aug 2003; 27(4): 333 342.
Study Design
Design
The proposed research is speciﬁcally designed to investigate the ability of a novel tool to identify 
atypically developing infants from their typically developing peers. There will be an initial portion for 
usability feedback of hardware and software. For testing: For the ﬁrst portion of the study (Part A) we 
will recruit up to 10 infants for analysis for up to two sessions each. After this initial testing, 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 duration
1) We estimate that it will take two years from the date of IRB approval to enroll all subjects and 
complete the study. 2) At minimum, some subjects may be asked to experienced the Gym 1x. At most, a 
subject will be asked to use the Gym for up to 5 consecutive days. Each day the infant will use the gym, 
both with and without toys, for 3 minutes.  3) 5/01/2015 - 8/01/2017
Characteristics of the Study Population
Target population
Two populations will be involved: 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.
Subjects enrolled by Penn Researchers
50

Page 9 of 13
Subjects enrolled by Collaborating Researchers
0
Vulnerable Populations
x Children Form
Pregnant women (if the study procedures may affect the condition of the pregnant woman or 
fetus) Form
Fetuses and/or Neonates Form
Prisoners Form
Other
None of the above populations are included in the research study
The following documents are currently attached to this item:
There are no documents attached for this item.
Subject recruitment
Infants with typical development will be recruited from siblings of patients at The Childrens Hospital of 
Philadelphia (CHOP), and through local parent groups. Potential candidates in the at-risk group will be 
invited to participate through a variety of mechanisms within CHOP. The primary avenue for 
recruitment will be through the Neonatal Follow-up clinic at CHOP. Infants who are receiving services 
at the Center for Rehabilitation will also be invited to participate.  In efforts to recruit a population that 
is easily testable on multiple days, testing may be done at a local daycare.
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does 
the study team plan to directly use social media to recruit for the research?
No
The following documents are currently attached to this item:
There are no documents attached for this item.
Subject compensation*
Will subjects be ﬁnancially compensated for their participation?
Yes
The following documents are currently attached to this item:
There are no documents attached for this item.
If there is subject compensation, provide the schedule for compensation per study visit or session 
and total amount for entire participation, either as text or separate document
For the usability portion the individual caregivers will be compensated 10 dollars. Part A Families will 
be compensated 50 dollars for the testing. Families participating in Part B will be compensated 100 
dollars for their ﬁrst visit (clinical evaluation plus ﬁrst gym session) and 25 dollars for each session 
thereafter ($200 total). Should the authorized representative of the research participant (infant) decide to 
withdrawal prior to completion of the study, compensation will be prorated. Compensation will be 
through a reloadable ClinCard. Any daycare that agrees to participate in the study will also receive a 
100 dollar gift card for infant/children's toys and activities.

Page 10 of 13
Study Procedures
Suicidal Ideation and Behavior
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)?
No
Procedures
Prior to being assessed by the therapist, the parent or legal guardian will be consented. They will also be 
asked to ﬁll out general surveys including, a demographic survey, and a case report form, and a user 
feedback survey which provides relevant information, on both the family's and infant's medical history 
and experience. After being assessed by a certiﬁed therapist for approximately one hour, both atypical 
and typical infants will be observed playing within the Gym. The environment will be prepared such 
that only items safe for infants will be in the testing and play areas. Fort the usability: The caregiver 
may be asked to closely observe and examine the hardware and the software of the system. The 
caregiver may then offer the toy to the infant for familiarization, observe the infant play and capture and 
upload a video of this interaction. The caregiver may be asked to complete a feedback and observation 
survey that will provide relevant information about the interaction and software and hardware 
experience. Part A) Data quantifying infants actions with and without toys will be collected in one or 
two sessions. Infants will be tested for their reaction to the gym without toys and then their reactions 
with 1 or multiple toys. The baby will be placed in the center of the gym. The baby will be allowed to 
settle and play for 1 minute then data will be collected again for 1-3 minutes. Each session will be 
recorded using the Microsoft Kinect camera. Arm/hand/leg position data will be collected with the 
kinect camera, grasp pressure and forces will be collected, toy position and angular data will be 
collected via Kinect and inertial sensors, and central pressure data will be collected via the novel mat. 
Video data mapping their reaction may be collected using "Autism and Beyond" developed for research 
by Duke University.  Part B) Data quantifying infant actions will be collected for 5 consecutive days 
under two conditions: with toys and without toys (control); the no toys condition will be tested ﬁrst and 
the toy condition immediately after. The data from the no toy condition will be used to adjust the 
observations in the toy condition and will be used to account for the infants baseline actions per day. A 
test session will proceed as follows: First, the infant will be placed on his or her back at a pre-
determined position on the gym mat in the no toy condition. Data will be collected for 3 minutes. The 
infant will be removed. The toys will be placed in the gym and adjusted for the infant reach; hanging 
toys will be placed at about 75% of the infants reach. After, the infant will be placed again with respect 
to the pre-determined position. To detect an infants intentional movement toward a speciﬁc toy, the 
location of each toy will be randomized within possible locations per toy type. The baby will be 
allowed to settle and play for 1 minute then data will be collected again for 1-3 minutes. Each session 
will be recorded using the Microsoft Kinect camera. Arm/hand/leg position data will be collected with 
the kinect camera, grasp pressure and forces will be collected, toy position and angular data will be 
collected via Kinect and inertial sensors, and central pressure data will be collected via a pressure mat.  
General Procedure: A caregiver or parent will be seated at the head of the baby (out of babys sight) to 
provide comfort if needed. Infants will be required to be alert and unhampered by clothing with their 
limbs free to move. They will be placed on their backs and allowed to roll or crawl as long as they stay 
within the perimeter of the device. If infants become frustrated (cries and is unsettled), the parent will 
be asked to pick them up and calm them. The trial will be restarted. If several attempts are unsuccessful, 
the session will be ended and attempted later in the day. We will take precautions to minimize the 
likelihood of participants experiencing any injury or discomfort. To avoid bumps, bruises or crashing 
into toys, participants will be supervised at all times by a trained study team member during CHOP 
sessions, including by a licensed pediatric physical therapist during developmental evaluations, and 
caregivers will be trained to place infants on their backs during home Gym play sessions. Caregivers 
will also be able to reposition their infants if he or she is uncomfortable.
The following documents are currently attached to this item:
There are no documents attached for this item.
Deception
Does your project use deception?
No

Page 11 of 13
International Research
Are you conducting research outside of the United States?
No
Analysis Plan
We will identify a battery of metrics derived from kinematic and kinetic measurements of infant 
movement that are able to discriminate between atypical and typical infants and evaluate neuromotor 
impairments. Metrics quantifying one and two-handed reach and grasp actions as well as leg and body 
actions will be derived from the data. We will also determine the reliability/reproducibility of our 
methods across the repeated measurements taken in the home. We also will examine how each metric 
correlates with the BINS and BSITDIII scores.  The key primary metrics are unimanual and bimanual 
arm use, leg use, grasp forces, arm position when being used, and arm velocity when used. Secondary 
measures will be center of pressure from starting position, toy speed, toy acceleration, toy tilt angle, 
arm synchronicity, leg synchronicity, leg distance to toy, and respective differences in the percentage of 
arm use for reaching and for grasping.  Given our long-term goal of detecting the emergence or lack of 
emergence of multiple milestones in the development of infants, we will examine a variety of metrics. 
Some of these milestones are the emergence of hand dominance using the relationship between the right 
and left hands; the emergence of unimanual or bimanual reaching using the relationship of the hand 
position to the toy, the hand speed, the frequency of movements; the emergence of unimanual grasping 
using grasping forces, the emergence of undifferentiated bimanual grasping detected by monitoring 
when the right and left arms start to move together toward a toy, and the emergence of differentiated 
bimanual grasping. For each variable, we anticipate having 120 data points per second for a minimum 
of 180 seconds. Initially, kinetic metrics, and frequency of reaching and grasping will be summarized 
using means and standard deviations each day, to assess for variability. Intraclass correlations 
coefﬁcients (ICC) will be calculated to examine reliability/reproducibility of each measurement over 
the 5 days. If the ICCs are relatively high (.9), we will average the 5 days to create a single summary 
ﬁgure for each measurement to test. Using these summary ﬁgures, we will ﬁrst perform 2-sample t-tests 
or Wilcoxon rank sum tests on the averages or ranks of each metric respectively, where the two groups 
represent atypical and typical infants, stratiﬁed by age group. Given our stratiﬁed groups of younger/
older and typical/atypical infants, we anticipate having relatively large differences across most 
measures. Should the ICCs be low, due to learning we will use a 2-factor ANOVA in repeated measures 
where day would be the repeated measure and age group and infant type would be the 2 factors. For 
non-normal distributions, such as many zeroes for the atypical group or other non-normal/skewed 
distribution, we will use either Poisson (log-linear) regression or a Negative Binomial (ZINB) 
regression. All analyses will be performed using SAS statistical software. As we are looking for proof 
of concept, we will be looking for relatively large differences between atypical and typical babies. In 
order to build a machine algorithm to analyze the baby data, we will build a test data set from publically 
held you tube videos. We will pull YouTube videos from babies between the ages of 1month and 12 
months.
The following documents are currently attached to this item:
There are no documents attached for this item.
Subject Conﬁdentiality
All study personnel will have access to a locked ﬁle cabinet containing consent forms, evaluation 
assessments, and collected data. The locked ﬁle cabinet will be located at the Rehabilitation Robotics 
Lab, Philadelphia, PA, 19146. Both electronic data and hard copy records will be kept for a minimum 
of 10 years. Electronic data will be kept on password protected computers. After 10 years, any 
documents no longer needed will be destroyed by secure shredding at Penn Rittenhouse and electronic 
data will be deleted from computers. Research subjects will be identiﬁed in the research data by code 
and at no time will a direct link exist between collected data and research subjects. When data results 
are reported they will be presented in aggregate form (i.e. group characteristics only) and no individual 
identiﬁers will be used. Dr. Kording's lab will be helping to develop the algorithm. Data will be shared 
with them and it may be necessary to have data stored on their password protected computers at Hayden 
Hall (106 Hayden Hall, 240 S 33rd St, Philadelphia, PA 19104 ) CHOP and Penn maintain strict 
policies, systematic procedures and sufﬁcient resources for data management in compliance with 
HIPAA and IRB regulations for safeguarding participant information to protect against loss of 
conﬁdentiality. Electronic data will be stored in secure, HIPAA-compliant, password-protected systems. 
Hard copies of data collection instruments and training logs will be stored in a locked cabinet in a 

Page 12 of 13
locked ofﬁce or laboratory. Participants will be assigned a unique identiﬁer that contains no protected 
health information. Access to the identiﬁers of the coded data will be controlled by the PI and Co-PI. 
All members of the study team will undergo Human Subjects Research training. Human subjects safety 
monitoring will be the responsibility of the Co-PI. All adverse events will be reported in accordance 
with IRB and NIH requirements.
Sensitive Research Information*
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record?
No
Data Disclosure
Will the data be disclosed to anyone who is not listed under Personnel?
Yes, Sam Pierce, a researcher at CHOP is not listed under Personnel. Also, Elliot Warshowsky, research 
assistant to Dr. Helen Loeb, will have access to the data. HIPAA and CITI are attached to the protocol.
Data Protection*
x Name
x Street address, city, county, precinct, zip code, and equivalent geocodes
x All elements of dates (except year) for dates directly related to an individual and all ages over 89
x Telephone and fax number
x Electronic mail addresses
Social security numbers
x Medical record numbers
Health plan ID numbers
Account numbers
Certiﬁcate/license numbers
Vehicle identiﬁers and serial numbers, including license plate numbers
Device identiﬁers/serial numbers
Web addresses (URLs)
Internet IP addresses
Biometric identiﬁers, incl. ﬁnger and voice prints
x Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code
None
Does your research request both a waiver of HIPAA authorization for collection of patient information 
and involve providing Protected Health Information ("PHI") that is classiﬁed as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a 
recipient outside of the University of Pennsylvania covered entity?
No
Consent
1. Consent Process
Overview
Informed consent will be obtained by the research physical therapist, the trained study coordinator, or 
an investigator, and will be documented in the electronic database. The family will have the opportunity 

Page 13 of 13
to ask questions throughout the entire process. The parent or legal representative must provide written 
informed consent prior to the start of any study activities. Written assents of minors will not be obtained 
due to the age of the participants. Regarding the location of where informed consent will be obtained, 
and due to the fact that the SmarToyGym and tests are portable, testing can occur at CHOP, PIRM, 
participants' homes, and local day care centers. Informed consent could therefore be obtained in any of 
these locations.
Risk / Beneﬁt
Potential Study Risks
The risks are minimal and all testing will be non-invasive. All treatment and assessment activities in the 
proposed research present no more than minimal risk to study participants. Risks include those involved 
with any developmental assessment or home play time, including bumps and bruises from poor control 
of movement or crashing into toys. Infants may also become frustrated if they attempt motor activities 
that they are as yet unable to perform, such as reaching or manipulating a toy. The environment will be 
prepared such that only items safe for infants will be in the testing area. Participants at risk for motor 
delays may rely on life-sustaining medical equipment, such as external respiratory support. For these 
babies, routine daily risk includes breaches in the medical support equipment (such as decannulation), 
which can happen during therapy sessions, ﬂoor play time, clothing changes, and generally anytime 
throughout the day. If any study participant requires life-sustaining medical equipment, s/he will be 
accompanied at all times by a caregiver trained to respond to any breaches in medical support. 
Enrollment of these babies will also be conducted in consultation with the medical team. Additionally, 
protected health information will be collected as part of study records, and breaches of this information 
outside of the study team resulting in loss of conﬁdentially is an unlikely but potential risk. Alternatives 
to participation in this study include not participating or seeking a developmental evaluation elsewhere. 
All risks and alternatives will be explicitly stated in consent documents.
Potential Study Beneﬁts
There are no direct beneﬁts to participants in this study. The knowledge gained will inform early 
detection and rehabilitation practices for other children at risk for neuromotor impairment, may lead to 
the development of treatment interventions, and the risk to participants is minimal.
Risk / Beneﬁt Assessment
Minimal risk
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