A Pilot Study on Virtual Reality-based Rehabilitation for Children With Traumatic Brain Injuries
Phase: NA
Conditions: Traumatic Brain Injury
Sponsor: University of Massachusetts, Lowell

PROTOCOL TITLE: Virtual Reality-based Rehabilitation for Children with Traumatic 
Brain Injuries 
 
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HRP-503  v.12.10.18 
PROTOCOL TITLE: 
 
Virtual Reality-based Rehabilitation for Children with Traumatic Brain Injuries 
 
PRINCIPAL INVESTIGATOR: 
Name: Jiabin Shen 
Department/Center: CIRP 
Telephone Number: 614-355-5878 
Email Address: Jiabin.shen@nationwidechildrens.org 
VERSION NUMBER/DATE: 6/April 8 2019 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
Original 
 
 
2 
7_3_2018 
Added new assessments, edited questions, 
edited study population 
N 
3 
9_10_2018 
Expanded recruitment to include other 
inpatient and outpatient locations and trauma 
registry, added Epic Patient Reminder list, 
changed timing of follow-up 
Y 
3 
10_25_2018 
Added fully-adjusted scores to NIH Toolbox 
Y 
4 
11_5_2015 
Added new survey (TBI-QOL) 
Y 
5 
12_10_2015 
Changed inclusion criteria related to agitated 
behavior. Changed wording on timing, 
procedures, visit structure, and recruitment for 
clarification purposes. Removed visit option in 
public locations. Added text appointment 
reminders, ClinCard receipts, and parking 
reimbursements and receipts for research only 
visits. Changed the blinding structure so the 
person doing the assessments is blinded only to 
the intervention group. 
Y 
6 
4_8_2019 
Added emailing flyer to recruit subjects. 
 
 
 
1.0 
Study Summary 
 
Study Title 
Virtual Reality-based Rehabilitation for Children with 
Traumatic Brain Injuries 
Study Design 
Between-subjects Randomized Clinical Trial 

PROTOCOL TITLE: Virtual Reality-based Rehabilitation for Children with Traumatic 
Brain Injuries 
 
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Primary Objective 
Refine clinically-appropriate paradigms for VR childhood 
TBI rehabilitation research 
Secondary 
Objective(s) 
Explore feasibility, safety and preliminary efficacy of the 
VICT program 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
VR-based interactive cognitive training (VICT) program 
IND/IDE #  
N/A 
Study Population 
Children 7-17 years with TBI 
Sample Size 
Approximately 30 
Study Duration for 
individual 
participants 
Up to 6 months 
Study Specific 
Abbreviations/ 
Definitions  
TBI-Traumatic Brain Injury 
VR-Virtual Reality 
VICT-Virtual Reality-based Cognitive Training  
 
2.0 
Objectives 
2.1 Describe the purpose, specific aims, or objectives. 
Our primary objective is to refine clinically-appropriate paradigms for 
VR childhood TBI rehabilitation research. The secondary objective is 
to explore feasibility, safety and preliminary efficacy of the VICT 
program. There are two specific aims of the study.  
Aim 1. Refine clinically-appropriate paradigms for VR childhood TBI 
rehabilitation research.  
Aim 2. Explore feasibility, safety and preliminary efficacy of the 
VICT program. 
2.2 State the hypotheses to be tested. 
Since this is a preliminary exploratory study, there are no specific 
hypotheses to be tested. 
3.0 
Background 
3.1 Describe the relevant prior experience and gaps in current 
knowledge. 
The Centers for Disease Control and Prevention (CDC) classifies 
childhood traumatic brain injury (TBI) as the leading cause of death 
and acquired disability in children, with an estimated 700,000 
childhood TBI cases every year in the United States.1-4 Defined as a 
disruption in the normal function of a child’s brain that can be caused 
by a bump, blow, or jolt to the head, or a penetrating head injury, 
childhood TBIs often result in significant impairment in cognitive 
functions,1 particularly in executive functions (EFs) due to the 

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vulnerability of the frontal lobes, especially in moderate to severe 
TBIs.5-7 EF involves a set of core cognitive capacities for self-
controlled discipline, creativity, and flexibility.8, 9 This study will 
focus on training the three core EFs identified by cognitive science: 
inhibitory control (the ability to override a strong internal 
predisposition or external lure and do what is more appropriate or 
needed), working memory (the ability to hold and process information 
in mind as needed), and cognitive flexibility (the ability to adjust to 
changing environmental demands and think from different 
perspectives).8 Deficits in core EFs have profound implications for the 
children’s daily EF8 and quality-of-life (QoL),10 as reflected in 
increased attention problems,11 poorer academic performance,12 and 
poorer psychosocial adjustment.13  
However, evidence-based EF training programs specifically designed 
for childhood TBI are unavailable.14-17 As early as 2015, the CDC 
reported to Congress that post-TBI cognitive rehabilitation was the 
No. 1 unmet health care need among children with TBI and called for 
more innovation in this area.2 Although a combination of 
computerized and non-computerized cognitive games has been shown 
effective in improving healthy children’s EFs,9,18 four key obstacles 
hamper the successful implementation of such interventions in 
children with TBI: affordability, accessibility, adherence, and 
generalizability. First, implementation of broad-spectrum EF training 
programs is both costly for families and resource-demanding for 
hospitals.19 Second, existing EF training requires the presence of both 
therapists and patients at the hospital or clinic, which impedes 
accessibility for families living in remote areas, contributing to 
disparities in health outcomes. Third, existing EF training typically 
uses rudimentary paper-and-pencil tasks or artistically substandard 
flat-screen computer tasks, both of which are unappealing to children 
and adolescents who are increasingly accustomed to engaging video 
games available to them outside the medical setting.20 This may 
negatively affect children’s long-term rehabilitation outcomes by 
decreasing their willingness to participate planned training activities, 
especially for follow-up sessions after discharge. Fourth, partially due 
to the lack of variety and richness, existing EF interventions are often 
limited in helping children transfer learned skills to untrained life 
activities.9 
3.2 Describe any relevant preliminary data. 
The NCH Inpatient Rehabilitation Unit admits an average of 30 
children with TBI (ICD-9 codes: 803, 850, 851, 854; no deaths, no 
asphyxia) annually. A five-year review of records shows that 80% (24 
children/year) or more are eligible to participate in the proposed K99 
study. Open-end feedback from patients and families at NCH 
suggested broad interest in participating in the study. Our target 

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sample size (N=30) is reasonable for an 18-month recruitment period. 
Recruitment will be monitored during the study. Additionally, we 
have recruited two pediatric patients with TBI from the NCH 
rehabilitation unit who pilot-tested the VICT program and the pre- and 
post-intervention measures. Both patients and their family and 
clinicians expressed high enthusiasm and satisfaction with the 
intervention. 
3.3 Provide the scientific or scholarly background for, rationale for, 
and significance of the research based on the existing literature 
and how will it add to existing knowledge. 
Virtual reality (VR) offers an exciting alternative EF rehabilitation 
strategy for three reasons. First, VR technology has the capability to 
offer a multitude of activities for training children with TBI in core 
EFs8 within a versatile virtual environment. Such an enriched, 
immersive environment has already been shown effective in 
promoting structural and functional recovery of the human brain.21 
Furthermore, because all VR-based EF training occurs within a safely 
controlled, automated virtual environment, it takes minimal physical 
space and personnel resources to implement in a medical setting, 
reducing expenses for both the hospitals and the families. Second, 
VR-based EF training can be readily provided via Internet and mobile 
platforms. This allows EF training, especially those sessions 
scheduled after discharge, to be completed without requiring children 
to leave home. Last but not least, unlike traditional computer-based 
EF training, we expect VR-based EF training to exert two positive 
effects on children’s rehabilitation22: (1) improved adherence. VR-
based EF training was found especially appealing to pediatric patients 
in our pilot testing, possibly due to the youth population’s increasing 
exposure to electronic games in recent years; (2) potentially better 
skill transfer to real life. Although research suggests mixed results of 
computerized training for cognitive skills in general, we expect VR 
training to translate trained skills into daily EF skills and overall QoL 
in pediatric TBI patients because (1) EFs are domain-general 
cognitive skills that can be gained in one setting and transferred to 
another;23 (2) studies using representative national samples of children 
have supported EF as domain-general skills and documented positive 
relations between EFs and real-life outcomes,24 and (3) Our pilot test 
of the VICT program on two pediatric patients with TBI at NCH 
showed positive changes of core EF scores after intervention 
(although this preliminary result should be interpreted with caution 
given that the changes could reflect other factors, such as natural 
recovery). 
The overall goal of the proposed research is to evaluate the feasibility, 
safety, and efficacy of a VR-based interactive cognitive training 
(VICT) program in children 7-17 years with complicated mild  to 

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severe TBI. The VICT program is an integrative hardware and 
software VR system that trains the three core EFs (inhibitory control, 
working memory, and cognitive flexibility)8 within a challenging 3D-
animated rescue mission. The research is significant because it will 
provide important feasibility and safety data regarding implementing 
a novel VR-based EF rehabilitation program for children with TBI. 
This project is also expected to provide important data regarding the 
intervention’s efficacy on children’s core EF and daily EF (primary 
outcome) as well as attention problems and health-related QoL 
(secondary outcomes). Finally, findings from this project are expected 
to inform future development of a comprehensive VR-based cognitive 
rehabilitation program to help children with TBI achieve a healthy and 
productive life post-injury. 
Reference List 
1. 
Faul M, Xu L, Wald MM, Coronado V. Traumatic brain injury in the 
United States. Atlanta, GA: National Center for injury Prevention and 
Control, Centers for Disease Control and Prevention. 2010. 
2. 
Centers for Disease Control and Prevention. Report to congress on 
traumatic brain injury in the United States: epidemiology and 
rehabilitation. Atlanta, GA: National Center for Injury Prevention and 
Control. 2014:1-72. 
3. 
Keenan HT, Bratton SL. Epidemiology and outcomes of pediatric 
traumatic brain injury. Developmental Neuroscience. 2006;28(4-
5):256-263. 
4. 
Hiu Lam W, Mackersie A. Paediatric head injury: incidence, aetiology 
and management. Pediatric Anesthesia. 1999;9(5):377-385. 
5. 
Scheibel RS, Levin HS. Frontal lobe dysfunction following closed head 
injury in children: Findings from neuropsychology and brain imaging. 
Development of the Prefrontal Cortex: Evolution, Neurobiology, and 
Behavior. 1997: 241-260. 
6. 
Scott JG, Schoenberg MR. Frontal lobe/executive functioning. In: The 
Little Black Book of Neuropsychology. Springer. 2011:219-248. 
7. 
Leblanc N, Chen S, Swank PR, Ewing-Cobbs L, Barnes M, Dennis M, 
et al. Response inhibition after traumatic brain injury (TBI) in children: 
Impairment 
and 
recovery. 
Developmental 
Neuropsychology. 
2005;28(3):829-848. 
8. 
Diamond A. Executive functions. Annual Review of Psychology. 
2013;64:135-168. 
9. 
Diamond A, Lee K. Interventions shown to aid executive function 
development 
in 
children 
4 
to 
12 
years 
old. 
Science. 
2011;333(6045):959-964. 
10. Mangeot S, Armstrong K, Colvin AN, Yeates KO, Taylor HG. Long-
term executive function deficits in children with traumatic brain 

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injuries: Assessment using the Behavior Rating Inventory of Executive 
Function (BRIEF). Child Neuropsychology. 2002;8(4):271-284. 
11. Willcutt EG, Doyle AE, Nigg JT, Faraone SV, Pennington BF. Validity 
of the executive function theory of attention-deficit/hyperactivity 
disorder: 
a 
meta-analytic 
review. 
Biological 
Psychiatry. 
2005;57(11):1336-1346. 
12. Diamantopoulou S, Rydell A-M, Thorell LB, Bohlin G. Impact of 
executive functioning and symptoms of attention deficit hyperactivity 
disorder on children's peer relations and school performance. 
Developmental Neuropsychology. 2007;32(1):521-542. 
13. Riggs NR, Blair CB, Greenberg MT. Concurrent and 2-year 
longitudinal relations between executive function and the behavior of 
1st and 2nd grade children. Child Neuropsychology. 2004;9(4):267-276. 
14. Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas 
M, et al. Evidence-based cognitive rehabilitation: updated review of the 
literature from 2003 through 2008. Archives of Physical Medicine and 
Rehabilitation. 2011;92(4):519-530. 
15. Gordon WA, Zafonte R, Cicerone K, Cantor J, Brown M, Lombard L, 
et al. Traumatic brain injury rehabilitation: state of the science. 
American 
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Physical 
Medicine 
& 
Rehabilitation. 
2006;85(4):343-382. 
16. Niemeier JP, Grafton LM, Chilakamarri T. Treating Persons With 
Traumatic Brain Injury History and Updates. North Carolina Medical 
Journal. 2015;76(2):105-110. 
17. Ommaya AK, Adams KM, Allman RM, Collins EG, Cooper RA, Dixon 
CE, et al. Opportunities in rehabilitation research. Journal of 
Rehabilitation Research and Development. 2013;50(6):vii- xxxii. 
18. Carruthers K, Zampieri C, Damiano D. Relating motor and cognitive 
interventions in animals and humans. Translational Neuroscience. 
2014;5(4):227-238. 
19. Brooks C, Lindstrom J, McCray J, Whiteneck GG. Cost of medical care 
for a population-based sample of persons surviving traumatic brain 
injury. Journal of Head Trauma Rehabilitation. 1995;10(4):1-13. 
20. Greenfield PM. Mind and Media: The Effects of Television, Video 
Games, and Computers. Psychology Press. 2014. 
21. Grealy MA, Heffernan D. The rehabilitation of brain injured children: 
the case for including physical exercise and virtual reality. Pediatric 
Rehabilitation. 2001;4(2):41-49. 
22. Hsu K-S, Jiang J-F, Wei H-Y, Lee T-H. Application of the 
Environmental Sensation Learning Vehicle Simulation Platform in 
Virtual Reality. Eurasia Journal of Mathematics, Science & Technology 
Education. 2016;12(5):1477-1485. 

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23. Zelazo, P. D., & Cunningham, W. A. Executive Function: Mechanisms 
Underlying Emotion Regulation. In J. J. Gross (Ed.), Handbook of 
Emotion Regulation. 2007;135-158. New York: Guilford Press. 
24. Best, John R., Patricia H. Miller, and Jack A. Naglieri. "Relations 
between executive function and academic achievement from ages 5 to 
17 in a large, representative national sample." Learning and Individual 
Differences. 2011;21(4): 327-336. 
4.0 
Study Endpoints 
4.1 Describe the primary and secondary study endpoints. 
The primary study endpoint is the protocol feasibility (defined as 
protocol completion rate and subjective VR experience ratings) and 
safety (see section 4.2) of the VICT program. The second study 
endpoint is the preliminary efficacy of the VICT program, defined as 
the changes in NIH Toolbox Composite Scores before and after the 
intervention. 
4.2 Describe any primary or secondary safety endpoints. 
The primary safety endpoint is the number of adverse events. The 
secondary endpoint is the scores on participants’ simulator sickness 
and exertion. 
5.0 
Study Intervention/Investigational Agent 
5.1  Description:  
The hardware of the VICT program consists of a fully-immersive 
High Tech Computer (HTC) VIVETM VR viewer (OLED display with 
2160×1200 resolution, 90Hz refresh rate, and 110 degrees of field of 
view) powered by a high-performance laptop (Dell AlienwareTM 17), 
a pair of surround sound headphones reworked to integrate with the 
VR viewer, and a wireless one-hand controller for the child to interact 
with the virtual environment using gestures. Furthermore, to avoid the 
burden of the equipment’s weight on a child’s head, we created a 
special mechanical arm to suspend the VR viewer in front of a child’s 
eyes with adjustable headphone positions. With the system securely 
fixed on a wheeled workstation, a child can operate the program by 
reclining on the bed/wheelchair in his/her own patient room. To 
ensure the hygiene, each child will use a new facial pad for the viewer 
and a pair of new earphone covers. All parts of the equipment will be 
sanitized with germicidal wipes after each use.   
For the software, the Windows 10-based VICT program invites 
children to rescue an animated character named “Lubdub” from a 
castle. The program consists of three challenging and child-friendly 
tasks that correspond to the three core EFs. During the game, children 
need to (1) direct a group of sentinels away from the castle gates (VR 
Task #1, adapted from the Spatial Stroop Task to train Inhibitory 

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Control), (2) successfully open a series of castle gates by replicating 
the cryptography sequence of items surrounding each gate in 
forward/backward order (VR Task #2, adapted from the Visual 
Working Memory Task to train Working Memory), and finally (3) 
rescue Lubdub inside the castle by strategically matching patterns 
between the Lubdub and the four surrounding guards (VR Task #3, 
adapted from the Wisconsin Card Sorting Task to train Cognitive 
Flexibility). A tutorial mode preceding the training lets children learn 
how to interact with VR. In the training mode, children will complete 
each task starting at the easiest level and gradually moving to more 
difficult levels as easier levels are mastered. Each training session 
consists of 10-30 trials per task, taking about 15 minutes in total. 
Children will receive visual/audio feedback to learn and optimize their 
performance.  
6.0 
Procedures Involved* 
The procedure involved for the study is described in detail below: 
 
1) Baseline assessment. All approximately 30 children will complete the NIH 
Toolbox Cognition Battery tests, CPT 3, Virtual Reality Assessment, and the TBI-
QOL Short Form prior to the randomization sequence. Both the assessor and the 
child will be unaware of group assignment at this point. Additionally, data 
regarding baseline measurement including proportion of planned baseline measures 
that are completed and the duration of each assessment will be documented.  
 
2) Intervention. Following the baseline assessment, the approximately 30 children 
will be randomly assigned to one of the following two groups: intervention group 
(VICT training) or control group (a comparable VR game without cognitive 
training). The random allocation sequence will be generated using a SAS-based 
randomization program with 1:1 allocation ratio and random block sizes of 2 and 
4. Both groups will first be provided a tutorial to be familiar with the VR 
environment. The length of time for either intervention game will be a minimum of 
15 minutes of total play. If they are in the hospital, they will play approximately 15 
minutes per day during their stay. If they have already been discharged from the 
hospital, the length of time is a minimum of 15 minutes of total play but can be 
more spread across their choice of days. Trained researchers who generate the 
randomization sequence and implement the VR will not participate in any 
subsequent outcome assessment. Note that although the length of training will vary 
across children depending on their length of stay or if they have been discharged, 
this arrangement has unique advantages over a fixed length of training in that: a) it 
provides consistency with standard therapies children are scheduled to receive, 
ensuring intervention to meet children’s medical needs; and b) it ensures consistent 
timing and sufficient retention rates for future assessment. 
 
Additionally, AEs and SAEs will be monitored in real-time throughout the 
intervention. Quantitative user feedback such as sickness, fatigue, and time 
estimates will be measured at the end of both the first and the last VR session. The 

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semi-structured interview from the User Feedback Survey will also be conducted 
at the first and last VR session on children’s perceived VR experience, benefits, 
and challenges.  
 
3) Post-intervention assessment. At completion of intervention, all children will 
again complete the NIH toolbox Cognition Battery tests, the Conners CPT 3, the 
Virtual Reality Assessment, and the TBI-QOL Short Form with trained staff 
blinded to the intervention assignment. Data regarding post-intervention 
measurement including proportion of planned post-intervention measures that are 
completed and duration of each assessment will also be documented.  
 
4) Follow-up assessment. All children will complete a follow-up assessment 
within approximately 6 months after intervention completion. Clinically, this gives 
the child and family a long enough time to identify cognitive and behavioral 
problems. Research staff blinded to group assignment will administer the NIH 
Toolbox tests, the Conners CPT 3, the Virtual Reality Assessment, and the TBI-
QOL Short Form to children at this visit. Children will complete the child-PedsQL 
Generic Core Scales and their parents or legal guardians/representatives will 
complete the BRIEF2, CBCL-APS, and parent-PedsQL. Data regarding follow-up 
measurement including proportion of planned follow-up measures that are 
completed and duration of each assessment will be documented. Data regarding 
recruitment including number of children screened per month; number of children 
enrolled per month; proportion of eligible children who enroll, and treatment-
specific retention rates will be documented throughout the study and aggregated at 
this stage. 
 
7.0 
Data and Specimen Banking* 
7.1 If data or specimens will be banked for future use, describe where 
the specimens will be stored, how long they will be stored, how the 
specimens will be accessed, and who will have access to the 
specimens. 
7.2 List the data to be stored or associated with each specimen. 
7.3 Describe the procedures to release data or specimens, including: the 
process to request a release, approvals required for release, who 
can obtain data or specimens, and the data to be provided with 
specimens. 
8.0 
Sharing of Results with Subjects* 
8.1 Describe whether results (study results or individual subject 
results, such as results of investigational diagnostic tests, genetic 
tests, or incidental findings) will be shared with subjects or 
others (e.g., the subject’s primary care physicians) and if so, 
describe how the results will be shared. 
Individual subject results will not be shared with subjects or others. 
Study results in aggregated forms may be published in peer-reviewed 

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journals or presented at professional conferences or academic talks. 
The publications may be shared with subjects upon request.  
9.0 
Study Timelines* 
9.1 Describe: 
• 
The duration of an individual subject’s participation in the 
study. 
o An individual subject’s participation includes up to 
three assessment visits (pre-intervention visit, post-
intervention visit, and follow-up visit) as well as the 
intervention training. The assessment visits last 
approximately 60 minutes per visit. The intervention 
training will last a minimal of 15 minutes. Since part 
of the purpose of the study is to explore the dose 
effect of the intervention, we do not set an upper limit 
of the intervention length, which could depend on 
patient’s preference and patient’s length of stay (if 
inpatient). We expect the total duration of subject’s 
participation to last up to six months (depending on 
how far out the subject’s follow-up appointment is 
scheduled upon completion of intervention). 
• 
The duration anticipated to enroll all study subjects. 
o Approximately 24 months  
• 
The estimated date for the investigators to complete this 
study (complete primary analyses) 
o August 31, 2021 
10.0 Inclusion and Exclusion Criteria* 
10.1 Describe how individuals will be screened for eligibility. 
Using electronic medical records and working with medical colleagues 
located in the hospital, trained research staff will identify potential 
participants admitted to NCH with a complicated mild, moderate, or severe 
TBI. Once identified as eligible to participate, research staff will approach 
legal guardians and eligible children on the hospital unit to introduce the 
research project. Staff will ensure children are awake, alert, and able to sign 
the assent form (if ≥ 9 years) and demonstrate understanding of the study 
before being approached for consent. In addition, a trauma registry request 
will be performed monthly to identify TBI patients discharged within the 
last 3 months. These patients, if eligible, will be mailed a study invitation, 
followed by an introduction phone call. Additional recruitment of 
discharged patients will be performed at follow up appointments using study 
flyers. Patients may also self-refer from the public domain through postings 
on sites such as clinicaltrials.gov (NCT03611062) and via IRB approved 
recruitment emails. Discharged patients will be offered the opportunity to 

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return to the hospital to receive the training. Consent and assent will be 
obtained at an in-person meeting. All TBI patients will be tracked using a 
Patient Reminder List in Epic. 
10.2 Describe the criteria that define who will be included or 
excluded in your final study sample. 
Inclusion criteria are as follows: 1) diagnosed with TBI (ICD-9 codes 803, 
850, 851, or 854) and between 7 to 17 years old (inclusive) when admitted; 
2) lowest post-resuscitation Glasgow Coma Scale (GCS)=13-15 combined 
with trauma-related abnormalities on neuroimaging or a depressed skull 
fracture (complicated mild TBI, CDC/NIH definition), GCS=9-12 (moderate 
TBI, CDC/NIH definition), and GCS=3-8 (severe TBI, CDC/NIH definition); 
3) fluent in English-based communication; and 4) Physicians note closest to 
time of enrollment does not include information on agitation; or if under 
observation for agitation, currently score <28 on the Agitated Behavior Scale 
(ABS), indicating mild to no agitation. To minimize the possibility of 
confounding by comorbidities and cognition, the following exclusion criteria 
are 
set, 
as 
consistent 
with 
existing 
literature: 
1) 
severe 
physical/visual/cognitive comorbidities secondary to TBI that prevent proper 
utilization of a VR-based game and valid administration of the study 
measures; 2) premorbid neurological disorder or neurodevelopmental issues 
prior to injury that prevent proper utilization of a VR-based game and valid 
administration of the study measures; and 3) patients who are restricted from 
using electronic gaming devices. 
10.3 Indicate specifically whether you will include or exclude each of 
the following special populations: (You may not include 
members of the above populations as subjects in your research 
unless you indicate this in your inclusion criteria.) 
• 
Adults unable to consent: No 
• 
Individuals who are not yet adults (infants, children, 
teenagers): Yes, this study will include children and 
adolescents 7-17 years old 
• 
Pregnant women: No 
• 
Prisoners: No 
11.0 Vulnerable Populations* 
11.1 If the research involves individuals who are vulnerable to 
coercion or undue influence, describe additional safeguards 
included to protect their rights and welfare. 
Using electronic medical records and working with medical 
colleagues located in the hospital, trained research staff will identify 
potential participants admitted to NCH with a complicated mild, 
moderate, or severe TBI. Once identified as eligible to participate, 
research staff will approach legal guardians and eligible children on 

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the hospital unit to introduce the research project. Staff will ensure 
children are awake, alert, and able to sign the assent form (if ≥ 9 
years) and demonstrate understanding of the study before being 
approached for consent.  
 
In addition, a trauma registry request will be performed monthly to 
identify TBI patients discharged within the last 3 months. These 
patients, if eligible, will be mailed a study invitation, followed by an 
introduction phone call. Additional recruitment of discharged 
patients will be performed at follow up appointments using study 
flyers. Patients may also self-refer from the public domain through 
postings on sites such as clinicaltrials.gov (NCT03611062) and 
through IRB approved recruitment emails. Discharged patients will 
be offered the opportunity to return to the hospital to receive the 
training.  
 
Consent and assent will be obtained at an in-person meeting. 
Children will only be approached if the subject is interested in 
learning more about this research after initial study introduction. The 
researchers will ensure that the subjects understand that participation 
is voluntary and will not affect any treatment he/she may receive in 
the current or future visits.   
 
Link information between study data and patient identification 
information will be kept separately from the study data and stored on 
a secure server in a password protected file on a password protected 
computer located in the Research Institute at Nationwide Children’s 
Hospital at NCH. 
12.0 Local Number of Subjects 
12.1 Indicate the total number of subjects to be accrued locally. 
The study will recruit approximately 30 children with complicated 
mild, moderate, or severe TBI at Nationwide Children’s Hospital. 
13.0 Recruitment Methods 
13.1 Describe when, where, and how potential subjects will be 
recruited. 
From August 2018 to August 2020, researchers from NCH Center for 
Injury Research and Policy will work with colleagues throughout 
various departments/units across the hospital (Inpatient Rehab Unit, 
Neurosurgery Inpatient Unit, etc.) to identify and approach potential 
participants admitted to NCH. Other potential participants already 
discharged will be identified through trauma registry data and mailed 
invitation letters followed by an introduction phone call. Additional 
recruitment of discharged patients will be performed at follow up 
appointments using study flyers. Patients may also self-refer from the 

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public domain through postings on sites such as clinicaltrials.gov 
(NCT03611062) and through IRB approved recruitment emails. 
These participants will also be sent the study letter and receive an 
introduction phone call if they are interested. Once participants have 
been identified as appropriate for the VR intervention, the research 
associates will explain and consent the legal guardian and assent the 
patient if they are 9 or older. 
Subjects will only be approached if the subject is interested in learning 
more about this research. The researchers will ensure that the subjects 
understand that participation is voluntary and will not affect any 
treatment he/she (or their child) may receive in the current or future 
visits. The legal guardian will give consent for this research, and 
his/her child will give assent if age >=9 years. 
13.2 Describe the source of subjects. 
All inpatient and outpatient departments/units at NCH with patients 
with TBI, including but not limited to Inpatient Rehab Unit, 
Neurosurgery Inpatient Unit, Outpatient Rehab Unit, Neurosurgery 
Outpatient Unit. Patients may also be identified through trauma 
registry data. Participants may also self-refer from the public domain 
through postings on sites such as clinicaltrials.gov (NCT03611062) 
and through IRB approved recruitment emails. 
13.3 Describe the methods that will be used to identify potential 
subjects. 
Researchers from NCH Center for Injury Research and Policy will 
work with colleagues throughout various departments/units across the 
hospital (Inpatient Rehab Unit, Neurosurgery Inpatient Unit, etc.) to 
identify and approach potential participants admitted to NCH. Other 
potential participants already discharged will be identified through 
trauma registry data and mailed invitation letters followed by an 
introduction phone call. Additional recruitment of discharged patients 
will be performed at follow up appointments using study flyers. 
Patients may also self-refer from the public domain through postings 
on sites such as clinicaltrials.gov (NCT03611062) and through IRB 
approved recruitment emails. 
13.4 
Describe materials that will be used to recruit subjects.  
Flyers and introductory letters will be used to recruit participants. 
(attached). Phone, SMS, and email reminders will also be sent prior 
to the scheduled appointments. 
13.5 Describe the amount and timing of any payments to subjects. 
Children will be paid $30 for completing Visit 1 (pre-intervention 
assessment), $40 for completing intervention/training and Visit 2 
(post-intervention assessment), and $50 for completing Visit 3 
(follow-up assessment). Parents will be paid $50 for completing Visit 

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3 (follow-up assessment). All incentives will be paid through 
Greenphire ClinCards. 
Patients who come to the hospital solely for research purposes will 
also be provided a parking pass free of charge. 
Patients/parents will sign receipts for both receiving the ClinCard and 
the parking pass (if applicable). 
14.0 Withdrawal of Subjects* 
 
The research is expected to pose minimal safety/toxicity concerns to subjects. If a 
subject verbally or behaviorally indicated motion sickness, VR side effects, or 
other discomfort, he/she will be provided with the option to withdrawn from the 
study upon request. Medical care will be provided at the direction of the 
attending physicians/nurses. 
 
If more than 20% of subjects report SAEs due to the study procedures, the 
researchers will stop the study protocol, re-evaluate and revise the protocol, re-
submit it for IRB approval, before resuming participant recruitment 
15.0 Risks to Subjects* 
We believe that there is minimal risk for being in this study. 
It is possible that the subject might feel motion sickness using the virtual reality 
goggle. They might also experience other virtual reality side effects, which can 
include but are not limited to, blurry vision, eye strain, headaches, dizziness, 
fatigue, or nausea. The subject has the right to terminate using the virtual reality 
goggle any time during the study if there is any discomfort arising from using the 
virtual reality goggle. The risk of motion sickness will be minimized by allowing 
subjects to terminate use of the VR intervention at any time during the study. 
Although we will take every precaution including secure data storage on 
password-protected computers and REDCap, there is a small chance of loss of 
confidentiality of study information. The risks related to patient confidentiality 
will be minimized by creating a separate link file for patient study ID and the 
MRN. The study ID will be used on the questionnaires. Patients' medical data 
will be reviewed and abstracted by trained researchers. All data will be stored on 
a secure server at NCH. The Patient ID-Participant ID link file will be stored in a 
separate location on the server from other study data for an additional layer of 
security and confidentiality. 
16.0 Potential Benefits to Subjects* 
There are no known direct physical, psychological or social benefits immediately 
for the subject, although it is possible that the subject might have fun playing the 
virtual reality games and he/she might experience improved cognitive 
rehabilitation with use of the virtual reality tools. 

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In general, we anticipate that this study will provide critical data to improve 
rehabilitation methods available for pediatric TBI patients, and potentially help 
future patients to further improve TBI rehabilitation. 
17.0 Data Management* and Confidentiality 
17.1 Describe the data analysis plan, including any statistical 
procedures or power analysis. 
To examine the research paradigm (Aim 1), we will compute average 
number of children screened and enrolled per month, proportion of 
eligible children who enroll, treatment-specific retention rates, 
proportion of children who adhere to assigned condition, proportion 
of planned measures that are completed, and average duration of 
completing each measurement. To examine the feasibility and safety 
of the VICT program (Aim 2), the total number of AEs/SAEs, mean 
simulator sickness scores, and mean Borg exertion scores will be 
computed and compared between the intervention and control group 
using independent samples t-tests. Additionally, open-end feedback 
from children, parents, and clinicians on optimizing the VR games and 
best practices in protocol implementation will be synthesized and 
submitted to the VR development team for improvement. Finally, to 
explore the preliminary efficacy of the VICT program (Aim 2), 
difference scores from baseline to post-intervention and baseline to 
follow-up of the composite NIH Toolbox score, TBI-QOL, and 
Conners CPT 3 will be compared between the intervention group and 
the control group using analysis of covariance (ANCOVA) 
controlling for baseline scores. BRIEF2, CBCL-APS, and PedsQL 
(parent/child) scores at follow-up will be compared between the two 
groups using ANCOVA controlling for baseline scores. Cohen’s d for 
core EFs changes will be computed as the preliminary intervention 
effect size. Finally, dosage effect will be evaluated within regression 
analyses, with dosage (0 for controls, cumulative hours of VICT 
training for intervention group) as the primary predictor and post-
intervention NIH Toolbox scores as the outcome variable. 
17.2 Describe the steps that will be taken to secure the data (e.g., 
training, authorization of access, password protection, 
encryption, physical controls, certificates of confidentiality, and 
separation of identifiers and data) during storage, use, and 
transmission. 
All data will be independently entered into a computerized database 
by trained research staff and verified by the PI. All data files will be 
maintained in the central electronic database system, REDCap 
(Research Electronic Data Capture), which is securely stored at the 
Research Institute at NCH. Each participant will be assigned a 
unique Study ID number. The master file that links the participants’ 
names to their Study IDs will be maintained only in a password 

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protected file in a password-protected computer at the Research 
Institute at Nationwide Children’s Hospital. All measurement and 
randomization procedures will only use Study IDs to record data 
without participants’ names attached. 
17.3 Describe any procedures that will be used for quality control of 
collected data. 
Once data are collected and entered into electronic databases by one 
researcher, another researcher or the PI will independently verify the 
records to ensure accuracy.          
17.4 Describe how data or specimens will be handle study-wide: 
• 
What information will be included in that data or associated 
with the specimens? 
The data to be collected include: Age, gender, race, injury 
severity scores, including Glasgow Coma Scale score and 
Rancho Scale level, gaming performance in the virtual program, 
and standard neuropsychological testing results. Demographic 
and medical variables listed above will be collected via patients' 
medical records. We will also include the amount of time spent 
in each rehab therapy using the Rehabilitation Provision of 
Services flow sheet in EPIC. Performance in games will be 
automatically recorded by the virtual reality computer program. 
Cognitive 
variables 
will 
be 
collected 
via 
standard 
neuropsychological tests. 
A Microsoft Excel spreadsheet will be created for use by the 
study recruiters in order to keep track of patients that fit the 
inclusion criteria and are recruited, and also of patients who 
meet exclusion criteria and are not recruited. The spreadsheet 
will include the following variables: MRN, patient name, 
gender, age, guardian name(s), telephone number(s), email 
address(es), recruited (Y/N), study ID number, study group 
(Intervention or Control), dates of VR therapy, times of VR 
therapy, and reason for exclusion (for patients that are not 
recruited). The rationale behind the eligibility spreadsheet is to 
track how many pediatric TBI patients are treated, and of those, 
how many are willing to participate in our study. This 
spreadsheet will be helpful for research project planning in order 
to guide our enrollment number prediction and also to reach out 
to families after discharge in order to schedule their follow-up 
research appointments. This password-protected spreadsheet 
will be kept in a secure file folder on password protected 
computers in the Research Institute at Nationwide Children’s 
Hospital. Only researchers on the IRB will have access to the 
secure folder where the file is located. 

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• 
Where and how data or specimens will be stored? 
Data will be stored either on paper forms or electronically on 
password-protected computers and/or REDCap databases 
• 
How long the data or specimens will be stored? 
Data will be stored up to 10 years after the completion of the 
study. 
• 
Who will have access to the data or specimens? 
Only personnel listed on the IRB application will have access 
to the data. 
• 
Who is responsible for receipt or transmission of the data or 
specimens? 
Personnel listed on the IRB application will be responsible for 
receipt or transmission of the data. 
• 
How data or specimens will be transported? 
Currently there is no need to transport data.  
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
Not Applicable as the study involves no more than minimal risk to subjects. 
19.0 Provisions to Protect the Privacy Interests of Subjects 
Password-protected spreadsheet and other electronic databases will be kept in a 
secure file folder on password protected computers in the Research Institute at 
Nationwide Children’s Hospital. Only researchers on the IRB will have access to 
the secure folder where the file is located. 
Eligible subject information will be entered on a hospital approved password 
protected computer password protected data registry in a locked research office. 
Enrolled subjects will be assigned a study ID number which will be how all 
study documents are labeled. The PI and limited trained research staff will be 
responsible for maintaining all components of the research record containing 
participants' identifying information. 
We will use several strategies to protect the privacy of participants: 
1. Research staff will be trained in the importance of protecting participants' 
privacy. 
2. Each participant will be identified by a unique ID number rather than by name 
or medical record number. Participants' names will not appear on materials 

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used during data analysis. The master list of participants' names and 
corresponding numbers will be kept only in electronic format in a password 
protected file in a secure folder on password protected computers.  
3. All electronic data files will be stored in secure folder on a password-protected 
computer in a locked research office. Only members of the research team will 
have access to the files. 
4. All hard copies of the data will be kept in a locked file cabinet in a locked 
office. No hard copies will be kept of the master list of participants' names and 
corresponding numbers. Only study staff will have access to these documents. 
5. Publications of reports will not identify participants in the study or contain 
information leading to the identification of participants. 
We have no plans to contact subjects after their study participation or to share 
their PHI with other investigators. 
 
20.0 Compensation for Research-Related Injury 
Not Applicable as the study involves no more than minimal risk to subjects. 
21.0 Economic Burden to Subjects 
21.1 Describe any costs that subjects may be responsible for because 
of participation in the research. 
There are no costs that subjects may be responsible for because of 
participation in the study. 
22.0 Consent Process 
Researchers from Research Institute at Nationwide Children’s Hospital will 
obtain informed consent from subjects for this research. 
Researchers from NCH Center for Injury Research and Policy will work with 
colleagues throughout various departments/units across the hospital (Inpatient 
Rehab Unit, Neurosurgery Inpatient Unit, etc.) to identify and approach potential 
participants admitted to NCH. Other potential participants already discharged 
will be identified through trauma registry data and mailed invitation letters 
followed by an introduction phone call. Additional recruitment of discharged 
patients will be performed at follow up appointments using study flyers. Patients 
may also self-refer from the public domain through postings on sites such as 
clinicaltrials.gov (NCT03611062) and through IRB approved recruitment emails. 
These participants will also be sent the study letter and receive an introduction 
phone call if they are interested.  Once participants have been identified as 
appropriate for the VR intervention, the research associates will explain and 
consent the legal guardian and assent the patient if they are 9 or older. 
 
Subjects will only be approached if the subject is interested in learning more 
about this research. The research associates will ensure that the subjects 

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understand that participation is voluntary and will not affect any treatment he/she 
(or their child) may receive in the current or future visits. 
 
 
 
When legal guardians are not available to consent, persons who are authorized to 
consent/sign for medical care as listed on EPIC will provide consent (in addition 
to the patient’s assent if older than 9 years old). 
 
23.0 Process to Document Consent in Writing 
Not applicable as this study presents no more than minimal risk of harm to 
subjects and involves no procedures for which written documentation of consent 
is normally required outside of the research context. 
 
24.0 Setting 
24.1 Describe the sites or locations where your research team will 
conduct the research. 
• 
Identify where your research team will identify and recruit 
potential subjects. 
Subjects will be identified and recruited throughout various 
departments/units across the hospital (Inpatient Rehab Unit, 
Neurosurgery Inpatient Unit, etc.). Other potential participants 
already discharged will be identified through trauma registry 
data and mailed invitation letters followed by an introduction 
phone call. Additional recruitment of discharged patients will be 
performed at follow up appointments using study flyers. Patients 
may also self-refer from the public domain through postings on 
sites such as clinicaltrials.gov (NCT03611062) and through IRB 
approved recruitment emails. These participants will also be sent 
the study letter and receive an introduction phone call if they are 
interested. 
• 
Identify where research procedures will be performed. 
All research procedures will be performed at Nationwide 
Children’s Hospital. 
• 
Describe the composition and involvement of any community 
advisory board. 
N/A 
25.0 Resources Available 
25.1 Describe the resources available to conduct the research: For 
example, as appropriate: 

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• 
Justify the feasibility of recruiting the required number of 
suitable subjects within the agreed recruitment period. For 
example, how many potential subjects do you have access to? 
What percentage of those potential subjects do you need to 
recruit? 
• 
Describe the time that you will devote to conducting and 
completing the research. 
• 
Describe your facilities. 
• 
Describe the availability of medical or psychological resources 
that subjects might need as a result of an anticipated 
consequences of the human research. 
• 
Describe your process to ensure that all persons assisting with 
the research are adequately informed about the protocol, the 
research procedures, and their duties and functions. 
26.0 Multi-Site Research* 
Not Applicable 
 
27.0  Protected Health Information Recording 
 
1.0 
Indicate which subject identifiers will be recorded for this research. 
☒  Name 
☒  Complete Address 
☒  Telephone or Fax Number 
☐  Social Security Number (do not check if only used for ClinCard) 
☒  Dates (treatment dates, birth date, date of death) 
☒  Email address , IP address or url 
☒  Medical Record Number or other account number 
☐  Health Plan Beneficiary Identification Number 
☐  Full face photographic images and/or any comparable images (x-rays) 
☐  Account Numbers 
☐  Certificate/License Numbers 
☐  Vehicle Identifiers and Serial Numbers (e.g. VINs, License Plate Numbers) 
☐  Device Identifiers and Serial Numbers 
☐  Biometric identifiers, including finger and voice prints 
☐  Other number, characteristic or code that could be used to identify an 
individual 
☐  None (Complete De-identification Certification Form) 
 
2.0   
Check the appropriate category and attach the required form* on the Local 
Site Documents, #3. Other Documents, page of the application.  (Choose one.) 
☒  Patient Authorization will be obtained. (Include the appropriate HIPAA 
language (see Section 14 of consent template) in the consent form OR attach 
the HRP-900, HIPAA AUTHORIZATION form.) 

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☐  Protocol meets the criteria for waiver of authorization. (Attach the HRP-901, 
WAIVER OF HIPAA AUTHORIZATION REQUEST form.) 
☐  Protocol is using de-identified information. (Attach the HRP-902, DE-
IDENTIFICATION CERTIFICATION form.) (Checked "None" in 1.0 above) 
☐  Protocol involves research on decedents. (Attach the HRP-903, RESEARCH 
ON DECEDENTS REQUEST form.) 
☐  Protocol is using a limited data set and data use agreement. (Contact the 
Office of Technology Commercialization to initiate a Limited Data Use 
Agreement. 
 
*Find the HIPAA forms in the IRB Website Library, Templates. 
 
Attach the appropriate HIPAA form on the “Local Site Documents, #3. 
Other Documents”, page of the application. 
 
3.0    How long will identifying information on each participant be maintained? 
For duration of the study (two years) plus five additional years for publication, 
revision, and potential external inquiries/requests for re-analyzing data as part of 
the reproducible research effort. 
4.0 
Describe any plans to code identifiable information collected about each 
participant. 
Eligible subject information will be entered on a hospital approved password 
protected computer password protected data registry in a locked research office. 
Enrolled subjects will be assigned a study ID number which will be how all study 
documents are labeled. The PI and limited trained research staff will be 
responsible for maintaining all components of the research record containing 
participants' identifying information. 
 
 
5.0 
Check each box that describes steps that will be taken to safeguard the 
confidentiality of information collected for this research: 
 ALL 
Research records will be stored in a locked cabinet in a secure location 
Research records will be stored in a password-protected computer file 
The list linking the assigned code number to the individual subject will be 
maintained separately from the other research data 
Only certified research personnel will be given access to identifiable subject 
information 
 
6.0 Describe the provisions included in the protocol to protect the privacy interests 
of subjects, where "privacy interests" refer to the interest of individuals in being 
left alone, limiting access to them, and limiting access to their information. (This 
is not the same provision to maintain the confidentiality of data.) 

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1. Research staff will be trained in the importance of protecting participants' 
privacy. 
2. Each participant will be identified by a unique ID number rather than by name 
or medical record number. Participants' names will not appear on materials 
used during data analysis. The master list of participants' names and 
corresponding numbers will be kept only in electronic format in a password 
protected file in a secure folder on password protected computers.  
3. All electronic data files will be stored in secure folder on a password-protected 
computer in a locked research office. Only members of the research team will 
have access to the files. 
4. All hard copies of the data will be kept in a locked file cabinet in a locked 
office. No hard copies will be kept of the master list of participants' names and 
corresponding numbers. Only study staff will have access to these documents. 
5. Publications of reports will not identify participants in the study or contain 
information leading to the identification of participants. 
We have no plans to contact subjects after their study participation or to share 
their PHI with other investigators. 
 
Confidential Health Information 
 
1.0 
Please mark all categories that reflect the nature of health information to be 
accessed and used as part of this research. 
 
☒  Demographics (age, gender, educational level) 
☒  Diagnosis 
☐  Laboratory reports 
☐  Radiology reports 
☒  Discharge summaries 
☒  Procedures/Treatments received 
☒  Dates related to course of treatment (admission, surgery, discharge) 
☐  Billing information 
☐  Names of drugs and/or devices used as part of treatment 
☒  Location of treatment 
☒  Name of treatment provider 
☐  Surgical reports 
☐  Other information related to course of treatment 
☐  None 
 
2.0 
Please discuss why it is necessary to access and review the health information 
noted in your response above. 
Diagnosis will be used to identify patients. Age, gender, race, injury severity 
scores, including Glasgow Coma Scale score and Rancho Scale level, time spent 
in therapy, and neuropsychological testing results will be obtained from patient’s 

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individual medical records as control variables in the statistical analyses of this 
study so that potential confounding factors can be accounted for. Location of 
treatment (floor/room) is needed to locate the patient for participant recruitment 
purposes. 
A Microsoft Excel spreadsheet will be created for use by the study recruiters in 
order to keep track of patients that fit the inclusion criteria and are recruited, and 
also of patients who meet exclusion criteria and are not recruited. The 
spreadsheet will include the following variables: first and last initial, age, gender, 
date screened, approached (Y/N), recruited (Y/N), and reasons for exclusion. If 
the patient is recruited, the spreadsheet will also include: MRN, patient name, 
guardian name(s), telephone number(s), email address(es), study ID number, 
study group (intervention or control), dates of VR therapy, and times of VR 
therapy. The rationale behind the eligibility spreadsheet is to track how many 
pediatric TBI patients are treated, and of those, how many are willing to 
participate in our study. This spreadsheet will be helpful for research project 
planning in order to guide our enrollment number prediction and also to reach 
out to families after discharge in order to schedule their follow-up research 
appointments (within 6 months). This password protected spreadsheet will be 
kept in a secure file folder on password protected computers in the Research 
Institute at Nationwide Children’s Hospital. Only researchers on the IRB will 
have access to the secure folder where the file is located. 
 
3.0 
Is the health information to be accessed and reviewed the minimal necessary 
to achieve the goals of this research?  ☒ Yes    ☐ No 
 
4.0 
Will it be necessary to record information of a sensitive nature? 
  ☐ Yes   ☒ No 
 
5.0 
Do you plan to obtain a federally-issued Certificate of Confidentiality as a 
means of protecting the confidentiality of the information collected? 
 ☐ Yes   ☒ No