Effect of Virtual Reality-based Training on Postural Control in Youth With Autism Spectrum Disorder
Phase: NA
Conditions: Autism Spectrum Disorder
Sponsor: Indiana University

IRB#: 19116 
1 
Effect of virtual reality-based training on postural control in 
youth with autism spectrum disorder 
Dr. Georgia Frey, Ph.D., FACSM 
# 112, Department of Kinesiology, Indiana University 
1025 E. 7th Street, Bloomington, IN 47405 
Surabhi Date, M.P.T., Ph. D. Candidate  
Department of Kinesiology 
School of Public Health, Indiana University, Bloomington 
Date: January 1, 2024

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Table of Contents: 
Study Schema 
1.0 
Background & Rationale 
2.0 
Objective(s) 
2.1 
Primary Objective 
3.0 
Outcome Measures 
3.1 
Primary Outcome Measures 
4.0 
Eligibility Criteria 
4.1 
Inclusion Criteria 
4.2 
Exclusion Criteria 
5.0 
Study Design 
6.0 
Enrollment/Randomization 
7.0 
Study Procedures 
8.0 
Study Calendar 
9.0 
Reportable Events 
10.0 
Data Safety Monitoring 
11.0 
Study Withdrawal/Discontinuation 
12.0 
Statistical Considerations 
13.0 
Data Management 
14.0 
Privacy/Confidentiality Issues 
15.0 
Follow-up and Record Retention 
16.0 
References 
17.0 
Appendix

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Abbreviations 
ASD 
Autism Spectrum Disorder 
VR 
Virtual Reality/active video games 
ASSQ 
Autism Spectrum Screening Questionnaire 
n 
Number of participants 
EHI-SF 
The Edinburgh Handedness Inventory-short form 
3D 
Three Dimensional 
PBS 
Pediatric Berg’s Balance Scale 
HR 
High resolution 
Hz 
Hertz 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
m 
Meter 
sec 
Seconds 
min 
Minutes 
mm 
Millimeter  
ANOVA 
Analysis of Variance 
SPSS 
Statistical Package for the Social Sciences 
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
HIPAA 
Health Insurance Portability and Accountability Act  
IB 
Investigator’s Brochure 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 

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SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
1.0 
Background & Rationale 
Postural control deficits, also referred to as balance deficits, are a noted example of 
impaired motor-skills and are increasingly considered as one of the primary markers for autism 
spectrum disorder (ASD)1–5. However, there are very few controlled clinical trials examining 
effects of balance interventions in individuals with ASD. Although balance appears to improve 
with increasing age in these individuals, it plateaus and never reaches that of a typically developing 
adult6,7. Interventions addressing the postural control delays in this population are pivotal to 
improving quality of life as they will reduce the risk and frequency of falls8, improve ease and 
independence in performing activities of daily living9, and improve participating in health-related 
physical activity10. However, to date there exist few effective interventions based on well-designed 
research that address balance deficits in youth with ASD.  
Identifying home-implemented, cost-effective, generalizable, and enjoyable balance 
interventions that promote adherence has been an on-going challenge in the physical therapy 
profession11. Private insurance limits or altogether denies coverage of ASD-specific services such 
as physical therapy, occupational therapy, and speech therapy on the grounds that they are 
experimental, unproven or the responsibility of educational system12. The average annual cost of 
clinical therapies and related services for autistic individuals ranges between $40,000 to $60,000 
per person13 and so may not be cost prohibitive to many who need these services, especially 
considering the other supports this population requires for every-day functioning. It is imperative 
that scientists and clinicians develop research-based best practices for balance interventions that 
are also cost-effective and accessible to better address the rehabilitation needs of not only those 
with ASD, but also anyone with balance deficits.  
Virtual reality/ active video games (VR) are an approach to addressing balance deficits, 
that is both culturally relevant and highly desirable among youth, including those with ASD14,15. 

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This tool also presents an opportunity to provide youth with ASD an effective, enjoyable, and cost-
effective balance intervention. Postural control/balance training should be based on the proven 
theories of motor learning and motor control16,17. Preliminary studies in people with ASD have 
used various techniques such as using a robotic arm to move a target on the screen18, wearing prism 
goggles18 , video modelling and video feedback19, music therapy20  to explore the following motor 
learning theories: implicit and explicit learning18,21, feedback-based mechanisms19,22, principles of 
joined movements20, and goal directed movements with the knowledge of results and 
performance16. Most of these studies were based on non-randomized, non-controlled, and/or pre-
posttest designs and thus the findings are insufficient to provide evidence regarding which of the 
motor learning theories is most effective for designing an intervention23.  
The foundation of many VR active games involve motor learning/control tenets as the 
require an individual to control their center of gravity over the base of support to successfully 
complete game-required movements, consequently providing an opportunity for training postural 
control skills24. It has been shown to be effective in improving static and dynamic balance in those 
with ASD25,26 and other types of disabling conditions such as developmental coordination 
disorder24 and cerebral palsy27.  The therapeutic elements of VR active gaming typically 
incorporate the motor learning principles of feedback and task-specificity. Also, therapeutic VR 
tools engage the person in repetitive motor practice at variable intensity by constantly providing 
knowledge of performance and knowledge of results28. These components of neurorehabilitation 
help in facilitating restoration of movement capabilities29,30 and some studies have reported the 
potential of VR to alter neuroplasticity29. Additionally, VR active gaming provides variability of 
learning by allowing multiple tasks at varying difficulty targeting center of pressure movement of 
the individual’s body to emphasize dynamic balance skills, while also maintaining high levels of 
interest and motivation which is required for promoting adherence to the intervention9. Virtual 
reality active gaming enables the delivery of a stimulus in a standardized and reproducible manner 
and can be adapted according to the participant’s needs31,32. This approach also utilizes visual and 
proprioceptive information which are often heavily relied upon for maintaining balance by 
individuals with ASD33. Despite the fact that VR active gaming incorporates scientific mechanisms 
for improving balance, there exist few, evidence-based best practices that use this method to 
address balance in youth with ASD.  

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In addition to being based on principles of motor learning/control, commercially available 
VR active gaming can be a cost-effective, at-home intervention. Commercially available systems 
cost from $200 to $1000 for the consoles with an additional $50 to $100 for individual games, 
which could be a one-time investment. About 67% of U.S (United States). households already own 
at least one VR system34 and, if there is valid and reliable evidence to support therapeutic 
outcomes, insurance may pay for these devices. Additionally, children tend to enjoy active gaming 
and this approach may provide an advantage over traditional therapeutic approaches regarding 
various accessibility issues (e.g., transportation issues), adherence, and at-home use14,26. 
Therefore, VR active gaming should be explored further as a stand-alone treatment or an adjunct 
to conventional balance rehabilitation approaches.   
There are few well designed studies using VR-based interventions to address balance in 
children and youth with ASD. Previous research in this area consists mainly of quasi-experimental 
studies 26,35,36, which, although useful in providing descriptive information, are limited in providing 
strong, best-practice evidence. These studies have demonstrated improvements in certain balance 
variables such as one- and two-footed balance26,35, heel-toe walking distance26, and balance 
components of certain clinical motor assessments (e.g., Movement Assessment Battery for 
Children-2nd ed25, Bruininks-Oseretsky Test of Motor Proficiency, 2nd ed35).  
To date only two control group design studies have used VR active gaming-based 
interventions to improve balance in individuals with ASD. Milajerdi and colleagues compared 
three conditions in children with ASD (n=20 per group): physical activity intervention, active 
video gaming, and usual therapies. After 24 sessions over 8 weeks, throwing and catching skills, 
but not balance skills, improved and there were no differences between conditions25. There are 
several factors that may have contributed to the lack of significant balance skill improvement in 
this study. First, only one VR game (tennis) was used, and this can be played standing with minimal 
center of pressure movement, also reducing the variability of training and variability in the task, 
and consequently restricting motor learning. Second, only providing one game option does not 
allow for choice and this can impact motivation, participation, and engagement15. Third, 
adherence, enjoyability, and motivation were not reported and therefore no conclusions could be 
drawn regarding either retention of treatment effects or long-term use.    
Caldani and colleagues used an open-case control design to test the hypothesis that short-
term balance training using VR would lead to neuroplastic changes in the cerebellum leading to 

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improvements in postural control in youth with ASD37. They compared the effect of 6 minutes of 
postural control training using 2 customized active-video games with 6 minutes of rest between 
each trial (n=20 each in intervention and control groups). The specifically designed game consisted 
of moving a dot on a screen, which represented the participant’s center of pressure. The subject 
moved the dot to either a pre-defined target or to avoid the pre-defined target by standing on a 
force platform. The control group rested for the duration of the intervention. The researchers 
reported a reduction in postural sway immediately after the intervention under both eyes open and 
eyes closed conditions but speculated that the changes were due to test-retest. This outcome could 
have been predicted and it is unfortunate that the researchers did not plan for this accordingly. This 
test-retest response limits translation of the intervention over longer duration as the dose, that is 
duration of the intervention, is insufficient to cause behavioral changes17.   
Overall, out of the five studies using VR active gaming interventions in youth with ASD, 
including the previously described studies using some type of control group, three reported it to 
be beneficial for improving balance26,35,37 and two were inconclusive25,36. Findings from all of 
these studies are compromised due to 1) lack of randomized controlled trials17,25,37, 2) lack of 
objective balance measures26, 3) variability in intervention duration, 4) small sample sizes (10-29 
subjects), 5) limited game options, 6) lack of clear identification of motor learning/control 
principles in the research design, (7) variability in game design (i.e. 3 were not commercially 
available35–37), and 8) no assessment beyond immediate-post intervention. The current published 
literature does not provide sufficient evidence for the use of VR active gaming as a modality to 
address postural control/balance deficits in individuals with ASD.   
The purpose of this study is to deliver a VR active gaming-based static and dynamic 
balance intervention to children and youth with ASD that addresses several of the aforementioned 
gaps in the literature by: 1) using a controlled clinical trial design, 2) using objective measures of 
static and dynamic balance, 3) using select commercially available VR active games that 
incorporate specific motor learning principles that impact balance, 4) using a participant sample 
based on a power calculation to ensure a robust statistical analysis, and 5) assessing retention 
effects 4 weeks post-intervention. Addressing these gaps will significantly contribute to the 
knowledge base by verifying if VR active gaming interventions are effective in improving static 
and dynamic balance in youth with ASD.   
2.0 
Objectives 

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2.1 
Primary Objective 
H1: Participation in VR active video gaming incorporating explicit and implicit learning, feedback 
and knowledge of results, and knowledge of performance motor tenets will lead to increased 
postural control, as reflected by improved static and dynamic balance. This hypothesis will be 
tested by Specific Aim 1: to assess the effect of a short-term (3 days/week for 2 weeks) VR active 
video gaming intervention on static balance, versus traditional balance training exercises, in youth 
with ASD.   
H2: Participation in VR active video gaming incorporating explicit and implicit learning, feedback 
and knowledge of results, and knowledge of performance motor tenets will reduce the deviation 
in the spatiotemporal parameters of the gait due to increased dynamic balance and improved motor 
coordination. This will be tested by Specific Aim 2: to assess the effect of a short-term (3 
days/week for 2 weeks) VR active video gaming intervention on spatiotemporal parameters of 
gait, as a measure of dynamic balance, versus traditional balance training exercises, in youth with 
ASD.   
 
3.0 
Outcome Measures/Endpoints 
3.1 
Primary Outcome Measures: 
1. High resolution pressure mat: Static balance will be objectively measured using an 
HR Mat pressure mat (Tekscan Inc.). The center of pressure will be measured at 
100Hz using the center of pressure coordinates by inbuilt software50. The area of the 
postural sway and direction of the sway will be measured as indicators of static 
balance with participants standing on the pressure mat with hands at their side under 2 
conditions: eyes open and eyes closed for 30 seconds each condition51. A member of 
the research team will stand beside the participant and provide balance support as 
needed.  
2. Qualisys Motion Capture system: Step length, stride length, step width, double 
support period, cadence and velocity are the gait parameters that will be measured as 
indicators of dynamic balance using Qualisys motion capture system36,37. The 

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Qualisys motion capture system will be used to assess gait as a measure of dynamic 
balance. The system is composed of 13-infrared cameras that capture light reflected 
by passive markers at a frequency of 100 Hz. It is a reliable and a valid tool for gait 
assessment46,47. The biomechanical model of feet will be constructed using Visual 3D 
software for gait analysis. Participants will wear the same sneakers/sports shoes for 
each assessment. Nine markers will be placed bilaterally (18 total) at the following 
points: distal aspect of the great toe, 1st metatarsal, 5th metatarsal, top of the foot, 
medial malleolus, and lateral malleolus, proximal heel, distal heel, and lateral heel. A 
comfortable walking speed for each participant will be recorded using a stopwatch to 
measure the time it takes them to walk back and forth on a 15-meter-long-platform 3 
times and the average of the 3 trials will be calculated.  Participants will then walk at 
the same speed at least 5 times or until the entire gait cycle is captured by the infra-
red camera system twice. Gait cycle is defined as heel-strike to heel strike on the 
dominant foot. A couple of practice trials will be performed to ensure understanding 
of the procedure and verbal prompting will be used to remind the participant to walk 
typically. Biomechanical models of feet will be constructed using Visual 3D software 
for gait analysis. If the participant is unable to perform this assessment as described, it 
will be rescheduled up to two times before study dismissal.  
3. Pediatric Balance Scale (PBS): The PBS will be used to assess static and dynamic 
balance. It is a valid and reliable clinical balance assessment tool for children and 
youth with motor impairments48,49.  It is a 14-component battery that evaluates daily 
living tasks such as sitting to standing, transferring from one chair to another, and 
sitting and standing without support. Item numbers 1-3 and 9 -14 are specific to 
dynamic balance while item numbers 4-8 are specific to the static balance. 
Participants are graded as 0-4 on each component of the scale with 56 being the 
highest total score achieved. A higher score indicates better postural control. 
Interpretation of the scores is as follows: 41 to 56 denotes a low fall risk, 21 to 40 a 
medium fall risk, and 0 to 20 a high fall risk. The PBS takes fifteen to twenty minutes 
to administer48. A different researcher from the study team will record the PBS to 

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avoid any assessment bias. The researcher will demonstrate each task and the 
participant will be allowed 1-2 practice trials before official assessment as per the 
instructions provided in the tool. The researcher is well trained in administrating the 
PBS. Inter- and Intra-rater reliability will be checked at least four times throughout 
the course of the study by scoring a videotaped administration of the tool. An 
intraclass correlation of 0.9 must be achieved to avoid retraining on the PBS.  
3.2 
End points: 
1. Primary endpoints: Reduction in PBS total score by 3.7 points. This is in accordance 
with the MCID range reported by Chen et al, 2013 as 3.66-5.83 for PBS in children 
with neuromotor impairments.  
2. For static balance: 1) reduction in the sway area of 95% confidence ellipse for center 
of pressure, 2) reduction in mediolateral direction of the postural sway.  
3. For dynamic balance: Reduction in 1) step width, 2) double support period. Increase 
in 1) step length, 2) Cadence, 3) Gait velocity  
4. Secondary endpoints: Safety.  
 
 
4.0 
Eligibility Criteria 
4.1 
Inclusion Criteria 
a) age 7-22 years38,39,  
b) existing ASD DSM-5 level 1 or 2 diagnosis confirmed by medical record/ educational services 
categorized under ASD/ therapeutic services categorized under ASD/ any other official 
document indicating the diagnosis of ASD, 
c) able to follow instructions and 
d) able to stand unsupported for at least 20 minutes. 
4.2 
Exclusion Criteria 
a) epilepsy or other medical conditions which can be exacerbated by looking at a screen,  
b) Uncorrected vision loss or any other eye condition prohibiting looking at the screen for a 
prolong time,  

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c) co-occurring musculoskeletal conditions such as joint or muscle pain or stiffness that limits 
mobility, implanted plates, pins, or screws that limit mobility, fractures or recent surgeries or any 
other physical condition that could interfere with the ability to play an active video game 
d) co-occurring neurological conditions such as numbness or muscle weakness, temporary loss 
of vision, speech or strength, loss of consciousness (black out), Dizziness or lightheadedness, 
Impaired memory or confusion, any other cooccurring diagnosis that could be negatively 
impacted by playing an active video game 
e) any other health conditions that are contraindicated to or may interfere with physical activity 
such as impaired hearing (uncorrected), medically documented balance disorder, Any heart 
condition prohibiting exercise, chronic pain or any pain at the time of testing, need assistance to 
stand for 20 minutes or more, 
f) aggression or other severe behaviors that may limit the ability to safely participate in the 
intervention. 
As participants in the intervention group will be using hand-held and not a head-mounted device 
for VR active video gaming, we are not anticipating any VR sickness. There are no other VR/ 
active gaming related issues reported in the literature which can negatively impact participants’ 
health due to 20-minute intervention duration.  
 
5.0 
Study Design 
Single blinded randomized controlled clinical trial design will be used. After obtaining the 
consent material, potential participants will be screened using inclusion and exclusion criteria, 
ASSQ and screening questionnaire. Co-PI will create and administer the assignments. 
Participants will be blinded to the allocation process to either the intervention or the control 
group.   
 
 
 

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Flow diagram for randomized, controlled trial  
 
6.0 
Enrollment/Randomization 
40 school age children and youth with ASD will be recruited through local community agencies 
(e.g., schools, churches, and rehabilitation centers), social media platforms (e.g., Facebook and 
Reddit) and direct contact. Participants will be divided into 2 groups based on their age such as, 
group 1: 7-14 years and group 2: 15-22 years. Co-PI will allocate participant based on the coin 
flip such that heads = intervention group and tails = control group. The next participant in the 
same age range (range 1: 7-14 years, range 2: 15-22 years) will be assigned to the other group. 

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The process will continue till there are 10 participants in each age range for each intervention 
and control group (total n = 40).  
7.0 
Study Procedures 
1. Prior to day 1: Informed consent materials, a screening questionnaire, and Autism 
Spectrum 
Screening 
Questionnaire 
(ASSQ) 
will 
be 
sent 
electronically 
to 
parents/caregivers. Participants and parents/caregivers in both groups will be given access 
to a video of the data collection space, intervention space setting, and a short introduction 
of the research personnel for review. If the participants are 18 years or older, this 
information will be shared with the participants directly and they will fill the 
questionnaires. If the participant is less than 18 years old, the information will be shared 
with the parent/legal guardian to be completed. Additionally, The ASSQ is a commonly 
used valid and reliable 27-item checklist to be filled in by parent/caregiver for assessing 
symptom characteristics of ASD41–43. The ASSQ can be completed in 10 minutes using a 
3-point Likert scale with possible score range being 0 of 54 with 19 being a cut off for a 
parent/caregiver rating identifying ASD44. This tool will be used as a part of demographic 
screening of the participants prior to the pre-intervention day and used to better describe 
individual autism symptoms than is available in a medical or educational diagnosis. The 
researcher will subsequently contact participants and parent/caregiver to review the 
information, check for understanding, (particularly the terminology used in the ASSQ), 
assess eligibility via screening tool and address any other questions prior to study inclusion 
and visit. 
Study participation will require 9 visits: 1 pre-intervention visit, 6 intervention visits, 1 
 
post-intervention visits and 1 retention visit.  Participants will receive $10 Amazon or 
 
Kroger gift card after completing each session with total possible compensation of $90. 
 
2. Pre-intervention/ session 1: 
2.1 As part of familiarization, participants will be shown and allowed to handle the different data 
collection instruments and ask questions. The intervention group will be shown the Nintendo 
Switch to get familiarized with their operation and functions.  Parents/caregivers of the participants 
(under 18 years of age) in the intervention group will be handed over the Nintendo Switch Sports 

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to be connected at their home for the duration of intervention. Participants 18 years of age or older 
will be given the device. Researchers will provide any technological assistance required for this 
purpose. 
2.2 Weight will be recorded using a calibrated scale and height measured using a stadiometer. The 
Edinburgh Handedness Inventory-short form (EHI-SF) will be used to assess hand-preference. It 
is a valid and reliable 4-item checklist of everyday tasks and participants score their hand 
preference on 5-point Likert scale (for each item, always right= 100, usually right= 50, usually 
left= 50, always left= -100)45. A researcher will read the rating scale to those with low literacy 
level45. Handedness will be determined using a laterality quotient. The laterality quotient is 
interpreted as left handers (-100 to -61), mixed handers (-60 to +60) and right handers (61 to 100). 
Hand length will be calculated using a tape cloth, measured from greater tuberosity to distal end 
of middle digit on the right hand and leg length iliac crest to ground on the right leg.   
Participants will be shown the different data collection instruments to handle, get familiarized and 
ask questions. Participant’s hand dominance will be recorded using the Edinberg Handedness 
Inventory-short form23,24. Participant’s foot dominance will be recorded by asking them to kick an 
imaginary ball placed on the ground in front of them. Practice trials for balance and gait 
assessments will be conducted to ensure understanding of the protocol. Baseline assessments for 
posture and gait will be performed.   
 
2.3 Dynamic balance assessment: Dynamic balance will be assessed as previously described using 
Qualisys motion capture system and dynamic components of PBS. The biomechanical model of 
feet will be constructed using Visual 3D software for gait analysis. Participants will wear the same 
sneakers/sports shoes for each assessment. Nine markers will be placed bilaterally (18 total) at the 
following points: distal aspect of the great toe, 1st metatarsal, 5th metatarsal, top of the foot, medial 
malleolus, and lateral malleolus, proximal heel, distal heel, and lateral heel. A comfortable walking 
speed for each participant will be recorded using a stopwatch to measure the time it takes them to 
walk back and forth on a 15-meter-long-platform 3 times and the average of the 3 trials will be 
calculated.  Participants will then walk at the same speed at least 5 times or until the entire gait 
cycle is captured by the infra-red camera system twice. Gait cycle is defined as heel-strike to heel 
strike on the dominant foot. A couple of practice trials will be performed to ensure understanding 
of the procedure and verbal prompting will be used to remind the participant to walk typically 

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2.4 Static balance assessment: Static balance will be assessed as previously described using 
pressure mat and static components of PBS. The area of the postural sway and direction of the 
sway will be measured as indicators of static balance with participants standing on the pressure 
mat with hands at their side under 2 conditions: eyes open and eyes closed for 30 seconds each 
condition51. A member of the research team will stand beside the participant and provide balance 
support as needed.  
3. Intervention/ session 2-7:  
Session 2 will occur 3-5 days after the baseline assessment. 
3.1: Intervention group: Participants will choose 2 interactive video games on the Nintendo Switch 
Sports from golf, Frisbee, beach tennis, soccer, Volleyball, badminton, bowling, and chambara. 
The researcher will supervise the sessions via zoom. These games address motor learning 
principles as follows. First, they cause movement of the body’s center of pressure in mediolateral-
, anteroposterior-, and diagonal directions without the participant paying active attention to the 
directional changes, leading to implicit and explicit learning. Second, they display the score 
achieved by the participant during- and after- each game leading to the participant having 
knowledge of the performance and the results. Third, playing 2 games provides task and training 
variability.  
Games will be played for 10 minutes each with a 5-minute break in between. The same 2 games 
will be played each session. Participants will stand at least 3 meters away from the TV while 
playing the games. Verbal prompts /motivators will be provided during the games. Each session 
will take approximately 40 minutes. The caregivers will be present at one-hands distance from the 
participant to prevent any falls. Additionally, participants will be asked to place a chair at a 
reachable distance which they can hold on to prevent falls.  Ideally, each session will occur with 
an off day in between, however this may not be realistic depending on participant and caregiver 
schedules and so sessions will occur at participant/caregiver convenience.  
 
Control group: Control group participants will receive balance instruction from the researcher at 
home via Zoom. The following standard balance exercises52 will be performed for 15 minutes with 
5 minutes of warm and cool down each. Breaks will be given as per the participants’ need and 
verbal prompts/motivators provided. The caregivers will be present at one-hands distance from the 

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participant to prevent any falls. Additionally, participants will be asked to place a chair at a 
reachable distance which they can hold on to prevent falls.  
Warm up exercises: Neck flexion-extension, shoulder flexion-extension, shoulder abduction-
adduction, shoulder clockwise rotation, elbow flexion-extension, hip flexion-extension, hip 
abduction-adduction, knee flexion-extension, ankle plantar flexion- dorsi flexion, trunk flexion-
extension. All exercises will be done by standing holding the back of a chair for 5 repetitions 
bilaterally. 
Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front 
of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both 
sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing 
on a balance board for 30 seconds for 3 repetitions.  
Cool down exercises: Stretching of calf muscles, quadriceps, hamstrings, lateral trunk flexors, 
truck extensors, shoulder abductors, shoulder adductors for 10 seconds each for 5 repetitions 
bilaterally. All stretches will be done by standing holding the back of a chair whenever 
necessary.    
 
4. Post-intervention/ session 8 and 9: 
Static and dynamic balance will be reassessed as previously described to examine retention effects 
of the VR active gaming intervention (see study calendar). Session 8 will be at least 3-5 days after 
session 7. Parent/caregiver will return the Nintendo Switch Sports to the researcher. Session 9 will 
be 4 weeks after session 7. Each session will be for approximately 60 minutes. 
 
8.0 
Study Calendar 
Prior to Day 1 
Session 1 
Session 2-7 
Session 8 
Session 9 
Familiarization 
video 
Familiarization 
with study tools 
3-5 days after 
baseline 
assessment 
Reassessment of 
dynamic and 
static balance 3-
5 days after 
session 7 
excluding 
Reassessment of 
dynamic and 
static balance 
4 weeks after 
session 7 
excluding 

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demographic 
parameters such 
as EHI-SF, leg 
and arm length, 
weight, height. 
demographic 
parameters such 
as EHI-SF, leg 
and arm length, 
weight, height. 
Informed 
consent 
material, 
Screening 
questionnaire 
and ASSQ 
Acquisition of 
demographic 
information 
Intervention 
group: Playing 
select video games 
under supervision 
via Zoom 
Duration: 1 hour Duration: 1 hour 
Autism 
spectrum 
screening 
questionnaire 
Baseline 
dynamic and 
static balance 
assessment 
Control group: 
Performing 
standard balance 
exercises under 
supervision via 
Zoom 
  
  
Researcher-
parent/ 
caregiver 
interaction 
Duration: 1.5 
hours 
Duration: 30- 40 
minutes per 
session 
  
 
9.0 
Reportable Events 
Any event that requires prompt reporting to the IU IRB per the IU HRPP Policy on Reportable 
Events will be reported within five business days in compliance the IU HRPP Policy.  Minor 
noncompliance and minor protocol deviations not meeting the requirements for prompt reporting 
will be reported at time of protocol renewal.  
For questions about the rights as a research participant, to discuss problems, complaints, or 
concerns about a research study, or to obtain information or to offer input, please contact the IU 

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(Indiana University) Human Research Protection Program office at 800-696-2949 or at 
irb@iu.edu. 
10.0 
Study Withdrawal/Discontinuation 
After reviewing the consent and/or assent form and having their questions answered, participants 
may decide to sign the forms and participate in the study. Or they may choose not to participate in 
the study. The decision is up to the participants. If they choose not to participate in this study or 
change their mind after signing the consent document, it will not affect their usual medical care or 
treatment or relationship with Indiana University. 
If participants change their mind and decide to leave the study in the future, the study team will 
help them withdraw from the study safely. If they decide to withdraw, they should contact one of 
the a researchers to make them aware. Researchers will instruct the participant to stop playing the 
Nintendo Switch Sports and the researcher will collect the gaming console from the participant. 
The researchers may stop the participation in the study even if participant do not want to stop if 
there is any incidence which leads to participant acquiring any exclusion criteria of this study such 
as any neurological or orthopedic condition affecting balance, epilepsy, or any type of injury that 
prevents you from continuing your participation during the data collection process of the study.  
The PI will be responsible for data and safety monitoring. The study team will meet at least bi-
weekly to discuss any difficulties while conducting the experimental protocols and review the 
data. Dr. Frey will always be available online when data collection is occurring. Minutes of each 
of the meetings will be maintained on the designated One-Drive folder for the Physical Activity 
Research lab.  
11.0 
Statistical Considerations 
According to prior research study examining the similar paradigm using Xbox games (Ghobadi 
et al. 2019), we predict the medium effect size (f=0.25) to detect significant changes within 
groups, between groups and effect of timepoint on static and dynamic balance. Power analysis 

IRB#: 19116 
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(using G*power 3.1.9.7 software) indicates 14 subjects in each group to have 0.8 power to detect 
this effect (alpha 0.05). To account for the likelihood of attrition and noncompliance, total 40 
participants are being recruited. Data from participants who engage in all the intervention 
sessions will be included in the analysis.  
 
SPSS (Statistical Package for the Social Sciences) and MATLAB will be used for processing and 
analyzing the data.  Participants demographic and health characteristics will be compared using 
paired sample t-tests. Intention to treat analysis will be used for addressing effects of treatment or 
control on static and dynamic balance. The dependent variables for static balance include: 1) sway 
area of 95% confidence ellipse for center of pressure(mm2), 2) direction of center of pressure sway 
as anteroposterior and mediolateral (mm). The dependent variables for dynamic balance are: 1) 
step length (m), 2) stride length (m), 3) step width (m), 4) double support period (sec), 5) cadence 
(steps/min) and 6) gait velocity (meters/min). Total PBS score will be dependent variable for both 
static and dynamic balance.  
Two-way repeated measures ANOVA (analysis of variance) will be used to determine 1) within 
intervention and control group, for assessing the main effect of group, 2) between intervention and 
control group for assessing main effect of time, and 3) between - within interaction for assessing 
the interaction term. Statistical significance will be declared if p ≤ 0.05 (two-tailed).   
Dr. David Koceja (koceja@indiana.edu) will assist with the statistical considerations. 
12.0 
Data Management 
Qualisys motion capture system, visual 3D and HR mat use the inbuilt software for collecting 
and cleaning the data. HR mat data will be exported to MATLAB for analysis of postural sway. 
The data will be stored on an access-controlled computer situated in laboratory 70 E of the 
School of Public Health building in Indiana University Bloomington. Only approved study 
personnel will have access to this data.  
13.0 
Privacy/Confidentiality Issues 
Participants will be recruited through flyers posted in the community and various Indiana 
University Buildings. Subjects will be assessed in the private setting of Physical activity and 

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Biomechanics labs in the School of Public Health building. Informed consent form will be 
obtained from the subjects prior to the research procedure online via Qualtrics. All phone 
conversations regarding the consent/ assent process will occur in the private setting of the 
researcher’s office behind the closed doors. The intervention will take place at participants own 
home ensuring privacy. All the data collected for this study will be placed in a locked cabinet in 
laboratory 70 E of the School of Public Health building in Indiana University Bloomington. The 
only people that will access this information are approved study personnel. 
14.0 
Follow-up and Record Retention 
Session numbers 8 and 9 will be follow-up and retention assessment sessions. Session 8 will 
occur 3-5 days after the last intervention day and session 9 will occur 4 weeks after the last day 
of intervention. The data will be retained for 3 years after the end of the study. 
 
 

IRB#: 19116 
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15.0 
References 
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Autism Dev Disord. 2019;49(7):2873-2900. doi:10.1007/s10803-019-04014-z 
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clinical application and research evidence. Child Care Health Dev. 2006;32(5):535-542. 
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aiming movements in persons with autism spectrum disorders. Autism. 2009;13(4):411-433. 
doi:10.1177/1362361309105659 
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Zampella CJ, Wang LAL, Haley M, Hutchinson AG, de Marchena A. Motor Skill Differences in 
Autism Spectrum Disorder: a Clinically Focused Review. Curr Psychiatry Rep. 2021;23(10). 
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Jelsma D, Geuze RH, Mombarg R, Smits-Engelsman BCM. The impact of Wii Fit intervention 
on dynamic balance control in children with probable Developmental Coordination Disorder and 
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 25. 
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Physical Activity and Exergaming on Motor Skills and Executive Functions in Children with 
Autism Spectrum Disorder. Games Health J. 2021;10(1):33-42. doi:10.1089/g4h.2019.0180 
 26. 
Ghobadi N, Ghadiri F, Yaali R, Movahedi A. The Effect of Active Video Game (Xbox Kinect) 
on Static and Dynamic Balance in Children with Autism Spectrum Disorders. Journal of 
Research in Rehabilitation of Sciences. 2019;15(1):13-18. doi:10.22122/jrrs.v15i1.3410 
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Jelsma J, Pronk M, Ferguson G, Jelsma-Smit D. The effect of the Nintendo Wii Fit on balance 
control and gross motor function of children with spastic hemiplegic cerebral palsy. Dev 
Neurorehabil. 2013;16(1):27-37. doi:10.3109/17518423.2012.711781 
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Dechsling A, Shic F, Zhang D, et al. Virtual reality and naturalistic developmental behavioral 
interventions for children with autism spectrum disorder. Res Dev Disabil. 2021;111:103885. 
doi:https://doi.org/10.1016/j.ridd.2021.103885 

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 29. 
Deutsch JE, Westcott McCoy S. Virtual Reality and Serious Games in Neurorehabilitation of 
Children and Adults: Prevention, Plasticity, and Participation. Pediatric Physical Therapy. 
2017;29:S23-S36. doi:10.1097/PEP.0000000000000387 
 30. 
Miguel-Rubio A de, Rubio MD, Salazar A, et al. Is Virtual Reality Effective for Balance 
Recovery in Patients with Spinal Cord Injury? A Systematic Review and Meta-Analysis. J Clin 
Med. 2020;9(9):2861. doi:10.3390/jcm9092861 
 31. 
Wang E, Thomas JJ, Rodriguez ST, Kennedy KM, Caruso TJ. Virtual reality for pediatric 
periprocedural care. Curr Opin Anaesthesiol. 2021;34(3):284-291. 
doi:10.1097/ACO.0000000000000983 
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Cano Porras D, Siemonsma P, Inzelberg R, Zeilig G, Plotnik M. Advantages of virtual reality in 
the rehabilitation of balance and gait: Systematic review. Neurology. 2018;90(22):1017-1025. 
doi:10.1212/WNL.0000000000005603 
 33. 
Morris SL, Foster CJ, Parsons R, Falkmer M, Falkmer T, Rosalie SM. Differences in the use of 
vision and proprioception for postural control in autism spectrum disorder. Neuroscience. 
2015;307:273-280. doi:10.1016/j.neuroscience.2015.08.040 
 34. 
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outcomes: A systematic review. Am J Prev Med. 2012;42(6):630-638. 
doi:10.1016/j.amepre.2012.02.023 
 35. 
Travers BG, Mason AH, Mrotek LA, et al. Biofeedback-Based, Videogame Balance Training in 
Autism. J Autism Dev Disord. 2018;48(1):163-175. doi:10.1007/s10803-017-3310-2 
 36. 
Hocking DR, Ardalan A, Abu-Rayya HM, et al. Feasibility of a virtual reality-based exercise 
intervention and low-cost motion tracking method for estimation of motor proficiency in youth 
with autism spectrum disorder. J Neuroeng Rehabil. 2022;19(1). doi:10.1186/s12984-021-
00978-1 
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improve postural control in children with autism spectrum disorders: preliminary evidences. Sci 
Rep. 2020;10(1). doi:10.1038/s41598-020-64922-4 

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effects of a single treadmill session with additional ankle loading on gait in children with 
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for Balance Rehabilitation in Children with Autism Spectrum Disorder. Children. 2022;9(8). 
doi:10.3390/children9081152 
 
 

IRB#: 19116 
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16.0 
Appendix 
1. Recruitment Flyer: 
 
 
Details: The study consists of 9 sessions occurring over 7-8 weeks, 6 at-home 
intervention sessions (30-40 minutes) and 3 testing sessions (1.0-1.5 hour) at the 
School of Public Health. 
  
If you find this study interesting, and you think you would like to participate, please 
contact Surabhi Date <dates@iu.edu> for enrollment screening. 
Thank you! 
 
Surabhi Date 
<dates@iu.edu 
Surabhi Date 
<dates@iu.edu 
Surabhi Date 
<dates@iu.edu 
Surabhi Date 
<dates@iu.edu 
Surabhi Date 
<dates@iu.edu 
Surabhi Date 
<dates@iu.edu 
Surabhi Date 
<dates@iu.edu 
Surabhi Date 
<dates@iu.edu 

IRB#: 19116 
28 
 
 
 
2. ASSQ: 
Autism Spectrum Screening Questionnaire (ASSQ) 
Please read the statement below and indicate by answering, No, Somewhat, or Yes if this your 
child/you stands out as different from other children/adults of his/her age in the following ways: 
 
 
No  
0 
Somewhat 
1 
Yes 
2 
1 
is old-fashioned or precocious 
 
 
 
2 
is regarded as an "eccentric professor" by the other children 
 
 
 
3 
lives somewhat in a world of his/her own with restricted 
idiosyncratic intellectual interests 
 
 
 
4 
accumulates facts on certain subjects (good rote memory) 
but does not really understand the meaning 
 
 
 
5 
has a literal understanding of ambiguous and metaphorical 
language 
 
 
 
6 
has a deviant style of communication with a formal, fussy, 
old-fashioned or "robotlike" language 
 
 
 
7 
invents idiosyncratic words and expressions 
 
 
 
8 
has a different voice or speech 
 
 
 
9 
expresses sounds involuntarily; clears throat, grunts, 
smacks, cries or screams 
 
 
 
10 
is surprisingly good at some things and surprisingly poor at 
others 
 
 
 
11 
uses language freely but fails to make adjustment to fit 
social contexts or the needs of different listeners 
 
 
 
12 
lacks empathy 
 
 
 
13 
makes naïve and embarrassing remarks 
 
 
 
14 
has a deviant style of gaze 
 
 
 

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15 
wishes to be sociable but fails to make relationships with 
peers 
 
 
 
16 
can be with other children but only on his/her terms 
 
 
 
17 
lacks best friend 
 
 
 
18 
lacks common sense 
 
 
 
19 
is poor at games: no idea of cooperating in a team, scores 
"own goals" 
 
 
 
20 
has clumsy, ill coordinated, ungainly, awkward movements 
or gestures 
 
 
 
21 
has involuntary face or body movements 
 
 
 
22 
has difficulties in completing simple daily activities because 
of compulsory repetition of certain actions or thoughts 
 
 
 
23 
has special routines: insists on no change 
 
 
 
24 
shows idiosyncratic attachment to objects 
 
 
 
25 
is bullied by other children 
 
 
 
26 
has markedly unusual facial expression 
 
 
 
27 
has markedly unusual posture 
 
 
 
 
 
 

IRB#: 19116 
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3. Screening Questionnaire (Qualtrics survey) 
 
Screening questionnaire: Effect of virtual reality-based training on postural control in 
youth with autism spectrum disorder (ASD) 
Q1 Name of the participant: 
________________________________________________________________ 
 
 
 
Q2 Do you have any of the following documents confirming autism diagnosis: 
 
▢ Document provided by the physician  (1)  
▢ School services categorized under ASD  (2)  
▢ Seeking therapeutic services categorized under ASD  (3)  
▢ Any other official documents indicating the diagnosis of ASD, please specify:  (4) 
__________________________________________________ 
 
 
 
Q3 Will you be willing to provide researcher with a copy of those document under HIPPA safety 
regulations? 
o Yes  (1)  
o No  (2)  
 
 
 
Q4 Does participant currently receive any medications? 
 
o Yes  (1)  
o No  (2)  
o If yes, please mention the medications:  (3) 
__________________________________________________ 
 
 
 

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31 
 
Q5 Does the participant currently have any of the following musculoskeletal conditions? 
 
Yes (1) 
No (2) 
Joint or muscle pain or 
stiffness that limits mobility 
(1)  
o  
o  
Fractures or recent surgeries 
(2)  
o  
o  
Implanted plates, pins, or 
screws that limit mobility (3)  
o  
o  
Any other physical condition 
that could interfere with the 
ability to play an active video 
game (4)  
o  
o  
 
 
 
 

IRB#: 19116 
32 
 
Q6 Does participant currently have any of the following neurological symptoms? 
 
Yes (1) 
No (2) 
Numbness or muscle 
weakness (1)  
o  
o  
Temporary loss of vision, 
speech or strength (2)  
o  
o  
Loss of consciousness (black 
out) (3)  
o  
o  
Dizziness or lightheadedness 
(4)  
o  
o  
Impaired memory or 
confusion (5)  
o  
o  
Epilepsy or seizures (6)  
o  
o  
Any other cooccurring 
diagnosis that could be 
negatively impacted by 
playing an active video game 
(7)  
o  
o  
 

IRB#: 19116 
33 
 
Q7 Does participant currently have any of the following symptoms? 
 
Yes (1) 
No (2) 
Uncorrected vision loss or 
any other eye condition 
prohibiting looking at the 
screen for a prolong time (1)  
o  
o  
Impaired hearing 
(uncorrected) (2)  
o  
o  
Medically documented 
balance disorder (3)  
o  
o  
Any heart condition 
prohibiting exercise (4)  
o  
o  
Chronic pain or any pain at 
the time of testing (5)  
o  
o  
Aggression or other severe 
behaviors that may limit the 
ability to safely participate in 
this study (6)  
o  
o  
Assistance to stand for 20 
minutes or more (7)  
o  
o  
 
 
 
Q8 Does participant currently receive physical or occupational therapy specifically for 
improving balance? 
o Yes  (1)  
o No  (2)  
 
 
 
Q9 Has participant received physical or occupational therapy in the past specifically for 
improving balance? 
 
o Yes  (1)  
o No  (2)  
 
 

IRB#: 19116 
34 
 
 
Q10 Do you perceive participant having any challenges with balancing self such as frequent 
tripping while walking, frequent falls, uses support while walking or standing unsupported? 
o Yes  (1)  
o No  (2)  
o If yes, please specify:  (3) __________________________________________________ 
 
 
 
Q11 Does participant currently play any video games? 
o Yes  (1)  
o No  (2)  
o If yes, specify the gaming consoles:  (3) 
__________________________________________________ 
 
 
 
Q12 What the frequency of playing the video games?  
________________________________________________________________ 
________________________________________________________________ 
________________________________________________________________ 
________________________________________________________________ 
________________________________________________________________ 
 
 
 
Q13 Does participant currently play active video games (which involves participant moving his 
body to move the avatar on the screen)? 
 
 
o Yes  (1)  
o No  (2)  
o If yes, what is the frequency and average duration:  (3) 
__________________________________________________ 
 
 
 

IRB#: 19116 
35 
 
Q14 Does participant currently have access to Nintendo Switch Sports (2022) game? 
o Yes  (1)  
o No  (2)  
 
 
Q15 Does participant have any other challenges that may limit their ability to engage in this 
study such as will he/she be able to engage in video game activity for 10 minutes without getting 
distracted? 
________________________________________________________________ 
________________________________________________________________ 
________________________________________________________________ 
________________________________________________________________ 
________________________________________________________________ 
 
 
 
Q16 Will the participant need any individualized motivation such as visual schedule, checklist, 
sticker chart, etc. for engaging in this research? Please specify: 
________________________________________________________________ 
________________________________________________________________ 
________________________________________________________________ 
________________________________________________________________ 
________________________________________________________________ 
 
 
 
 
 

IRB#: 19116 
36 
 
4. Consent form: 
 
INDIANA UNIVERSITY INFORMED CONSENT STATEMENT FOR RESEARCH 
Effect of virtual reality-based training on postural control in youth with 
autism spectrum disorder 
 
IRB Protocol Number:19116 
 
ABOUT THIS RESEARCH  
You are being asked to participate in a research study. Scientists do research to answer important 
questions which might help change or improve the way we do things in the future.  
This consent form will give you information about this study to help you decide whether you want 
to participate. It is your choice whether or not you want to be in this research study. Please read 
this form, and ask any questions you have, before agreeing to be in this study. 
Further reference “you” in this document refers to either yourself (if you are a participate 18 years 
of age or older) or your child, if they are participating. 
 
WHY IS THIS STUDY BEING DONE? 
We are doing this study because we are trying to find out more about the effect of using 
commercially available virtual reality-based balance training (like Nintendo Switch) in children 
and youth with autism spectrum disorder (ASD) regarding the ability to balance and walk.  
You are being asked to participate in this study because you indicated you are diagnosed with 
Autism Spectrum Disorder and are interested in video games.  
The study is being conducted by Dr. Georgia Frey, and Surabhi Date, M.P.T. from Indiana 
University, School of Public Health, Department of Kinesiology.  
 
WHAT WILL HAPPEN DURING STUDY? 
We want to tell you about some things that will happen if you decide to participate in this study. 
This study will take place at the Physical Activity and Biomechanics Labs at the School of 
Public Health, Indiana University, Bloomington, and your home. We think it will last for about 9 
sessions spread over the period of about 7-8 weeks. 
If you want to be in this study, here are the things that we will ask you to do:   
 

IRB#: 19116 
37 
 
 
Prior to visit 1:  
• A screening questionnaire will be sent to you to complete electronically. If you less than 
18 years old (a minor), your parent/guardian will complete the questionnaire on your behalf 
for accuracy. The screening questionnaire will ask various questions about any medications 
you may take and your medical history to make sure you are healthy enough to participate.  
 
• You will be sent the Autism Spectrum Screening Questionnaire (ASSQ) to be completed 
electronically which will also be completed by your parent/guardian if you are a minor. 
The questionnaire is used as an initial screening for high functioning ASD.  
 
• The study team will then contact you to review the information, check for understanding, 
assess eligibility via screening tool and address any other questions prior to study inclusion 
and visiting research laboratories.  
 
• If it is determined that you are eligible to participate, you will be given access to a video 
which will give you information about the lab where you will be coming to do some of the 
study activities, and a short introduction of the research personnel.  
 
• You will then be randomly assigned (like flipping a coin) to one of two groups: the Virtual 
Reality Group, or the Exercise Group. This will determine what activities or exercise you 
complete for the upcoming sessions.  
 
Session 1/Pre-intervention, approximately 1.5 hours (this session takes place at the lab):  
 
• Your height and weight will be measured.  
 
• You will be asked some basic questions to determine which hand you prefer to use to 
complete daily tasks such as writing, throwing a ball, and brushing your teeth. For 
determining the foot dominance, you will be asked to kick an imaginary ball placed on 
ground in front of you. 
 
 
• The length of your hand and length will be calculated using a tape cloth, measured from 
your right shoulder to end of your middle finger on the right hand and leg length from waist 
to ground on the right leg.  
 
• We will then measure your “postural sway.” You will be asked to stand on a large mat that 
has sensors. You will stand on the mat for 30 seconds with your eyes open, and then for 30 

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seconds with your eyes closed. The mat will measure your body’s natural unconscious 
small movements (or “sway”), that happen around your center of gravity.  
 
• Next, your balance will be assessed using the Pediatric Berg’s balance Scale (PBS) to 
determine your ability to safely balance during daily activities.  You will be asked to 
complete activities like sitting and standing without help, standing with your eyes closed, 
reaching forward with your arms stretched in front of you, placing your right then left foot 
on a stool, standing with alternating foot in front, and standing on one foot, alternating right 
and left. The researcher will demonstrate each task, and you can practice1-2 times before 
the test begins. 
 
• After this, measurements will be taken of you walking using special cameras. You will be 
instructed to walk on a pathway with removable markers placed at your lower back using 
a special tape over your cloths/shoes, at the base of your big toe, sides of both ankles, on 
your knees and both of your heels. You will walk 3 times at your typical speed and the 
average speed will be calculated. Then video recording will be done when you walk the 
distance back and forth at your average walking speed to record how you walk. You will 
be instructed to walk till 5 trials are completely recorded by the camera system. A couple 
of practice trials will be performed to ensure understanding of the procedure and a study 
team member will remind you to walk like you normally do. If you are not able to do this 
assessment, it will be rescheduled up to two times before it is decided you should be 
withdrawn from the study. 
 
• We will set up a recurring zoom meeting link for future visits and share it with you at the 
end of this visit. 
 
• Lasty, if you were randomized to the Virtual Reality Group, you will be given the controller 
for the Nintendo Switch© system so that you can familiarize yourself with how the 
controller works and the various buttons. Study personnel will also show you how to use 
the controller and will answer any questions you may have. You will be handed over the 
Nintendo switch console and sports game to take home. You will also be given instructions 
on how to set it up if needed.  
 
Sessions 2-7/ Intervention: 3 times a week for two weeks, 30-40 minutes each (these sessions 
take place at home):  
 
The first session will be about 3-5 days after the lab visit. 
 
Virtual Reality Group: These sessions will occur at your home while a researcher supervises via 
Zoom. If you are in this group, you will choose 2 interactive video games on the Nintendo Switch 

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from golf, Frisbee, beach tennis, soccer, Volleyball, badminton, bowling, and chambara. Games 
will be played for 10 minutes each with a 5-minute break in-between. The same 2 games will be 
played at each session in the same sequence. Researchers will provide verbal prompts and 
encouragement during the games. Each session will take approximately 30-40 minutes.  Ideally, 
each session will occur with an off day in between, however this may not be realistic depending 
on your schedules and so sessions will occur at your convenience.  
 
Exercise Group: If you are in this group, you will receive instructions from the researcher at home 
via Zoom. The following standard balance exercises will be performed for 15 minutes with 
5 minutes of warm and cool down each. Breaks will be given as needed and verbal 
prompts/motivators will be provided.  
Warm up exercises: Free body movements such as bending your neck backward and 
forward, shoulder clockwise rotations, bending and straitening elbows, moving ankles up and 
down. All exercises will be done by standing holding the back of a chair for 5 repetitions on each 
side. 
Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot 
in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times 
on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and 
standing on a pillow for 30 seconds for 3 repetitions.  
Cool down exercises: Stretching of certain body parts such as calf muscles, knee and hip 
muscles, shoulder muscles for 10 seconds each for 5 repetitions bilaterally. All stretches will be 
done by standing holding the back of a chair whenever necessary.   
 
Sessions 8 and 9/ post-intervention: approximately 1 hour each (these sessions take place at 
the lab):  
 
• 3-5 days after session 7, you will complete all the balance and walking measurements as 
of session #1 excluding parameters such as hand and foot dominance, leg and arm length, 
weight, height. It will take approximately 1 hour.  
•  Session #8 will occur 3-5 days after session #7 and session #9 will occur 4 weeks after 
session #7. 
You will not receive the results of any of these tests or procedures because they are being done 
only for research purposes. 
WHAT ARE THE RISKS OF TAKING PART IN THIS STUDY? 
1. Physical discomfort- You may feel uncomfortable or pain in your legs or feet due to 
standing for 10 minutes at a time. You may also feel discomfort in your hands from using 
the controller for an extended period of time if you are in the Virtual Reality Group. If this 
is the case, you can ask to take a break at any time. You can also ask to sit at any point, or 
can you decide that you want to discontinue the visit.  

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2. Risk of falling- There is a slight risk that you may fall during physical exercise and/or while 
playing virtual reality games. If you are a minor, you will have a parent present at all times 
during the sessions to ensure your safety as well as a chair nearby to hold onto to steady 
yourself or sit as needed. Study personnel will be able to see you at all times via Zoom 
while you are doing the tasks and will give safety prompts as needed.   
3. Loss of confidentiality- As with any study, there is a possible risk of loss of confidentiality. 
All study data will be stored on an encrypted password protected computer and in a locked 
area. Only approved study personnel will be able to access your study information. 
Not all of these things may happen to you. None of them may happen. Things may happen that 
researchers do not know about yet. If they do, we will make sure that you get help to deal with 
anything bad that might happen. 
 
WHO WILL PAY FOR MY TREATMENT IF I AM INJURED?  
If you are injured as a result of participating in this study, you will be responsible for seeking 
medical care and for the expenses associated with any care received. Costs not covered by your 
health care insurer will be your responsibility. Also, it is your responsibility to determine the extent 
of your health care coverage. No money or funds are set aside to pay for these types of injuries. 
However, you are not giving up any legal rights or benefits to which you are otherwise entitled by 
signing this Informed Consent form.  
 
WHAT ARE THE BENEFITS OF TAKING PART IN STUDY? 
We do not think you will have any personal benefits from taking part in this study, but we hope to 
learn things that will help other people in the future. 
 
WILL I BE PAID FOR PARTICIPATION? 
You will receive a $10.00 Amazon gift card each time you complete a session, for a total possible 
compensation of $90.00.  
 
WILL IT COST ME ANYTHING TO PARTICIPATE?  
There is no cost to you for taking part in this study. 
 
HOW WILL MY INFORMATION BE USED? 

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The following individuals and organizations may receive or use your identifiable information: 
• The researchers and research staff conducting the study 
• The Institutional Review Boards (IRB) or its designees that review this study  
• Indiana University 
• US government or agencies as required by law 
Information collected for this study may be used for other research studies or shared with other 
researchers for future research. If this happens, information that could identify you, such as your 
name and other identifiers, will be removed before any information is shared. Since identifying 
information will be removed, we will not ask for your additional consent. 
HOW WILL MY INFORMATION BE PROTECTED? 
Every effort will be made to keep your personal information confidential, but we cannot guarantee 
absolute confidentiality. No information which could identify you will be shared in publications 
about this study. Your personal information may be shared outside the research study if required 
by law and/or to individuals or organizations that oversee the conduct of research studies. 
 
WHO SHOULD I CALL WITH QUESTIONS OR PROBLEMS? 
For questions about the study or a research-related injury, contact researchers Surabhi Date, at 
812-603 - 8031 or Dr. Georgia Frey at 812-855-1262. After business hours, please call Dr. Georgia 
Frey at 812-855-1262. 
For questions about your rights as a research participant, to discuss problems, complaints, or 
concerns about a research study, or to obtain information or to offer input, please contact the IU 
Human Research Protection Program office at 800-696-2949 or at irb@iu.edu. 
 
WHAT IF I DO NOT PARTICIPATE OR CHANGE MY MIND? 
After reviewing this form and having your questions answered, you may decide to sign this form 
and participate in the study. Or you may choose not to participate in the study. This decision is up 
to you. If you choose not to participate in this study or change your mind after signing this 
document, it will not affect your usual medical care or treatment or relationship with Indiana 
University. 
If you change your mind and decide to leave the study in the future, the study team will help you 
withdraw from the study safely. If you decide to withdraw, please contact one of the above 
researchers to make them aware. 

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The researchers may stop your participation in the study even if you do not want to stop if there is 
any incidence which leads to you acquiring any exclusion criteria of this study such as any 
neurological or orthopedic condition affecting your balance, epilepsy, etc. or any type of injury 
that prevents you from continuing your participation during the data collection process of the 
study. 
 
PARTICIPANT’S CONSENT  
In consideration of all of the above, I agree to participate in this research study. I will be given a 
copy of this document to keep for my records.  
For participants 18-22 years old: 
Participant’s Printed Name: ______________________________________________ 
Participant’s Signature: _____________________________________Date: ___________ 
Printed Name of Person Obtaining Consent: _________________________________ 
Signature of Person Obtaining Consent: ___________________________Date: __________ 
 
For participants 15-17 years old: 
Printed Name of Child: ___________________________________________________ 
Printed Name of Parent: __________________________________________________ 
Signature of Parent: ______________________________________ Date: __________ 
 
Printed Name of Person Obtaining Consent: _________________________________ 
Signature of Person Obtaining Consent: ___________________________Date: __________ 
 
 
 
 
 
 
 

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5. Assent Form: 
Indiana University Assent to Participate in Research  
Effect of virtual reality-based training on postural control in youth with 
autism spectrum disorder 
 
IRB protocol number: 19116 
 
We are doing a research study. Research study is a special way to learn about something. We are 
doing this research study because we are trying to find out more about the effect of using a video 
game system (like Nintendo Switch) in children and youth with Autism Spectrum Disorder 
(ASD) on their ability to balance and walk.  
Why am I being asked to be in this research study? 
You are being asked to be in this research study because you or your parent/guardian have 
indicated that you are diagnoses with autism spectrum disorder and are interested in video 
games. 
What will happen during this research study? 
We want to tell you about some things that might happen if you are in the study. This study will 
take place at the Physical Activity and Biomechanics Labs at School of Public Health, Indiana 
University, Bloomington, and your home. We think it will last for about 9 sessions spread over 
7-8 weeks. 
If you want to be in this study, here are the things that we will ask you to do.  
Before you come to the lab: 
Your parent/guardian will complete a couple of questionnaires that will be ask questions about 
any medications you take and about your physical health to make sure it is safe for you to 
participate in the study. They will also answer questions that are used to determine if someone 
might have ASD. 
You will be shown a video which will give you information about the lab where you will be 
coming to do some of the study activities, and information about the people that will be working 
with you during the study. 
You will then be randomly assigned (like flipping a coin) to one of two groups: the Virtual 
Reality Group, or the Exercise Group. This will determine what activities or exercise you will do 
for the upcoming sessions. 
During your first visit to the lab, about 90 minutes: 

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We will measure your height, weight, and length of your arm and leg. You will also stand on a 
large mat that has sensors that will measure how much your body moves back and forth while you 
are standing. You will stand on the mat for 30 seconds with your eyes open, and then for 30 seconds 
with your eyes closed.  
 
Then, we will measure how well you are able to balance by having you do some activities like 
sitting and standing without help, standing with your eyes closed, reaching forward with your arms 
stretched in front of you, placing your right then left foot on a stool, standing with alternating foot 
in front, and standing on one foot, alternating right and left. The researcher will show you how to 
do each of these, and you can practice a couple of times before the test begins. 
 
You will then do some walking in the lab with special sensors that are attached to your lower 
back and feet. This will measure how you walk. The sensors are attached with special tape and 
are not painful. A special camera will take pictures as you walk, and video recording will be 
done as well. You will do this several times and will be reminded to walk at a normal pace.  
Lastly, if you are in the Virtual Reality Group, your parent/guardian will receive the Nintendo 
switch™ console and the sports game to take home.  
At home, 3 times a week for two weeks for 30-40 minutes: 
o If you are in the Virtual Reality Group, you will choose 2 video games on the Nintendo 
Switch from golf, Frisbee, beach tennis, soccer, Volleyball, badminton, bowling, and 
chambara. Games will be played for 10 minutes each with a 5-minute break in-between. 
The same 2 games will be played at each session in the same sequence. Researchers will 
provide verbal prompts and encouragement during the games as they watch you via 
Zoom. Each session will take approximately 30-40 minutes.  Ideally, each session will 
occur with an off day in between, however this may not be realistic depending on your 
schedules and so sessions will occur at your convenience.  
 
o If you are in the Exercise Group, you will perform balance exercises for 15 minutes with 
5 minutes of warm and cool down each. Some of the exercises are standing with one foot 
in front of the other for 10 seconds, standing on 1 foot for 10 seconds, standing with feet 
together etc. Breaks will be given, and you will be given instructions and encouragement 
by the study personnel who will be watching via Zoom.  
Second and third visit to the lab, about an hour: 
Session #8: 3-5 days after session 7, you will complete all the balance and walking 
measurements that you did in session #1 excluding parameters such as EHI-SF, leg and arm 
length, weight, height. It will take approximately 1 hour.  

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On session #9: 4 weeks after session #7, you will once again complete all the same activities you 
completed during visit #8. It will take approximately 1 hour.  
 
Are there any bad things that might happen during the research study? 
Sometimes bad things happen to people who are in research studies. These bad things are called 
“risks.” The risks of being in this study might be  
1. Physical discomfort- You may feel uncomfortable or pain in your legs or feet due to 
standing for 20 minutes at a time. You may also feel discomfort in your hands from using 
the controller for an extended period of time if you are in the Virtual Reality Group. If 
this is the case, you can ask to take a break at any time. You can also ask to sit at any 
point, or can you decide that you want to discontinue the visit.  
2. Risk of falling- There is a slight risk that you may fall during physical exercise and/or while 
playing virtual reality games. You will have a caregiver present at all times during the 
sessions to ensure your safety as well as a chair nearby to hold onto to or sit as needed. A 
member of the study team will be able to see you at all times via Zoom while you are doing 
the activities and will give you instructions on how to be safe as needed.   
3. Loss of confidentiality- As with any study, there is a possible risk that someone outside 
the study could see your private information. All of your information will be kept on 
computers that only people working on the study will be able to see and use.  
Not all of these things may happen to you. None of them may happen. Things may happen that 
researchers do not know about yet. If they do, we will make sure that you get help to deal with 
anything bad that might happen. 
  
Are there any good things that might happen during the research study? 
We do not know for sure if you will have any personal benefits. We hope to learn something that 
will help other people someday. 
 
Will I get money or payment for being in this research study? 
You will receive a $10.00 Amazon gift card each time you complete a session, for a total 
possible compensation of $90.00. 
 

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Who can I ask if I have any questions? 
If you have any questions about this study, you can ask your parents or guardians or the 
researcher. Also, if you have any questions that you did not think of now, you can ask them later. 
For questions about the study or a research-related injury, contact researchers Surabhi Date, at 
812-603 - 8031 or Dr. Georgia Frey at 812-855-1262. After business hours, please call Dr. 
Georgia Frey at 812-855-1262.  
What if I do not want to be in the study? 
If you do not want to be in this study, you do not have to. It is up to you. If you say you want to 
be in it and then change your mind, that is OK. All you have to do is tell us that you do not want 
to be in it anymore. No one will be mad at you or upset with you if you do not want to be in it. 
 
My choice: 
If I write my name on the line below, it means that I agree to be in this research study. 
________________________________ 
________________ 
Subject’s signature 
Date 
 
________________________________ 
Subject’s printed name 
 
________________________________ 
_________________ 
Signature of person obtaining assent 
Date 
 
________________________________ 
Name of person obtaining assent 
 
 
 
 
 

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6. Edinburgh Handedness Inventory-short form 
 
 
 
 

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7. Pediatric Berg’s Balance Scale: