Immersive Virtual Reality to Improve Outcomes in Patients With Stroke: A Pilot Study
Phase: NA
Conditions: Stroke
Sponsor: VA Office of Research and Development

Immersive Virtual Reality to 
Improve Outcomes in Patients with 
Stroke: A Pilot Study
NCT04429945
February 24, 2023

Specific Aims 
Over the last decade, virtual reality (VR) has emerged as a cutting-edge technology in stroke 
rehabilitation.  VR is defined as a type of user-computer interface that implements real-time simulation of 
an activity or environment allowing user interaction via multiple sensory modalities.  VR interventions in a 
stroke population have been shown to be equivalent to usual care therapies and to enhance motor, 
cognitive, and psychological recovery when utilized as an adjunct.  The proposed feasibility pilot project 
will address the RR&D goal of maximizing functional recovery by pilot testing an immersive VR 
intervention designed to increase exercise dosage for the upper limb and decrease pain for inpatient 
Veterans post stroke without increasing therapist time [1]. The VR 
intervention will use a head mounted display, more commonly 
known as goggles, to which selected APPs can be uploaded. APPs 
and goggles are commercially available and have been selected 
based on the following criteria: (1) address the treatment goals of 
overall upper extremity neurologic recovery, hand dexterity, and 
pain reduction, (2) utilized while patient lying in bed, (3) provide 
no stimulation to move legs or reach outside of bed area, (4) 
simple to use (require no technological expertise), (5) involve 
graded head, neck, upper extremity movement and distraction to 
reduce pain, and (6) cognitive burden ranges from minimal to 
moderate. The VR intervention will be administered bedside for 
two 30-minute therapy sessions per day for four weeks. Our long-term goal is to provide 
Veterans with an exercise and pain reduction modality that can serve as an adjunct to 
scheduled therapy and assist with the clinic to home transition. Our short-term goal is to 
determine the feasibility of conducting a randomized controlled trial to determine the 
effectiveness of using VR as an adjunct to usual care therapy to enhance upper extremity 
neurologic recovery and hand dexterity and to decrease pain. Our proposal is innovative in four 
distinct ways. First, we will use immersive 3-dimensional rather than the more typically used 2-
dimensional VR. Immersion and the resulting ‘presence’ within the virtual environment are thought to be 
the principal mechanisms of positive change [2]. Second, we will assess pain reduction after 
stroke using VR APPs, which is not well represented in the literature.  Third, we are using VR 
as an adjunct therapy - adding additional therapy time with less burden on clinicians than is required in 
traditional therapy. Finally, VR, when used in patients’ rooms, presents an opportunity similar to home-
based practice exercises. Our targeted enrollment is 10 clinical staff (Research Question (RQ) 1.1) and 10 
inpatient Veterans being treated for stroke (Aim 2).  
 
Specific Aim 1: Determine the feasibility and tolerability of using a therapeutic VR platform in an 
inpatient comprehensive stroke rehabilitation program. 
RQ 1.1: What is the feasibility of using the VR platform from the clinician perspective?   
RQ 1.2: What is the tolerability for inpatients post-stroke using the VR platform? 
Specific Aim 2:  Estimate the initial clinical efficacy, or effect size, associated with the VR platform 
using APPS for distraction and upper extremity exercise for Veterans post-stroke.  
RQ 2.1: What are the estimated effect sizes and degree of precision for the outcomes of upper 
extremity neurologic recovery, hand dexterity, and pain? 
RQ 2.2: How clinically responsive are dexterity and upper extremity neurologic recovery 
(primary) outcomes to early stroke rehabilitation using a therapeutic VR platform? 
 
Impact. Veterans and clinicians will gain experience using a portable VR platform that increases access 
to care by making additional therapeutic activities available outside of usual scheduled therapy time. This 
unique experience offers the potential for seamless transition from inpatient rehabilitation to the home. 
Moreover, policy makers can observe firsthand the potential benefits and limitations of using therapeutic 
VR in comprehensive stroke care. The results of this study will inform a subsequent larger trial, which will 
focus on the effectiveness of immersive VR for patients in both the subacute and chronic stages post-
stroke and will begin inpatient and continue post discharge into the patient’s home.  
Figure 1  VR intervention 

Research Plan 
Background and Significance 
Over the last decade, virtual reality (VR) has emerged as a cutting-edge technology in stroke 
rehabilitation.  VR is defined as a type of user-computer interface that implements real-time simulation of 
an activity or environment allowing user interaction via multiple sensory modalities [3]. VR interventions 
can be characterized as immersive or non-immersive.  Immersion refers to the sensation of being inside a 
particular environment or world, for example, a three-dimensional world [4]. Non-immersive VR typically 
uses commercial video game systems developed by the entertainment industry for home use, although 
some researchers have developed rehabilitation specific non-immersive VR applications [5-7]. Non-
immersive VR uses 2D interfaces such as Nintendo Wii, Microsoft Xbox, and Sony PlayStation [8-10].   
Immersive VR uses a 3D virtual environment with the intention of making the user feel a part of, inside, or 
immersed in the environment to the extent that they become unaware of their physical surroundings [4].  
Immersive VR experiences typically involve the use of a Head Mounted Display (HMD) which creates a 
three-dimensional image in all fields of view. We will use the most current VR technology, which at this 
time is a wireless immersive HMD application with hand controllers such as the Oculus Quest.   
Upper Limb VR Research.  Upper limb deficits occur in up to 85% of stroke survivors and 
significantly affect performance of activities of daily living (ADLs) [11].  The literature on the use of VR in 
stroke rehabilitation is fairly extensive, but is characterized by small, lesser quality studies with widely 
varying definitions of what constitutes a VR intervention. The stroke VR literature base has been criticized 
for lack of a control group, making it difficult to discern if positive effects were the result of the VR 
intervention itself or simply the result of extra therapy time, for example, when VR is used as an adjunct 
[12]. Studies on the use of VR for post-stroke upper limb dysfunction have shown mixed results [4-10, 13-
17]. A Cochrane Review published in 2017 [18] concluded that overall effects of VR on upper extremity 
function were not significantly different when compared with conventional therapy (including both 
specialized VR systems designed for rehabilitation or commercial gaming consoles).  However, when VR 
was utilized as an adjunct to standard care compared with no additional intervention (increased overall 
therapy time), the VR group experienced statistically significant benefits in upper limb function 
(Standardized Mean Difference (SMD) = 0.49, 95% confidence interval (CI) 0.21 to 0.77).  The overall 
quality of the trials included for upper limb function outcomes was low.  The Cochrane Review also found 
a small, yet statistically significant effect of VR on ADLs (SMD = 0.25, CI 0.06-0.43). Because of the 
heterogeneity in outcomes used in studies investigating the effect of VR on upper limb function post-
stroke, two systematic reviews and meta-analyses (SR/MA) [3, 19] grouped outcomes by the International 
Classification of Function domains. For studies that used a virtual world environment approach to VR, 
medium effect sizes (ES) were found: Body Structure/Function ES = 0.43 [3] to 0.54 [19], Activity ES  = 
0.54 [3] to 0.62 [19], and Participation ES = 0.38 [19] to 0.56 [3]. Gains post intervention were preserved 
at follow up [19]. A limitation of both SR/MAs was the variability in how VR was delivered in terms of 
intensity and duration [3, 19] and lack of clarity regarding control group therapy.  
Three recent randomized controlled trials (RCTs) [12, 20, 21] of non-immersive VR interventions 
(using 2D interfaces) that included control groups dose matched for therapy time found mixed results. A 
single-center study [21] that compared 10 sessions of a self-administered upper extremity rehabilitation 
program including four game applications on a smart phone and tablet with control therapy of one hour of 
conventional OT per day found a significant difference on the Fugl-Meyer Assessment-Upper Extremity 
(FMA-UE) at one-month follow-up in favor of the intervention group. In contrast, neither the EVREST trial 
[12] that compared 10 sessions of commercial gaming with control recreational activities or the VIRTUES 
multi-center trial [20] that compared 16 sessions of VR designed for rehabilitation with conventional 
therapy found significant differences.  The authors of the EVREST study did, however, speculate that 
utilizing an immersive VR system might have led to significant results. As VR becomes more immersive, 
more interactive, and less expensive, and because of its flexibility, studies of the use of VR in the inpatient 
environment [22] suggest that VR is efficacious, easy to use, safe, and contributes to high patient 
satisfaction.  
 
VR and Pain.  A recent multi-site study (N =546) found a 30% prevalence of pain across the acute, 
subacute, and chronic post-stroke stages [23]. Cognitive factors (e.g., attention) are important to pain 
perceptions, even when people are not engaged in specific tasks [24]. Theory suggests that VR directly or 
indirectly affects cognitive and attentional processes to attenuate pain. VR can be a distraction 

mechanism that consumes cognitive and attentional resources to limit pain processing capabilities [25].  A 
randomized crossover study found a 56% reduction in time thinking about pain when using VR versus 
self-selected distraction (e.g., meditation, smartphone; p <.001) [26]. VR may also create neurobiological 
interactions in the brain by regulating sensory stimulation to produce an analgesic effect [27].  Sense of 
immersion and presence are important to distraction and analgesia because distraction therapy is the 
most commonly used intervention in VR pain research [28]. A rapid evidence assessment of VR (20 
studies, N = 337) found strong evidence for short-term reduction in pain intensity and moderate evidence 
for pain analgesia [29]. A meta-analysis (14 studies, N = 581) estimated a large standardized effect (0.90, 
95% CI = .72 to 1.08) for VR pain distraction studies using between-group and mixed-model designs [30]. 
Thus, integration of VR during rehabilitation may have promising implications for post-stroke pain. 
 
Neuroplasticity.  Decades of animal research and recent research in human subjects provides 
compelling evidence that the adult brain affected by stroke can reorganize itself in response to experience 
and training, with sufficient repetition playing a critical role [31-35].  In patients with subacute stroke, gains 
in the upper limb and hand dexterity (strength, ROM, speed of movement) require more intensive 
repetitive task practice than gains in lower limb and mobility [1, 36, 37].  In addition, task motivation is 
essential for learning [31-35].  Immersive VR exposure is hypothesized to deliver the crucial impetus to 
drive lasting neural changes by providing a motivating environment for post-stroke patients to retrain 
movement, ROM, movement speed, fractionation (use of individual fingers), and force production [38]. In 
the proposed study, immersive VR will be utilized as adjunct therapy, allowing patients to increase their 
therapy dose and thereby engage in the repetition essential for motor learning. 
 
 
Immersive VR. Non-immersive VR environments are projected on 2D screens (e.g., laptop).  Non-
immersive VR can facilitate stroke symptom improvement [12, 20, 21], but it is lower on the immersion 
spectrum and less efficacious than immersive 3D VR [28, 39]. Immersion and presence are theoretical 
mechanisms of change which may facilitate greater learning within virtual environments [25, 40]. 
Immersive VR interventions may be cost-effective and less resource intensive than many traditional 
interventions with comparable efficacy [41]. 
 
Significance. According to the VA Informatics and Computing Infrastructure, in Fiscal Year (FY) 
2018 there were more than 10,000 unique Veteran inpatient admissions for stroke.  The proposed study is 
an innovative treatment paradigm utilizing sophisticated immersive VR technology available at the 
bedside to increase therapy dosage. This cutting-edge technology has the potential to not only drive 
neurologic recovery by augmenting the brain’s own intrinsic repair capacity in response to a stroke insult 
(neuroplasticity), but also improve Veterans’ quality of life by diminishing pain and enhancing self-efficacy.  
Immersive VR could ultimately become a new standard of care in acute inpatient rehabilitation, allowing 
unlimited rehabilitation experiences for patients with stroke.  In addition, there is strong potential for 
seamless transition to home, as immersive VR technology rapidly becomes more sophisticated and less 
costly. Finally, the proposed research supports modernization of the Veterans’ Health Administration by 
incorporating technology-assisted rehabilitation, addresses the RR&D goal of maximizing functional 
recovery, and focuses on VA Office of Research and Development priorities including access to care, 
mental health, health care value, and pain.  
 
Preliminary Studies  
Virtual Reality Pilot for Fear of Movement for Veterans with Chronic Pain. In a pilot study [42, 
43] in the James A. Haley Veterans’ Hospital (JAHVH) inpatient Chronic Pain Rehabilitation Program, Dr. 
Winkler and Fellow, Dr. Chris Fowler, found evidence for the feasibility of VR within the chronic pain 
population as well as a decrease in fear of movement, pain interference with mobility, pain intensity, and 
pain catastrophizing. Veteran attendance (91%) and completion of attended 20-minute VR sessions was 
high (97%). Veterans typically rated 20-minute VR sessions as ‘too short’. 
 
Research Design and Methods  
Design. Our methodological framework is based on the work by Virtual Reality Clinical Outcomes 
Research Experts (VR-CORE) committee [39]; we will use their VR2 clinical study design: conducting 
early prospective testing with a focus on feasibility and tolerability (Aim 1), and initial efficacy (Aim 2). Per 
VR-CORE guidelines, we will use a single group so that we may optimize recruitment to represent the 
breadth and depth of our target patients.  

Population. There are two populations for the proposed project. The first is Veterans (N=10) who 
have been diagnosed with an acute ischemic or hemorrhagic stroke and post-stroke are admitted to 
JAHVH inpatient rehabilitation. Inclusion criteria are: (1) Age 18-80, (2) Stroke diagnosis verified by brain 
imaging. Exclusion criteria are: (1) Unable to follow instructions or participate in immersive VR therapy 
due to significant cognitive impairment, (2) History of seizures. The second population includes the 
occupational therapists (OT) and the rehabilitation nurses (clinician champions) working in the 
Comprehensive Interdisciplinary Inpatient Rehabilitation Program, who will provide data on the feasibility 
of using VR in an inpatient environment (Research Question (RQ) 1.1). 
Recruitment. All patients admitted to the Comprehensive Interdisciplinary Inpatient Rehabilitation 
Program at JAHVH (a designated Primary Stroke Center) with a diagnosis of acute ischemic or 
hemorrhagic stroke will be considered for inclusion in the study. A minimum of five beds will be 
designated for study participants. The Comprehensive Interdisciplinary Inpatient Rehabilitation Program 
admits 3.5 stroke patients per month, 42 per year. We feel this is a sufficient subject pool from which to 
enroll the target sample size of 10 patients (16% of the patients admitted over the 18-month enrollment 
period). We have found that the technology is motivating to patients which will help retention.  
Procedure and Data Collection.  
VR Intervention. The VR intervention uses off the shelf technology: Oculus Quest 
Head Mounted Display and commercially available APPs specifically developed or adapted 
for Oculus Quest.  APP selection for individual patients will be guided by motor difficulty of 
the APPs.  See Table 1. For example, patients will begin with the green coded APPs, the 
easiest activity level in the toolkit.  These APPs primarily address pain via distraction with 
minimal head and neck movement, but no hand movement, required.  As tolerated, 
patients will advance to more difficult APPs which require hand and finger movement, with 
the high-level APPs requiring controlled movement. 
 
Table 1 APPs in VR Toolkit for the Oculus Quest 
Hand Controller Use 
Outcome 
APP Name 
Source 
Description 
None 
Min 
Mod 
R 
D 
P 
 
 
  
Ocean Rift 
Oculus 
Distraction (nature, music) 
X 
 
 
  
Within 
With.in 
Distraction (cinematic vr) 
X 
 
 
  
Nature Treks 
Sidequestvr 
Distraction (nature) 
X* 
 
 
  
National 
Geographic 
Explore 
Oculus 
Distraction (nature) 
X* 
  
  
 
Mr. Scribbles 
Oculus 
Hand, finger movement 
X 
  
  
 
Virtual Piano 
Sidequestvr 
Play piano by moving hands up and down 
X 
  
  
 
Cubism 
Sidequestvr 
Grab shapes with hand and put in 
container 
X 
  
  
  
VR Fishing 
Oculus 
Holding fishing rod, coordination 
  
  
X 
R=neurologic recovery, D=hand dexterity, P=pain 
Level of difficulty: Green=passive, minimal movement, Blue=moderate movement, Pink=controlled movement 
* hand controller used to select view, intact extremity can be used 
 
APPs are commercially available and have been selected based on the following criteria: (1) 
address the treatment goals of overall upper extremity neurologic recovery, hand dexterity, 
and pain reduction, (2) can be utilized while patient lying in bed, (3) provide no stimulation 
to move legs or reach outside of bed area, (4) are simple to use (require no technological 
expertise), (5) involve graded head, neck, upper extremity movement and distraction to 
reduce pain, (6) cognitive burden ranges from minimal to moderate. Because hand tracking 
APP technology is developing/improving at a rapid pace, upon notice of funding, it is likely that we will 
need to update the VR Toolkit (Appendix 4).   
Prior to beginning the intervention, clinician champions (OT and nursing) and 
project manager OT Delikat will be instructed in the use of the head mounted display and 
VR APPs by technology expert Kaplan.  Staff will have the opportunity to practice with the 

head mounted display and APPs for two weeks prior to using the APPs with patients.  
Following IRB approval and funding on site, potential subjects will be identified by the admitting physician, 
PI Tran, and/or the project manager in Dr. Tran’s absence. The project manager will use a HIPAA waiver 
to check inclusion and exclusion criteria.  
 
Week 1 Baseline and Pre-intervention Data Collection. Once patients are enrolled, the 
project manager (an OT) will collect baseline data and administer the pre-intervention outcome measures. 
See Table 2. Also, PI/physician Tran, OTs Co-I Winkler and project manager Delikat, and 
technology expert Co-I Kaplan will select APPs from the VR Toolkit (Appendix 4) that best 
address the individual patient’s treatment goals, based on his/her current functional level.   
 
 
Weeks 2-4 VR Intervention. Patients will be instructed in the use of the head 
mounted display with VR APPs by project manager OT Delikat. It is anticipated that subjects 
may need 1-3 sessions of instruction.  VR dosage will be two one-half hour sessions per therapy 
day, facilitated by OT project manager Delikat and clinician champions, overseen by PI 
Tran. The timing of VR sessions will vary based on the patient’s therapy schedule.  During 
the VR session, the patient will be reclining or seated in bed with both bed rails raised.  The 
clinician champion will bring the VR Headset to the bedside and assist the patient with 
donning the device.  Once the patient is comfortable using the head mounted display with 
VR APPs, the clinician champion will begin each session by setting the patient up and 
making sure that they are successfully engaging with the APP. The clinician champion will 
return 30 minutes later to remove the VR head mounted display from the room.  This 
process will be repeated a second time each therapy day. Patients can initiate use of a more 
challenging APP (blue category) that gradually includes hand/arm movement. Some 
patients may progress to the pink category in which hand/arm coordination is required. 
Week 4 Post-Intervention Data Collection. The average length of stay on the acute 
inpatient rehabilitation unit at JAHVH is 4-6 weeks. Accordingly, post-intervention data will be collected in 
week 5 or at the end of week 4 if the Veteran is being discharged. RQ 1.2 tolerability data will be collected 
throughout the subjects’ participation in the study. 
 
 
End of Data Collection.  Once all Veterans have completed the study, RQ 1.1 feasibility 
data will be collected from clinician champions. 
Outcomes 
Aim 1. Feasibility is the degree to which the VR treatment can be successfully integrated 
within the flow of usual care [15]. Feasibility will be measured with a six item survey (Appendix 5), based 
on the Consolidated Implementation Framework [44], that will be administered to 10 clinical staff using 
REDCap®.  Tolerability refers to the prevalence of patient-reported physical (e.g., vertigo, nausea = 
“cybersickness”) and emotional (e.g., fear and anxiety) adverse effects of the VR treatment, along with 
any discomfort or inconvenience related to the VR equipment (e.g., ill-fitting headset, facial discomfort, 
inability to explore the three-dimensional environment fully due to limited mobility, etc.) [2, 39]. Tolerability 
data (complaints and adverse events frequencies) will be extracted from detailed meeting minutes where 
such events are reported and discussed. 
Aim 2. See Table 2. 
 
 

 
Analyses. With the proposed pilot study design, the overall analytic goals are to: (1) determine the 
feasibility and tolerability of using a therapeutic VR platform in an inpatient comprehensive stroke 
rehabilitation program and to (2) estimate, with reasonable precision, the effect sizes of upper 
extremity neurologic recovery, hand dexterity, and pain reduction outcomes.  
 
Aim 1. Qualitative descriptive analyses [49] will be used to address RQ 1.1 (feasibility) and 
RQ 1.2 (tolerability). For RQ 1.1, responses will be downloaded from REDCap®. The six survey items 
address three feasibility constructs: adaptability, patient need, and staff comments. Responses for each 
construct will be pasted into an excel spreadsheet, one tab for each construct. Responses will then be 
grouped by similar content. Results will be reported as themes and subthemes. Similarly, for RQ 1.2, 
patient concerns, complaints, and adverse events associated with use of the VR platform will be 
abstracted from the research team meeting notes and will be tabulated. Responses will then be grouped 
by similar content. Results will be reported as themes and subthemes. Note that all adverse events will be 
immediately reported per VA and IRB policy. The analyses described here are for dissemination 
purposes. 
 
Aim 2. For RQ 2.1, the primary outcomes will consist of pre- to post-intervention changes 
on two physical measures of stroke recovery: the Action Research Arm Test (ARAT) [45] (Appendix 6) 
and the Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity [47] (Appendix 7). Both 
of these measures are scored on a continuous scale, as is the outcome of pain, as listed in Table 2. 
Therefore, the initial step will be to examine distributions of each outcome measure, including distribution 
of change scores from pre- to post-intervention. To estimate effect sizes over 4 weeks with the use of the 
VR platform, standardized effect sizes and 95% confidence intervals will be calculated using the within-
group pre-test/post-test design described by Morris and DeShon (2002) [50] and Kadel and Kip (2012) 
[51] . Recognizing the pilot study design, yet concern over potential type I error due to multiple outcomes 
evaluated, the confidence intervals for the two co-equal primary outcomes will be evaluated with a type I 
error rate of 0.025 (i.e. to determine if the confidence interval for the outcome difference scores includes 
the null effect size value of 0); secondary outcome will be evaluated with a type I error rate of 0.01. The 
above confidence interval approach parallels use of the paired t-test to determine statistical significance.  
For RQ 2.1, since the effect sizes to be calculated are standardized measures, corresponding results 
across these outcomes will be directly comparable. However, these metrics do not necessarily translate to 
meaningful clinical differences (improvements). Therefore, for those outcome measures with published 
metrics for minimal clinically important difference (MCID) [52], results of the VR platform will be compared 
across outcomes. As listed in Table 2, the measures of dexterity and neurologic recovery have published 
references for MCID, whereas we are unaware of a published MCID for the Pain Outcomes Questionnaire 
VA (POQ-VA).  Therefore, for the POQ-VA, we will first determine the change (pre versus post scores) in 
Table 2 Aim 2 Outcome variables and covariates 
Variable 
Definition 
Source 
Outcomes 
Hand dexterity 
Appendix 6  
Action Research Arm Test (MCID*: chronic=5.7, acute=12) [45, 46]     
Primary 
 
Clinical 
assessment 
and  
Self-report 
Neurologic recovery 
Appendix 7 
Fugl-Meyer Assessment of Motor Recovery after Stroke-UE 
MCID*=4-7 [47]             Primary 
Pain  
   Appendices 8 and 9 
Pain Outcomes Questionnaire-VA, Initial, item 12 and Discharge, 
item 2 (Pain Numeric Rating Scale) (ES*= 0.85, medium effect, 
SEM*=0.79)  [48]         Secondary 
Demographic and Clinical 
Age 
Age on date of baseline data collection 
CPRS 
Sex 
Male, female 
Race/ethnicity 
Caucasian, African American, Hispanic, other 
Time since index stroke 
In days: index event - baseline data collection 
Type stroke    
Ischemic =0, hemorrhagic =1 
* MCID=Minimal Clinically Important Difference, ES=Effect Size, SEM=Standard Error of Measurement, CPRS=Computerized 
Patient Record System 

standard deviation units (from the baseline value) that denotes MCID for the measures of dexterity and 
neurologic recovery. We will then average these two calculations of standard deviation units to estimate 
the magnitude of change in pre-to-post scores on the POQ that may approximate MCID on this measure. 
Thus, in addition to comparison of standardized effect sizes across the three outcomes measures, all 
three measures will be compared in terms of proportion of subjects who experience MCID. 
Potential Limitations and Strategies. As this pilot study will employ a within-subject design to 
evaluate magnitude of stroke rehabilitation over 3 weeks with the use of VR technology, there will be no 
control condition to judge rehabilitation results to that which might be expected from time alone and 
natural history of stroke recovery. Therefore, as described for RQ 2.1, we will place a premium on 
evaluating rehabilitation results using MCID, which are highly relevant to patients and generally would not 
be expected to be achieved simply from time alone (4 weeks). 
Project Management Plan. Personnel. Dr. Tran will lead the administrative and scientific aspects 
of the project and will be responsible for recruitment and collection of medical data. Dr. Kip will oversee 
data management, analysis, and assist with interpretation of data. Project Manager Delikat, an 
Occupational Therapist (OT), will obtain informed consent, perform pre and post data collection, instruct 
study subjects in use of VR technology, and enter data into the study dataset.  Mr. Kaplan and PI 
Tran will perform initial technical assessment, instruct clinicians in use of VR technology, and update 
APPs weekly to meet individual patient needs. Dr. Winkler will serve as a Research Mentor and can 
provide OT expertise. Joel Scholten, MD will serve as our Program Partner from the Physical Medicine 
and Rehabilitation Office. 
PI Tran will meet with research mentor Winkler and Project Manager Delikat 
(Occupational Therapist [OT]) daily initially and then twice weekly to monitor participant 
clinical progress, APP intervention progression, and data collection. Technology expert 
Kaplan will be onsite weekly to check equipment and update APPs. Mr. Kaplan will be 
available as needed between weekly visits. While the primary strategy for team 
coordination will be twice-monthly research team VA Skype meetings led by PI Tran, 
problems will be addressed immediately by the team via Skype meeting. Scheduled twice-
monthly research team meetings will bring clinical and research team members together to review and 
interpret deidentified findings, discuss and resolve expected and unexpected issues that may arise, and to 
reinforce the project timelines.  
Data Management. Dr. Kip will create a dataset during the first month of the study using Excel 
software as Excel is easily imported into SAS for analysis. We have chosen to use Excel on our local 
research server rather than VA Informatics and Computing Infrastructure (VINCI) because this is a 
prospective cohort of new admissions and a relatively small sample. Data will be collected and entered 
into the database by Project Manager Delikat. Data entry will be verified by PI Tran. Data will be stored 
on the secure JAHVH Research Service R-drive. 
Dissemination. Dissemination will be led by Dr. Tran (PI).  Channels for dissemination include: (1) 
annual progress and final summary reports to VA RR&D service; (2) bulleted briefings to our Program 
Partner; (3) presenting findings at national and local research meetings/conferences and VA 
Cyberseminars and Military Health System Speaker series; and (4) submitting manuscripts to relevant 
peer-reviewed journals. 
Timeline. See Table 3 for timeline. 
Table 3   Timeline 
Task 
Person(s)  
Responsible 
 
Year 1 
Year 2 
 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
IRB, R&D 
T, PM 
 
 
 
 
 
 
 
 
 
Train staff 
T, PM, K2 
 
 
 
 
 
 
 
 
 
Enroll subjects 
T, PM 
 
 
 
 
 
 
 
 
 
Train patients 
PM 
 
 
 
 
 
 
 
 
 
Data Collection/Intervention 
T, PM 
 
 
 
 
 
 
 
 
 
Analyze Data 
K1 
 
 
 
 
 
 
 
 
 
Disseminate findings 
T, W, RT 
 
 
 
 
 
 
 
 
 
T=Dr. Tran, W=Dr. Winkler, K1=Dr. Kip, K2=Mr. Kaplan, PM=Project Manager, RT=Research Team