Evaluation of the Performance of VRP-Clinic in Healthy Subjects in the Support of Rehabilitation
Phase: NA
Conditions: Rehabilitation
Sponsor: VRHealth Group Ltd

 
Study Protocol 
VRP-CLINIC SOFTWARE EVALUATION - IN SUPPORT OF REHABILITATION 
Protocol# 
VRP02 
Version #, 
Date.  
Version 01 
22-March-2017 
Page 1 of 12 
 
 
 
Protocol title:  
EVALUATION OF THE PERFORMANCE OF 
VRP-CLINIC IN HEALTHY SUBJECTS IN THE 
SUPPORT OF REHABILITATION: A 
PROSPECTIVE, OPEN LABEL, SINGLE ARM 
STUDY 
 
 
   
Protocol number: VRP02  
Version number: 1 
Version Date:  22-Mar-17 
 
PRINCIPAL INVESTIGATOR:  Yair Barzilay, M.D.  
CO INVESTIGATOR:   Lilach Gavish, Ph.D 
 
 
 
 

 
Study Protocol 
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PROTOCOL APPROVAL 
I confirm that I have read this protocol named "EVALUATION OF THE PERFORMANCE OF 
VRP-CLINIC IN HEALTHY SUBJECTS IN THE SUPPORT OF REHABILITATION "; I 
understand it and I will work according to its contents and the applicable laws and 
regulations of Israel.   
 
PRINCIPAL INVESTIGATOR: 
 
 
 
 
_Yair Barzilay, MD________ 
_______________ 
_______________ 
 
Signature 
Date 
 
 
 
CO-INVESTIGATOR: 
 
 
 
 
__Lilach Gavish, PhD______ 
_______________ 
_______________ 
 
Signature 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Study Protocol 
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Table of Contents 
SYNOPSIS ................................................................................................................................. 4 
INTRODUCTION ........................................................................................................................ 6 
STUDY RATIONAL ................................................................................................................... 6 
STUDY OBJECTIVES ............................................................................................................... 6 
STUDY DEVICE ......................................................................................................................... 6 
Indications for Use ................................................................................................................. 6 
Device Description ................................................................................................................. 6 
VRP-clinic Software ........................................................................................................................ 6 
Hardware platform .......................................................................................................................... 7 
STUDY DESIGN ........................................................................................................................ 7 
Overview ................................................................................................................................ 7 
Endpoints: .............................................................................................................................. 7 
Primary Endpoint ............................................................................................................................ 7 
Secondary Endpoint: ...................................................................................................................... 7 
Study Duration ....................................................................................................................... 7 
STUDY POPULATION AND SUBJECT SELECTION .............................................................. 8 
Source and sample size ........................................................................................................ 8 
Eligibility ................................................................................................................................. 8 
Inclusion Criteria ............................................................................................................................. 8 
Exclusion Criteria ............................................................................................................................ 8 
Subject Termination ............................................................................................................... 8 
Compensation ........................................................................................................................ 8 
STUDY PROCEDURES ............................................................................................................. 9 
Screening ............................................................................................................................... 9 
Interventions and procedures: ............................................................................................... 9 
EVALUATIONS ......................................................................................................................... 9 
Physiotherapist Evaluation and Assessment of Videos ........................................................ 9 
Safety ..................................................................................................................................... 9 
STATISTICAL CONSIDERATIONS AND ANALYSIS ............................................................ 10 
Sample Size Justification ..................................................................................................... 10 
Subject Accountability .......................................................................................................... 10 
Data Analysis ....................................................................................................................... 10 
Study Hypothesis – Primary Endpoint: ......................................................................................... 10 
Safety - Secondary Endpoint ........................................................................................................ 10 
ADVERSE EVENTS ................................................................................................................ 10 
Anticipated Side Effects ....................................................................................................... 10 
Anticipated Adverse Effects/Risks ....................................................................................... 10 
MISCELLANEOUS .................................................................................................................. 11 
Ethical Considerations ......................................................................................................... 11 
Protocol Amendments ......................................................................................................... 11 
Study Monitoring .................................................................................................................. 11 
Study Documentation .......................................................................................................... 11 
Case Report Forms (CRFs) ................................................................................................. 11 
Study Termination ................................................................................................................ 11 
Maintenance and Retention of Records .............................................................................. 12 
Use of Information and Publication ...................................................................................... 12 
REFERENCES ......................................................................................................................... 12 
 

 
Study Protocol 
VRP-CLINIC SOFTWARE EVALUATION - IN SUPPORT OF REHABILITATION 
Protocol# 
VRP02 
Version #, 
Date.  
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SYNOPSIS 
Study Sponsor 
VRHealth, Shocken 32, Tel-Aviv 6105101, Israel 
Protocol Number 
VRP02 
Study Title 
Evaluation of the Performance of VRP-Clinic in the Support of 
Rehabilitation in Healthy Subjects: A prospective, open label, single 
arm study design 
Projected Study 
Period 
Initiation Date:  
July  2017 
Completion Date:  
August 2017 
Study Device 
VRP-Clinic  
Device 
Description and 
Indication for Use 
VRP-Clinic is a software system that is coupled with virtual reality 
hardware and head movement sensors, aimed at gamification of 
physiotherapy training 
Study Objectives 
Primary objective 
To verify that the movements included in a VRP-Clinic VR training 
session are self-explanatory and recognized by clinicians 
Secondary objectives 
To verify that these movements are considered useful for rehabilitation. 
Study Design  
Single center, prospective, open label, single arm.  
Following screening visit, eligible subjects will be enrolled into the study. 
Each subject will perform a series of neck movements guided by the 
VRP-Clinic software. The duration of the actual training session is 
expected to be 5 minutes. 
Every session will be recorded by video during which the face of the 
subject will be covered by the VR headset.   
The video will be evaluated by clinicians.  They will identify each 
movement seen on the video from a predefined list and define if such a 
movement is recommended as part of a rehabilitation training program 
Study Duration 
Study duration from the first enrollment to completion is expected to be 
four months. 

 
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Study Population 
Twenty (n=20) healthy subjects will be recruited 
Main Inclusion 
Criteria: 
1. Healthy male or female  
2. Age 18-65  
Main Exclusion 
Criteria: 
1. History of neck related disorders (Whiplash, disc degeneration 
disease or other acute cervical spine conditions) 
2. Current neck pain 
3. Under medical treatment or observation for any health-related 
issue during the study 
4. Recent trauma 
5. Oncology background 
6. Acute disease/illness 
7. Pregnancy.  
8. Using drugs that could potentially affect physical function and 
balance (such as corticosteroids, antipsychotics or 
antidepressants)   
9. Vision problems that require glasses (not all frame types can fit 
into the headset) 
Study Endpoints  
Primary Endpoint:  
Number of VRP-Clinic neck movements that the evaluator recognizes as 
useful for rehabilitation.  
Success acceptance criteria defined as:  80%  
Secondary Endpoint:  
Safety – Record of any adverse event occurring during the study.  
All AEs will be recorded and evaluated as part of the risk management 
for the device 
 
 

 
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INTRODUCTION 
One of the most common musculoskeletal dysfunctions in the population is dysfunction of 
the cervical spine reaching an annual prevalence of 30-50% in western societies and 
associated with considerable pain, disability, and costs [1, 2].  
Physical therapies are first line treatments aimed at improving muscle strength and range of 
motion, often requiring considerable commitment by subjects over a long period of time [3] 
and frequently requiring a home exercise program for a successful outcome [4]. However, 
compliance to home exercises is not as high as desired therefore, it is imperative to include 
new motivational interventions to increase compliance. 
Virtual reality (VR) technology has been used for several decades for a variety of 
psychosocial interventions. The use of VR was studied for a variety of rehabilitation 
conditions [5, 6].  Specifically, the effect of neck exercises using VR was previously tested 
on both asymptomatic individuals and patients with chronic neck pain and was shown to be 
useful in increasing cervical motion [7-9]. 
STUDY RATIONAL 
In recent years, commercial and research groups have been studying the effect of VR 
systems on the rehabilitative progress and developing new platforms. As the variety of 
available products widens, each system focuses on specific hardware and different 
rehabilitation aspects. The software presented in the current study focuses on the 
rehabilitation of the upper body. 
STUDY OBJECTIVES 
The current study was designed to evaluate neck movements performed according to the 
VRP-Clinic software, and to verify that they promote physical activities that correspond with 
physical rehabilitation.  
STUDY DEVICE  
Indications for Use 
VRHealth’s VRP-Clinic software, coupled with compatible VR (virtual reality) hardware 
(headset and supporting PC) is intended to promote physical rehabilitative processes of 
individuals requiring training of their head and neck muscles/joints as part of a physical 
therapy session.  
Prior to the first session using VRP-clinic, a medical practitioner will assess the patient and 
will determine the selection of movements included in such training. 
Device Description 
VRP-clinic Software  
VRP-Clinic software is used with several supported hardware platforms, delivering the same 
experience in each. Currently, the VRP-Clinic software supports Oculus rift and HTC VIVE 

 
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platforms – both systems use a PC based virtual reality platform and infra-red sensors to 
detect head movement of the user. 
 
A description of the software algorithm, a major routine/function level flow chart, a signed 
validation document, and a risk analysis table can be found in the Investigator Brochure. 
Hardware platform 
VRP-Clinic software is used with several supported hardware platforms, delivering the same 
experience in each. Currently, the VRP-Clinic software supports Oculus rift and HTC VIVE 
platforms – both systems uses a PC based virtual reality platforms and used infra-red 
sensors to detect head movement of the user.  In the current study, the Oculus rift platform 
will be used.  A description of the Oculus rift device and the manufacturer details can be 
found in Investigator Brochure. 
STUDY DESIGN 
Overview 
Single center, prospective, open label, single arm.  
The study will take place at Shaare Zedek Medical Center (SZMC).  The study will include a 
single visit.  Twenty (n=20) healthy subjects will be recruited to this study. Subjects must 
meet the eligibility criteria detailed in the protocol and sign the informed consent form prior to 
any study procedure.  
Each subject will receive an explanation from the study team on the device and study 
procedures.  Medical and demographic information will be collected.   
The subject will put on the VR headset and perform a series of neck movements guided by 
graphic instructions appearing in the VR environment. The study team will record any 
adverse event (AE) if such happens during/post training. 
The session will be recorded with a video camera.  Camera recording will start after the VR 
headset is placed on the subjects’ head and terminate before removing it, to ensure the 
participants’ privacy.   
The video will be viewed and evaluated separately by 4 clinicians.  The clinicians will identify 
each movement seen on the video from a predefined list and determine if such a movement 
is recommended as part of a rehabilitation training program for neck related pathologies. 
Endpoints: 
Primary Endpoint 
Number of VRP-Clinic neck movements that the assessing clinician recognizes as 
rehabilitation movements.  
Success acceptance criteria defined as:  80%  
Secondary Endpoint:  
Safety – Record of any adverse event occurring during the study.  
All AE's will be recorded and evaluated as part of the risk management for the device 
Study Duration 

 
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Duration of subject's participation: 30 minutes of which the actual exercise is expected to 
take not more than 5 minutes 
Study duration: The total study duration from recruitment to final data collection is estimated 
to be four months 
STUDY POPULATION AND SUBJECT SELECTION 
Source and sample size 
Twenty (n=20) healthy adult subjects will be included in this study.  The subject will be 
recruited by the investigator by use of an IRB approved advertisement. 
Eligibility 
Each subject will be evaluated by the Investigator to assess his/ her suitability for entry into 
this study according to the following criteria:   
Inclusion Criteria 
Eligible subjects must meet all of the following inclusion criteria: 
1. Healthy male or female  
2. Age 18-65  
Exclusion Criteria 
Eligible subjects must not meet any of the following exclusion criteria: 
1. History of neck related disorders (Whiplash, disc degeneration disease or other acute 
cervical spine conditions) 
2. Current neck pain 
3. Under medical treatment or observation for any health-related issue during the study 
4. Recent trauma 
5. Oncology background 
6. Acute disease/illness 
7. Pregnancy.  
8. Using drugs that could potentially affect physical function and balance (such as 
corticosteroids, antipsychotics or antidepressants)   
9. Vision problems that require glasses (not all frame types can fit into the headset) 
 
The investigator may withdraw a subject if, in his clinical judgment, it is in the best interest of 
the subject or if the subject cannot comply with the protocol.  At the discretion of the 
investigator, these subjects may be replaced.  Attempt should be made to complete any 
examinations. 
Subject Termination 
In case of dropout or subject removal the investigator will describe the reason for 
discontinuing the subject’s participation in the Termination CRF.  
Compensation  
At the end of the session, subjects will receive a coupon for use at the local cafeteria for 
purchase of a hot drink and cake (“café u maafe”) approximately worth 15 NIS as 
compensation for their time. 
 
 

 
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STUDY PROCEDURES 
Screening 
Eligibility: the volunteer will be screened to determine if he/she meets the study 
inclusion/exclusion criteria.   
Informed consent 
Prior to the study visit, informed consent will be obtained. When the 
participant fully understands the procedure, possible benefits and risks of the study, the 
subject will be asked to sign and date the informed consent document. 
Subject number 
If the subject meets the study inclusion/exclusion criteria , the subject 
will be assigned the next consecutive number. 
Medical history and demographic information: Basic medical and demographic 
information will be collected including age, gender, height, weight, head circumference, 
general medical background and specific information related to head/neck. 
Interventions and procedures:  
Subject Preparation and Instructions 
The subject will sit on a steady chair, with back support, in front of a desk were the device 
sensors are located.  Once starting the training program, the subject will receive instructions 
appearing in the graphic VR environment: 
Neck movements 
The software will guide the subjects to perform neck movements. 
EVALUATIONS 
Physiotherapist Evaluation and Assessment of Videos 
1. Identification of each movement seen in the video from the list detailed in "Neck 
Movement" section  
2. Determining if the use of such movement is recommended for rehabilitation 
Safety 
All adverse events (AEs) will be documented and evaluated as part of the risk management 
for the device 
 
 

 
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STATISTICAL CONSIDERATIONS AND ANALYSIS  
Sample Size Justification  
The rationale for the sample size is based on obtaining exact 95% confidence intervals for 
the activity movements which achieved 80% success.  When the sample size is 20, a one-
sided 95.0% confidence interval for a single proportion using the large sample normal 
approximation will extend at most 0.18 from the observed proportion. 
Subject Accountability   
A CONSORT flow diagram will be presented that will include the number of subjects 
screened and reasons for screening failures; the number of subjects, who were enrolled, as 
well as the reasons for all enrollment discontinuations grouped by major reason; A list of 
discontinued subjects, protocol deviations, and subjects excluded from the analyses. 
Data Analysis 
Descriptive statistics and summary tables will be provided giving sample size, absolute and 
relative frequency of categorical variables and sample size, arithmetic mean, standard 
deviation, median, minimum and maximum, percentiles and 95% CI (Confidence Interval) for 
means of continuous variables.  All measured variables and derived parameters will be listed 
individually and, if appropriate, tabulated by descriptive statistics. 
Study Hypothesis – Primary Endpoint: 
The number and percentage of neck movements which achieve a success rate of at least 
80% will be tabulated. Exact 95% binomial confidence intervals will be calculated for the rate 
of neck movements which achieve 80% success. 
Safety - Secondary Endpoint 
Adverse events will be coded according to coding dictionaries (MedDRA version 13.1 or 
higher) and presented in tables by system organ class, preferred term. The number and 
percentage of subjects who experienced any adverse events will be tabulated. 
ADVERSE EVENTS 
In this study, Serious Adverse Experience (SAE) is to be reported by the investigator 
within 24h to the IRB. The “Adverse Experience” CRF should be filled in all events of SAE and 
in other cases of Adverse Experience (AE) which, in the judgment of the investigator, affect 
this protocol.   
Anticipated Side Effects 
In this study, we are not anticipating any side effects.   
Anticipated Adverse Effects/Risks 
 
The movements not expected to cause any pain or discomfort. 
 
 

 
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MISCELLANEOUS 
Ethical Considerations 
Prior to study initiation the site shall obtain an Institutional Review Board 
(IRB)/Helsinki approval of the study. Any changes in the study protocol, informed consent 
forms, or investigator must be re-approved by the IRB and the approval documented.  All 
subjects enrolled in the study will provide their consent prior to entering the study.  An 
informed consent form shall be signed by the subject.  The investigator will retain the forms 
as part of the study records.  
 
This study will be performed in accordance with the Declaration of Helsinki, in 
agreement with the guidelines for conducting a clinical investigation in accordance with the 
principles of ICH GCP outlined in the E6 document and IRB guidelines. By signing the present 
protocol, participants in the study commit themselves to carry it out in accordance with local 
legal requirements 
Protocol Amendments 
 
Possible with IRB approval.  
Study Monitoring 
Study monitoring visits include a pre-study site evaluation and site initiation visit, 
periodic monitoring visits during the course of the investigation, and a final termination visit at 
the conclusion of the study.  The frequency of the monitoring visits will vary depending on the 
subject enrollment rate, the quantity and quality of data collection.    
Study Documentation 
 
Study documents include protocol and MOH documents, approvals, insurance, 
signed ICFs, copy of CRFs, training materials, SAE reports, investigator site file 
Case Report Forms (CRFs) 
Case Report Forms will be established to collect the required demographic and clinical 
information, as described by this protocol and the variables to be analyzed. Case Report 
Forms will be completed by the investigator or a designee who will be properly trained on 
study procedures and data recording requirements.  The investigator will maintain a separate 
enrollment log with the corresponding subject name, initials and subject code. All CRFs will 
have 1 original clearly filled with a ball point pen.  Any changes, amendments or additions to 
the forms will have to be marked though with a single line, dated, and initialed. The 
investigators will maintain a copy of the CRFs. 
Study Termination 
If the Principal Investigator determines that the conditions do not allow the 
continuation of the study, then it will be terminated.  Among the conditions that may justify 
the study termination without limitation are the followings: 
• Subject safety 
• Inability to enroll subjects at acceptable rate 
• Insufficient adherence to the protocol that could have a potential impact on the study 
outcomes 

 
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Maintenance and Retention of Records 
The records will be kept at least two years after the study. 
Use of Information and Publication 
Specified in contract with the Investigators, research records will be available to 
study personnel, and the Institutional Review Board, where applicable.  Research records 
may be used after removal of subject names or other identifying information as specified in 
the Informed Consent.  Information collected in this study that was not previously published 
is considered confidential information and is the property of VRHealth.   
REFERENCES 
1. 
Hogg-Johnson, S., et al., The burden and determinants of neck pain in the general population: 
results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated 
Disorders. J Manipulative Physiol Ther, 2009. 32(2 Suppl): p. S46-60. 
2. 
Holm, L.W., et al., The burden and determinants of neck pain in whiplash-associated disorders 
after traffic collisions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain 
and Its Associated Disorders. J Manipulative Physiol Ther, 2009. 32(2 Suppl): p. S61-9. 
3. 
Campbell, R., et al., Why don't patients do their exercises? Understanding non-compliance with 
physiotherapy in patients with osteoarthritis of the knee. J Epidemiol Community Health, 2001. 
55(2): p. 132-8. 
4. 
Salo, P., et al., Effects of long-term home-based exercise on health-related quality of life in 
patients with chronic neck pain: a randomized study with a 1-year follow-up. Disabil Rehabil, 
2012. 34(23): p. 1971-7. 
5. 
Palma, G.C., et al., Effects of virtual reality for stroke individuals based on the International 
Classification of Functioning and Health: a systematic review. Top Stroke Rehabil, 2017. 24(4): 
p. 269-278. 
6. 
Ravi, D.K., N. Kumar, and P. Singhi, Effectiveness of virtual reality rehabilitation for children 
and adolescents with cerebral palsy: an updated evidence-based systematic review. 
Physiotherapy, 2016. 
7. 
Sarig Bahat, H., et al.,. Cervical kinematic training with and without interactive VR training for 
chronic neck pain - a randomized clinical trial. Man Ther, 2015. 20(1): p. 68-78. 
8. 
Sarig-Bahat, H., P.L. Weiss, and Y. Laufer, Cervical motion assessment using virtual reality. 
Spine (Phila Pa 1976), 2009. 34(10): p. 1018-24. 
9. 
Chen, K.B., et al., Use of Virtual Reality Feedback for Patients with Chronic Neck Pain and 
Kinesiophobia. IEEE Trans Neural Syst Rehabil Eng, 2016.