Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System
Phase: NA
Conditions: Stroke
Sponsor: Tan Tock Seng Hospital

Study Protocol (Jintronix) Version 3, Dated 30th August 2016 
Page 1 of 17 
 
 
STUDY PROTOCOL 
 
PROTOCOL TITLE: 
Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix 
Virtual Reality Telerehabilitation System 
 
PROTOCOL NUMBER: 2016/00442 
PROTOCOL VERSION: 3 
PROTOCOL DATE: 30 August 2016 
 
PRINCIPAL INVESTIGATOR:  
Mr Christopher Kuah Wee Keong, Principal Occupational Therapist, Tan Tock 
Seng Rehabilitation Centre 
 
STUDY SITE: 
TTSH Rehabilitation Centre 
Centre for Advanced Rehabilitation Therapeutics 
 
CO-INVESTIGATORS/COLLABORATORS: 
Dr Karen Chua Sui Geok, Senior Consultant, Tan Tock Seng Rehabilitation 
Medicine 
Dr Loh Yong Joo, Consultant, Tan Tock Seng Rehabilitation Medicine 
Dr Wee Seng Kwee, Principal Physiotherapist, Tan Tock Seng Rehabilitation 
Centre 
Dr Emily Tan En Xian, Senior Resident, Tan Tock Seng Rehabilitation 
Medicine 
Ms Juliana Wang Yun Ying, Senior Physiotherapist, Tan Tock Seng 
Rehabilitation Centre 
Ms Ng Chwee Yin, Senior Occupational Therapist, Tan Tock Seng 
Rehabilitation Centre 
 
 
 
 
 
 
O F F I C I AL  U S E  O N L Y  
Doc Name : Protocol Template 
Doc Number : 207-002 
Doc Version : 03 
Date : 01 June  09 

Study Protocol (Jintronix) Version 3, Dated 30th August 2016 
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TABLE OF CONTENTS 
 
1. 
BACKGROUND AND RATIONALE ........................................................................................................................ 4 
1.1. 
GENERAL INTRODUCTION ........................................................................................................................................ 4 
1.2. 
RATIONALE AND JUSTIFICATION FOR THE STUDY ...................................................................................................... 4 
A. 
RATIONALE FOR THE STUDY PURPOSE ..................................................................................................................... 4 
B. 
RATIONALE FOR DOSES SELECTED ........................................................................................................................... 4 
C. 
RATIONALE FOR STUDY POPULATION ....................................................................................................................... 5 
D. 
RATIONALE FOR STUDY DESIGN .............................................................................................................................. 5 
2. 
HYPOTHESIS AND OBJECTIVES ......................................................................................................................... 6 
2.1. 
HYPOTHESIS ........................................................................................................................................................... 6 
2.4. 
POTENTIAL RISKS AND BENEFITS: ............................................................................................................................ 6 
A. 
END POINTS - EFFICACY ......................................................................................................................................... 6 
B. 
END POINTS - SAFETY ............................................................................................................................................ 7 
 
3.     STUDY POPULATION ...............................................................................................................................................5 
3.1. 
LIST THE NUMBER OF SUBJECTS TO BE ENROLLED. .................................................................................................... 7 
3.2. 
CRITERIA FOR RECRUITMENT .................................................................................................................................. 7 
3.3. 
INCLUSION CRITERIA .............................................................................................................................................. 7 
3.4. 
EXCLUSION CRITERIA ...................................................................................... ERROR! BOOKMARK NOT DEFINED. 
3.5. 
WITHDRAWAL CRITERIA .................................................................................. ERROR! BOOKMARK NOT DEFINED. 
3.6. 
SUBJECT REPLACEMENT ................................................................................... ERROR! BOOKMARK NOT DEFINED. 
4. 
TRIAL SCHEDULE ..................................................................................................................................................... 8 
5.     STUDY DESIGN ..........................................................................................................................................................6 
5. 
STUDY DESIGN ................................................................................................................................................... 8 
5.1. 
SUMMARY OF STUDY DESIGN .................................................................................................................................. 8 
6. 
METHODS AND ASSESSMENTS ......................................................................................................................... 12 
6.1. 
RANDOMISATION AND BLINDING ........................................................................................................................... 12 
6.2. 
CONTRACEPTION AND PREGNANCY TESTING .......................................................................................................... 12 
6.3. 
STUDY VISITS AND PROCEDURES ........................................................................................................................... 12 
7. 
TRIAL MATERIALS ................................................................................................................................................. 13 
7.1. 
TRIAL PRODUCT (S) .............................................................................................................................................. 13 
7.2. 
STORAGE AND DRUG ACCOUNTABILITY .................................................................................................................. 13 
8. 
TREATMENT ............................................................................................................................................................. 13 
8.1. 
RATIONALE FOR SELECTION OF DOSE .................................................................................................................... 13 
8.2. 
STUDY DRUG FORMULATIONS ................................................................................................................................ 13 
8.3. 
STUDY DRUG ADMINISTRATION ............................................................................................................................. 14 
8.4. 
SPECIFIC RESTRICTIONS / REQUIREMENTS ............................................................................................................ 14 
8.5. 
BLINDING ............................................................................................................................................................. 14 
8.6. 
CONCOMITANT THERAPY........................................................................................................................................ 14 
9. 
SAFETY MEASUREMENTS .................................................................................................................................... 14 
9.1. 
DEFINITIONS ........................................................................................................................................................ 14 
9.2. 
COLLECTING, RECORDING AND REPORTING OF “UNANTICIPATED PROBLEMS INVOLVING RISK TO SUBJECTS OR 
OTHERS” – UPIRTSO EVENTS TO THE NHG DOMAIN SPECIFIC REVIEW BOARDS (DSRB) ................................................... 14 
9.3. 
COLLECTING, RECORDING AND REPORTING OF SERIOUS ADVERSE EVENTS (SAES) TO THE HEALTH SCIENCE 
AUTHORITY (HSA) ............................................................................................................................................................. 14 

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9.4. 
SAFETY MONITORING PLAN ................................................................................................................................... 15 
9.5. 
COMPLAINT HANDLING –....................................................................................................................................... 15 
10. DATA ANALYSIS ..................................................................................................................................................... 15 
10.1. 
DATA QUALITY ASSURANCE ................................................................................................................................... 15 
10.2. 
DATA ENTRY AND STORAGE .................................................................................................................................. 15 
11. SAMPLE SIZE AND STATISTICAL METHODS ................................................................................................ 15 
11.1. 
DETERMINATION OF SAMPLE SIZE ......................................................................................................................... 15 
11.2. 
STATISTICAL AND ANALYTICAL PLANS .................................................................................................................... 15 
12. ETHICAL CONSIDERATIONS .............................................................................................................................. 16 
12.1. 
INFORMED CONSENT ............................................................................................................................................. 16 
12.2. 
IRB REVIEW ......................................................................................................................................................... 16 
12.3. 
CONFIDENTIALITY OF DATA AND PATIENT RECORDS .............................................................................................. 16 
13. PUBLICATIONS ....................................................................................................................................................... 16 
14. RETENTION OF TRIAL DOCUMENTS ............................................................................................................... 16 

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STUDY PROTOCOL 
 
1. 
BACKGROUND AND RATIONALE 
 
 
1.1. 
General Introduction 
 
With First World health system and aging population in Singapore, patients who survived 
and suffered from chronic disability after conditions like stroke, spinal cord injury, traumatic 
brain injury and degenerative joint diseases are getting more prevalent.  Such patients 
faced the long term challenges of maintaining and living well with a chronic condition.  
 
After receiving intensive inpatient care, patients faced multiple challenges in accessing 
intensive therapy inputs.  This may be due to several factors, for examples, accessibility 
issues to outpatient, community and home rehabilitation services due to logistical, financial 
and other personal issues; lack of trained rehabilitation professionals and therapists in 
certain community service sectors; and reduced compliance, motivation and interest due to 
delayed or limited professional inputs.  As a result, gains made by patients in time-limited 
inpatient/outpatient rehabilitation may be lost or not built upon as monitoring of their level 
of participation and progress is reduced. 
 
1.2. 
Rationale and justification for the Study 
 
 
a. 
Rationale for the Study Purpose 
 
With the emphasis on improving population health, reducing the need for hospital care, and 
promoting self-management, it will be beneficial to make good use of current available 
technologies to complement centre-based therapy with cost effectiveness and efficiency.   
 
One mode of such care delivery to a patient’s home is through a telerehabilitation system that 
enables remote monitoring of patients’ participation and performance in individualised home 
exercises.  In addition, timely review and adjustments in the home programs to cater to progress 
or changes in patients’ performance can be carried out by therapists remotely. 
 
In the recent years, there has been an increased utilisation of virtual reality applications in 
physical rehabilitation for specific training objectives, such as, movement retraining, balance 
control and strength training. Virtual reality exercises when prescribed with defined training 
objectives and duration can potentially be valuable to increase patients' training intensity in the 
comfort of their own homes. 
 
b. 
Rationale for Device (Jintronix System) Selected 
 
The Jintronix Virtual Reality Platform (Figure 1) was developed by a Canadian based team 
consisting of a group of therapists and IT specialists.  It is an online system with a series of 
therapeutic games meant to rehabilitate patients depending on their individual needs and 

Study Protocol (Jintronix) Version 3, Dated 30th August 2016 
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physical deficits.  This system, that has been approved by the FDA, is in contrast to commercially 
off-the-shelves gaming systems (such as Wii, Kinect, Playstation) that most patients find 
challenging in playing the games due to complexity and speed of the games. 
 
          
       
 
 
               Figure 1: Training with the Jintronix System in Sitting and Standing Positions 
 
Another advantage of using Jintronix is that it provides immediate feedback to users and allows 
for performance charting over time.  New games are also added on a regular basis to allow for 
more training options and to sustain interest.  In a study conducted by Archambault et al (2014), 
more than 80% of subjects found training with the Jintronix to be user-friendly and enjoyable, with 
all subjects having the ability to progress in the virtual reality- based training sessions.  In 
addition, there are currently ongoing trials in a few States of U.S.A. using the Jintronix Virtual 
Reality Platform. 
 
In terms of affordability, as long as the user owns a laptop and a HDMI TV, the user is just 
required to purchase a $300 Kinect Camera and pay a monthly subscription of $50 for the 
licence. The licence also allows access to regular updates to the suite of games. 
 
Hence, the purpose of our device innovation trial is to develop a telerehabilitation service utilising 
the Jintronix Virtual Reality Platform to complement current outpatient services for intensifying 
home exercise participation in a cost effective and efficient manner and also to improve patients’ 
clinical and functional outcomes. 
c. 
Rationale for Study Population 
 
Patients who have completed their acute to subacute inpatient rehabilitation will be considered.  
The majority of patients receiving outpatient and home based rehabilitation at TTSH 
Rehabilitation Centre and Centre for Advanced Rehabilitation Therapeutics are patients who have 
had a stroke.  Hence this group of outpatients that are at least 3 months post-stroke will be 
recruited.  They will benefit from increased intensity of upper limb, balance and/or gait 
rehabilitation with Jintronix telerehabilitation system that facilitates them to further exercise at 
home and not just at the clinic. 
d. 
Rationale for Study Design 
 
The study is designed to evaluate the feasibility of a novel telerehabilitation service based on the 
Jintronix Virtual Reality Platform to complement existing outpatient therapy services of TTSH 

Study Protocol (Jintronix) Version 3, Dated 30th August 2016 
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Rehabilitation Centre (including its outpatient service arm at Centre for Advanced Rehabilitation 
Therapeutics). 
 
2. 
HYPOTHESIS AND OBJECTIVES 
 
 
2.1. 
Hypothesis 
 
The primary hypothesis is that Jintronix telerehabilitation system is a clinically feasible service to 
be used for outpatient and home based rehabilitation at TTSH Rehabilitation Centre and Centre 
for Advanced Rehabilitation Therapeutics. 
 
2.2. 
Primary Objectives 
 
The primary objective is to evaluate if Jintronix telerehabilitation system is a clinically feasible 
service to be used for outpatient and home based rehabilitation at TTSH Rehabilitation Centre 
and Centre for Advanced Rehabilitation Therapeutics. 
 
2.3. 
Secondary Objectives 
 
Short Term: 
a. 
To explore a more cost-effective method of increasing intensity of rehabilitation without 
the need for additional therapist manpower.  
  
b. 
To assess virtual reality exergames potential adverse side effects. 
 
Long Term: 
a. 
To develop best practice guidelines/protocols for physical rehab virtual reality 
rehabilitation that are easily reproducible, validated and effective. 
 
b.  
To develop home-based virtual reality exergames with tele-health capabilities to facilitate 
continual rehabilitation with remote biofeedback mechanisms.  
 
c.  
To pioneer new knowledge in the field of rehabilitation therapeutics using advanced 
serious game technologies. 
 
d. 
To improve quality of life of patients by optimizing their functional potential using 
enhanced therapeutic systems. 
2.4. 
Potential Risks and benefits:  
a. 
End Points – Efficacy 
(1) Inability to activate or achieve complete movement trajectory or slowness to adapt to training 
environment. 
(2) Computer-related eye or visual complaints due to prolonged concentration to the screen. 
(3) Mild leg fatigue or discomfort related to repetitive standing and ambulating if needed 
(4) Rare risk of seizures due to prolonged visual feedback. 

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(5) Low risk of falls (will be under close supervision by therapist/carer) 
 
b. 
End Points – Safety 
A. Benefits to Patients 
(i) increased home exercise intensity with improved compliance 
(ii) improved patient therapy outcomes 
(iii) cost-savings due to reduction in clinic visits 
(iv) high level of acceptance/satisfaction with a telerehabilitation service 
 
B. Benefits to Outpatient Rehabilitation Service/Staff 
(i) optimisation of healthcare resources (manpower, clinic resources) 
(ii) successful work re-organisation to run a telerehabilitation service 
 
3. 
STUDY POPULATION 
 
3.1. 
List the number of subjects to be enrolled.  
The number of subjects to be enrolled for this study will be 35.  
3.2. 
Criteria for Recruitment 
 
Based on inclusion criteria and exclusion criteria as stated below, suitable patients will be 
recruited for the study. 
 
3.3. 
Inclusion Criteria 
 
1. Patient with motor deficit(s) due to stroke as diagnosed by CT or MRI, who are attending 
outpatient rehabilitation services at TTSH Rehabilitation Centre and Centre for Advanced 
Rehabilitation Therapeutics. 
2. Post stroke of at least 3 months with stable neurological status. 
3. Age 21 to 75 years old inclusive. 
4. Able to perform at minimal level of assistance (i.e. carer provides only up to 25% of 
physical support to subject) for sitting, standing and/or walking tasks. 
5. Has a primary carer that must be present with subject in all trial sessions. 
6. Able to understand and participate in a 15 minutes trial Jintronix session during screening. 
3.4. 
Exclusion Criteria 
 
    1. Patient with severe cognitive, perceptual (include hemi-neglect), and/or emotional-   
          behavioural issues that preclude from participation. 
    2. Experiencing moderate to severe levels of pain (Visual Analogue Scale > 5). 
    3. Has previous seizure episodes. 
    4.   Has unstable medical conditions which may affect participation (e.g.     
          unresolved sepsis, postural hypotension, end stage renal failure) or anticipated life  
          expectancy of <1 year due to malignancy or neurodegenerative disorder. 
    5.   Has known poor cardiac ejection fraction (<30%) or lung function(FEV1<30%).               
    6. Is non-weight bearing for either of the lower limbs.  
    7.   Is Pregnant or breast feeding. 
    8.   The competency of the carer: in which the potential participant will not be recruited if  

Study Protocol (Jintronix) Version 3, Dated 30th August 2016 
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          his/her carer is unable to pass the competency check by the study team. 
3.5. 
Withdrawal Criteria 
 
Criteria for stopping research are dependent on the following factors:  
  
(1) Completion of recruitment of all subjects.  
 
(2) Permanent software failure of the Jintronix Telehrehabilitation System which cannot be 
repaired.   
 
(3) Premature cessation of funds from grant or sponsor. 
 
(4) Serious adverse events deemed to be related to research study: E.g. serious injury, falls, 
severe increase in pain, >30% above baseline scores). 
 
(5) New medical problems unrelated to study intervention. 
 
3.6. 
Subject Replacement 
 
Subjects who drop out will not be replaced. 
4. 
TRIAL SCHEDULE 
 
Each recruited participant will undergo the following program: 
 
Outcomes Evaluation at 4 time points: week 0 (pre-Phase 1), week 3 (post-Phase 1), week 7 
(post-Phase 2) and 1 month-Phase 2. 
 
Phase 1 Training at Outpatient Clinic Service : 9 sessions (3x per week) over 3 weeks training 
with Jintronix Virtual Reality Platform in-clinic with therapist.  Carer training and competency 
evaluation will be conducted before starting Phase 2. 
 
Phase 2 Training at Home with Telerehabilitation : 20 sessions (5x per week) over 4 weeks 
training with Jintronix Virtual Reality Platform at home with trained carer and remote monitoring 
by therapist. 
 
5. 
STUDY DESIGN 
 
5.1. 
Summary of Study Design 
 
Exercise Training Protocol 
i.  Therapist’s Prescription 
The therapist will prescribe and pre-program exercises individualised to the needs of the subject.  
Based on results of screening (with the inclusion/exclusion criteria) and the first outcome 
evaluation (i.e. week 0 assessment), the therapist will prescribe accordingly the choice and 
challenge level of exercises including the required posture (i.e. in sitting or standing).   

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This prescription of exercises will be further modified by the therapist as needed as the subject 
goes through subsequent training sessions so as to provide an appropriate level of physical 
workout for the participant.  The therapist will also ensure that rest breaks will be adequately 
embedded in the 45-minutes long session based on subject’s performance. 
 
For both Phase 1 and Phase 2 training, only the therapist will be able to prescribe and make 
changes; subject will not be able to access the controls needed to make these changes. 
    
The prescription list can include 3 different components available on the system:  
 
(a) “assessments” - standardized measurements of the user’s abilities (for example, see Figure 2) 
 
                                  
 
 
Figure 2. Jintronix “Assessment” for Functional Reach 
 
(b) “exercises” - movement training with guidance from a virtual exercise coach (for example, 
shoulder movements as shown in Figure 3) 
                                  
 
 
Figure 3. Jintronix “Exercise” for Shoulder Movements 
 
 
 
 
 
 

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(c) “activities”- games-based exercises (for examples, see Figures 4, 5 and 6) 
 
                                 
 
 
Figure 4. Jintronix “Activities” for Bilateral Upper Limb Coordination  
                                                involving Catch and Carry Motions  
 
                                
 
 
                                   Figure 5. Jintronix “Activities” for Trunk Control 
                               involving Weight Shifting Motions in Sitting Positions 
 
                                
 
 
                         Figure 6. Jintronix “Activities” for Balance in Standing Position 
                                                     Involving Kicking Motions 
 

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Before performing an activity on Jintronix, the system guides the user through trunk and range of 
motion calibrations, where applicable. 
 
ii. Phase 1 Clinic-based Training 
 
Subject will be instructed and assisted by the therapist for this phase with the carer present. 
   
In addition, the carer will be trained on understanding and ability on ensuring a safe physical 
environment at home, ability to use Jintronix Virtual Reality System, ability to safely guide and 
handle subject and fall management.   
 
For the last 3 sessions (i.e. 7,8 and 9) of this Phase 1, therapist will let carer handle the subject 
with the therapist supervising and evaluating carer’s ability in ensuring participant’s safety. 
 
The carer will then be evaluated with the Carer Education and Competency Form at the end of 
this Phase 1.  Phase 2 will commence only if carer is competent, i.e., all statements in the Carer 
Education and Competency Form is rated as “C” (for Competent). 
 
iii. Phase 2 Home-based Training 
 
Equipment will be set up and tested to be operational at the subject’s home and will be loaned to 
subject at no cost for the duration of the subject’s participation.  This will include: 
 
- 
computer with installed Jintronix Virtual Reality Platform 
- 
Kinect sensor  
- 
WIFI connection 
Carer: 
 
Therapist will evaluate with carer his/her competency by re-evaluating with the Carer Education 
and Competency Form after the home set-up.  This is to ensure carer’s understanding and ability 
on ensuring a safe physical environment at home, ability to use Jintronix Virtual Reality System, 
ability to safely guide and handle subject and fall management. 
 
Subject: 
 
Each subject is expected to login and perform prescribed exercises everyday (Mondays to 
Fridays only) for 4 weeks with carer’s guidance and assistance.  Each exercise session duration 
is 45 minutes.  The subject can decide regarding preferred exercise time (i.e. before 3 pm). 
 
Therapist: 
 
Therapist will review each subject’s performance and re-adjust program games parameters to 
upgrade or downgrade level of challenge via remote processing in-clinic within the same day of 
each training day if needed (i.e. after 3pm).  Any change of program games parameters will be 
documented. 
 

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6. 
METHODS AND ASSESSMENTS 
 
These include subjects’ performances and feedback, carer competency and therapists’ 
operations and feedback and technical usability: 
 
(i) Subjects’ Physical Performance: To be carried out at week 0 (pre-Phase 1), week 3 (post-
Phase 1), week 7 (post-Phase 2), and 1-month Post Phase 2. Standard stroke outcome 
measures will be used: 
- Upper Limb measurement: Fugl Meyer Upper Limb Motor Assessment 
- Balance measurement: Berg Balance Test 
- Endurance: 6 minute Walk Test 
- Gait Speed: 10 metre Walk Test  
- Pain: Visual Analogue Scale 
- Stroke Self-Efficacy Questionnaire  
 
(ii) Subjects’ Performance: include compliance, ease of system utilisation (measured by rating 
scale), ability to carry out exercises with changes done remotely by therapist, and user 
satisfaction.  
 
(iii) Carer Competency: include carer’s understanding and ability on ensuring a safe physical 
environment at home, ability to use Jintronix Virtual Reality System, ability to safely guide and 
handle subject and fall management. 
 
(iv) Therapists’ Operations: include ease of system utilisation (measured by rating scale), total 
number of remote monitoring sessions per day, actual man-hours required to review and re-
adjust after each subject exercise session, and documentation of each remote monitoring. 
 
(v) Therapists’ Feedback: include user satisfaction and system usefulness. 
 
(vi) Technical Issues: include system reliability and need for support service trips to subjects’ 
homes – measured by i) number of visits required for technical support due to system 
breakdown/problems; ii) number of man-hours to solve the technical problems. 
 
6.1. 
Randomisation and Blinding 
 
No randomization and blinding needed for this feasibility trial. 
6.2. 
Contraception and Pregnancy Testing 
 
Not applicable in this study. 
 
6.3. 
Study Visits and Procedures 
 
a. Screening Visits and Procedures 
 
Screening will be done by either the Principal Investigator or Co-investigators based on 
the inclusion and exclusion criteria stated above. 

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b. Study Visits and Procedures 
 
Subjects will be undergoing outpatient and/or home based rehabilitation during the trial 
period.  
 
c. Final Study Visit: 
 
Will be at 1-month Post Phase 2 for outcomes evaluation in outpatient clinic as stated in 
Point 6 above. 
 
d. Post Study Follow up and Procedures 
 
Not applicable in this study. 
e. Discontinuation Visit and Procedures 
 
If the subject decides to withdraw from the study for any reasons without any adverse 
effects, he/she will receive standard care for his/her condition. This will include outpatient 
and/or home based conventional rehabilitation therapy if indicated and occasional use of 
commercial off the shelf gaming consoles if clinically indicated at intervals determined by 
clinicians.  
 
If the subject is withdrawn from the study due to adverse effects, he/she will be given 
appropriate care under medical supervision until the symptoms of any adverse event 
resolve or the condition becomes stable. 
 
7. 
TRIAL MATERIALS 
 
7.1. 
Trial Product (s) 
 
Not applicable in this study. 
 
7.2. 
Storage and Drug Accountability 
 
Not applicable in this study. 
 
8. 
TREATMENT 
8.1. 
Rationale for Selection of Dose 
 
The number of training sessions within the training period is determined by principles of exercise 
prescription (3-5 times per week, 45 minutes each session). 
 
8.2. 
Study Drug Formulations 
 
Not applicable in this study. 
 

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8.3. 
Study Drug Administration 
 
Nil drug administered. 
 
The Jintronix telerehabilitation system will be supervised by experienced physiotherapists and 
occupational therapists. 
 
8.4. 
Specific Restrictions / Requirements  
 
No restrictions or limitations on existing rehabilitation therapies, no alterations or restrictions in 
patients’ own medications, herbs, vitamins and mineral supplements while participating in the 
study. 
 
8.5. 
Blinding 
 
No blinding needed for this feasibility trial. 
8.6. 
Concomitant therapy 
 
No interruptions or alterations to existing medical or rehabilitation therapies will be enforced 
during the research trial. 
 
9. 
SAFETY MEASUREMENTS 
9.1. 
Definitions 
Define terms e.g. what would be regarded as UPIRTSO events, Serious adverse events etc.. 
Include details of the protocol specific reporting, procedures, including the individual responsible for 
each step (e.g. the Investigator, the medical monitor, etc.), how decisions will be made regarding 
determining relatedness and grading severity, how reports will be distributed and what follow up are 
required. Include specific details of reporting procedures for:  
 Deaths and life threatening events 
 other SAEs 
 Other adverse events 
 
9.2. 
Collecting, Recording and Reporting of “Unanticipated Problems Involving Risk to 
Subjects or Others” – UPIRTSO events to the NHG Domain Specific Review Boards 
(DSRB) 
 
9.3. 
Collecting, Recording and Reporting of Serious Adverse Events (SAEs) to the Health 
Science Authority (HSA) 
 
1. For Industry sponsored Trials 
 
Not applicable in this study. 
 
2. For Principal Investigator initiated Trials  
 
Not applicable in this study. 
 

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9.4. 
Safety Monitoring Plan 
 
Data and subject feedback will be reviewed after every 5 subjects recruited. In addition, 
any negative feedback in terms of subject feedback or therapist opinion will be discussed 
at 4 weekly meetings. 
 
9.5. 
Complaint Handling – 
 
Complaints will be reported to the PI and data will be stored in safe and secure rooms 
under locked cabinets. 
 
10. 
DATA ANALYSIS 
10.1. Data Quality Assurance 
 
Data will be reviewed after every 5 subjects recruited. Random checks will be                               
undertaken by co-investigators and PI. 
 
10.2. Data Entry and Storage 
 
Hard copies of research data (case record forms - CRF) will be stored in locked cupboards within 
locked rooms. Soft copies of the data will be stored in password protected computers accessed 
only by members of the study team (PI, Co-I). 
 
The electronic data can be accessed by Jintronix company as the system runs on an online 
platform.  All subjects’ Jintronix accounts will be fully de-identified and coded.   
 
All subjects’ data and Jintronix coded accounts will be stored up to 6 years after the completion 
of the study, then deleted.  
 
 
11. 
SAMPLE SIZE AND STATISTICAL METHODS 
 
11.1. Determination of Sample Size  
 
Not applicable in this pilot feasibility trial. 
11.2. Statistical and Analytical Plans 
Descriptive statistics will be used to present the demographic and baseline characteristics for all 
patients. If the outcome data is normally distributed, one-way analysis of variance (ANOVA) will 
be used to analyse the differences in outcome between time points. If the data is not normally 
distributed, the Kruskal-Wallis H Test will be used to analyse the differences in outcome between 
time points. 
 
All data analysis will be conducted using SPSS version 21. 
 

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12. 
ETHICAL CONSIDERATIONS 
12.1. Informed Consent 
 
Patients will be approached prior to initiation of any study procedure, by the treating physician, 
PI, co-investigators or research associates involved in study. They will be given copy of Informed 
Consent Form (ICF) and adequate time to read through and understand the procedures and ask 
for clarifications prior to informed consent. Consent will be taken in the outpatient gymnasium or 
clinic and to protect patient confidentiality and no coercion or force will be used during the 
consent process and patient will be given the option to volunteer. Only the PIs, Co-Is or study 
administrators will be involved in taking informed consent. 
 
12.2. IRB review 
 
This protocol is submitted together with the associated informed consent documents to NHG 
DSRB. 
 
12.3. Confidentiality of Data and Patient Records 
 
Hard copy data will be coded with code numbers/subjects initials only and the list of subjects' full 
names and NRIC numbers matching these codes will be kept in the investigator file located in a 
locked cupboard. Hard copy records will be kept in locked cupboard within locked rooms and soft 
copy records will be kept in password protected computers in the clinic within locked room 
premises. 
 
The electronic data can be accessed by Jintronix company as the system runs on an online 
platform.  All subjects’ Jintronix accounts will be fully de-identified and coded.   
 
All subjects’ data and Jintronix coded accounts will be stored up to 6 years after the completion 
of the study, then deleted.  
 
13. 
PUBLICATIONS 
 
As per data sharing agreements and research collaborative agreements, joint and independent 
publications will be permitted with non-identification of research patients. 
14. 
RETENTION OF TRIAL DOCUMENTS 
 
Records for all participants, including CRFs, as well as IRB records and other regulatory 
documentation will be retained by PI in locked cupboard within locked rooms. Soft copy records 
will be stored in password protected computers located in locked rooms. 
 
Hard copy and soft copy data will be destroyed 6 years after completion of the study. 
 
 
 

Study Protocol (Jintronix) Version 3, Dated 30th August 2016 
Page 17 of 17 
List of Attachments 
 
Appendix 1 
Study Schedule: Located on main English ICF 
Appendix 2 
Blood Sampling Summary : Not applicable 
Appendix 3 
Questionnaires used in the Trial: Not applicable 
 
Appendix 4 
Laboratory Tests: Not applicable 
Appendix 5 
Sample Patient Information Sheet and Informed Consent Form: 
Located on NHG ROAM ethics submission attachments