Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
Phase: NA
Conditions: Stroke
Sponsor: Rutgers, The State University of New Jersey

Protocol Version 6.0 – 5-25-2021
 
Title of Project:
Home Based Virtual Rehabilitation for upper extremity 
Principal Investigator:
Gerard G Fluet PT PhD
Funding Source(s):
NIDILRR  #90RE5021-01-00
NIH NICHD #1R15HD095403-01A1
1. Purpose/Specific Aims
The overarching aim of this study is to provide a mechanism for patients to engage in 
progressive motor practice for a meaningful time period. We aim to improve on the positive 
outcomes found in our work on patients in the chronic phase and the pilot work being done 
on patients in the acute in-patient phase post stroke to determine whether we can further 
improve functional recovery using a home based system.
Aim 1:  Evaluate compliance with Home-Based Virtually Simulated hand/arm gaming 
activities and two computer game groups, one with motivation enhanced (ME) simulations 
and one with non-enhanced (MnE) versions,  as compared to compliance with Standard 
hand/arm home Exercises (HBSE). Hypothesis:  Participants in the ME and MnE group will 
show significant compliance as compared to the control group (HBSE) and the ME group 
will be superior to the MnE group. 
Primary Outcome Measures: For the HBVS group, 1) time on task will be measured by the 
daily computer file time stamp and 2) amount of moving time will be measured by the actual 
movement time recorded by the games.  For the computer games groups 1) time on task will 
be measured by recording start and stop time of practice in a notebook and 2) amount of 
moving time will be measured by commercially available activity monitors. 
Aim 2: Evaluate the effectiveness of home-based virtually simulated hand/arm gaming 
activities (HBVS) for individuals with stroke as compared to a program of standard hand/arm 
home exercises (HBSE). Hypothesis:  Participants completing HBVS training will exhibit 
significantly improved clinical, kinematic and neurophysiological outcomes as compared to 
the control group (HBSE). 
Primary Outcome Measures for Aim 2: Wolf Motor Function Test, Upper Extremity 
Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke, Action Research Arm Test, 
Perception of System Questionnaire, the Stroke Impact Scale, Kinematics, Cortical mapping.  
Aim 3: Evaluate the impact of the motivation enhancements designed into computer games 
to provide a more enjoyable training experience. Hypothesis: Enjoyment of the games will be 
a more valid predictor of compliance than personal factors. 
Pro20160000945
           5/13/2024
           5/12/2025

Home Based Virtual Rehabilitation
Gerard G Fluet DPT PhD
Protocol Version 4.0 – 12-16-2019 
- 2 -
Primary Outcome Measures for Aim 3: The Intrinsic Motivation Inventory, The Patient 
Activation Measure, qualitative data collected during semi-structured interviews. 
2. Background and Significance
Studies have shown that sustained hand rehabilitation training is important for continuous 
improvement and maintenance of function following a stroke. It is unimaginably difficult to 
pursue education, employment and community participation without being able to 
independently use one’s hands. The primary goal of this study is to test an exciting new 
technology that can be easily used in the home for long-term hand and upper extremity 
training.  Recovery of hand function post brain injury is particularly recalcitrant to currently 
available interventions. To date, the best efforts of groups studying traditionally presented as 
well as technology-based therapeutic interventions for the hemiplegic hand and arm have 
produced measurable changes in motor function and motor control but fall far short of major 
reductions in disability. 
If the amount of therapy is critical to rehabilitation, our current institutional limitations 
undermine the probabilities for successful outcomes. After discharge from the inpatient stay, 
access to rehabilitation therapy can be difficult for some patients.  This is due in part to 
inadequate insurance, lack of transportation, and the patient’s dependence on their caregiver. 
Having access to long-term rehabilitation training anywhere and at any time is necessary for 
sub-acute and chronic patients to continuously improve their functional abilities. 
Innovative telerehabilitation systems have been developed using information and 
communication technologies to provide rehabilitation services at a distance. Many studies 
have developed video-game driven systems from commercially available gaming consoles 
such as Wii and Microsoft Kinect [1]. Other groups have examined the use of custom-made 
tele-rehabilitation systems [2, 3]. These systems do not address hand rehabilitation.  There is 
a vital need to explore intensive home-based upper extremity interventions that focus on the 
hand. 
3.
Research Design and Methods 
This study will be a single blind randomized controlled trial. Subjects will be blinded to the 
purpose of the study. All outcome measures will be performed by a therapist blinded to group 
assignment. A controlled trial will be utilized to determine the additive effect of presenting 
rehabilitation activities in a virtual environment as compared to standard upper extremity 
exercise.  We will randomize subjects to treatment and control groups using a computerized 
random number generator.
3.1. Duration of Study
Each subject will perform a pre-study evaluation, train using one of the protocols for three to 
twelve months, perform a post study evaluation as well as one and six month retention 
evaluations. 
3.2 Study Sites
Pro20160000945
           5/13/2024
           5/12/2025

Home Based Virtual Rehabilitation
Gerard G Fluet DPT PhD
Protocol Version 4.0 – 12-16-2019 
- 3 -
Testing and initial training will take place in the Bergen Building of the Rutgers Biomedical 
and Health Sciences Campus in Newark. Home training will take place in subjects’ homes. 
3.3 Sample Size Justification 
In this pilot study we will seek sufficient power to detect a clinically significant difference in 
the Wolf score changes in these two pre-planned, primary comparisons. To evaluate these 
effects of training, we will assume a power level of .8 and a significance level of 0.05. With 
presumed correlation among repeated measures of 0.1 and effect size of 0.3, we will need a 
sample size of 25 subjects in each of the three  groups (HBVS, ME and MnE) to observe a 
significant  effect for the first comparison (G*Power, version 3.1.5). Although we will screen 
for patients with homogeneous impairments, by its nature stroke is an extremely variable 
condition. Due to possible subject attrition, we will use a total of 30 subjects in each of the 
two groups. 
3.4 Subject Selection and Enrollment Considerations 
3.5.1 Inclusion Criteria
1) healthy persons between the ages of 20 and 90
2) persons six weeks post stroke between the ages of 20 and 90
2) person with enough shoulder, elbow, wrist, and hand movement to actively interact 
with the video games
3.5.2 Exclusion Criteria
1) person with severe arm weakness and cannot move the arm enough to interact with 
the video games 
2) person with severe increase in tone of their weak arm
   3) person with difficulty following instructions or paying attention to computer video    
games for at least ten minutes, 
4) person with visual problems that make it difficult for them to interact with an 
entire computer screen
3.5.3 Subject Recruitment 
Subjects will be recruited through flyers, stroke support groups, and clinician referrals. 
We will assume that approximately 15-20% of the population will satisfy our inclusion 
criteria based on our previous experience with upper extremity rehabilitation in this 
population.  Hence we will approach 300 persons. 
3.5.4 Consent Procedures
Example: The study will be explained to the potential subject by the study staff, the 
consent will be read, and their questions will be answered. If s/he wishes to enroll, the 
Pro20160000945
           5/13/2024
           5/12/2025

Home Based Virtual Rehabilitation
Gerard G Fluet DPT PhD
Protocol Version 4.0 – 12-16-2019 
- 4 -
subject will sign the consent form. The study staff obtaining consent will also sign and 
date the consent form, and a copy will be given to the subject sought from each 
prospective subject or the subject’s legally authorized representative, in accordance with 
federal & state law and institutional policy. If the study staff member performing the 
consent process identifies issues suggesting that the prospective subject may not be 
capable of participating in the consent process due to dementia, a Folstein Mini Mental 
Status will be performed. Prospective subjects screening positive for dementia will not 
be included in the study. 
3.5.5 Subject Costs and Compensation
There are no costs for the subjects. The subjects will be paid 100$ at each of the retention 
tests. 
4.
Study Variables
4.1 Independent Variables or Interventions 
The two computer game groups, Motivation Enhanced (ME) and Motivation Non-
Enhanced (MnE) will use the NJIT- Home Virtual Rehabilitation System (HoVRS) to play 
a series of computer games developed to practice movement of the hand and fingers. Subjects 
will first come into our lab, perform pre-tests as well as a pre-intervention training session. 
Then a physical therapist and engineer will set up the apparatus in subject’s home and will 
train them on how to use the system and play the games in their home during the first week. 
The physical therapist and engineer will be in contact with subjects throughout the training 
and will visit subjects’ homes as needed if problems are encountered. Additionally, the system 
allows the therapist to remotely monitor each day’s activity. 
  
4.1.1 Device Description
NJIT HoVRS has two sub-systems to deliver home-based training: 1) a patient based platform 
to provide the training and 2) a server based online data logging and reporting system. In the 
patient’s home, a cross platform virtual reality training application runs video games 
(developed in the Unity 3D game engine using the language C#) on their home computer. 
4.1.11
Hardware
The Leap Motion Controller (LMC) a commercially developed infrared tracking device 
developed for home video game control is used to capture motion of the hand and arm 
movement without requiring wearable sensors.  The device’s USB controller reads the sensor 
data into its own local memory and performs any necessary resolution adjustments. This data 
is then streamed via USB to the Leap Motion image API.  From there, we programmed the 
system to feed tracking data into virtual reality activities by calling the Leap Motion API. 
If the patient’s arm is weak and he/she cannot support the hand against gravity above the Leap 
Motion Controller, the Armon™ Edero, a commercially available, spring-based arm support, 
will be provided to the subject (Figure 1). The Edero provides 12 different levels of passive 
Pro20160000945
           5/13/2024
           5/12/2025

Home Based Virtual Rehabilitation
Gerard G Fluet DPT PhD
Protocol Version 4.0 – 12-16-2019 
- 5 -
support allowing it to accommodate a wide range of patient sizes and strength levels. It 
requires a single setting that can be provided during the patient’s initial evaluation 
4.1.1.2
Software
Patients will either use their own home computer or will be provided with a computer if 
needed. A user-friendly GUI interface lists all of the training activities allowing patients to 
choose which activity they want to begin with using just one mouse click. Currently twelve 
games have been developed, each one designed to focus on training a specific hand or arm 
movement such as wrist rotation or finger individuation. All games are downloadable via 
HoVRS website.
The video home exercise group will be taught a progression of home exercises for their 
hand and arm. These exercises will be taught to them using web-based movies that they will 
view on a computer screen.  Subjects will first come into our lab, perform pre-tests as well 
as a pre-intervention training session. The therapist will then work with the subjects in their 
home and visit them once or twice in the first week to ensure that they are independent 
exercising with the videos. The video exercise activities will include hand opening activities, 
reaching and grasping different sized objects, individual finger movements, and forearm 
rotation activities chosen to ensure the trained movements are similar to the ones addressed 
by the computer games.
4.1.1.2
Software
Patients will either use their own home computer or will be provided with a computer if 
needed. A user-friendly GUI interface lists all of the video home exercises allowing patients 
to choose which activity they want to begin with using just one mouse click. Currently 
twelve exercises have been developed, each one designed to focus on training a specific 
hand or arm movement such as wrist rotation or finger individuation. All games are 
downloadable via the HoVRS website.
4.2 Dependent Variables or Outcome Measures
All subjects will come to our lab and complete a quality of life questionnaire (Stroke Impact 
Scale) [4] and undergo clinical and kinematic testing immediately pre and post training as 
well as at 1 and 6 months post training. Additionally they will complete a perception of the 
system questionnaire [5] after training is completed. 
Clinical Measures.  The main clinical outcome will be the Wolf Motor Function Test [6] 
because it is a balanced test of arm and hand use [7, 8].  The secondary measures will be the 
Upper Extremity Fugl-Meyer Assessment[9], the Action Research Arm test[10],
and Kinematic/Kinetic Measures.  To explore the mechanism of improvement, changes in 
kinematics and kinetics of the hand and arm will be used to elucidate recovery of 
impairment. Two types of kinematic data will be collected; 1) data obtained from the 
patient’s daily performance during the training and 2) data collected during the 4 testing 
Pro20160000945
           5/13/2024
           5/12/2025

Home Based Virtual Rehabilitation
Gerard G Fluet DPT PhD
Protocol Version 4.0 – 12-16-2019 
- 6 -
periods.   Data obtained from the patient’s daily gaming performance during the training will 
include duration of motor activity, hand opening and closing range of motion, pronation and 
supination range of motion, maximum fractionation (a measure of finger individuation), 
hand opening velocity, hand trajectory smoothness, game duration and game score. 
Data collected during the 4 testing periods includes computer-based outcome measures and 
the Real-World Reach to Grasp Test. There are four computer based outcome measures in 
this data set. 1) Maximum Finger Opening is collected using a CyberGlove™ (Immersion, 
USA) (2) Pinch Force Tracking Error measures the ability to control active finger extension 
and flexion to modulate their pinch grip force to control a cursor to track a sine wave. (3) 
Maximum Pinch Force is measured as the maximum force a subject can exert on a force 
sensor held between their paretic thumb and index finger and, (4) Figure 8 Tracking Error 
measures forearm and shoulder control needed to trace a horizontal figure 8 shape while the 
arm is in a supported horizontal position[11] (5) Max finger extension and abduction 
(collected using a CyberGlove) (6)Maximum supination with hand open, measured with an 
Optitrack system. (7) Maximum pronation with hand open, measured with an Optitrack 
system (8) Maximum MCP flexion with PIP and DIP extension measured with an Optitrack 
system.
The Kinematic Reach-Grasp Test analyzes the kinematics of everyday movements 
involving grasping and manipulating real-world household objects and will be used to 
measure changes in real-world function. The Reach-Grasp Test will be administered to both 
the hemiparetic and non-hemiparetic upper extremity at all assessment time points. Subjects 
will sit in a chair and reach for objects placed 20 cm from the hand starting position. The 
subjects will be instructed to grasp the objects from the table and place it onto a 10 cm high 
platform located 5 cm to the right of the object. Subjects will be required to have all five 
fingertips touch the object at the time of the grasp[12]. 
In an attempt to expand our understanding of the motivation  and adherence to the 
autonomous home rehabilitation program, we will perform an in depth qualitative analysis 
focusing on subjects’ unique perceptions and understandings of their participation in the 
proposed rehabilitation program. Using a Grounded Theory approach, data collection and 
analysis will follow these steps: 1) A trained interviewer will ask open-ended questions in a 
telephone interview conducted after follow up testing, allowing participants to reflect on and 
describe their experiences. 2) Investigators will read participants' narratives to develop a 
general sense of the subjects’ experiences and attitudes toward the rehabilitation program. 3) 
Investigators will identify emerging narrative themes in participants’ experiences and 
attitudes toward the program. 4) Finally, an iterative coding process will be used to refine 
initial findings and synthesize these themes.
4.3 Risk of Harm 
There is less than minimal risk involved. The VR experiments are non-invasive and pose no 
obvious risk. Transient fatigue of the hand and arm are possible, but this risk is not greater than 
that posed by normal daily activities following a stroke. 
Pro20160000945
           5/13/2024
           5/12/2025

Home Based Virtual Rehabilitation
Gerard G Fluet DPT PhD
Protocol Version 4.0 – 12-16-2019 
- 7 -
4.4 Potential for Benefit
The benefits of taking part in this study may be:  Patient may regain better use of their hand and 
arm. However, it is possible that patients might receive no direct personal benefit from taking 
part in this study.
5.   Data Handling and Statistical Analysis
All efforts will be made to keep subjects’ personal information confidential. All subject names 
will be removed from the data and the data will be tagged using a coded ID number. 
Demographic, clinical outcome and survey data will first be recorded on paper. All kinematic 
and computerized performance data will be collected on computer. These computer files will be 
identified by the coded subject ID number. All data will be transferred to an Excel spreadsheet 
with subjects identified by this same ID number. Spreadsheets will be stored on a drive that is 
password protected. Data will only be accessible to study staff and will be retained for seven 
years. The link between subject identity and subject ID number will be destroyed when data 
collection is completed.
Our primary outcome measures will be the WMFT (Aim 2) and the duration of motor activity 
(measure of compliance, Aim 1). The primary outcome measures and all secondary outcome 
measures described above will be subjected to a repeated measured analysis of variance, with 
between-group factors Therapy Type (Virtual Simulations (VS), Standard Exercise (SE)) and 
within-group factor Test (Before, Post, One Month retention,  Six Months Retention). Our post-
hoc analyses of the Therapy Type by Test interaction effects will focus on the Month 1 versus 
Month 6 comparison. We will be quantifying training effects by comparing group means as well 
as by percent change in performance, and by comparing the recovery curves obtained from Tests 
1-4. All clinical outcomes used are well established measures of upper extremity functional 
recovery with published minimum clinically important differences which we will use to evaluate 
the significance of our findings.
7. Reporting Results
7.1 Individual Results
No disease screening data will be collected. Patient’s changes on clinical tests will be shared 
with them during testing sessions. These sessions are conducted by licensed Physical 
Therapists who have training to help persons with stroke interpret clinical examination 
findings. 
7.2 Aggregate Results
Subjects will not be informed of aggregate findings. 
7.3 Professional Reporting
De-identified, aggregate findings will be published in professional journals and presented at 
scientific meetings. 
8. Bibliography
Pro20160000945
           5/13/2024
           5/12/2025

Home Based Virtual Rehabilitation
Gerard G Fluet DPT PhD
Protocol Version 4.0 – 12-16-2019 
- 8 -
1.
Metcalf CD, Robinson R, Malpass AJ, Bogle TP, Dell TA, Harris C, Demain SH: 
Markerless motion capture and measurement of hand kinematics: validation and 
application to home-based upper limb rehabilitation. IEEE Transactions on Biomedical 
Engineering 2013, 60(8):2184-2192.
2.
Piron L, Tombolini P, Turolla P, Zucconi C, Agostini M, Dam M, Santarello G, Piccione 
F, Tonin P: Reinforced feedback in virtual environment facilitates the arm motor 
recovery in patients after a recent stroke. Virtual Rehabilitation, 2007 2007:121-123.
3.
Adamovich S, Merians A, Boian R, Tremaine M, Burdea G, Recce M, Poizner H: A virtual 
reality (VR)-based exercise system for hand rehabilitation post stroke. Presence 2005, 
14:161-174.
4.
Duncan PW, Wallace D, Lai SM, Johnson D, Embretson S, Laster LJ: The stroke impact 
scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. Stroke 
1999, 30(10):2131-2140.
5.
Merians AS, Poizner H, Boian R, Burdea G, Adamovich S: Sensorimotor training in a 
virtual reality environment: does it improve functional recovery poststroke? 
Neurorehabil Neural Repair 2006, 20(2):252-267.
6.
Wolf SL, Thompson PA, Morris DM, Rose DK, Winstein CJ, Taub E, Giuliani C, Pearson 
SL: The EXCITE trial: attributes of the Wolf Motor Function Test in patients with 
subacute stroke. Neurorehabil Neural Repair 2005, 19(3):194-205.
7.
Wolf S, Winstein C, Miller J, Taub E, Uswatte G, Morris D, Giuliani C, Light K, Nichols-
Larsen D: Effect of constraint-induced movement therapy on upper extremity 
function 3 to 9 months after stroke. JAMA 2006, 296:2095 - 2104.
8.
Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer 
RJ, Wagner TH, Krebs HI, Volpe BT et al: Robot-assisted therapy for long-term upper-
limb impairment after stroke. N Engl J Med, 362(19):1772-1783.
9.
Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S: The post-stroke hemiplegic 
patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med 1975, 
7(1):13-31.
10.
Yozbatiran N, Der-Yeghiaian L, Cramer SC: A standardized approach to performing 
the action research arm test. Neurorehabilitation and Neural Repair 2008, 22(1):78-90.
11.
Fluet GG, Qiu Q, Merians AS, Patel J, Adamovich SV: Neurophysiologic and clinical 
responses  to recovery-oriented virtual rehabilitation of hand function in a person 
with subacute stroke: a case study In: International Conference on Virtual 
Rehabilitation: 2015; Valencia, Spain; 2015: 1-8.
12.
Adamovich S, Fluet GG, Merians AS, Mathai A, Qiu Q: Recovery of hand function in 
virtual reality: Training hemiparetic hand and arm together or separately. Conf Proc 
IEEE Eng Med Biol Soc 2008, 2008:3475-3478.
Pro20160000945
           5/13/2024
           5/12/2025