Robotic Rehabilitation for Stroke Survivors
Conditions: Chronic Stroke
Sponsor: State University of New York at Buffalo

 
Title  
Understanding the efficacy of the robotic rehabilitation of chronic stroke 
patients: pilot testing 
IRB Institution 
University at Buffalo 
IRB Approval period 
12/6/21-12/5/22 

 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federalwide Assurance ID#: FWA00008824 
Page 1 of 37 
 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions ....................................................................................................... 2 
1.0 
Study Summary ........................................................................................................ 4 
2.0 
Objectives* .............................................................................................................. 5 
3.0 
Scientific Endpoints* ............................................................................................... 5 
4.0 
Background* ............................................................................................................ 6 
5.0 
Study Design* .......................................................................................................... 9 
6.0 
Study Intervention/Investigational Agent .............................................................. 10 
7.0 
Local Number of Subjects ..................................................................................... 12 
8.0 
Inclusion and Exclusion Criteria* .......................................................................... 13 
9.0 
Vulnerable Populations* ........................................................................................ 14 
10.0 Eligibility Screening* ............................................................................................ 15 
11.0 Recruitment Methods ............................................................................................. 16 
12.0 Procedures Involved*............................................................................................. 17 
13.0 Study Timelines* ................................................................................................... 19 
14.0 Setting .................................................................................................................... 20 
15.0 Community-Based Participatory Research ............................................................ 21 
16.0 Resources and Qualifications ................................................................................. 21 
17.0 Other Approvals ..................................................................................................... 22 
18.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 22 
19.0 Data Management and Analysis* .......................................................................... 23 
20.0 Confidentiality* ..................................................................................................... 24 
A. 
Confidentiality of Study Data ......................................................................... 24 
B. 
Confidentiality of Study Specimens ................................................................ 25 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 26 
22.0 Withdrawal of Subjects* ........................................................................................ 27 
23.0 Risks to Subjects* .................................................................................................. 28 
24.0 Potential Benefits to Subjects* .............................................................................. 28 
25.0 Compensation for Research-Related Injury ........................................................... 29 
26.0 Economic Burden to Subjects ................................................................................ 29 
27.0 Compensation for Participation ............................................................................. 29 
28.0 Consent Process ..................................................................................................... 30 
29.0 Waiver or Alteration of Consent Process ............................................................... 34 
30.0 Process to Document Consent ............................................................................... 35 
31.0 Multi-Site Research (Multisite/Multicenter Only)*............................................... 35 
32.0 Banking Data or Specimens for Future Use* ........................................................ 37 
 
 
 

 
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IRB Version: 1/23/19 
Template Instructions 
Sections that do not apply: 
• In several sections, the addition of checkboxes for Not Applicable have been 
added to the template as responses.   
o If an N/A checkbox is present, select the appropriate justification 
from the list.   
o If an N/A checkbox is not present, or if none of the existing 
checkboxes apply to your study, you must write in your own 
justification. 
• In addition: 
o For research where the only study procedures are records/chart 
review:  Sections 6, 21, 22, 24, 25, 26 and 27 do not apply. 
o For exempt research:  Section 6 may not apply. Section 6.1 will 
still apply if there is a study intervention. 
 
Studies with multiple participant groups: 
 
• If this study involves multiple participant groups (e.g. parents and children), 
provide information in applicable sections for each participant group. Clearly 
label responses when they differ.  For example: 
Response Example 
Intervention Group:  
Control Group: 
Formatting: 
• Do not remove template instructions or section headings when they do not apply 
to your study. 
If you are pasting information from other documents using the “Merge Formatting” 
Paste option will maintain the formatting of the response boxes. 
Amendments: 
• When making modifications or revisions to this and other documents, use the 
Track Changes function in Microsoft Word. 
• Update the version date or number on Page 3. 
 
 

 
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PROTOCOL TITLE: 
Include the full protocol title. 
Response: Pilot study on the physiological response of robotic rehabilitation 
therapy for improving the performance of ADLs of stroke patients 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response:  
Nikhil Tej Kantu 
Dept. of Mechanical and Aerospace 
Room 809 Furnas Hall, Buffalo, NY 14260 
Phone: 716-645-1459 
nikhilte@buffalo.edu 
VERSION NUMBER/DATE: 
Include the version number and date of this protocol. 
Response: version 2, 12-29-2021 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
12/29/2021 
Modification 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FUNDING: 
Indicate any funding for this proposal. This should match the Funding Sources 
page in Click IRB. 
Response: N/A 
 
GRANT APPLICABILITY: 

 
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Indicate whether this protocol is funded by a grant (e.g. NIH, foundation grant).  
For a grant with multiple aims, indicate which aims are covered by this research 
proposal. 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission.     
Response: N/A 
 
RESEARCH REPOSITORY: 
Indicate where the research files will be kept, including when the study has been 
closed.  The repository should include, at minimum, copies of IRB 
correspondence (approval, determination letters) as well as signed consent 
documents.  This documentation should be maintained for 3 years after the study 
has been closed.   
Response: The copies of IRB correspondence or signed consent forms will be 
stored in a locked cabinet located in Furnas Hall Room 809. Only personnel 
related to the project will have access to the document. 
Location: Cabinet with key access 
Address: Room 809 Furnas Hall, Buffalo, NY 14260  
Department: Dept of Mechanical and Aerospace Engineering 
1.0 Study Summary 
 
Study Title 
Understanding the efficacy of the robotic rehabilitation of 
chronic stroke patients: pilot testing 
Study Design 
This pilot randomized controlled trial study will provide the 
efficacy of robotic rehabilitation for practicing activities of 
daily living. The study will compare the range of motion of 
robotic therapy and the activities of daily living.  
Primary Objective 
Range of motion data for activities daily living and the same 
tasks performed in the robotic device will be compared.  
Also, EMG and IMU (Inertial Measurement Unit) data will 
be collected during the robotic task to understand the 
physiological effect of the robot on adults.  
Secondary 
Objective(s) 
The efficacy of the virtual reality during robotic therapy will 
be studied along with the primary objective.  
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
This study includes manipulation of a robotic device to 
perform a task that is similar to activities of daily living such 
as turning a pickle jar, pouring water from a pitcher, etc. 
IND/IDE #  
N/A 
Study Population 
Chronic stroke 
Sample Size 
40 

 
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Study Duration for 
individual 
participants 
2 Years 
Study Specific 
Abbreviations/ 
Definitions  
 sEMG: surface electromyography 
 IMU: Inertial Measurement Unit 
 ADL: active daily living 
 DOF: degree of freedom 
 SPINDLE: Spherical parallel instrument for Daily Living 
Emulation (Robotic device for occupational therapy) 
2.0 Objectives* 
2.1 Describe the purpose, specific aims, or objectives of this research. 
Response:  
(1) Investigate the movement and surface electromyography when performing 
activities of daily living using a robotic emulator  
(2) Compare the range of motion of activities of daily living to the range of 
motion of robotic emulator 
(3) Investigate the efficacy of the virtual reality in addition to the robotic therapy 
to promote enhancing the performance of activities during daily living  
 
2.2 
State the hypotheses to be tested, if applicable. 
NOTE:  A hypothesis is a specific, testable prediction about what you expect to 
happen in your study that corresponds with your above listed objectives. 
Response:  
(1) We hypothesized that physiological response (ex. range of motion) during 
activities of daily living in robotic therapy is similar to the actual activities of 
daily living.  
(2) We hypothesized that virtual reality would improve the training effect of 
robotic therapy to learn the new movement of stroke patients.  
 
3.0 Scientific Endpoints* 
 
2.1    Describe the scientific endpoint(s), the main result or occurrence under 
study.   
 
NOTE:  Scientific endpoints are outcomes defined before the study begins to determine 
whether the objectives of the study have been met and to draw conclusions from the data.  
Include primary and secondary endpoints.  Some example endpoints are:  reduction of 
symptoms, improvement in quality of life, or survival.  Your response should not be a 
date.   
Response: The two primary outcome measures will be the motion and the muscle 
activation data of the upper body during active daily living tasks with and without 
the rehabilitation robot. Motion trajectory using a motion capture system will be 

 
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averaged for all subjects to understand the nominal pattern during each active 
daily living. Using the collected data set, the baseline of range of motion, 
smoothness, task duration, and the number of sub movements will be established. 
Surface electromyography data will be recorded and post-processed on the upper 
limb and trunk to identify a nominal activation pattern of the upper body with the 
correlation of the joint angle trajectory. The same data set will be created when 
individuals perform identical tasks with the robot and virtual reality system. In 
addition, the hand posture will be recorded from the motor encoder of the robot 
system. 
 
4.0 Background* 
4.1 Provide the scientific or scholarly background, rationale, and significance 
of the research based on the existing literature and how it will contribute to 
existing knowledge.  Describe any gaps in current knowledge. Include 
relevant preliminary findings or prior research by the investigator.  
Response: About 6.6 million individuals in the United States suffer from stroke-
related motor impairments[1]. Patients with stroke often lose function of their 
upper limbs and have difficulty performing activities of daily living (ADLs). The 
first three months after the onset of stroke falls within a crucial time window as 
most of the arm recovery happens by spontaneous neurologic recovery during this 
period[2]. During this acute stage, motor learning may help improve motor 
impairment and facilitate recovery[3]. Occupational therapy (OT) services are 
often utilized to remediate or restore the function of the upper limbs. However, 
even after the completion of standard therapy, up to 75% of individuals 
experience continuous challenges with ADLs. These residual impairments 
affecting ADLs indicate that OT may only have been moderately effective in 
improving ADLs outside of the hospital or clinic setting[4]. Improvement of 
motor function for ADLs may occur through more intensive therapy.  
 
Robotic interventions have been developed in the past to satisfy the high-intensity 
and repeated training. Many robotic interventions have been successful in 
improving upper limb motor scores and strength[5-8], but the consensus in 
literature demonstrates that these improvements do not always transfer to the 
performance of ADLs[7]. There are three potential reasons for the limited transfer 
of robotic training to ADL performance. First, the current robotic therapy has 
focused more on the individual training of either proximal or distal arm joints. 
However, simultaneous training of proximal and distal joints is essential to 
perform daily living tasks[9][10]. Second, many robotic interventions focused on 
reaching tasks that are different from object manipulation. Many ADLs include 
manipulation tasks that require complicated three-dimensional hand posture 
changes. Third, robotic training sessions are often limited to patients in clinical 
settings because robotic systems are bulky and expensive, which makes the home-
use challenging.   
 
In our work, we designed a new training strategy using a parallel manipulator, 

 
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named Spherical Parallel Instrument for Daily Living Emulation (SPINDLE). The 
design is inspired by the well-known agile eye structure, which has a 3-RRR 
structure that enables three-dimensional rotations[11][12]. By using a 3-RRR 
parallel structure, this device features high stiffness, precise manipulation, and 
low inertia. This device will mimic activities of daily living tasks, including 
complicated object manipulation tasks. This device will interact with the user, and 
provide a compact table-top device with high torque and wide range of motion 
compared to off-the-shelf devices. This portable device will allow patients to train 
not only in the clinic but also at home or in community centers. Moreover, 
SPINDLE lets users explore and interact with the device like an external object 
similar to the daily living environment.  
 
Using virtual reality (VR) for stroke rehabilitation is not a novel method. As early 
as decades ago, VR became an essential tool to enhance rehabilitation along with 
traditional methods. In 2001, a personal computer-based VR system was 
developed to recover hand function for stroke patients. This system utilized four 
routines which corresponded to four specific components of hand movements: 
range, speed, fractionation, and strength. This system proved to be an excellent 
addition to the traditional rehabilitation tools, as shown in the outcome of 
patients[13]. However, the VR routines were simple in design and might not be 
engaging enough for patients to follow in the long term. Around a year later, 
another study was conducted to observe the effect of VR on foot-based 
interactions. This time two VR exercises were created to be based on real-life 
situations and objects[14]. Nonetheless, there still could be improvements for the 
exercises to be more engaging. The need for change in VR rehabilitation led to a 
shift to VR gaming as a means to keep patients motivated. In 2008, a handheld 
stylus was provided for patients to play a list of VR games, such as tennis and 
archery, as part of the rehabilitation routine[15]. This approach, nevertheless, 
limited the range of motion as patients had to stand in front of a VR activity 
station in order to play the games. In later years, the emergence of enhanced VR 
devices and systems such as Wii gaming system and Xbox Kinect allowed VR 
rehabilitation to overcome these challenges[16][17][21]. The exercises in VR also 
became more similar to real-life activities such as sports, cooking, and home 
cleaning, which made the rehabilitation more enjoyable as well as 
practical[16][18][20][21][22]. In addition, there was a shift from using off-the-
shelf VR games (e.g. sports games created by Wii) to using more customized 
games[18][20][21]. However, the activities in current VR rehabilitation routines 
are still limited in diversity and range of motions. 
4.2 Include complete citations or references.  
Response: 
[1] Benjamin EJ, Blaha MJ, Chiuve SE et al. Heart disease and stroke statistics-
2017 update: a report from the american heart association. Circulation 2017; 
135(10): e146e603.  
[2] Kwakkel G, Kollen B and Twisk J. Impact of time on improvement of 
outcome after stroke. Stroke 2006; 37(9): 23482353.  

 
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[3] Duncan P, Studenski S, Richards L et al. Randomized clinical trial of 
therapeutic exercise in subacute stroke. Stroke 2003; 34(9): 21732180.  
[4] Sturm JW, Dewey HM, Donnan GA et al. Handicap after stroke: how does it 
relate to disability, perception of recovery, and stroke subtype? the north east 
melbourne stroke incidence study (NEMESIS). Stroke 2002; 33(3): 762768.  
[5] Mehrholz J, Haadrich A, Platz T et al. Electromechanical and ¨ robot-assisted 
arm training for improving generic activities of daily living, arm function, and 
arm muscle strength after stroke. Cochrane database of systematic reviews 2012; 
4(6).  
[6] Prange G, Jannink M, Groothuis-Oudshoorn C et al. Systematic review of the 
effect of robot-aided therapy on recovery of the hemiparetic arm after stroke. 
Journal of rehabilitation research and development 2009; 43(2): 171 184.  
[7] Kwakkel G, Kollen BJ and Krebs HI. Effects of robot-assisted therapy on 
upper limb recovery after stroke: a systematic review. Neurorehabilitation and 
neural repair 2008; 22(2): 111121.  
[8] Lo AC, Guarino PD, Richards LG et al. Robot-assisted therapy for long-term 
upper-limb impairment after stroke. New England Journal of Medicine 2010; 
362(19): 17721783.  
[9] Oujamaa L, Relave I, Froger J et al. Rehabilitation of arm function after 
stroke. literature review. Annals of physical and rehabilitation medicine 2009; 
52(3): 269293.  
[10] Timmermans AA, Seelen HA,Willmann RD et al. Technologyassisted 
training of arm-hand skills in stroke: concepts on reacquisition of motor control 
and therapist guidelines for rehabilitation technology design. Journal of 
neuroengineering and rehabilitation 2009; 6(1): 1.  
[11] Gosselin C, Sefrioui J and Richard MJ. On the direct kinematics of spherical 
three-degree-of-freedom parallel manipulators with a coplanar platform. Journal 
of Mechanical Design 1994; 116(2): 587593.  
[12] Gosselin CM, Pierre ES and Gagne M. On the development of the agile eye. 
IEEE Robotics & Automation Magazine 1996; 3(4): 2937. 
 [13] Jack, D., Boian, R., Merians, A., Tremaine, et al. (2001). Virtual reality-
enhanced stroke rehabilitation. IEEE Transactions on Neural Systems and 
Rehabilitation Engineering, 9(3), 308-318. doi:10.1109/7333.948460 
[14] Boian, R., Deutsch, J., Lee, C. S., Burdea, G., & Lewis, J. Haptic effects for 
virtual reality-based post-stroke rehabilitation. 11th Symposium on Haptic 
Interfaces for Virtual Environment and Teleoperator Systems, 2003. HAPTICS 
2003. Proceedings. doi:10.1109/haptic.2003.1191289 
[15] Broeren, J., Bjorkdahl, A., Claesson, L., Goude, et al.. Virtual Rehabilitation 
after Stroke. Organizing Committee of MIE 2008. 
[16] Saposnik, G., Mamdani, M., Bayley, et al. Effectiveness of Virtual Reality 
Exercises in STrokeRehabilitation(EVREST): Rationale, Design, and Protocol of 

 
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a Pilot Randomized Clinical Trial Assessing the Wii Gaming System. 
International Journal of Stroke, 5(1), 47-51.  
[17] Saposnik, G., Teasell, R., Mamdani, M., Hall, J., Mcilroy, W., Cheung, D., 
Bayley, M. (2010). Effectiveness of Virtual Reality Using Wii Gaming 
Technology in Stroke Rehabilitation. Stroke, 41(7), 1477-1484.  
[18] Turolla, A., Dam, M., Ventura, L., Tonin, P., Agostini, M., Zucconi, C.,  
Piron, L. (2013). Virtual reality for the rehabilitation of the upper limb motor 
function after stroke: A prospective controlled trial. Journal of NeuroEngineering 
and Rehabilitation, 10(1), 85.  
[19] Shin, J., Ryu, H., & Jang, S. (2014). A task-specific interactive game-based 
virtual reality rehabilitation system for patients with stroke: A usability test and 
two clinical experiments. Journal of NeuroEngineering and Rehabilitation, 11(1), 
32.  
[20] Samuel, G., Oey, N., Choo, M., Ju, H., Chan, W., Kok, S., Ng, Y. (2017). 
Combining levodopa and virtual reality-based therapy for rehabilitation of the 
upper limb after acute stroke: Pilot study Part II. Singapore Medical Journal, 
58(10), 610-617.  
[21] Aşkın, A., Atar, E., Koçyiğit, H., & Tosun, A. (2018). Effects of Kinect-
based virtual reality game training on upper extremity motor recovery in chronic 
stroke. Somatosensory & Motor Research, 35(1), 25-32.  
[22] Warland, A., Paraskevopoulos, I., Tsekleves, E., Ryan, J., Nowicky, A., 
Griscti, J., Kilbride, C. (2018). The feasibility, acceptability and preliminary 
efficacy of a low-cost, virtual-reality based, upper-limb stroke rehabilitation 
device: A mixed methods study. Disability and Rehabilitation, 41(18), 2119-2134. 
[23] Wu P, Zeng F, Li YX, et al. Changes of resting cerebral activities in subacute 
ischemic stroke patients. Neural Regen Res. 2015;10(5):760-765. 
doi:10.4103/1673-5374.156977 
[24] P. He, B. Xu and J. Kang, "Spherical Parallel Instrument for Daily Living 
Emulation (SPINDLE) to Restore Motor Function of Stroke Survivors," 2020 8th 
IEEE RAS/EMBS International Conference for Biomedical Robotics and 
Biomechatronics (BioRob), 2020, pp. 364-369, doi: 
10.1109/BioRob49111.2020.9224451. 
5.0 Study Design* 
5.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response:  
The experiment will consist of four different sets of patient groups. All the 
patients will perform the natural ADLs before the experiment and after the 
experiments. The patients will be randomly assigned to the below four groups 
such that the total number of each group A-D will be identical: 

 
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1) Group A: Active assistive robotic therapy experiment 
Ten chronic stroke patients will conduct tasks similar to representative ADL 
tasks with the robotic device, and assistive force will be provided by the 
electrical motors to guide their hand to complete daily living tasks.  
2) Group B: Active resistive robotic therapy experiment 
Ten chronic stroke patients will conduct tasks similar to representative ADL 
tasks with the robotic device, and resistive force will be provided by the 
electrical motors to guide their hand to complete daily living tasks.  
3) Group C: Active assistive virtual robotic therapy experiment 
Ten chronic stroke patients will conduct representative ADL tasks with the 
assistive force will be provided by the robotic device and virtual reality 
goggle. Head-mounted goggle will be used to visualize the starting and goal 
point of the task.  
4) Group D: Active resistive virtual robotic therapy experiment 
Ten chronic stroke patients will conduct representative ADL tasks with the 
resistive force will be provided by the robotic device and virtual reality 
goggle. Head-mounted goggle will be used to visualize the starting and goal 
point of the task.  
Four studies will be designed using the above four groups.  
1) Compare Group A and B: the physiological measures (movement and sEMG 
signals) of ADLs in the robotic device with resistive versus assistive forces 
will be compared by performing same ADL tasks. 
2) Compare Group A and C: the physiological measures (movement and sEMG 
signals) of ADLs during the robotic device with assistance force, with and 
without virtual reality will be compared by performing same ADL tasks.  
3) Compare Group B and D: the physiological measures (movement and sEMG 
signals) of ADLs during the robotic device with resistance force, with and 
without virtual reality will be compared by performing same ADL tasks.  
4) Compare Group C and D: the physiological measures (movement and sEMG 
signals) of ADLs in the robotic device with resistive versus assistive forces, 
with virtual reality will be compared by performing same ADL tasks. 
6.0 
Study Intervention/Investigational Agent 
1.1 Description: Describe the study intervention and/or investigational 
agent (e.g., drug, device) that is being evaluated. 
Response:  
Spherical Parallel Instrument for Daily Living Emulation (SPINDLE) is a robotic 
rehabilitation device for stroke patients who needs more intense manipulation 
practice. The device was developed by Dr. Jiyeon Kang and students who are 
involved in this study from University at Buffalo. It is a compact table-top device 
that enables stroke patients to train diverse activities of daily living training and 
increase the time of occupational therapy at home. With SPINDLE, you can 

 
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simulate daily living activities such as opening a jar, pouring water, turning the 
key, or flipping a book page by manipulating the handle of the device. The 
structure of SPINDLE consists of 3D printed links and three motors. Each motor 
has an encoder that can track the device handle. Three motors of SPINDLE give 
the proper resistant force based on different activities. The user can feel up to 39 
N when holding in the middle of the handle, which covers most of the daily living 
activities we can experience in daily life.  Using the robotic device, subjects can 
practice up to 180-degree rotations in three rotational axes. SPINDLE will 
provide users a tremendous convenience and an efficient home-based recovery 
method, helping users improve the quality of life and reduce the risk of exposure 
to COVID-19. In addition to SPINDLE, we will use an off-the-shelf virtual reality 
device Vive Pro (HTC, Taiwan). The user needs to wear the wireless goggles and 
can have three dimensional visual experience. For some groups, this virtual reality 
goggle will be used to promote the training effect which is demonstrated by other 
stroke related studies.  
 
 
 
6.1 Drug/Device Handling: If the research involves drugs or device, 
describe your plans to store, handle, and administer those drugs or 
devices so that they will be used only on subjects and be used only by 
authorized investigators. 
• 
If the control of the drugs or devices used in this protocol will 
be accomplished by following an established, approved 
organizational SOP (e.g., Research Pharmacy SOP for the 
Control of Investigational Drugs, etc.), please reference that 
SOP in this section. 
Response: SPINDLE will be stored in Furnas 809 or at UBMD where the study 
will be conducted. Only researchers in this study have access to the device. The 
device will be handled only by the researchers who are included in this study who 
have enough knowledge to operate the device. Dr. Jiyeon Kang will make sure 
that researchers are properly trained before the device is used by the subjects.  
 
6.2 If the drug is investigational (has an IND) or the device has an IDE 
or a claim of abbreviated IDE (non-significant risk device), include 
the following information: 
• 
Identify the holder of the IND/IDE/Abbreviated IDE. 
• 
Explain procedures followed to comply with sponsor 
requirements for FDA regulated research for the following: 

 
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Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
Response: This is a Non-significant Risk device according to 21 CFR 812.2(b). 
- 
The risk of the device is minimal: repeated training with/without the robot can 
be fatiguing subjects. There is a higher chance for the resistive force group 
subjects. Some subjects who are assigned to the virtual reality group may feel 
dizzy. If this is the case, the participant is withdrawn from the study 
immediately.  
- 
The device is NON-INVASIVE: the subject will only hold the handle of the 
device during tasks similar to activities of daily living. 
- 
This is NOT a drug study. 
- 
Biologic samples are NOT collected. 
 
7.0 Local Number of Subjects 
7.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response: 40 (Chronic stroke) 
 
7.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response: 100 (Screen failure rate will be due to vision/cognitive/auditory 
capability to perform survey or other exclusion criteria. Patients with hemorrhage 
stroke and Aphasia will also fall in the exclusion criteria for this study. These 
above capabilities and conditions are assessed by the professional clinicians) 
7.3 Justify the feasibility of recruiting the proposed number of eligible subjects 
within the anticipated recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit? 
Response:  
We typically see between 200-300 patients with stroke in a 4 weeks period at 
Buffalo General Medical Center (BGMC) and UBMD Neurology clinic. 
Assuming a conservative 10% of those patients are interested or eligible for the 

 
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study, the expected number of patients recruited over a 2 years period is around 
500.  
This study also includes chronic stroke participants. As this study will be 
conducted in a college, recruiting 40 subjects will be feasible considering two 
years of study duration. 
 
8.0 Inclusion and Exclusion Criteria* 
8.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
Response:  
1) Stroke participants (40): Episode of single ischemic stroke past six 
months (chronic stroke) [23] and over 18 years old. Medically and 
neurologically stable as assessed by medical history. 
8.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:  
Stroke patients who are in serious uncontrolled medical conditions; excessive pain 
in any joint of the more affected extremity that could influence participation in the 
tasks; impossibility to perform at least two tasks with the shortest trajectories in 
the pre-test of SPINDLE; 45º of shoulder flexion and 45º of elbow flexion to be 
able to use SPINDLE; dizziness and discomfort by using a virtual reality system. 
Patients with hemorrhage stroke are excluded as we are targeting homogenous 
patientgroup as we are only targeting ischemic stroke patients (who are affected 
blood clot in their brain arteries). We also exclude Aphasia patients as they will 
be having difficulty in understanding the training process. Once the screening 
process is completed, participants will undergo practice trials with SPINDLE to 
ensure their comfort to manipulate the device. 
 
8.3  Indicate specifically whether you will include any of the following special 
populations in your study using the checkboxes below.   
 
NOTE:  Members of special populations may not be targeted for enrollment in 
your study unless you indicate this in your inclusion criteria. 
Response:   
☐ 
Adults unable to consent 
☐ 
Individuals who are not yet adults (infants, children, teenagers) 
☐ 
Pregnant women 

 
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☐ 
Prisoners 
 
8.4 Indicate whether you will include non-English speaking individuals in your 
study.  Provide justification if you will exclude non-English speaking 
individuals.  
In order to meet one of the primary ethical principles of equitable selection 
of subjects, non-English speaking individuals may not be routinely excluded 
from research as a matter of convenience. 
In cases where the research is of therapeutic intent or is designed to 
investigate areas that would necessarily require certain populations who 
may not speak English, the researcher is required to make efforts to recruit 
and include non-English speaking individuals.  However, there are studies 
in which it would be reasonable to limit subjects to those who speak 
English.  Some examples include pilot studies, small unfunded studies with 
validated instruments not available in other languages, studies with 
numerous questionnaires, and some non-therapeutic studies which offer no 
direct benefit. 
Response: We will exclude non-English speaking individuals. All instructions 
should be equally provided to the user for consistency. There will be no benefit or 
therapeutic effect related to this study. 
 
9.0 Vulnerable Populations* 
If the research involves special populations that are considered vulnerable, 
describe the safeguards included to protect their rights and welfare.   
NOTE: You should refer to the appropriate checklists, referenced below, to ensure you 
have provided adequate detail regarding safeguards and protections. You do not, 
however, need to provide these checklists to the IRB. 
9.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: 
  
☒ 
N/A:  This research does not involve pregnant women. 
9.2 For research that involves neonates of uncertain viability or non-viable 
neonates, safeguards include: 
NOTE CHECKLISTS: Non-Viable Neonates (HRP-413), or Neonates of Uncertain 
Viability (HRP-414) 
Response:  
 

 
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☒ 
N/A:  This research does not involve non-viable neonates or neonates of 
uncertain viability. 
9.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
 
☒ 
N/A:  This research does not involve prisoners. 
9.4 For research that involves persons who have not attained the legal age for 
consent to treatments or procedures involved in the research (“children”), 
safeguards include:   
NOTE CHECKLIST: Children (HRP-416) 
Response:  
 
☒ 
N/A:  This research does not involve persons who have not attained the 
legal age for consent to treatments or procedures (“children”). 
9.5 For research that involves cognitively impaired adults, safeguards include: 
NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  
 
☒ 
N/A:  This research does not involve cognitively impaired adults. 
9.6 Consider if other specifically targeted populations such as students, 
employees of a specific firm, or educationally or economically 
disadvantaged persons are vulnerable.  Provide information regarding 
their safeguards and protections, including safeguards to eliminate 
coercion or undue influence. 
Response:  
 
☒ 
N/A:  This research does not involve students, employees of a specific 
firm or economically or disadvantaged persons. 
10.0 
Eligibility Screening* 
10.1 Describe screening procedures for determining subjects’ eligibility.  
Screening refers to determining if prospective participants meet inclusion and 
exclusion criteria.  
Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaire).  
Response:   
For stroke participants, Clinician will evaluate cognitive ability by chart review 
and then, answering the questionnaire of a screening sheet (see stroke 
criteria.docx). Hearing issues will be evaluated by asking questions and 

 
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answering. Visual issues will be evaluated by asking them to read the first part of 
the questionnaire. Prior to the participation of the training, participants will try 
to manipulate SPINDLE to check the required range of motion to perform task.   
 
Data will be only collected from screened participants.  
 
 
 
 
☐ 
N/A:  There is no screening as part of this protocol. 
11.0 
Recruitment Methods 
☐ 
N/A:  This is a records review only, and subjects will not be 
recruited.  NOTE:  If you select this option, please make sure that 
all records review procedures and inclusion/exclusion screening 
are adequately described in other sections. 
11.1 Describe when, where, and how potential subjects will be recruited.  
NOTE:  Recruitment refers to how you are identifying potential participants and 
introducing them to the study.  Include specific methods you will use (e.g. 
searching charts for specific ICD code numbers, Research Participant Groups, 
posted advertisements, etc.). 
Response:  
For stroke patients, potential subjects will be recruited at Buffalo General Medical 
Center at 100 High Street, Buffalo, NY, 14203, UBMD Neurology clinic at 5851 
Main Street, Williamsville, NY, 14221, and UBMD Neurology clinic at 
conventus, 1001 Main Street, 4th floor. Buffalo, NY, 14203. All patients with 
stroke get an evaluation by the stroke service. Potential participants will be 
recruited/informed about the research opportunity during a routine clinical 
encounter by clinician who will be the part of the research team.  Should the 
subject be interested, a detailed description of the study from the consent 
document will be provided verbally and in writing and consent will be obtain. 
 
11.2 Describe how you will protect the privacy interests of prospective subjects 
during the recruitment process.   
NOTE:  Privacy refers to an individual’s right to control access to him or herself.   
Response: Before explaining the experiment to the potential participants, the 
examiner will ask the question of whether she or he is interested in participating 
in this research and want to hear more about the details of the study. The 
researcher will emphasize that participation in this study is voluntary, and subjects 
may withdraw at any time with no consequences. Also, the researcher will explain 

 
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that there will be a video recording upon the participant’s consent. The researcher 
will explain that the participant does not have to agree to record videos, if they 
wish to participate in the study only. The recruitment process will be conducted 
by clinician during the routine check-up. The recruitment process will be 
performed in a private room of BGMC or UBMD Neurology clinic. 
 
11.3 Identify any materials that will be used to recruit subjects.  
NOTE:  Examples include scripts for telephone calls, in person announcements / 
presentations, email invitations.  
For advertisements, include the final copy of printed advertisements with your 
submission. When advertisements are taped for broadcast, attach the final 
audio/video tape.  NOTE:  You may submit the wording of the advertisement prior 
to taping to ensure there will be no IRB-required revisions, provided the IRB also 
reviews and approves the final version. 
 Response:  
Participants will be recruited by stroke team at BGMC or UBMD Neurology 
clinic.  
 
12.0 
Procedures Involved* 
12.1 Provide a description of all research procedures or activities being 
performed and when they are performed once a subject is screened and 
determined to be eligible. Provide as much detail as possible.   
NOTE:  This should serve as a blueprint for your study and include enough detail 
so that another investigator could pick up your protocol and replicate the research.  
For studies that have multiple or complex visits or procedures, consider the 
addition of a schedule of events table in in your response. 
Response:  
Participants will be asked to wear comfortable clothing that won’t restrict their 
natural movement. Prior to the data collection, participants will be asked whether 
they consent or dissent to the video recording. Participant will be randomly 
assigned to a specific group using Matlab function, but the researcher will assign 
them to a different group manually if one group has too many participants compared 
to the other one. Participants are required to wear reflective markers on the whole 
body to record the motion by a Vicon motion capture system. Markers will be 
attached on the skin or clothes until they are visible to Vicon system. Similarly, 
Delsys surface electromyography sensors with embedded IMU are attached to the 
skin of the participant to record the muscle activation during the active daily living. 
These sensors are frequently used in clinical trials where study requires human gait 
analysis and muscle activation analysis. Participants who only provided written 
consent to the video recording will be recorded during full trials. Study team 
members will show tutorial video recordings of each activity and will also perform 
live demonstration to help the participant to understand the task. Later, participant 

 
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will practice task trials for about 5 minutes until they feel comfortable to conduct 
the experiment with the robotic device or the virtual reality goggle. Representative 
active daily living tasks will be chosen and ask the participant to repeat each task 
for 10 times. There will be 5 minutes of break provided between tasks. After 
finishing six representative active living tasks, the study will be completed and the 
participant can leave the study. Examples of the representative active daily tasks 
are as follows (Engdahl 2019): 
1. Screwing a lightbulb: Participants will have a lightbulb on the table in front of 
them that is parallel to the table’s surface and 75% of arm’s length away from the 
torso. The subject will perform 3 twists counterclockwise, unscrewing the lightbulb 
from the socket, and will then, performing 3 clockwise twists, screw the lightbulb 
back into the socket.  
2. Screwing a screw: Participants will use a screwdriver to screw a screw into a 
board flat on the table. The subject will first unscrew the screw with 3 
counterclockwise twists and then screw the screw back in with 3 clockwise twists. 
3. Drinking water: Participants will first have to reach forward and grasp the cup 
that is 75% of the arm length from the torso. The subject will then bring the cup to 
their mouth to mimic drinking water from the cup. 
4. Hammer a nail: Participants will first pick up the hammer that lies next to the 
striking area. The subject will then hammer the area marked as the striking area 3 
times. 
5. Throwing out the trash: Participants will first grasp a piece of paper crumpled 
into a ball that is next to them on the table. They will then throw the piece of 
paper with an overhand throw into a garbage can that is 6 feet away.  
6. Combing Hair: Participants will hold a comb when they start the test. They will 
then comb their hair from back to front 3 times. The subject will then restart the 
task, but will comb their hair from front to back 3 times. 
Except for the control group, the participant will hold the handle and conduct 
representative daily livings tasks similar to the above examples. The starting and 
the ending posture of each task will be visually described on a computer monitor. 
Depending on the group, participants will receive different types of forces. The 
passive group only receives only a small force to overcome the friction of the 
device. The active resistance group will receive a small resistance to provide 
small challenges to perform the task. The active assistance group will receive 
assistive force from the robotic device similar to the following publication:  
J. Kang, S. Logan, J. C. Galloway, and S. K. Agrawal, “A chase-game to teach 
children on a robot to follow moving objects," in IEEE International Conference 
on Robotics and Automation (ICRA), 2014, pp. 234–239.  
The virtual reality group will wear a HTC Vive Pro Head mount device instead of 
using a computer monitor for indicating the starting and ending posture. The head 
strap will be adjusted to fit the head-mounted device to the user. Before the 
experiment, ten minutes of adjusting time will be provided to the user to ensure 
they do not feel dizzy by wearing the virtual reality device.  

 
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12.2 Describe what data will be collected.   
NOTE:  For studies with multiple data collection points or long-term follow up, 
consider the addition of a schedule or table in your response. 
Response: This experiment is a single session study. Reflective, sEMG, and IMU 
(Inertial Measurement Unit) data will be collected. In addition, the device 
movement from embedded encoders of the robotic device. All data will be 
collected during the same day. The video of trials will be recorded for only 
participants who agreed to take the recording. 
 
12.3 List any instruments or measurement tools used to collect data 
(e.g. questionnaire, interview guide, validated instrument, data collection 
form).   
 
Include copies of these documents with your submission. 
Response: Vicon motion capture system, Delsys Trigno sEMG system, and HTC 
Vive Pro virtual reality system will be used in this study. A robotic device, named 
SPINDLE, will be used by stroke participants as a potential intervention for 
stroke patients. (please see the attached document for robotic rehabilitation device 
- SPINDLE) 
12.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response: N/A 
 
12.5 Indicate whether or not individual subject results, such as results of 
investigational diagnostic tests, genetic tests, or incidental findings will be 
shared with subjects or others (e.g., the subject’s primary care physician) 
and if so, describe how these will be shared. 
Response: The experimental result will not be shared with the subjects. 
 
12.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
Response: Anonymous, aggregated results may be shared as posters, 
presentations, or publications. 
13.0 
Study Timelines* 
13.1 Describe the anticipated duration needed to enroll all study subjects. 
Response: All data will be collected in two years of a time window. 

 
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13.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response: Maximum of four hours will be used to collect the data 
 
13.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
Response: We expect to collect and analyze the data within two years. 
 
14.0 
Setting 
14.1 Describe all facilities/sites where you will be conducting research 
procedures.  Include a description of the security and privacy of the 
facilities (e.g. locked facility, limited access, privacy barriers).  Facility, 
department, and type of room are relevant.  Do not abbreviate facility 
names.   
NOTE:  Examples of acceptable response may be:  “A classroom setting in the 
Department of Psychology equipped with a computer with relevant survey 
administration software,” “The angiogram suite at Buffalo General Medical 
Center, a fully accredited tertiary care institution within New York State with 
badge access,” or, “Community Center meeting hall.” 
Response: A laboratory setting (Furnas Hall  Room 809) in the Department of 
Mechanical and Aerospace Engineering equipped with a Vicon motion capture 
system, Delsys sEMG system, and HTC Vive virtual reality system. A computer 
station can control Vicon, Delsys, and virtual reality system all together 
simultaneously. Research procedures will be also conducted in a private hospital 
room at Buffalo General Medical Center or UBMD Neurology Clinic.  
 
 
 
 
14.2 For research conducted outside of UB and its affiliates, describe: 
• Site-specific regulations or customs affecting the research 
• Local scientific and ethical review structure 
NOTE:  This question is referring to UB affiliated research taking place outside 
UB, i.e. research conducted in the community, school-based research, 
international research, etc.  It is not referring to multi-site research.  UB affiliated 
institutions include Kaleida Health, ECMC, and Roswell Park Cancer Institute.   
Response:  

 
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☒ 
N/A:  This study is not conducted outside of UB or its affiliates. 
15.0 
Community-Based Participatory Research 
15.1 Describe involvement of the community in the design and conduct of the 
research.  
NOTE:  Community-Based Participatory Research (CBPR) is a collaborative 
approach to research that equitably involves all partners in the research process 
and recognizes the unique strengths that each brings.  CBPR begins with a 
research topic of importance to the community, has the aim of combining 
knowledge with action and achieving social change to improve health outcomes 
and eliminate health disparities. 
Response:  
 
☒ 
N/A:  This study does not utilize CBPR. 
15.2 
Describe the composition and involvement of a community advisory 
board. 
Response:  
 
☒ 
N/A:  This study does not have a community advisory board. 
16.0 
Resources and Qualifications 
16.1 Describe the qualifications (e.g., education, training, experience, expertise, 
or certifications) of the Principal Investigator and staff to perform the 
research.  When applicable describe their knowledge of the local study sites, 
culture, and society.  Provide enough information to convince the IRB that 
you have qualified staff for the proposed research.  
NOTE:  If you specify a person by name, a change to that person will require prior 
approval by the IRB.  If you specify a person by role (e.g., coordinator, research 
assistant, co-investigator, or pharmacist), a change to that person will not usually 
require prior approval by the IRB, provided that the person meets the 
qualifications described to fulfill their roles. 
Response:  
Jiyeon Kang (PI) has background on rehabilitation robotics and collected 
biomechanical data of healthy individuals, Parkinson disease, cerebral palsy, and 
cerebellar ataxia patients. Amit Kandel MD. has practice on various stroke 
patients and works in Buffalo General Medical Center. Ghazala Saleem has 
background on occupational therapy and worked with stroke, traumatic injury, 
and pediatric disorder patients. Student researchers will be get involved this study. 
Student researchers who are working in this project finished CITI program 
training to establish a basic knowledge of human subjects research. Amit Kandel 
MD. will be involved in recruitment and consent.  

 
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Describe other resources available to conduct the research.  
16.2 Describe the time and effort that the Principal Investigator and research 
staff will devote to conducting and completing the research. 
NOTE:  Examples include the percentage of Full Time Equivalents (FTE), hours 
per week.  The question will elicit whether there are appropriate resources to 
conduct the research. 
Response: We estimate that the student PI (Nikhil Kantu) will devote 30% of time 
to the study and Co-PIs (Jiyeon Kang, Amit Kandel MD and Ghazala Saleem) 
will devote 10% of their time to the study.  The research assistants will devote 
30% of their time to the study. 
 
 
16.3 Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if 
applicable. 
NOTE:  One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Response: NA. This research only collects the motion and muscle activation data 
during active daily living tasks or perform similar movement in the robotic 
device. There should be no negative medical or psychological consequences 
related to this present study. 
 
16.4 Describe your process to ensure that all persons assisting with the research 
are adequately informed about the protocol, the research procedures, and 
their duties and functions. 
Response: Dr. Kang will train all personnel who will conduct human subject 
studies. Their role will be assigned and informed about the protocol, procedures, 
and duties. Before starting this study, all staff members will run a dry-run test to 
practice their knowledge.  
 
17.0 
Other Approvals 
17.1 Describe any approvals that will be obtained prior to commencing the 
research (e.g., school, external site, funding agency, laboratory, radiation 
safety, or biosafety). 
Response:  
 
☒ 
N/A:  This study does not require any other approvals. 
18.0 
Provisions to Protect the Privacy Interests of Subjects 

 
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18.1 Describe how you will protect subjects’ privacy interests during the course 
of this research. 
NOTE:  Privacy refers to an individual’s right to control access to him or herself.  
Privacy applies to the person.  Confidentiality refers to how data collected about 
individuals for the research will be protected by the researcher from release.  
Confidentiality applies to the data.   
Examples of appropriate responses include:  “participant only meets with a study 
coordinator in a classroom setting where no one can overhear”, or “the 
participant is reminded that they are free to refuse to answer any questions that 
they do not feel comfortable answering.”   
Response: Participants will be assigned an unidentifiable code when analyzing the 
data. During the study, the participant can ask questions anytime. 
18.2 Indicate how the research team is permitted to access any sources of 
information about the subjects.   
NOTE:  Examples of appropriate responses include:  school permission for review 
of records, consent of the subject, HIPAA waiver.  This question does apply to 
records reviews. 
Response: This study does not require any source of information about the 
subjects except the basic anthropomorphic data such as age, height, and weight. 
 
19.0 
Data Management and Analysis* 
19.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Response: The collected motion capture data will be labeled and filtered with a 4th 
order Butterworth filter. All sEMG data will be post-processed by bandwidth 
filter, enveloped, smoothed, and scaled. To define the beginning and the end of 
each repetition, the speed of the markers is used as a threshold. The data will be 
time scaled and averaged over different trials.         
A comparison between the tasks in the physical world and robotic device will be 
performed. A two-way ANOVA will be performed to investigate the significant 
change. Prior to the main analysis, normality assumption will be checked with 
Kolmogorov-Smirnov test. Two-way ANOVA will be performed for different 
tasks and experiment conditions. It will be followed by post-hoc analysis to 
determine whether there is an effect from different tasks that are designed in 
different experimental conditions. The statistical significance will be defined as p 
< 0.05. Programming software, including Matlab, SPSS, and Labview will be 
used for the analysis. 
 
19.2 If applicable, provide a power analysis.   
NOTE:  This may not apply to certain types of studies, including chart/records 
reviews, survey studies, or observational studies.  This question is asked to elicit 

 
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whether the investigator has an adequate sample size to achieve the study 
objectives and justify a conclusion.  
Response: This is an investigational pilot study. No power analysis has been 
performed. 
 
19.3 Describe any procedures that will be used for quality control of collected 
data. 
Response: The post-processed data will be visually investigated whether all the 
procedures were properly applied. Outliers will also be detected during this 
investigation.  
 
20.0 
Confidentiality* 
 
A. Confidentiality of Study Data 
 
Describe the local procedures for maintenance of confidentiality of study data 
and any records that will be reviewed for data collection.   
 
20.1 
A.  Where and how will all data and records be stored?  Include 
information about:  password protection, encryption, physical controls, 
authorization of access, and separation of identifiers and data, as applicable.  
Include physical (e.g. paper) and electronic files. 
Response: All sensors data and videotape will be stored in a lab computer for at 
least 3 years in a password protected folder regarding this project. After the data 
is used in the study, all data will be deleted from the main computer. Only coded 
data will be reported in research papers, conference presentations and 
participating research lab meetings.  
Recorded videos or pictures will be stored and saved by a coded patient identifier 
as well. If the portions of the videotapes and pictures are shown to scientific and 
educational audiences for research and instructional proposes, facial features or 
specific individual identifiers will be not exposed in the tape/picture provided in 
such sessions. Videos or pictures will be saved for three years, and then destroyed 
from the main storage computer. 
 
20.2 
A.  How long will the data be stored? 
Response: All sensors' data and video recording will be stored at least 3 years in a 
password protected folder regarding this project. After the use of the 
data/recording, it will be deleted from the main computer. 
20.3 
A.  Who will have access to the data? 

 
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Response: Only researchers directly involved in the study will have access to this 
data. Access will only be available to those working on the project through 
password protection. 
 
20.4 
A.  Who is responsible for receipt or transmission of the data? 
Response: Only Dr. Jiyeon Kang will be responsible or the receipt or transmission 
of the data. 
 
20.5 
A.  How will the data be transported? 
Response: There is a low probability that data will be transported. But if there is a 
certain need, a password-protected hard drive will be used.  
 
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study 
specimens.   
 
☒ 
N/A:  No specimens will be collected or analyzed in this research.   
(Skip to Section 19.0) 
 
20.6 
B.  Where and how will all specimens be stored?  Include information 
about:  physical controls, authorization of access, and labeling of specimens, as 
applicable.   
Response:  
 
20.7 
B.  How long will the specimens be stored? 
Response:  
 
20.8 
B.  Who will have access to the specimens? 
Response:  
 
20.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response:  
 
20.10 B.  How will the specimens be transported? 
Response: 

 
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21.0 
Provisions to Monitor the Data to Ensure the Safety of 
Subjects* 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
 
NOTE:  Minimal risk studies may be required to monitor subject safety if the research 
procedures include procedures that present unique risks to subjects that require 
monitoring.  Some examples include:  exercising to exertion, or instruments that elicit 
suicidality or substance abuse behavior.  In such cases, N/A is not an acceptable 
response. 
 
21.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 
Response: This is a single session study which only records the motion and 
muscle activation of participants while participants are performing simple daily 
active tasks with or without the robot. The participants will move the robot by 
holding the handle to perform tasks similar to activities of daily living, in addition 
to the virtual reality goggle. The robot has an emergency switch that will be 
operated in case of any kind of emergency. 
After every session study team will review the data to evaluate for no harm 
caused to the participants. There will be regular weekly meeting with the faculty 
to discuss any new adverse effects.  
 
21.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 
Response: N/A 
 
21.3 Describe any safety endpoints. 
Response: N/A 
 
21.4 Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
Response: N/A 
 
21.5 Describe the frequency of safety data collection. 
Response: N/A 
 

 
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21.6 Describe who will review the safety data. 
Response: N/A 
 
21.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response: N/A 
 
21.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response: N/A 
 
21.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response: N/A 
 
22.0 
Withdrawal of Subjects* 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
22.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Response: The active daily living tasks are quite simple and easy to perform for 
individuals. Though highly unlikely, if the participant cannot follow the active 
daily living tasks he or she may be withdrawn from the study. Also, if the 
participant feels dizzy from the virtual reality system, then she/he will be 
withdrawn from the study. 
 
22.2 Describe any procedures for orderly termination.   
NOTE:  Examples may include return of study drug, exit interview with clinician.  
Include whether additional follow up is recommended for safety reasons for 
physical or emotional health. 
Response: An exit interview will be performed if a patient withdrew.  
 
22.3 Describe procedures that will be followed when subjects withdraw from the 
research, including retention of already collected data, and partial 
withdrawal from procedures with continued data collection, as applicable. 
Response: Subjects can leave the research at any time; it will not be held against 
you. If you stop being in the research, already collected data may not be removed 
from the study database. 

 
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23.0 
Risks to Subjects* 
23.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related to their participation in the research. 
Consider physical, psychological, social, legal, and economic risks.  Include 
a description of the probability, magnitude, duration, and reversibility of the 
risks.  
NOTE:  Breach of confidentiality is always a risk for identifiable subject data. 
Response: This research involves minimal risk to participants. Though highly 
unlikely, there can be fatigue by repeating active daily living tasks multiple times 
or manipulating the robot. 
If this is the case, the participant can request a break as much as he/she needs. 
Also, attaching electrodes on the skin can cause mild skin irritation.  
The virtual headset may cause some discomfort such as motion sickness, 
nausea, or other discomforts, while viewing virtual reality content. Once the 
participant expresses discomfort, we will stop the experiment and remove the 
virtual reality headset. These adverse effects are temporary and won’t last for long 
time. 
 
23.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
Response: Researchers who will perform this study will be trained to ask the 
participant if the participant feels fatigued every 15-20 minutes.  
 
23.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response: We do not expect any risk in this experimental procedure. 
 
23.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response: We do not expect any risk in this experimental procedure. 
 
23.5 If applicable, describe risks to others who are not subjects. 
Response: We do not expect any risk in this experimental procedure. 
 
24.0 
Potential Benefits to Subjects* 

 
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24.1 Describe the potential benefits that individual subjects may experience by 
taking part in the research.  Include the probability, magnitude, and 
duration of the potential benefits.  Indicate if there is no direct benefit.   
NOTE:  Compensation cannot be stated as a benefit. 
Response: No direct benefits are expected for subjects in this study.  
 
25.0 
Compensation for Research-Related Injury 
☒ 
N/A:  The research procedures for this study do not present risk of 
research related injury (e.g. survey studies, records review studies).  This 
section does not apply.   
25.1 
If the research procedures carry a risk of research related injury, 
describe the available compensation to subjects in the event that such 
injury should occur.   
Response: 
 
25.2 
Provide a copy of contract language, if any, relevant to compensation for 
research related injury. 
NOTE:  If the contract is not yet approved at the time of this submission, submit the 
current version here.  If the contract is later approved with different language 
regarding research related injury, you must modify your response here and 
submit an amendment to the IRB for review and approval. 
Response:  
 
26.0 
Economic Burden to Subjects 
26.1 
Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
Response: There will be no cost that subjects will be responsible for because of 
participation in the research. 
 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
27.0 
Compensation for Participation 
27.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 
Response:  
 

 
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☐ 
N/A:  This study is not enrolling subjects, or is limited to records 
review procedures only.  This section does not apply. 
☒ 
N/A:  There is no compensation for participation.  This section 
does not apply. 
28.0 
Consent Process 
28.1 Indicate whether you will be obtaining consent.   
NOTE:  This does not refer to consent documentation, but rather whether you will 
be obtaining permission from subjects to participate in a research study.   
Consent documentation is addressed in Section 27.0. 
☒ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 27.0) 
 
28.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 
Response: The consent form is obtained by PI or researchers in the laboratory 
located in Furnas Hall Room 809.  
 
28.3 Describe how you will ensure that subjects are provided with a sufficient 
period of time to consider taking part in the research study.   
NOTE:  It is always a requirement that a prospective subject is given sufficient 
time to have their questions answered and consider their participation.  See “SOP: 
Informed Consent Process for Research (HRP-090)” Sections 5.5 and 5.6. 
Response: The participant will be informed before the consent that he or she can 
use as much as time as he/she needs. Participants will also be informed to be 
allowed to ask questions or withdraw the study when she or he felt discomfort 
during the study.  
 
28.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response: This is a single session study. 
 
28.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-090).” Pay particular attention to Sections 5.4-5.9. If not, 
or if there are any exceptions or additional details to what is covered in the 
SOP, describe: 
• 
The role of the individuals listed in the application who are involved in 
the consent process 
• 
The time that will be devoted to the consent discussion 

 
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• 
Steps that will be taken to minimize the possibility of coercion or 
undue influence 
• 
Steps that will be taken to ensure the subjects’ understanding 
Response:  
 
☒ 
We have reviewed and will be following “SOP: Informed Consent Process 
for Research (HRP-090).” 
 
Non-English Speaking Subjects  
☒ 
N/A:  This study will not enroll Non-English speaking subjects.   
(Skip to Section 26.8) 
28.6 Indicate which language(s) other than English are likely to be 
spoken/understood by your prospective study population or their legally 
authorized representatives. 
 
NOTE: The response to this Section should correspond with your response to 
Section 6.4 of this protocol. 
Response:  
 
28.7 If subjects who do not speak English will be enrolled, describe the process 
to ensure that the oral and written information provided to those subjects 
will be in that language, how you will ensure that subjects are provided with 
a sufficient period of time to consider taking part in the research study, and 
any process to ensure ongoing consent. Indicate the language that will be 
used by those obtaining consent.  
NOTE:  Guidance is provided on “SOP:  Informed Consent Process for Research 
(HRP-090).” 
Response:  
 
 
Cognitively Impaired Adults 
☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 26.9) 
28.8   Describe the process to determine whether an individual is capable of 
consent.  
Response:  
 

 
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Adults Unable to Consent 
☒ 
N/A:  This study will not enroll adults unable to consent.  
(Skip to Section 26.13) 
When a person is not capable of consent due to cognitive impairment, a legally 
authorized representative should be used to provide consent (Sections 26.9 and 
26.10) and, where possible, assent of the individual should also be solicited 
(Sections 26.11 and 26.12). 
28.9  Describe how you will identify a Legally Authorized Representative (LAR).  
Indicate that you have reviewed the “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)” for research in New 
York State.  
NOTE:  Examples of acceptable response includes: verifying the electronic 
medical record to determine if an LAR is recorded. 
Response:  
 
☒ 
We have reviewed and will be following “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).”  
28.10 For research conducted outside of New York State, provide information 
that describes which individuals are authorized under applicable law to 
consent on behalf of a prospective subject to their participation in the 
research. One method of obtaining this information is to have a legal 
counsel or authority review your protocol along with the definition of 
“legally authorized representative” in “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).” 
Response:  
 
28.11 Describe the process for assent of the adults: 
• 
Indicate whether assent will be obtained from all, some, or none of the 
subjects.  If some, indicate which adults will be required to assent 
and which will not. 
Response:  
 
• 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 
Response:  
 

 
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28.12 Describe whether assent of the adult subjects will be documented and the 
process to document assent.   
NOTE:  The IRB allows the person obtaining assent to document assent on the 
consent document using the “Template Consent Document (HRP-502)” Signature 
Block for Assent of Adults who are Legally Unable to Consent. 
Response:  
 
 
Subjects who are not yet Adults (Infants, Children, and Teenagers) 
☒ 
N/A:  This study will not enroll subjects who are not yet adults.   
(Skip to Section 27.0) 
28.13 Describe the criteria that will be used to determine whether a prospective 
subject has not attained the legal age for consent to treatments or 
procedures involved in the research under the applicable law of the 
jurisdiction in which the research will be conducted (e.g., individuals under 
the age of 18 years).  For research conducted in NYS, review “SOP: 
Legally Authorized Representatives, Children, and Guardians (HRP-013)” 
to be aware of which individuals in the state meet the definition of 
“children.”  
NOTE:  Examples of acceptable responses include: verification via electronic 
medical record, driver’s license or state-issued ID, screening questionnaire. 
Response:  
 
28.14For research conducted outside of New York State, provide information 
that describes which persons have not attained the legal age for consent to 
treatments or procedures involved the research, under the applicable law of 
the jurisdiction in which research will be conducted.  One method of 
obtaining this information is to have a legal counsel or authority review 
your protocol along the definition of “children” in “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013).” 
Response:  
 
28.15 Describe whether parental permission will be obtained from: 
Response:  
☐  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the 
child. 

 
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☐ 
Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for 
the care and custody of the child. 
☐ 
Parent permission will not be obtained.  A waiver of parent permission is 
being requested. 
NOTE:  The requirement for parent permission is a protocol-specific determination 
made by the IRB based on the risk level of the research.  For guidance, review the 
“CHECKLIST: Children (HRP-416).”  
28.16Describe whether permission will be obtained from individuals other than 
parents, and if so, who will be allowed to provide permission.  Describe 
your procedure for determining an individual’s authority to consent to the 
child’s general medical care. 
Response:  
 
28.17 Indicate whether assent will be obtained from all, some, or none of the 
children.  If assent will be obtained from some children, indicate which 
children will be required to assent. 
Response:  
 
28.18 When assent of children is obtained, describe how it will be documented. 
Response:  
 
29.0 
Waiver or Alteration of Consent Process 
Consent will not be obtained, required information will not be disclosed, or the 
research involves deception. 
☒ 
N/A:  A waiver or alteration of consent is not being requested. 
29.1 If the research involves a waiver or alteration of the consent process, please 
review the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-
410)” to ensure that you have provided sufficient information for the IRB to 
make the determination that a waiver or alteration can be granted.   
NOTE:  For records review studies, the first set of criteria on the “CHECKLIST: 
Waiver or Alteration of Consent Process (HRP-410)” applies.  
Response:  
 
29.2 If the research involves a waiver of the consent process for planned 
emergency research, please review the “CHECKLIST: Waiver of Consent 
for Emergency Research (HRP-419)” to ensure you have provided sufficient 

 
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information for the IRB to make these determinations.  Provide any 
additional information necessary here: 
Response:  
 
30.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 29.0) 
30.1 Indicate whether you will be following “SOP: Written Documentation of 
Consent (HRP-091).” If not or if there are any exceptions, describe whether 
and how consent of the subject will be obtained including whether or not it 
will be documented in writing.   
NOTE:  If your research presents no more than minimal risk of harm to subjects 
and involves no procedures for which written documentation of consent is normally 
required outside of the research context, the IRB will generally waive the 
requirement to obtain written documentation of consent.  This is sometimes 
referred to as ‘verbal consent.’  Review “CHECKLIST: Waiver of Written 
Documentation of Consent (HRP-411)” to ensure that you have provided sufficient 
information.  
If you will document consent in writing, attach a consent document with your 
submission.  You may use “TEMPLATE CONSENT DOCUMENT (HRP-
502)”.  If you will obtain consent, but not document consent in writing, attach the 
script of the information to be provided orally or in writing (i.e. consent script or 
Information Sheet).   
Response:  
 
☒ 
We will be following “SOP:  Written Documentation of Consent” 
(HRP-091). 
31.0 
Multi-Site Research (Multisite/Multicenter Only)* 
☒ 
N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply. 
 
31.1 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 
Response:  
 
31.2 If this is a multi-site study where you are the lead investigator, describe the 
processes to ensure communication among sites, such as the following. See 
“WORKSHEET: Communication and Responsibilities (HRP-830).”: 

 
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• 
All sites have the most current version of the IRB documents, including 
the protocol, consent document, and HIPAA authorization. 
• 
All required approvals have been obtained at each site (including 
approval by the site’s IRB of record). 
• 
All modifications have been communicated to sites, and approved 
(including approval by the site’s IRB of record) before the 
modification is implemented. 
• 
All engaged participating sites will safeguard data as required by 
local information security policies. 
• 
All local site investigators conduct the study appropriately in 
accordance with applicable federal regulations and local laws. 
• 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with local policy. 
Response:  
 
31.3 Describe the method for communicating to engaged participating sites (see 
“WORKSHEET: Communication and Responsibilities (HRP-830)”): 
• 
Problems (inclusive of reportable events) 
• 
Interim results 
• 
Study closure 
Response:  
 
31.4 
If this is a multicenter study where you are a participating 
site/investigator, describe the local procedures for maintenance of 
confidentiality. (See “WORKSHEET: Communication and 
Responsibilities (HRP-830).”) 
• 
Where and how data or specimens will be stored locally? 
• 
How long the data or specimens will be stored locally? 
• 
Who will have access to the data or specimens locally? 
• 
Who is responsible for receipt or transmission of the data or 
specimens locally? 
• 
How data and specimens will be transported locally? 
Response:  
 
31.5 
If this is a multicenter study and subjects will be recruited by methods not 
under the control of the local site (e.g., call centers, national 
advertisements) describe those methods.  Local recruitment methods are 
described elsewheres in the protocol. 
• 
Describe when, where, and how potential subjects will be 
recruited. 

 
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• 
Describe the methods that will be used to identify potential 
subjects. 
• 
Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For 
advertisements, attach the final copy of printed advertisements. 
When advertisements are taped for broadcast, attach the final 
audio/video tape. You may submit the wording of the 
advertisement prior to taping to preclude re-taping because of 
inappropriate wording, provided the IRB reviews the final 
audio/video tape.) 
Response:  
 
32.0 
Banking Data or Specimens for Future Use* 
☒ 
N/A:  This study is not banking data or specimens for future use or 
research outside the scope of the present protocol.  This section does not 
apply. 
32.1 If data or specimens will be banked (stored) for future use, that is, use or 
research outside of the scope of the present protocol, describe where the 
data/specimens will be stored, how long they will be stored, how the 
data/specimens will be accessed, and who will have access to the 
data/specimens.  
NOTE:  Your response here must be consistent with your response at the “What 
happens if I say yes, I want to be in this research?” Section of the Template 
Consent Document (HRP-502). 
Response:  
 
32.2 List the data to be stored or associated with each specimen. 
Response:  
 
32.3 Describe the procedures to release banked data or specimens for future 
uses, including: the process to request a release, approvals required for 
release, who can obtain data or specimens, and the data to be provided with 
specimens. 
Response: