Usability Testing of Affordable Haptic Robots for Stroke Therapy
Phase: NA
Conditions: Stroke, Hemiplegia
Sponsor: University of Pennsylvania

Official title: Usability Testing of Affordable Haptic Robots for Stroke 
Therapy (Theradrive) 
 
NCT number: NCT02772809 
 
Document date: July 14, 2020 

Page 1 of 17
Modiﬁcation
Basic Info
Conﬁrmation Number:
chcbiijd
Protocol Number:
819787
Created By:
VIVIO, NICHOLAS
Principal Investigator:
JOHNSON, MICHELLE J
Protocol Title:
Usability Testing of Affordable Haptic Robots for Stroke Therapy
Short Title:
Theradrive Usability
Protocol Description:
Stroke survivors with hemiplegia will be evaluated by rehabilitation professionals and asked to 
perform a battery of assessments to test the viability and usability of a force-feedback robot that 
adapts to each individual subject's performance. Subsequently, they will be asked to complete 
post-assessment questionnaires that provide feedback to the researchers on their observations 
and thoughts about the therapy devices.
Submission Type:
Biomedical Research
Application Type:
EXPEDITED Category 4
PennERA Protocol Status
Approved (No CR)
Resubmission*
No
Are you submitting a Modiﬁcation to this protocol?*
Yes
Current Status of Study
Study Status
Closed to subject enrollment (remains active)
If study is currently in progress, please enter the following
Number of subjects enrolled at Penn since the study was initiated
23
Actual enrollment at participating centers
0
If study is closed to further enrollment, please enter the following
Number of subjects in therapy or intervention
0

Page 2 of 17
Number of subjects in long-term follow-up only
0
IRB Determination
If the change represents more than minimal risk to subjects, it must be reviewed and approved by the 
IRB at a convened meeting. For a modiﬁcation to be considered more than minimal risk, the proposed 
change would increase the risk of discomfort or decrease beneﬁt. The IRB must review and approve the 
proposed change at a convened meeting before the change can be implemented unless the change is 
necessary to eliminate an immediate hazard to the research participants. In the case of a change 
implemented to eliminate an immediate hazard to participants, the IRB will review the change to 
determine that it is consistent with ensuring the participant&prime;s continued welfare. Examples: 
Convened Board Increase in target enrollment for investigator initiated research or potential Phase I 
research Expanding inclusion or removing exclusion criteria where the new population may be at 
increased risk Revised risk information with active participants Minor risk revisions that may affect a 
subject&prime;s willingness to continue to participate Expedited Review Increase in target enrollment 
at Penn where overall enrollment target is not exceeded or potentially sponsored research Expanding 
inclusion or removing exclusion where the new population has the same expected risk as the previous, 
based on similarities of condition Revised risk information with subjects in long-term follow-up Minor 
risk revisions with no subjects enrolled to date 
Expedited Review
Modiﬁcation Summary
Please describe any required modiﬁcation to the protocol. If you are using this form to submit an 
exception or report a deviation, enter 'N/A' in the box below.
Adding Kristine Lima as study contact, updating Kevin Bui, Carol Wamsley and Sam Gaardsmoe 
human cert, and removing Suneet Sharma, who is no longer involved in the study. The protocol will 
also be changed to allow for the inclusion of data only, from protocol 823511, which has similar 
recruitment population.
Risk / Beneﬁt
Does this amendment alter the Risk/Beneﬁt proﬁle of the study?
No
Change in Consent
Has there been a change in the consent documents?
No
If YES, please choose from the options below regarding re-consenting
Deviations
Are you reporting a deviation to this protocol?*
No
Exceptions
Are you reporting an exception to this protocol?*
No

Page 3 of 17
Protocol Details
Resubmission*
Yes
Study Personnel
Principal Investigator
Name:
JOHNSON, MICHELLE J
Dept / School / Div:
4482 - RM-Rehabilitation Medicine
Campus Address
Mail Code
4283
Address:
PENN MEDICINE RITTENHOUSE
1800 LOMBARD ST., 1ST FLR.
City State Zip:
PHILADELPHIA PA 19146-8400
Phone:
215-893-2665
Fax:
215-893-2686
Pager:
Email:
johnmic@pennmedicine.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
09/07/2015
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
Study Contacts
Name:
TORRES, WILSON O
Dept / School / Div:
4482 - RM-Rehabilitation Medicine
Campus Address
Mail Code
4283
Address:
HUP 
3400 SPRUCE ST 
City State Zip:
PHILADELPHIA PA 19104-4283
Phone:
215-893-2695
Fax:
-
Pager:
Email:
Wilson.Torres@uphs.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
04/17/2019
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA

Page 4 of 17
Name:
LIMA, KRISTINE S
Dept / School / Div:
4482 - RM-Rehabilitation Medicine
Campus Address
Mail Code
4283
Address:
1800 Lombard St 
Penn Medicine Rittenhouse 
City State Zip:
PHILADELPHIA PA 19146-4283
Phone:
215-893-2679
Fax:
-
Pager:
Email:
kristine.lima@uphs.upenn.edu
HS Training Completed:
No
Training Expiration Date:
Name of course completed :
Other Investigator
None
Responsible Org (Department/School/Division):
4482 - RM-Rehabilitation Medicine
Key Study Personnel
Name:
WAMSLEY, CAROL
Department/School/Division:
Health System
HS Training Completed:
Yes
Training Expiration Date:
02/08/2017
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
DEKERLEGAND, JENNIFER
Department/School/Division:
Health System
HS Training Completed:
Yes
Training Expiration Date:
07/24/2014
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
BUI, KEVIN
Department/School/Division:
Health System
HS Training Completed:
Yes
Training Expiration Date:
08/11/2018
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
RAIZEN, SARAH F
Department/School/Division:
School of Engineering
HS Training Completed:
Yes
Training Expiration Date:
11/02/2020
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA

Page 5 of 17
Name:
LYN, BREANNA
Department/School/Division:
School of Engineering
HS Training Completed:
Yes
Training Expiration Date:
10/21/2020
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
GAARDSMOE, SAMUEL
Department/School/Division:
Health System
HS Training Completed:
No
Training Expiration Date:
Name of course completed:
Disclosure of Signiﬁcant Financial Interests*
Does any person who is responsible for the design, conduct, or reporting of this research protocol have 
a FINANCIAL INTEREST?
No
Penn Intellectual Property*
To the best of the Principal Investigator's knowledge, does this protocol involve the testing, 
development or evaluation of a drug, device, product, or other type of intellectual property (IP) that is 
owned by or assigned to the University of Pennsylvania?
Yes
If yes, please provide any readily available information on such IP. For example, a brief description of 
the IP, any relevant docket number (if disclosed to the Penn Center for Innovation (PCI), patent 
application or patent numbers, inventor's names, and/or other relevant details.*
Dr. Michelle Johnson is one of the inventors of the system in question
Certiﬁcation
I have reviewed the Financial Disclosure and Presumptively Prohibited Conﬂicts for Faculty 
Participating in Clinical Trials and the Financial Disclosure Policy for Research and Sponsored 
Projects  with all persons who are responsible for the design, conduct, or reporting of this research; and 
all required Disclosures have been attached to this application.
Yes
Biomedical Research
Clinical Trial*
Is this a clinical trial?
Yes
If Yes, please be aware that for each clinical trial conducted or supported by a Federal department or 
agency, one IRB-approved informed consent form used to enroll subjects must be posted by the 
awardee or the Federal department or agency component conducting the trial on a publicly available 
Federal Web site that will be established as a repository for such informed consent forms.
Investigator Initiated Trial*
Is this an investigator initiated trial?
Yes

Page 6 of 17
If Yes, please be aware that the investigator may be required to create and manage a record of this trial 
in https://clinicaltrials.gov.
Drugs or Devices*
Does this research study involve Drugs or Devices?
Yes: Investigational devices that may qualify as Non-Signiﬁcant Risk.
IND Exemption
For studies that fall under an IND exemption, please provide the number below
For studies including IND or IDE's, please provide the number(s) below
IDE Review*
NOTE: For research involving investigational devices, you are required to review the guidance on 
Managing Research Device Inventory. Consult the Penn Manual for Clinical Research: https://
somapps.med.upenn.edu/pennmanual/secure/pm/investigational-product-management Please check the 
box Yes if you have reviewed the guidance.
Yes
Research Device Management*
Please indicate how research device(s) will be managed.
The device receipt, storage and dispensing is being conducted by the research team (please provide 
information in the protocol summary as to how this will be conducted)
Drug, Herbal Product or Other Chemical Element Management *
Please indicate how drugs, herbal products or other chemical entities will be managed.
Not Applicable (no drugs, herbal products or other chemical entities)
Radiation Exposure*
Are research subjects receiving any radiation exposure (e.g. X-rays, CT, Fluoroscopy, DEXA, pQCT, 
FDG, Tc-99m, etc.) that they would not receive if they were not enrolled in this protocol?
No
Gene Transfer*
Does this research involve gene transfer (including all vectors) to human subjects?
No
Human Source Material*
Does this research include collection or use of human source material (i.e., human blood, blood 
products, tissues or body ﬂuids)?
No
CACTIS and CT Studies*
Does the research involve Center for Advanced Computed Tomography Imaging Services (CACTIS) 
and CT studies that research subjects would not receive if they were not part of this protocol?
No
CAMRIS and MRI Studies*
Does the research involve Center for Advanced Magnetic Resonance Imaging and Spectroscopy 
(CAMRIS) and MRI studies that research subjects would not receive if they were not part of this 
protocol?
No
Investigational Agent or Device within the Operating Room*
Does the research project involve the use of an investigational agent or device within the Operating 
Room?
No

Page 7 of 17
Cancer Related research not being conducted by an NCI cooperative group*
Does this protocol involve cancer-related studies in any of the following categories?
No
Processing of Materials*
Will the research involve processing (such as over encapsulating, or compounding)?
No
In-House Manufacturing of Materials*
Will the research involve processing (such as over encapsulating, or compounding)?
No
Medical Information Disclosure*
Does the research proposal involve the use and disclosure of research subject's medical information for 
research purposes?
No
If the answer is YES, indicate which items is is provided with this submission:
CTRC Resources*
Does the research involve CTRC resources?
No
Pathology and Laboratory Medicine Resources*
Will samples be collected by hospital phlebotomy and/or processed or analyzed by any of the clinical 
laboratories of the University of Pennsylvania Health System?
No
Research Involves Apheresis, Cell Collection, and/or Blood Product Collection*
Does this research involve collection of blood products in the Penn Donor Center and/or the use of 
apheresis for treatment or collection of cells or other blood components?
No
Research involving blood transfusion or drug infusions*
Will your research involve blood transfusion or infusion of study drug in 3 Ravdin Apheresis Unit for 
research purposes?
No
Trial in Radiation Oncology
Is this research a prospective trial being done in Radiation Oncology, and if so, has this protocol been 
approved by the Radiation Oncology Protocol committee?
N/A
Study in Radiation Oncology
Is this research a retrospective study being done in Radiation Oncology, and if so, has this project been 
reviewed by the Radiation Oncology Clinical Research Group?
N/A
Use of UPHS services*
Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or 
procedures*, whether considered routine care or strictly for research purposes?
No
Primary Focus*
Clinical Trial (prospectively assigning subjects to health-related interventions to evaluate outcomes)

Page 8 of 17
Protocol Interventions
Sociobehavioral (i.e. cognitive or behavioral therapy)
Drug
x Device - therapeutic
Device - diagnostic (assessing a device for sensitivity or speciﬁcity in disease diagnosis)
Surgical
x Diagnostic test/procedure (research-related diagnostic test or procedure)
Obtaining human tissue for basic research or biospecimen bank
x Survey instrument
None of the above
The following documents are currently attached to this item:
There are no documents attached for this item.
Department budget code
None
Multi-Site Research
Other Sites
No other sites
Management of Information for Multi-Center Research
The following documents are currently attached to this item:
There are no documents attached for this item.
Protocol
Abstract
TheraDrive is a low-cost robotic system for post-stroke upper extremity rehabilitation. The system uses 
off-the-shelf computer gaming wheels with force feedback to help reduce motor impairment and 
improve function in the arms of stroke survivors. Preliminary results from various studies have shown 
that the original TheraDrive system lacked a robust mechanical linkage which could withstand the 
forces exerted by patients, lacked a patient-speciﬁc adaptive controller to deliver personalized therapy, 
and was not capable of delivering effective therapy to severely low-functioning patients. A new low-
cost, high-force haptic robot with a single degree of freedom has been developed to address these 
concerns.  This study has two purposes: ﬁrst, to test the viability and usability of the new robot system 
alongside the original TheraDrive system; and second, to test if low-functioning patients beneﬁt, and if 
so how much, from using force-feedback therapy as opposed to devices with zero impedance. This will 
be done by recruiting approximately 36 human subjects. Exercises will be performed by study subjects 
and an adaptive controller will monitor patient performance to ensure that exercises are difﬁcult but 
doable, which is important for maintaining patient motivation. We hypothesize that not only will the 
new system be viable, but that it will provide better robot-assisted therapy to a large variety of patients, 
especially low-functioning stroke survivors with hemiplegia.
Objectives
Overall objectives
This study is being performed to assess the usability of affordable force-feedback devices for stroke 
rehabilitation. For this pilot study, subjects will use two or more devices (a commercial force-feedback 

Page 9 of 17
joystick, commercial force-feedback wheel, and a custom force-feedback device) to complete games 
and exercise tasks to determine the ease of using these devices and their impact on motor performance 
and function. The long-term goal of this project is to develop an inexpensive high-force haptic 
rehabilitation robot that can safely be used by patients at home without therapist supervision. A sub-
goal was to simulate the human-machine interaction. We will use our assessment tools to determine 
upper arm kinematic and dynamic workspace recovery
Primary outcome variable(s)
The primary outcomes are motor control, as measured by the upper extremity Fugl-Meyer; ADL 
function; and grip strength as measured by a dynamometer; a custom metric to determine Kinematic 
workspace and dynamic workspace will be employed. Customized metrics will be deﬁned such as 
movement time, movement velocity, and accuracy. New outcome variables related to MRI: ﬁber density 
and hemisphere activation
Secondary outcome variable(s)
The secondary variables for motor impairment are upper extremity coordination, ﬁnger dexterity, and 
spasticity - the Box and Block and Ashworth assessments will be used to evaluate these.
Background
Recently published literature in top publications such as The New England Journal of Medicine, Stroke, 
and scientiﬁc statements from the American Heart Association's (AMA) Council on Clinical 
Cardiology, all recognize that robots have a long-term role to play in the rehabilitation of stroke 
survivors. One possible role is as a therapy assistant in rural areas that are a considerable distance from 
hospitals and inpatient rehabilitation centers. Another is in the development of more affordable haptic 
robot systems for nursing homes and adult daycare centers. For these reasons, there is a trend towards 
creating less expensive systems that can acheive functional treatment outcomes.  Past examples of low-
cost therapy systems inform the limitations, and thus the novel development solutions needed to 
advance the ﬁeld of neurorehabilitation. Game therapy with low-cost systems can reduce motor 
impairment. For example, Palanca, an early mechanotronic system that automated the rehabilitation 
process by having users play Pong, 30 minutes per day, ﬁve days per week, for a total of 13 sessions, 
showed signiﬁcant functional improvements in the impaired extremity. Another low-cost force-feedback 
system called Driver's Seat, introduced a driving simulator interface for rehabilitation robots. It used a 
force-feedback split-steering wheel with a force sensor for each hand that enabled the robot to respond 
differently to force inputs from each hand. In this case, the robot resisted forces applied by a stroke 
patient's unimpaired arm, forced the patient to use the impaired arm to assist in the completion of 
steering tasks. In addition, several commercial force-feedback joysticks such as UniTherapy, 
JavaTherapy, and the TheraJoy system have been developed to investigate viability as therapy robots in 
an under supervised environment. UniTherapy software includes a web-based interface that allows both 
the therapists and the patient to design and execute tracking exercises; the joystick is used to perform 
positioning and tracking exercises.
Study Design
Phase*
Not applicable
Design
Part A  Usability Study: Cross-sectional study comparing outcome variables for stroke survivors with 
varying levels of motor deﬁcit impairment in their upper extremity. Subjects with mild motor deﬁcits 
will be compared against stroke survivors with severe motor deﬁcits after completing exercises with 
both commercial and custom therapy devices. Therapy exercises will be performed in random order, 
decided prior to the session. It will be randomly determined which robot the patient will use ﬁrst, the 
order of operating modes used for the new robot, and the order of therapy exercises performed in each 
mode. Surface Electromyography (EMG) will be used in order to detect the small electric currents, or 
signals, which are generated by muscle activity. The collection of the strength and pattern of the signals 
will permit us to verify muscle activity over time. Part B  Therapy Study: Pre-post study looking at 
change in outcome variables over 12 therapy sessions (three times a week for one month). Only low and 
mid functioning stroke survivors will be asked to participate in Part B of the study, and only the custom 
haptic device will be used by the study subjects. Pre-post evaluations will be administered at session 1 
and 12. Surface Electromyography (EMG) will be used in order to detect the small electric currents, or 

Page 10 of 17
signals, which are generated by muscle activity. The collection of the strength and pattern of the signals 
will permit us to verify muscle activity over time.
Study duration
1) We estimate that it will take 3 years from the date of IRB approval to enroll all subjects and complete 
the study. 2) Part A - The subect's participation in the study will be limted to approximately 4 hours; 1-2 
hours to be evaluated by a therapist with expertise in stroke rehabilitation and 2-3 hours of assessing the 
viablity and usabilty of the various therapy devices.  Part B - Subjects enrolled in Part B will be asked 
to return 3 times a week for 1 month (12 sessions). All sessions will last approximately 1.5 hours.  3) 
Projected date of the proposed study: 3/1/14 to 7/1/17.
Resources necessary for human research protection
Describe research staff and justify that the staff are adequate in number and qualiﬁcations to conduct 
the research. Describe how you will ensure that all staff assisting with the research are adequately 
informed about the protocol and their research related duties. Please allow adequate time for the 
researchers to conduct and complete the research. Please conﬁrm that there are adequate facilities for 
the research.
All staff have taken the human subject certiﬁcation and HIPAA training. The PI will have regular 
meetings with the research team to ensure that the team is adequately trained. We will recruit from our 
therapy services.
Characteristics of the Study Population
Target population
Stroke survivors greater than 18 years of age with hemiplegia and varying levels of impairment.
Subjects enrolled by Penn Researchers
56
Subjects enrolled by Collaborating Researchers
0
Accrual
Various Penn and Good Shepherd Penn Partners (GSPP) databases will allow the research team to 
search the respective systems within the parameters of the inclusion/exclusion criteria. Given the 
number of stroke survivors over the age of 18 with hemiplegia served by the Penn and GSPP 
communty, recruitment of 56 (total for parts A, B) stroke survivors three months post event should be 
obtainable within the time frame speciﬁed. Justiﬁcation for the sample size is based on the fact that this 
is a pilot study. Also, we expect that in Part A, not all willing participants will be able to continue post 
evaluation by a therapist (more than mild depression or cognitive impairment will be detected). Ideally, 
all low-functioning stroke subjects who participated in Part A would participate in B; however, we 
expect some attrition from the original group, requiring more subjects to be recruited. Subjects may also 
participate in Part A.
Key inclusion criteria
Part A: Stroke survivors greater than 18 years of age with hemiplegia and varying levels of impairment. 
The subject's stroke must have occurred at least 3 months prior to enrollment in the study. Part B: Low-
functioning stroke survivors greater than 18 years of age with hemiplegia. The subject's stroke must 
have occurred at least 3 months prior to enrollment in the study.
Key exclusion criteria
1) An expert in stroke rehabilitation therapy will administer the Montreal Cognitive Assessment 
(MoCA) to each study participant. After the administration of the MOCA, the PI and therapist will use 
their to expertise and discretion to determine whether the participant scored well enough on particular 
components of the MOCA that are of particular concern to this study, e.g. visuospatial acuity and 
concentration.  2) No greater than mild depression. A member of the research team will administer 
Beck's Depression Inventory (BDI) to each study participant over the phone. If the participant is found 
to have greater than mild depression, as measured by the BDI , they will not qualify for the study. 3) 

Page 11 of 17
Participants must be able to sit upright for 4 hours at a time in Part A of the study; and 2 hours at a time, 
3 days a week, for Part B of the study. 4) Participants enrolled in Part B cannot currently be receiving 
rehabilitation.  5) Participants cannot have received Botox injections within the past 3 months. 6) 
Participants cannot be suffering from contractures (chronic loss of joint motion) or debilitating 
spasticity in the upper extremity. 7) If a participant is experiencing greater than mild pain, and/or the PI 
determines that the participant should no longer continue working with the novel therapy devices, the 
study will be stopped.
Vulnerable Populations
Children Form
Pregnant women (if the study procedures may affect the condition of the pregnant woman or 
fetus) Form
Fetuses and/or Neonates Form
Prisoners Form
Other
x None of the above populations are included in the research study
The following documents are currently attached to this item:
There are no documents attached for this item.
Populations vulnerable to undue inﬂuence or coercion
The study does not include any vulnerable populations.
Subject recruitment
Stroke survivors over the age of 18 with hemiplegia, who are three months post event, and have varying 
levels of impairment in the upper extremities will be recruited. All use of the TheraDrive system will 
take place at the Rehabilitation Robotics Lab on the ﬁrst ﬂoor of Penn Rittenhouse. A member of the 
Rehabilitation Robotics Lab using various databases such as Epic, Sunrise, Penn Data Store, and the 
Uniform Data System (UDS) that is particular to Penn Rittenhouse, will be used to identify potential 
subjects. After identifying subjects via the study's inclusion/exclusion criteria, a ﬂyer will be mailed 
out, and then if necessary, direct follow-up by phone or email will follow. Dr. Lenrow, M.D., a study 
investigator and expert on stroke rehabilitation, will provide guidance to the PI should questions arise 
regarding the enrollment of a particular study subject. Conversely, physicians with signiﬁcant stroke 
populations as patients will be approached by a member of the Rehabilitation Robotics Lab and asked 
to participate in the recruitment of study subjects. Physicians will be asked to refer any interested 
subjects to the lab's research coordinator. The coordinator will then reach out directly, either by phone 
or email, and schedule a time for the patient to come to the lab. More broadly, a ﬂyer will be posted 
both at the Penn Institute for Rehabilitation Medicine and Good Shepherd Penn Partners Penn Therapy 
and Fitness outpatient therapy practices with the contact information of the lab's research coordinator. 
Additionally, an advertisement will be placed in a university-wide newsletter - Express Weekly - with 
information regarding the study and how to contact a member of the lab. Possible study participants will 
also be directly solicited at the monthly Stroke Support Group meeting, which takes place in the dining 
hall on the third hall of Penn Rittenhouse. A member of the Rehabilitation Robotics Lab will brieﬂy 
explain the research, and a handout with contact information, will be provided should they want to 
contact our team for further information. In addition, data from protocol #823511 may be included for 
analysis, as they have similar recruitment population. Protocol #823511 allows the subjects to have their 
data available for analysis in this study.
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does 
the study team plan to directly use social media to recruit for the research?
Yes
Please identify which method(s) of social media you will utilize, the content of the text to be used, and 
the method(s) for posting this information (i.e., using Penn supported communication services). When 

Page 12 of 17
proposing the text to utilize, please be aware of any social media limitations (i.e., number of characters 
allowed in a tweet) and any appropriate conﬁdentiality practices necessary to be compliant with posting 
research recruitment text.*
One way we play on advertising the study is via the Express Weekly newsletter.  See attached for 
language to be used.
The following documents are currently attached to this item:
There are no documents attached for this item.
Subject compensation*
Will subjects be ﬁnancially compensated for their participation?
Yes
The following documents are currently attached to this item:
There are no documents attached for this item.
If there is subject compensation, provide the schedule for compensation per study visit or session 
and total amount for entire participation, either as text or separate document
15 dollars will be provided to study participants for each visit they make to the lab during Part A (i.e. 
two visits equals 30 dollars). Participants who complete Part B will receive an additional 75 dollars. 
Participants who enroll in Part C will also receive 50 dollars.
Study Procedures
Suicidal Ideation and Behavior
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)?
No
Procedures
Part A: Participation in this part of the study will include the following steps: 1) Informed Consent: 
After arrival, subjects will review and sign the consent form with study personnel present. 2a ) Pre-
Assessments: A member of the research team will evaluate the subjects' affected arm and assess their 
ability to use it. Subjects will be evaluated using a battery of assessments in order to determine their 
level of impairment such as the Beck Depression Inventory, Upper Extremity Fugl-Meyer, Montreal 
Cognitive Assessment, Jebson Taylor, Box in Block, Modiﬁed Ashworth, and grip strength using a 
dynamometer, etc.  2b) Workspace Assessment: The protocol for the kinematic workspace would entail 
of moving patients upper extremity in a series of motions that mark the key points of their workspace. 
This would include movement with extended elbow to manipulate the shoulder joint in the cardinal 
directions (e.g. horizontal movements at the abdominal and shoulder levels, and vertical movements at 
0, 45, 90 and 135 degrees), internal/external rotation of the shoulder, as well as functional movements 
of the arm. For the functional movements the patient would be asked to touch six points on their body, 
the left and right sides of their hips, their left and right shoulders, their mouth and the top of their head 
while being monitored by a Kinect camera. These actions are chosen as they cover areas necessary for 
ADLs such as eating, grooming and toileting and covers motion in clinically relevant planes. Each 
participant would be also given the standard clinical score. The movement protocols would be repeated 
under a loading condition where light weights (0.5-1lb) would be attached to subjects wrist. Given the 
additional mass, we would determine the change in the kinematic workspace space as well as the 
change in the joint torques. The protocol for recovery of dynamics would entail of the a series of 
motions using the TheraDrive systemas described in Theriault, A.,Nagurka,M.,Johnson,M.J:Therapeutic 
Potential of Haptic TherDrive: An Affordable Robot/Computer System for Motivating Stroke 
rehabilitation, in:5th IEEE RAS&EMBS International Conference,pp.415-420, 2014. The TheraDrive 
would be positioned at various locations in the subjects workspace (e.g. closer to the torso, away from 
the torso, higher/lower). The ability to exert speciﬁc torques at these locations would provide 
information on the dynamic capacity of the muscles within various points of the workspace. 3) Break: 

Page 13 of 17
Subjects will be given a 15 minute break. 4) First Therapy Device: Subjects will be introduced to 
several robots: a wheel, joystick, and custom crank chosen randomly (like the ﬂip of a coin). First, they 
will be trained in the use of all robots and their safety features. Following training, they will be asked to 
move each robot into different positions, ﬁrst without pressure applied to the handle, and then with 
pressure applied to the handle. After each exercise they will be asked about their level of exercise and 
level of pain discomfort. After subjects ﬁnish all exercises with a robot, they will be given a survey 
about the robot. They will also be given surveys to discuss their experience with the device and their 
level of motivation for use of them.  The surface EMG may be utilized during the entirety of the 
participant's interaction with the novel therapy device. Prior to its placement on the subject, the reason 
for its use will be thoroughly explained.  5) Break: Subjects will be given a 15 minute break. 6) 
Subsequent Therapy Device: Subjects will be instructed in the use of another robot. The same 
procedure will be followed as in the ﬁrst evaluation. The surface EMG may be utilized during the 
entirety of the participant's interaction with the novel therapy device. Prior to its placement on the 
subject, the reason for its use will be thoroughly explained.  7) Final Survey: Subjects will be given a 
survey asking them to evaluate the robots and indicate which robot they prefer. Part B: For subjects 
invited to participate in Part B of the study - only low functioning stroke surviviors are eligible -
participation in this part of the study will include the following steps: 1) Informed Consent: After 
arrival, subjects will review and sign the consent form with study personnel present. 2a) Pre-
Assessments: If subjects are only participating in Part B of the study, at their ﬁrst visit, a member of the 
research team will evaluate their affected arm and assess their ability to use it. Subjects will be 
evaluated using a battery of assessments in order to determine their level of impairment such as the 
Beck Depression Inventory, Upper Extremity Fugl-Meyer, Montreal Cognitive Assessment, Jebson 
Taylor, Box in Block, Modiﬁed Ashworth, and grip strength using a dynamometer, etc. If a study 
subject participated in Part A, they will not be reevaluated by a therapist. 2b) Workspace Assessment: 
Same as in Part A  2) Custom Therapy Device: Subjects will be introduced to the custom robot. They 
will be trained in the use of this robot and its safety features (1st session). Following training, they will 
be asked to move the robot into different positions. After each exercise subjects will be asked about 
their level of exercise and level of pain discomfort. Subjects will continue to work with the custom 
therapy device for 12 sessions over the course of one month.  The surface EMG may be utilized during 
the entirety of the participant's interaction with the novel therapy device. Prior to its placement on the 
subject, the reason for its use will be thoroughly explained.  3) Motivation Questionnaire: At the end of 
their 1st and 12th sessions, subjects will be asked to complete a questionnaire assessing their level of 
motivation. 4) Post-Study Survey: After their last session, subjects will be asked to complete a survey 
assessing the robot. 5) Post-Study Assessment: After their last session, a certiﬁed therapist will evaluate 
the participants' affected arm and assess their ability to use it. In addition, they will also be evaluated for 
depression and a mental health assessment will be given.
The following documents are currently attached to this item:
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Deception
Does your project use deception?
No
Analysis Plan
1) Clinical data will be analyzed to determine how subjects low versus high function perform on 
metrics developed using the robots.  2) Trajectory tracking using a baseline with zero resistance will be 
established for each patient. The root mean square metric will be used to assess accuracy in tracking 
tasks and subjects' performance across groups (low versus high) and devices in Part A, and across time 
in Part B. Using a 2-way ANOVA test for Part A, and an alpha of 0.05, signiﬁcant difference across 
groups will be detected. A paired t-test, and an alpha of 0.05, will detect signiﬁcant difference across 
time pre-post the 12 sessions. 3) Data collected from the surface EMG will be analyzed to verify 
muscle activity over time. 4) Data results will be used to build a simulation model of the human-robot 
tracking and determine a prediction of the joint and muscle forces that are used in Part A and Part B. 5) 
Data collected with the kinect will be assessed for kinematic and dynamic workspace. The data will be 
ﬁtted to a computerized model of the upper limb to extract forces and positions deﬁning dynamic and 
kinematic workspace.
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Are you conducting research outside of the United States?
No
Data conﬁdentiality
x Paper-based records will be kept in a secure location and only be accessible to personnel involved 
in the study.
x Computer-based ﬁles will only be made available to personnel involved in the study through the 
use of access privileges and passwords.
Prior to access to any study-related information, personnel will be required to sign statements 
agreeing to protect the security and conﬁdentiality of identiﬁable information.
x Wherever feasible, identiﬁers will be removed from study-related information.
A Certiﬁcate of Conﬁdentiality will be obtained, because the research could place the subject at 
risk of criminal or civil liability or cause damage to the subject's ﬁnancial standing, 
employability, or liability.
A waiver of documentation of consent is being requested, because the only link between the 
subject and the study would be the consent document and the primary risk is a breach of 
conﬁdentiality. (This is not an option for FDA-regulated research.)
Precautions are in place to ensure the data is secure by using passwords and encryption, because 
the research involves web-based surveys.
Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
identiﬁcation of subjects.
Subject Conﬁdentiality
All study personnel will have access to a locked ﬁle cabinet containing consent forms, evaluation 
assessments, and post-survey data. The locked ﬁle cabinet will be located at Penn Rittenhouse, 
Rehabilitiation Robotics Lab, 1800 Lombard Street, Philadelphia, PA, 19146. Both electronic data and 
hard-copy records will be kept for 10 years; they will be kept on password protected computers. After 
10 years, documents will be destroyed by secure shredding at Penn Rittenhouse and electronic data will 
deleted from computers. Research subjects will be identiﬁed in the research data by code, and at no 
time will a direct link exist between collected data and research subjects. When data results are reported 
they will be presented in aggregate form (i.e. group characteristics only) and no individual identiﬁers 
will be used.
Sensitive Research Information*
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record?
No
Subject Privacy
Privacy refers to the person's desire to control access of others to themselves. Privacy concerns people, 
whereas conﬁdentiality concerns data. Describe the strategies to protect privacy giving consideration to 
the following: The degree to which privacy can be expected in the proposed research and the safeguards 
that will be put into place to respect those boundaries. The methods used to identify and contact 
potential participants. The settings in which an individual will be interacting with an investigator. The 
privacy guidelines developed by relevant professions, professional associations and scholarly 
disciplines (e.g., psychiatry, genetic counseling, oral history, anthropology, psychology). 
As described in our recruitment strategy, ﬂyers will be posted in outpatient rehabilitation facilities with 
the research coodinator's contact information. At support group meetings, a brief description of the 
research study will be introduced, and contact information for the Rehabilitation Robotics Lab provided 
should the person be interested in participating. Various Penn Databases will be used to search for 
stroke survivors who meet our inclusion/exclusion criteria. If the subject is still undergoing treatment at 
Penn, the patient's treating physician will then be contacted. A physical ﬂyer describing the research 
study will be sent via mail, and possibly followed up with a phone call 1-2 weeks later. Only the PI and 
research coordinator will be contacting the patient directly by phone, thereby avoiding any overlap, or 

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multiple calls by the research team.
Data Disclosure
Will the data be disclosed to anyone who is not listed under Personnel?
Yes. Caspar Nguyen, a high school student interning at the Rehabilitation Robotics Lab will have access 
to the data. Caspar will mainly be working on data input and retrospectively analyzing data under the 
guidance of a senior research team member.
Data Protection*
x Name
x Street address, city, county, precinct, zip code, and equivalent geocodes
x All elements of dates (except year) for dates directly related to an individual and all ages over 89
x Telephone and fax number
x Electronic mail addresses
Social security numbers
Medical record numbers
Health plan ID numbers
Account numbers
Certiﬁcate/license numbers
Vehicle identiﬁers and serial numbers, including license plate numbers
Device identiﬁers/serial numbers
Web addresses (URLs)
Internet IP addresses
Biometric identiﬁers, incl. ﬁnger and voice prints
x Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code
None
Does your research request both a waiver of HIPAA authorization for collection of patient information 
and involve providing Protected Health Information ("PHI") that is classiﬁed as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a 
recipient outside of the University of Pennsylvania covered entity?
No
Tissue Specimens Obtained as Part of Research*
Are Tissue Specimens being obtained for research?
No
Tissue Specimens - Collected during regular care*
Will tissue specimens be collected during regulator clinical care (for treatment or diagnosis)?
No
Tissue Specimens - otherwise discarded*
Would specimens otherwise be discarded?
No
Tissue Specimens - publicly available*
Will tissue specimens be publicly available?
No
Tissue Specimens - Collected as part of research protocol*
Will tissue specimens be collected as part of the research protocol?
No

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Tissue Specimens - Banking of blood, tissue etc. for future use*
Does research involve banking of blood, tissue, etc. for future use?
No
Genetic testing
If genetic testing is involved, describe the nature of the tests,  including if the testing is predicative or 
exploratory in nature. If predictive, please describe plan for disclosing results to subjects and provision 
of genetic counseling. Describe how subject conﬁdentiality will be protected Note: If no genetic testing 
is to be obtained, write: "Not applicable."
Not applicable.
Consent
1. Consent Process
Overview
Subjects will receive a consent form at least 24 hours in advance of the study session. This will allow 
subjects sufﬁcient time to read over the form on their own, and come up with any questions or concerns 
prior to the commencement of the session. Before the session begins, study personnel will review the 
consent form and experimental procedure with the subject and answer any questions. The subject will 
then be given the opportunity to sign the consent form, with study personnel witnessing. Any subjects 
that decline to sign the consent form will be dismissed at that time. In addtion to the written informed 
consent that patients will sign prior to commencing their ﬁrst session in the Rehabilitation Robotics 
Lab, an oral informed consent will be read to all prospective participants over the phone. When a 
subject is either contacted by a a member of the research team or calls our lab inquiring about the study, 
the oral consent will be read prior to asking questions from the phone screening form or the Beck 
Depression Inventory.
Children and Adolescents
Not applicable.
Adult Subjects Not Competent to Give Consent
Yes. In fact, one of the exclusion criteria for this study is cognitive impairment. Thus, all subjects will 
be competent. See section on exclusion criteria for more details.
2. Waiver of Consent
Waiver or Alteration of Informed Consent*
No Waiver Requested
Minimal Risk*
Impact on Subject Rights and Welfare*
Waiver Essential to Research*
Additional Information to Subjects
Written Statement of Research*
No
If no written statement will be provided, please provide justiﬁciation
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Risk / Beneﬁt
Potential Study Risks
Subjects may experience fatigue or muscle strain if exercises are too intense. In the event of a robot 
malfunction, subjects may experience muscle strain or minor bruises. To minimize risk of injuries due 
to exercise, the intensity will be kept in the mild to moderate range. Exercise intensity must also be kept 
low in order to reduce the confounding effect of fatigue on experimental results. After each exercise, 
subjects will be questioned regarding the difﬁculty of the task, exercise intensity, and their discomfort 
level. At that time, the protocol will be adjusted accordingly. Subjects will be given ample time to rest 
as part of the experiment protocol.  Risk of injury from the robot stems from its ability to exert large 
forces. Therefore, we have implemented several layers of protection to prevent the robot from exerting 
forces that might cause injury. For example, the software permits the robot's commanded force to be 
limited and a stop command to be issued to the robot. In addition, the current to the motor that 
determines the forces is limited by a current limiter that will maintain current to a preset level. As a 
backup, there is a limit switch that will cut power to the motor if excessive forces are detected. And as a 
ﬁnal level of backup, another mechanical method (torque limiter) has been put in place that limits 
forces and is capable of physically disengaging the motor from the handle that the patient is griping. A 
spring inside the robot allows it to be compliant, which reduces the ability of patients to feel sudden 
starts or stops of the motor, and reduces the risk of injury in the event of a robot-patient collision. 
Padding on the robot provides further protection against any impacts. Furthermore, an emergency stop 
switch will be made available to both the subject and operator; it will cut power to the motor when 
triggered. If a subject is experiencing a level of pain great than three (mild) on the Visual Analog Pain 
Scale, the session will be stopped.
Potential Study Beneﬁts
There are no direct, major beneﬁts to a particular subject. Participation will help advance rehabilitation 
robotics research.
Alternatives to Participation (optional)
Data and Safety Monitoring
The principal investigator will monitor this protocol. See attached for the D&SM Plan.
The following documents are currently attached to this item:
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Risk / Beneﬁt Assessment
The risks involved in A and B are minimal - fatigue, frustration, minor bruising. There are no immediate 
direct beneﬁts to study participants.  Possible beneﬁts to society are signiﬁcant, as according to the 
American Heart Association, every year, 15 million people suffer a stroke. Most people survive the 
stroke, but have subsequent problems and many require assistance for activities of daily living.
General Attachments
The following documents are currently attached to this item:
Additional forms (kristinelima-citicompletionreport.pdf)
Additional forms (carolwamsley-citicertiﬁcate.pdf)
Additional forms (kevinbui-citirefresher-2018.08.29.pdf)
Additional forms (samgaardsmoe-citirefresher2018.08.08.pdf)