PFI: BIC Affordable and Mobile Assistive Robots for Elderly Care
Phase: NA
Conditions: Aging
Sponsor: University of Pennsylvania

 
 
  
 
 
PFI: BIC Affordable Mobile 
Assistive Robots for Elderly Care 
(Protocol) 
NCT #02807506 
AUGUST 13, 2018 

Page 1 of 13
Protocol Details
Basic Info
Conﬁrmation Number:
chafhbce
Protocol Number:
820915
Created By:
VIVIO, NICHOLAS
Principal Investigator:
JOHNSON, MICHELLE J
Protocol Title:
PFI: BIC Affordable and Mobile Assistive Robots for Elderly Care
Short Title:
Affordable Mobile Robots for the Elderly
Protocol Description:
This project develops and tests the use of service robots to track health of the elderly over time. 
The objectives are to develop a low-cost mobile manipulator capable of a limited set of elder-
relevant manipulation tasks (e.g. picking up dropped items). We will visualize and model the use 
of the service robot during deployments at an elder care facility. Feedback from focus groups with 
elders and clinicians will inform the necessary engineering innovation.
Submission Type:
Biomedical Research
Application Type:
EXEMPT Category 4
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

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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
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 :

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Other Investigator
Name:
YIM, MARK H
Dept / School / Div:
1306 - Mechanical Engineering and Applied Mechanics
Campus Address
Mail Code
6315
Address:
220 S. 33rd STREET
Suite 229A TOWNE BLDG
City State Zip:
PHILADELPHIA PA 19104-6315
Phone:
215-898-5269
Fax:
-
Pager:
Email:
yim@seas.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
05/23/2017
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
Responsible Org (Department/School/Division):
4482 - RM-Rehabilitation Medicine
Key Study Personnel
Name:
RODRIGUES MUCCHIANI, CAIO
Department/School/Division:
School of Engineering
HS Training Completed:
Yes
Training Expiration Date:
12/17/2017
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
SEFCIK, JUSTINE S
Department/School/Division:
Biobehavioral and Health Sciences
HS Training Completed:
Yes
Training Expiration Date:
02/04/2015
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
WEINSTEIN, AARON D
Department/School/Division:
School of Engineering
HS Training Completed:
Yes
Training Expiration Date:
09/22/2018
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
CACCHIONE, PAMELA Z
Department/School/Division:
Family and Community Health
HS Training Completed:
Yes
Training Expiration Date:
08/27/2014
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Disclosure of Signiﬁcant Financial Interests*
Does any person who is responsible for the design, conduct, or reporting of this research protocol have 

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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.*
The PI's in are involved in the invention of the system.
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
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
Medical Information Disclosure*
Does the research proposal involve the use and disclosure of research subject's medical information for 
research purposes?
Yes
If the answer is YES, indicate which items is is provided with this submission:
Modiﬁed research informed consent document that incorporates HIPAA requirements
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

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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*
Sociobehavioral (i.e. observational or interventional)
Protocol Interventions
x Sociobehavioral (i.e. cognitive or behavioral therapy)
Drug
Device - therapeutic
x 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
Protocol
Objectives
Overall objectives
The goal is to develop in three stages a new affordable robot with the participation of Living 
Independently for Elders (LIFE) members and clinicians. The robot will be developed by a 
multidisciplinary team headed by Dr Yim at UPENN (PI), Dr Lau at Savioke, and Drs. Johnson and 
Cacchionne at UPENN PM&R and UPENN Nursing respectively. We aim to build a low-cost robot 
platform that will focus on the simple, but key, repetitive, data-driven tasks that robots do well. Rather 
than attempt to create a robot helper that mimics humans, we aim to free human caregivers from the 
time-consuming tasks that robots can accomplish with facility, thereby allowing humans to focus on 
tasks that humans do best (i.e. human contact). Participatory reviews of the developed prototypes will 
be completed at each stage (each year) with the LIFE members and clinicians. There are three research 
questions we hope to answer all while building an effective system to synergistically satisfy the 
business needs: R1) Although activities of daily living (ADLs) for elder health have previously been 
documented and categorized, no research has been done to characterize them from the perspective of 
their feasibility of automation using an affordable mobile manipulation robot. How can we characterize 
known ADLs according to how much they would beneﬁt from robotic assistance given varying levels of 

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robot capabilities (mobility, limited manipulation, full manipulation)? R2) A manipulator arm must be 
safe, affordable, and performant enough to assist in ADLs for elder heath. What new breakthroughs are 
required to develop new manipulation technology that satisﬁes these constraints? What are the 
concomitant key usability and acceptance of service features required? R3) A data-driven service 
robotics system has the potential to affect elder health in a positive way. How can predictive service 
robotics best be used to maintain and improve elder health? Which speciﬁc robot behaviors have the 
most impact on elders' well-being?
Background
A growing elderly population coupled with low birth rates in the developed world is creating a crisis in 
healthcare. The number of senior citizens is outgrowing the number of working-age adults to care for 
them. In the US alone, the number of seniors over age 65 is projected to double from year 2000 to 2030, 
reaching 71.5 million. Similar statistics are found throughout the world. With the scarcity of care 
options available, robots are a welcome solution for assisting elders with small tasks that would 
normally be done by a caregiver. With an estimated 17,000 elder care facilities nationwide, merely 
placing a single affordable robot in each facility would result in a $170m business. In this vein, the past 
decades have seen an enormous amount of robotics research funded by institutions such as the NSF and 
DARPA, including a notable multi-million dollar effort by the European Union in the RoboEarth 
project which aims at hospital service. A variety of companies have also explored robots in the 
healthcare space. Aethon, Vecna, and Helpmate have automated materials transport/delivery with 
varying success. They have limited service capability in that they are not capable of manipulation. On 
the other side of capability, research robots such as Willow Garage's PR2 and Care-o-bot from 
Fraunhofer IPA have demonstrated mobile manipulation, but have costs between $100-500K. 
Fortunately, a number of factors are converging to make cost-effective robots possible now. Previous 
efforts have exploited rapid prototyping low-cost hardware such as 3D printing and mass customization 
of electronics to lower hardware costs. Additionally, the software necessary to power mobile 
manipulation robots and hardware costs, such as low-cost depth sensors (i.e. Microsoft's Kinect) are 
becoming better and cheaper each year. Through our own novel design and innovation coupled with 
capitalizing on the various factors that are precipitously driving down the costs of necessary 
components, we aim to develop an affordable and capable robot that will address the demographic shift 
towards the need for more elderly care. One key to making this system viable is maintaining 
effectiveness at low cost. This work will build on existing navigation and control software for mobile 
robots using a platform being commercialized by Savioke. On top of this, a new low-cost expanding 
prismatic joint arm developed at University of Pennsylvania will add manipulation capabilities. This 
hardware and software platform will enable the study of the usefulness of robots in an elder care 
facility. Limited tasks such as the delivery of water to patients can be used to monitor hydration of 
individuals over-time and pro-actively predict required service to aid in healthcare. The information 
gathered by these robots and how elders use them during ﬁeld use will help to learn how robots can 
help create a larger data-driven health monitoring system. The partners include the University of 
Pennsylvania's School of Engineering and Applied Science, School of Medicine, School of Nursing 
(Philadelphia PA), and Savioke (Sunnyvale, CA, a small business concern) along with LIFE, Living 
Independently For Elders (Philadelphia PA).
Study Design
Design
We plan to tackle the myriad aforementioned challenges in three stages.  First, based on focus group 
feedback, we will design a data collection plan for the robot to collect information about service tasks. 
This may include information such as the time it takes the robot to perform a task, when the task was 
requested, whether the robot succeeded at performing the task, etc. This data collection component will 
be deployed at LIFE or a LIFE-afﬁliated retirement community during the various trials. Additionally, 
our partners at Savioke (Dr. Lau is a co-PI on the NSF grant) will conduct additional focus groups in 
elderly care facilities in California, in order to get faster feedback on their prototype designs. The focus 
group methodology will be employed throughout to assess user needs and evaluate user experiences 
with the robot system being developed. Second, we will develop interactive data visualizations of the 
collected data and share these with the LIFE and LIFE-afﬁliated administrators, staff, and residents. 
These interactive data visualizations will make use of best practices in medical informatics and 
visualization and enable stakeholders to explore the data we have collected and from initial conclusions 
about resident's health and service needs. Based on feedback from the visualizations, we will ﬁne-tune 
our data collection process which will likely impact the robot design.  The ﬁnal step will be to develop 

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predictive models of when people want services performed so that our system can proactively deliver 
services when they are needed. By tracking residents' requests over time - a machine learning problem - 
we aim to build a model of what features in the environment trigger the service requests over time.
Study duration
1) We estimate that it will take three years from the date of IRB approval to enroll all subjects and 
complete the study. 2) A subject may choose to participate for as little as one focus group (1.5 - 2 hours) 
or may choose to participate in each part of the larger study over the course of three years. 3) 8/15/2014 
- 8/15/2017
Characteristics of the Study Population
Target population
1. Three populations will be involved: 1. Elders who are members of Living Independently For Elders 
(LIFE) run by the University of Pennsylvania, School of Nursing and their caregivers will be recruited 
for the study. The elder members will be drawn from those participating in the LIFE-afﬁliated 
retirement community (Mercy Douglas or Kearsley) or those on the Council of Elders for LIFE or those 
at LIFE. Elders must be members of LIFE and live at a LIFE-afﬁliated retirement community or 
participate in the elder council. Members of LIFE are age 55 and older, in need of medical care or 
supportive services, are state-certiﬁed as nursing home eligible, live in certain areas in Philadelphia 
County, Pennsylvania, prefer to continue living in their community for as long as possible, can be safely 
served and able to pay privately or through Medicare. Members of LIFE at Kearsley and Mercy 
Douglas require more assistance with physical, cognitive and social functioning and are provided a 24-
hour interdisciplinary clinical staff to assist them in meeting needs. Members are 62 years and older, in 
imminent risk of a nursing home placement, attends LIFE center daily (day program), able to have 
activities of daily living (ADL) needs met by caregivers, able to pay required rent for apartment, and 
able to function safely in community with other elders. And for the purpose of earlier prototyping and 
obtaining faster feedback on designs, Savioke may conduct additional focus groups at The Forum at 
Rancho San Antonio a Continuing Care Retirement Community located in Silicon Valley.  2. Clinicians: 
Clinicians will be recruited from the clinical staff working at LIFE, Kearsley, and Mercy Douglas which 
consists of primary care physicians, nurses and nurse practitioners, certiﬁed nursing assistants, home 
health aides, licensed social workers, physical and occupational therapists, personal care workers, etc. 
Subjects will also be excluded if they do not understand the study and refuse to comply with 
procedures.  Subjects will be excluded if they are unable to cognitively give consent. For the corn toss 
game, 30 participants will be recruited who are able to use both arms and reach up towards a cabinet, 
have a minimental score of 20 or higher, and are able to stand and reach
Subjects enrolled by Penn Researchers
155
Subjects enrolled by Collaborating Researchers
0
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
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Subject recruitment
Dr. Cacchione (UPENN Nursing Professor) and Ms. Ingrid Sidorov (Interim Chief Nursing Ofﬁcer) are 
afﬁliated with LIFE and will be responsible for reviewing LIFE's medical records. After potential study 
participants are identiﬁed, the commonly used Short Blessed Test (measures cognitive function in the 
elderly), SF-12, etc., may be administered for additional screening purposes. LIFE members will then 
be consented prior to participation in the focus groups by a member of the research team.  For any focus 
groups at The Forum at Rancho San Antonio, Savioke will liase with the Director of Wellness, Sharon 
Fay, with whom they have an established relationship. Residents at The Forum will then be consented 
using the same consent form used for any LIFE members.  Recruitment will be word of mouth, direct 
solicitation, and informational sessions convened with the assistance of the Council of Elders' and the 
research committee overseeing participant activities.
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?
No
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Subject compensation*
Will subjects be ﬁnancially compensated for their participation?
Yes
The following documents are currently attached to this item:
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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
25 dollars will be provided to each participant for her/his participation in year 1. An additional $25 will 
be provided in year 2 and year 3 should they continue to participate in focus groups and evaluation 
sessions. Subjects participating in only the evaluation session with the walking task will be paid $5.00 
per walk taken with the robot. Subjects participating in only the corn toss session will be paid $10.00. 
Subjects participating at The Forum at Rancho San Antonio will not be compensated ﬁnancially, 
however, snacks and beverages will be provided. No compensation will be provided due to the fact that 
the focus groups will be considerably shorter and limited in scope.
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
Year 1:  Need-ﬁnding focus groups of clinicians and elders will be conducted, consisting of no more 
than 8-10 persons at each session. The aim of the initial focus groups is to reconcile the needs of elders 
with the robot requirements in order to determine the robot behaviors. The focus groups will help deﬁne 
a set of robot behaviors critical to meeting the needs of elders. Some behaviors that may emerge are 
transporting objects, telecommunication, following, leading, monitoring, playing, coaching, escorting 
persons, etc. In a typical focus group session, participants will explain life at their location, create a 
prioritized list of key activities and needs in physical, cognitive and social domains, hear about the 
research and the current capabilities of the robot, describe how they could use the robot to meet needs 
and what may be lacking, and set-robot tasks list. The elders in the needs assessment focus group will 

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be those serving on the council of ELDERs for LIFE. A member check (respondent validation) will take 
place with certain members of the various focus groups. Development partners will be identiﬁed from 
the focus group sessions. They will meet quarterly with the team to address development issues with the 
robot .This team will function as the early assessors and will provide real time feedback.  Additionally, 
residents at The Forum at Rancho San Antonio in Silicon Valley will provide feedback via need-ﬁnding 
focus groups during year 1.  Year 2:  The robot prototype, consisting of the mobile base and a limited 
gripper, will be tested at a LIFE-afﬁliated retirement community with the elders and caregivers. The 
robot tasks evaluated will be involve services aimed at providing reminders, transport, telepresence, 
games, etc. Later that year, another version of the robot prototype, consisting of the mobile base 
incorporating improvements from the 1st round of assessments and an arm plus an articulated gripper, 
will be tested with elders and clinicians for 3 weeks. The robot tasks evaluated will be those involving 
mobility and some manipulation services such as hydration, picking up and transport etc. Data will be 
analyzed and results on robots usability will be provided as feedback to the development team in order 
to improve the system. THE ABOVE SUMMARY PARAGRAPH WAS INCLUDED IN OUR INITIAL 
IRB SUBMISSION, APPROVED OVER ONE YEAR AGO. BELOW ARE SOME ADDITIONAL 
DETAILS WHICH ARE THE MAIN MODIFICATION TO THE PROTOCOL.  1.) Subjects will be 
consented and be provided with a demographic survey (see attached).  2.) The robot prototype will be 
pre-programmed to complete key activities while located on site (Mercy Douglas or LIFE). The key 
activities are: (1) Encouraging exercise and companionship via walking; and (2) Helping elders remain 
hydrated by transporting them water at a scheduled time. Clinicians and caregivers will be consulted to 
determine how to tailor robot tasks to each consented patient.  3.) During the walking companion task, 
the robot will ask ambulatory participants to walk with the robot for the recommended 15 minutes of 
exercise time, at least one time per day. The robot will arrive at the elder's apartment at a prescheduled 
time selected by him/her. The amount of time the elder spends walking with the robot may be adjusted 
should the clinician/caregiver recommend a shorter time period (e.g. the walk time may be decreased if 
a patient suffers from sciatica).  4.) During the hydration task, the robot will bring a an 8 oz. bottle of 
water and a bottle opener to the elder. The frequency in which the robot bring water to the elder will be 
based upon the recommendation of the clinician/caregiver. The base recommendation will be 6, 8 oz. 
glasses of water outside of meal times. An example of a modiﬁcation to the base recommendation 
would be to increase the number of water bottles for those who have dry mouth, are on dialysis, or tend 
to forget to drink water (this is very common among the elderly population). For both the walking and 
hydration tasks, the patient can instruct the robot to return at a later time or to go away. All tasks will 
take place in the hallway either just outside of the participant's apartment or inside the apartment. There 
will be one observer on our team who will watch the robot-participant interaction and complete a 
checklist of usability and issues. There will be another observer on our team who will immediately ask 
the participant to complete a post robot assessment survey tailored to the task they just experienced.  
Example Procedure for the Walking Task Scenario: The robot approaches a participant and asks them if 
they want to go for their scheduled walk. The participant can say "yes" and go for the walk, "no", or 
reschedule the robot to come back at a later time. Observer #1 takes notes on the interaction and 
completes the relevant checklist items. If the participant goes for the walk, observer #2 asks them to 
complete the post-encounter survey.  After each usability test period, participants and their caregivers 
will have the opportunity to ﬁll out a global interaction survey about the experience and provide 
information on how to improve the robot for future usability testing periods. Procedure for corntoss 
game: 1.) Subjects will be consented and be provided with a demographic survey (see attached).  2.) 
The robot prototype will be pre-programmed to complete key activities while located on site (Mercy 
Douglas or LIFE). Participants will ﬁrst play the corn toss game without the assistance of the robot. 
They will retrieve the 3 bags from an upper cabinet, and play game against another participant. The 
participants will throw 3 bags and scores will be assessed. The participants will retrieve their own bags. 
In the second session, participants will repeat these steps; however someone from the research team will 
retrieve bags for the participant. At this point, there will be a pause and participants will be asked 
survey questions. Next, the same steps will be repeated, however the robot will retrieve the bags with a 
gripper from the upper cabinet and hand to the participant. Finally, the game will be repeated, but the 
robot will retrieve the bags at the end. Evaluations will then be repeated at the end. Clinicians and 
caregivers will be consulted to determine how to tailor robot tasks to each consented patient. After each 
usability test period, participants and their caregivers will have the opportunity to ﬁll out a global 
interaction survey about the experience and provide information on how to improve the robot for future 
usability testing periods. The entire interaction will last for 1.5-2 hours maximum. Year 3:  An improved 
prototype, consisting of the mobile base incorporating improvements from the 1st round of assessments 
and an arm plus articulated gripper will be tested with elders and clinicians at LIFE and/or a LIFE-
afﬁliated retirement community for 4 weeks. The robot tasks evaluated will involve mobility and 

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complex manipulation services such as opening doors etc. Data will be analyzed and results on robots 
usability will be provided as feedback to the development team in order to improve system. Overall, 
focus groups will be used throughout to assess and evaluate users interaction and experiences. Data will 
be collected by the robot during user interactions and aspects of the data will be evaluated and 
discussed with focus group members to critically assess robot's utility and progress. Research questions 
R2 and R3 will be addressed.  a. Key usability and acceptance of service features required for the 
development of new manipulation technology are affordable, safe, and usable will be identiﬁed and 
appropriate metrics developed. b. Health status of subject participant will be tracked over years 2 and 3 
and correlated with robot service record with the participant. Training and evaluation: Before each 
version of the robot is placed into service, demonstration and training sessions will occur where all 
potential clinical and elder users will be invited to learn about the robot and the experiment. Those 
willing to participate in a week-long study will sign informed consents. Data will be collected from the 
robot during the testing service and post -interviews will be conducted with a subset of participants to 
assess acceptance, problems and productivity issues. Participating elder members must agree to wear a 
tracking bracelet that will serve as an identiﬁer allowing the robot to recognize a person and as alternate 
means of gathering activity data.
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Deception
Does your project use deception?
No
Analysis Plan
The audio recorded tapes will be transcribed by a professional transcriptionist after each focus group 
session, and conversations will be preserved exactly as they occurred. Video may also be recorded. 
Digital video and audio ﬁles will be copied to a University of Pennsylvania secured research drive 
which will be established speciﬁcally for this project. The audio ﬁles will then be sent to a 
transcriptionist through Penn Secure Share. Upon receipt of he transcripts, the researchers will conﬁrm 
accuracy of each transcription against the recordings. Recordings and transcriptions will be kept in a 
password protected ﬁle/locked cabinet. Transcriptions will be uploaded to Atlas.ti, which is a data 
management software speciﬁcally designed for the qualitative analysis of large bodies of textual, 
graphical, audio and video data. Use of Atlas.ti will support coding units of text required for level one 
codes and synthesizing them into multiple levels of codes culminating in theme identiﬁcation. Analysis 
of the transcripts will be done on an on-going basis using content analysis. This process begins with 
level one coding in which the researchers analyze the text line by line. At this level coding is 
substantive, codifying the substance of the data using both the actual words participants used 
themselves and implicit codes the researchers develop. Following level one coding, level two coding 
requires comparing level one codes and developing categories. During the level two categorization 
phase, researchers ensure that categories appropriately reﬂect the concepts suggested by level one codes 
and are mutually exclusive. The ﬁnal phase of coding, level three coding, identiﬁes the central themes 
that emerge from the data. Summary statistics on the demographics questionnaire will also be 
calculated as part of the analysis plan.  Anticipated Outcomes: The validation phase will provide 
answers to the key questions: 1. How does the robot impact the clinical staff? We anticipate that the 
robot service would provide a beneﬁt to the clinical staff by increasing their productivity measured in 
terms of its impact on cost of service, use of time, and number of people able to be served. 2. How does 
the robot impact the elders? We anticipate that the robot service would provide a beneﬁt to the elders 
and increase their overall quality of life measured in terms of its ability to increase their overall mood, 
increase their engagement with the staff and each other, as well as help them to feel more competent/
independent.  3. How usable was the robot? We anticipate that the usefulness and usability of the robot 
is key to acceptance and satisfaction. We will measure usability in terms of ease of use, set-up time, # of 
faults/errors, and # of hours in operation without errors. We will evaluate our research questions deﬁne 
ﬁnal metrics for assessment of outcomes.
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Are you conducting research outside of the United States?
No
Subject Conﬁdentiality
All study personnel wil have access to a locked ﬁle cabinet containing consent forms, evaluation 
assessments, and collected data. The locked ﬁle cabinet will be located at Living Independently For 
Elders (LIFE) at 4508 Chestnut Street, Philadelphia, PA, 19139. Both electronic data and hard copy 
records will be kept for a minimum of 10 years. Electronic data will be kept on password protected 
computers. After 10 years, any documents no longer needed will be destroyed by secure shredding at 
Penn Rittenhouse and electronic data will be 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. Additionally, all hard copy data collected 
by Dr. Lau (i.e. consent forms and questionnaires), will be stored in the same aforementioned manner, 
but will be kept at Savioke's ofﬁces located at 2900 Gordon Ave., Ste 201, Santa Clara, CA 95051. Any 
video recordings collected by Savioke at The Forum and Rancho San Antonio will ﬁrst be analyzed for 
non-verbal cues and after analysis, faces will blurred and data stored on password protected computers 
located at Savioke in Santa Clara, CA.  Participants will be asked to create their own pseudonyms for 
use during the focus group sessions. This will help to ensure anonymity of participants during 
transcription and data analysis.The audio recorded tapes will be transcribed by a professional 
transcriptionist, and conversations will be preserved exactly how they occurred. Digital audio ﬁles will 
be copied to a University of Pennsylvania secured research drive which will be established speciﬁcally 
for this project. The ﬁles will then be sent to the transcriptionist through Penn Secure Share. Upon 
receipt of the transcripts, the researchers will conﬁrm accuracy of each transcription against the audio 
recordings. Audio recordings and transcriptions will be kept in a password protected ﬁle/locked cabinet 
within a locked ofﬁce at LIFE.
Sensitive Research Information*
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record?
No
Data Disclosure
Will the data be disclosed to anyone who is not listed under Personnel?
Dr. Tessa Lau, co-founder of Savioke Inc., and a co-PI on this study will have access to the data. She is 
HIPAA and CITI certiﬁed. Additionally, a PhD-level intern under Dr. Lau's supervision, Mike Chung, 
will have access to the study data. He is also HIPAA and CITI certiﬁed. Caspar Nguyen, a high school 
intern in Dr. Johnson's Rehab Robotics Lab, has been added to the protocol. She will be helping the 
team with data entry during her time at the lab.

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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
x Social security numbers
x 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
x 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
Consent
1. Consent Process
Overview
Subjects will receive a consent form at least 24 hours prior to 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 sessions. Before a session begins, study personnel will review the consent form 
and experimental procedure with subjects and answer any questions. All participants 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.
Risk / Beneﬁt
Potential Study Risks
The risks are minimal and all testing will be non-invasive.  Subjects may experience frustration using 
the robot due to difﬁculty understanding instructions and multi-component directives. Care will be 
taken to use 8th grade language this is often an IRB requirement and to deliver surveys verbally and in 
person. The robot interface will be as simple as possible to enable elder interaction and use. Additional 

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Signiﬁcant Risks: Still a minimal risk study. 1. Fatigue for user due to walking 2. Risk of falls during 
exercise  3. Frustration during use with the robot 4. Interaction with Robot gripper when passing an 
object Subjects may experience discomfort or embarrassment due to actions by the robot. Efforts will 
be made to ensure privacy in communication of sensitive reminders.  Subjects may experience 
discomfort or embarrassment sharing their thoughts in a focus group setting. Efforts will be made to 
foster an atmosphere of impartiality, conﬁdentiality and sensitivity to allow subjects to feel free to 
communicate their opinions.  Subjects may bump into robot and experience pain or muscle bruising. 
The robot will be equipped with obstacle avoidance sensors, alarms etc to allow it to alert and avoid 
elders. In the case of failure, an emergency stop button can be applied.  Subjects may experience fatigue 
due to walking, frustration while interacting with the robot, and while we will do everything possible to 
avoid fails, the risk does increase slightly.  For unforeseen challenges, we will work closely with LIFE 
and the staff to resolve.
Potential Study Beneﬁts
The beneﬁt is not to the individual subjects as it would be to the overall outcome of elderly care. We 
anticipate that Elders and clinicians will provide valuable insights into the development process of this 
robot. If successful, the robot will be able to be commercialized in the future.
Risk / Beneﬁt Assessment
Minimal risk
General Attachments
The following documents are currently attached to this item:
Additional forms (kristinelima-citicompletionreport.pdf)