Endurance, Energy Expenditure, Perceived Function, and Satisfaction of Persons With Transtibial Limb Loss Using a Running-Specific Prosthesis Modified for Walking
Phase: NA
Conditions: Transtibial Amputation
Sponsor: University of Washington

RECEIVED 
Human Subjects Division 
UNIVERSITY OF WASHING TON 
FEB O 5 2015 
BOX FOR COMMITTEE USE ONLY 
MASTER O COMM. 0 
INVESTIGATOR 0 
Human Subjects Division 
LJW 
Box 359470 
APPLICATION: Human Subjects Review 
APPLICATION NO. 
4-C/ ISO -E,1 
I. 
PRINCIPAL INVESTIGATOR (Provide all the information requested. Change of PI requires a modjficatjon. All paper-
based correspondence will be directed to this person. Please list the mailing address for paper-based correspondence. 
You may designate a contact person other than yourself in section II., below.) 
Name 
Brian Hafner 
Title PhD 
Position 
Associate Professor 
-----------
Home Institution (or source of paycheck) 
U • 
· t 
f w h · 
t 
UW Student? Home institution is UW, 
_ n_1._v_e_r_s_1.___,y'--o __ 
a_s __ 
1.n----=-g_ o_n ___________________ _ 
Home UW Department (if applicable) 
Rehab Medi cine 
Division 
Prosthetics & Orthotics 
UW Position or al?t?Oint_m_en_! (~oose the most apprQpria_!e ~ne)_; 
_ 
[X] Regular Faculty Appointment [ ] Research Faculty Appointment 
[ ] Visiting Faculty Appointment [ ] Dual Appointment with PNNL 
] Clinical Faculty Appointment 
Faculty: 
Student: 
[ ] Other (describe): 
[ ] Matriculated Undergraduate 
Student 
[ ] !3--~~-ic!~nt <E:. ~ e!!£>~ ~t_ the yw O! Local _v A __ 
] Graduate or Professional Student (matriculated or 
approved "On Leave") 
[ ] U_W Ac!mini~t!a!ion or §taff 
Campus Box # 
3 5 6 4 9 0 
Other Address if not at UW 
Telephone _206-685-4048 
Fax 
206 - 685 - 3244 
e-mail 
bhafner@uw . edu 
[ ] WW AMI Student 
[ ] None 
II. IRB CONT ACT PERSON (Provide all the information requested. Change of Contact Person requires a modjfjcatjon_ If 
this section is completed, all paper-based correspondence will be directed to this person.) 
Name 
Cody McDonald 
Title CPO 
Position 
Prosthetics & Orthotics 
Home Institution (or source of paycheck) 
University of Washington 
-------''---------"-----------------------
Home UW Department (if applicable) 
Rehab Medicine 
Division 
Prosthetics & Orthotics 
UW Posi!iQn or appointment (choose the m_~st appropriate one): _ 
. 
[ ] Regular Faculty Appointment 
[ ] Research Faculty Appointment 
[ ] Visiting Faculty Appointment 
[ ] Dual Appointment with PNNL 
[ ] Clinical Faculty Appointment 
Faculty: 
[ ] Other (describe): ___ 
_ __ 
[ ] Matriculated Undergraduate 
Student 
Student: 
[ ] Resident or Fellow at the UW or Local VA 
[X] Graduate or Professional Student (matriculated or 
approved "On Leave") 
[ ] UW Administration or Staff 
Campus Box # 
3 5 6 4 9 0 
Other Address if not at UW 
Telephone _206 - 221-6347 
Fax 
206-685-3244 
e-mail 
codym@uw . edu 
III. TITLE OF PROJECT: Evaluation of a Modified Running Prosthesis 
[ ] WWAMI Student 
[ ] None 
IV. SIGNATURES: The undersigned acknowledge that: 1. this application is an accurate and complete description of the 
proposed research; 2. the research will be conducted in compliance with the recommendations of and only after approval has 
been received from the Institutional Review Board (IRB). The lead researcher is responsible for all aspects of this research, 
including: reporting any serious adverse events or problems to the IRB, requesting prior IRB approval for modifications, and 
,equesUng conUnuing miew and app,oval. 
,.,...---7 r\ . \ \ h 
A. Investigator: 
Brian Hafner , PhD 
~ ~ 
':_l_ 
-\-\ <.I y--~1-1-/.:.3 ... 
e-1-1'~2-f'ltrr.,.5 
TYPED NAME PLUS SIGNATURE 
DATE 
B. Facu-lty sponsor (for student): 
Change requires a modification. 
TYPED NAME PLUS SIGNATURE 
DATE 
C. The Chair, Dean, or Director acknowledges the researcher is qualified to do the res~earch sufficient resources will be 
available, and (if no external funding review occurred) there was 
· .. -·~ .. .,, r · 
scientific merit. 
. 
Peter Esselman , MD 
;J d /_) 
TYPED NAME PLUS SIGNATURE 
APPLICATION: Human Subjects Review (13-1 I), Full Board or Subcommittee (Rev. I 1/26/2014) 

______ A~',(,=~~· _[_~-~-· - ----- -- FEB 1 9 2015 APPROVE 'th 
DISAPPROVE D 
IRB COMMITTEE SIGNATURE 
DATE 
r 
Subject to the following restrictions: _____________________ _________ _ 
. 
. 
r tt:s 1 ~ Lu ,J 
FEB 1 s 2016 
Penod of approval 1s one year, from ___ ___ ___ through ________ _ _ 
D 
Subject numbers are approved as described in this !RB Application unless otherwise indicated above in "Subject to the following 
conditions" or in an accompanying letter. 
*VALID ONLY AS LONG AS APPROVED PROCEDURES ARE FOLLOWED* 
APPLICATION: Human Subjects Review (13-11 ), Full Board or Subcommittee (Rev. 10/ 17/20 14) 

V. TYPE OF NEW SUBMISSION 
I I 
IRBshare 
MINIMAL RISK 
PAGE2 
I X J 
(The research meets the definition of minimal risk and falls into one or more expedited review categories. You are done with this 
table.) 
FULL COMMITTEE 
I I 
Full Committee (The research involves greater than minimal risk and requires review at a convened meeting of the IRB) 
Full Committee (The research involves no more than minimal risk but does not fit into one of the expedited review 
categories) 
METHODS: 
Please mark the boxes to indicate the methods which best describe your study: 
I I 
Social-Behavioral Procedures/Considerations 
Observational 
Behavioral Interventions 
Interview/Focus Groups 
I I 
Medical Procedures/Considerations 
Bio-hazardous Substances 
Controlled Substances 
Emergency Treatment 
Gene Transfer Study 
Stem Cell Research 
Magnetic Resonance imaging (MRI) 
lnvestigational/Approved Drugs and 
Biologics 
Population-Based Field Study 
Surveys/Questionnaires 
Other - Describe: 
lnvestigational/ Approved Devices 
Radiation Exposure 
Substance Abuse Treatment (with 
medication) 
Surgical Procedures 
Genetic Testing 
Complementary/Alternative Medicine 
Other - Describe: 
DOES YOUR RESEARCH INVOLVE OR IS IT ASSOCIATED WITH ANY OF THE FOLLOWING: 
Emergency Medicine 
Pregnant Women as a Target Population 
Genetics 
Stem Cells 
Neuroscience 
College of Arts and Sciences 
College of Education 
Dentistry 
Infectious Disease 
HIV/AIDS 
Psychiatry 
Rehabilitation Medicine 
Psycho-Social Drug Abuse Research 
Alaska Native/American Indian (ANAi) 
Public Health 
Global Health 
Health Services 
Quality of Care / Quality of Life 
Health Prevention/ Health Education 
Nursing 
VI. PRIMARY RESEARCH ROLES 
Some research projects are conducted by a large team of individuals. Other projects can be performed by only one or two individuals. 
The IRB does not need to know the name of every member of your research team - instead, the IRB wants to know who is fulfilling 
APPLICATION: Human Subjects Review (13-1 I), Full Board or Subcommittee (Rev. I 1/26/2014) 

PAGE3 
the following specific roles for your research. Note that the same individual may play multiple roles. If it is necessary to identify an 
individual by name, this will be specified below. Each section below must be completed. 
I. Information for individuals identified by name: 
The individuals below need to be identified by name. If these individuals change during the course of the research, a Modification 
approval from the IRB is needed before making the change. 
Subject Contact Person (to answer questions, receive complaints or reports of side effects, etc.) 
Check here if the same as: [ ] Lead Researcher [X] IRB Contact Person 
If one of these boxes is checked, you do not need to complete the rest of this table. 
Name ______________ Title __________ Position 
Home Institution (or source of paycheck) 
UW Student? Home institution is UW. 
Home UW Department (if applicable) ------------
UW Position or appointment (choose the most appropriate one): 
Division 
[ ] Regular Faculty Appointment 
[ ] Research Faculty Appointment 
[ ] Visiting Faculty Appointment [ ] Dual Appointment with PNNL 
[ ] Clinical Faculty Appointment 
Faculty: 
[ ] Other (describe): 
[ ] Matriculated Undergraduate 
Student 
Student: 
[ ] Resident or Fellow at the UW or Local VA 
] Graduate or Professional Student (matriculated or 
approved "On Leave") 
[ ] UW Administration or Staff 
Campus Box # 
Telephone 
Other Address if not at UW 
Fax ______ e-mail 
Study Coordinator 
Check here if the same as: [ ] Lead Researcher [X] IRB Contact Person [ ] Subject Contact Person 
lfone of these boxes is checked, you do not need to complete the rest of this table. 
Name ______________ Title ___________ Position 
Home Institution (or source of paycheck) 
UW Student? Home institution is UW. 
Home UW Department (if appl icable) 
UW Position or appointment (choose the most appropriate one): 
Division 
[ ] WWAMI Student 
[ ] None 
[ ] Regular Faculty Appointment 
[ ] Research Faculty Appointment 
[ ] Visiting Faculty Appointment [ ] Dual Appointment with PNNL 
[ ] Clinical Faculty Appointment 
Faculty: 
Student: 
[ ] Other (describe): 
[ ] Matriculated Undergraduate 
Student 
[ ] Resident or Fellow at the UW or Local VA 
[ ] Graduate or Professional Student (matriculated or 
approved "On Leave") 
[ ] UW Administration or Staff 
Campus Box # 
Telephone 
Other Address if not at UW 
Fax ______ e-mail 
2. Information for research staff who will perform procedures that involve risk to subjects: 
[ ] WWAMI Student 
[ ] None 
The individuals below do not need to be identified by name, rather, by qualifications. As long as the qualifications of the individuals 
and the procedures performed remain the same, a modification is not needed. 
If an individual is not an agent of the UW, indicate his/her institution or organization. Should an individual not be associated with an 
institution or organization, state so. For all non-UW individuals, it will be necessary for this individual to receive !RB review. There 
are a number of mechanisms by which this may occur. 
• 
If the non-UW individual is associated with Pacific Northwest National Laboratories, Puget Sound Blood Center, King 
County-Seattle Public Health, or Northwest Kidney Center: the UW has an institutional Authorization Agreement with 
these institutions by which it provides the IRB review (as long as any funding is administered through the UW). 
• 
If the non-UW individual is assoc1ated with the Fred Hutchinson Cancer Research Center, Group Health, Seattle children's, 
Swedish Medical Center, or Benaroya Research Institute at Virginia Mason: the terms of the UW's Cooperative IRB 
Agreement with these institutions may or may not allow the UW IRB to do the review. The individual should contact their 
institution's IRB for guidance. 
APPLICATION: Human Subjects Review ( I 3- 11 ), Full Board or Subcommittee (Rev. I 1/26/2014) 

PAGE4 
• 
If the non-UW individual is associated with an institution or organization in which the UW does not have a Cooperative IRB 
Agreement, it will be necessary for the non-UW individual to provide their own IRB review. If the non-UW individual's 
institution or organization does not have their own IRB or does not use an IRB for review of their research and the non-UW 
individual's institution or organization has a Federalwide Assurance (FWA), the non-UW individual's institution or 
organization may enter into an IRB Authorization Agreement with the UW. This means that the UW will provide IRB 
review for the non-UW individual. The non-UW Individual's institution or organization may also wish to enter into an IRB 
Authorization Agreement even if they have their own !RB to prevent duplication of effort. However, entering into an !RB 
Authorization Agreement with a non-UW individual's institution or organization is at the discretion of the HSD. 
• 
If the non-UW individual is not associated with an institution or organization or if the non-UW individual is associated with 
an institution or organization that does not have a FW A and does not routinely conduct research, an Individual Investigator 
Agreement may be entered into with the UW. The Individual Investigator Agreement extends the applicability of the UW's 
FW A to cover the non-UW individual, institution or organization. However, entering into an Individual Investigator 
Agreement with a non-UW individual, institution or organization is at the discretion of the HSD. 
Please see SOP Authorization Agreements for information on how to obtain an Agreement for your research. 
Study Procedures that involve risk to subjects 
[ ] Phlebotomy (blood draw) 
Who will perform this procedure? 
[ ] Licensed Practitioner 
Describe the qualifications for the Licensed Practitioner below, including whether they are affiliated with the UW, 
any requirement for professional license or credential, and/or experience in performing this procedure: 
[ ] Study Nurse 
Describe the qualifications for the Study Nurse below, including whether they are affiliated with the UW, any 
requirement for professional license or credential, and/or experience in performing this procedure: 
[ ] Other: 
[ ] MRI Scan 
Describe the qualifications for the Other Professional below, including whether they are affiliated with the UW, any 
requirement for professional license or credential, and/or experience in performing this procedure: 
Who will perform this procedure? 
[ ] Licensed Practitioner 
Describe the qualifications for the Licensed Practitio.ner below, including whether they are affiliated with the UW, 
any requirement for professional license or credential, and/or experience in performing this procedure: 
[ ] Study Nurse 
Describe the qualifications for the Study Nurse below, including whether they are affiliated with the UW, any 
requirement for professional license or credential, and/or experience in performing this procedure: 
[ ] Other: 
Describe the qualifications for the Other Professional below, including whether they are affiliated with the UW, any 
requirement for professional license or credential, and/or experience in performing this procedure: 
] Surgical or Physically Invasive Procedure 
Who will perform this procedure? 
[ ] Licensed Practitioner 
Describe the qualifications for the Licensed Practitioner below, including whether they are affiliated with the UW, 
any requirement for professional license or credential, and/or experience in performing this procedure: 
[ ] Study Nurse 
Describe the qualifications for the Study Nurse below, including whether they are affiliated with the UW, any 
requirement for professional license or credential, and/or experience in performing this procedure: 
[ ] Other: 
Describe the qualifications for the Other Professional below, including whether they are affiliated with the UW, any 
requirement for professional license or credential, and/or experience in performing this procedure: 
] Other Procedures Involving Risk to 
Subjects [name the procedure(s)]: 
APPLICATION: Human Subjects Review ( 13-11 ), Full Board or Subcommittee (Rev. 11/26/2014) 

PAGES 
Examples: behavioral therapy; dietary counseling; assessments and/or interpretations of test reults that require specific 
expertise (e.g. physical exam; fitness assessment; cognitive state; suicidality; mental health; interpretation of 
imaging tests, genetic tests, cognitive tests, etc.) 
For more than one "Other" procedures, copy and paste this portion of the table as many times as necessary. 
Who will perform this procedure? 
[ ] Licensed Practitioner 
Describe the qualifications of the Licensed Practitioner below, including whether they are affiliated with the UW, 
what is their professional license, and their experience in performing this procedure: 
[ ] Study Nurse 
Describe the qualifications of the Study Nurse below, including whether they are affiliated with the UW, what is 
their professional license, and their experience in performing this procedure: 
[ ] Other: 
Describe the qualifications of the Other Professional below, including whether they are affiliated with the UW, what 
is their professional license, and their experience in performing this procedure: 
3.a. Non-UW Individuals, Institutions or Organizations. It will be necessary for each non-UW individual, institution or 
organization listed below to receive IRB review of its involvement in this research. There are a number of mechanisms by which this 
may occur. 
Please only list the non-UW individual, institution or organization below if you are: 
• 
The direct recipient of an award or if you will be providing funding to the non-UW individual, institution or 
organization through a mechanism such as a sub-contract; and 
• 
If the non-UW individual, institution or organization will be acting on behalf of the UW research study to do any of 
the following: I) Obtain consent from subjects, 2) Perform procedures involving subject interaction or observation, 3) 
Obtain identifiable data/specimens, 4) Have access to, or receive coded or identifiable data/specimens, 5) Intervene by 
manipulating the environment. 
• 
If the non-UW individual is associated with Pacific Northwest National Laboratories, Puget Sound Blood Center, King 
County-Seattle Public Health, or Northwest Kidney Center: the UW has an institutional Authorization Agreement with these 
institutions by which it provides the IRB review (as long as any funding is administered through the UW). 
• 
If the non-UW individual is associated with the Fred Hutchinson Cancer Research Center, Group Health, Seattle children's, 
Swedish Medical Center, or Benaroya Research Institute at Virginia Mason: the terms of the UW's Cooperative IRB 
Agreement with these institutions may or may not allow the UW IRB to do the review. The individual should contact their 
institution's !RB for guidance. 
• 
If the non-UW individual, institution or organization is one in which the UW does not have a Cooperative !RB Agreement, it 
will be necessary for the non-UW individual, institution or organization to provide their own !RB review. If the non-UW 
individual, institution or organization does not have their own !RB or does not use an !RB for review of their research, and 
the non-UW individual, institution or organizatioR has a Federal Wide Assurance (FWA), the non-UW individual, institution 
or organization may enter into an IRB Authorization Agreement with the UW. This means that the UW will provide !RB 
review for the non-UW individual, institution or organization. The non-UW individual, institution or organization may also 
wish to enter into an !RB authorization Agreement even if they have their own !RB to prevent duplication of effort. However, 
entering into an !RB Authorization Agreement with a non-UW individual, institution or organization is at the discretion of 
the HSD. 
• 
If the non-UW individual is not associated with an institution or organization that has a Federal Wide Assurance (FWA) or if 
the institution or organization listed below does not have a FW A and does not routinely conduct research, an Individual 
Investigator Agreement may be entered into with the UW. The Individual Investigator Agreement extends the applicability 
of the UW's FW A to cover the non-UW individual, institution or organization. However, entering into an Individual 
Investigator Agreement with a non-UW individual, institution or organization is at the discretion of the HSD. 
Please see SOP Authorization Agreements for information on how to obtain an Agreement for your research. 
3b. Non-UW Individual, Organization or Location: 
If there is more than one non-UW individual, organi=ation, or location, copy and paste this table as many times as necessary. 
Name of the non-UW Individual, Organization or Location: 
APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee (Rev. 11 /26/2014) 

PAGE 6 
Address of the non-UW Individual, Organization or Location: 
Describe the activities that will be performed by/at the non-UW Individual, Organization or Location (if the 
specified activities will not be performed, please enter N/A): 
Obtain consent from the subjects: 
Perform procedures involving 
subject interaction or observation: 
Obtain identifiable data/specimens? 
Have access to, or receive coded or 
identifiable data/specimens: 
Intervene by manipulating the 
environment: 
VII. SECTION I - LIST EACH PROPOSED AND FUNDED GRANT OR CONTRACT RELEVANT TO THIS 
APPLICATION, AND ATTACH A COMPLETE COPY OF EACH GRANT OR CONTRACT. THIS SHOULD INCL.LIDE 
GRANTS THAT SUPPORT FACULTY TIME FOR DATA ANALYSIS AND MANUSCRIPT PREPARATION, (I.E. 
SALARY SUPPORT). IF NONE, CHECK HERE •. FOR CENTER OR PROGRAM PROJECT GRANTS LIST P.I. AND 
TITLE FOR EACH SEPARATE PROJECT OR CORE. ADD SHEETS IF NECESSARY. 
For Center, Program, and Institutional Training Grants (e.g., NIH "P" awards and "T" awards): Attach only the following components 
of the application. The terms used here are from the standard NIH applications for these types of grants. If the grant is from another 
agency, provide the equivalent application sections. 
• 
Cover page(s) 
• 
Project/Performance Site Location 
• 
Other Project Information 
• 
Research Plan (for Center or Program grants) 
• 
Research Training Program Plan (for Institutional Training grants) 
• 
Biosketch (profile) for the principal investigator on the grant 
For Department of Defense (DOD) funding, complete and attach the SUPPLEMENT: Department of Defense 
For Department of Justice (DOJ) funding, complete and attach the SUPPLEMENT: Department of Justice 
A. Type of proposal: 
C8:J Research 
O Contract 
O Fellowship 
O Training grant 
O Subcontract 
D Other, specify 
8. Name of principal investigator: 
Brian J. Hafner, PhD 
C. Name _of funding agency: 
Royalty Research Fund 
D. Agency's number (if assigned): 
A97186 
E. Title of proposal: 
Endurance, energy expenditure, perceived function, and satisfaction of persons with 
transtibial limb loss using a running-specific prosthesis modified for walking 
F. Inclusive dates: from 
03/01/15 
through 
04/30/16 
G. Status: 
C8:J New 
O Competing renewal 
O Non-competing renewal 
H. Submitted through UW Office of Sponsored Programs? 
C8:J Yes 
O No, (attach explanation) 
APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee (Rev. 11/26/2014) 

PAGE7 
VIII. SUMMARY OF ACTIVITY. Answer in spaces provided (add numbered, referenced, single-sided sheets when necessary). 
Do not refer to an accompanying grant or contract proposal. 
A. BACKGROUND AND PURPOSE OF RESEARCH. Provide relevant background information and explain in lay language 
why this research is important and what question(s) or hypotheses this activity is designed to answer. 
Amputation of a limb is a life-altering eve nt with profound physical , psychological , and 
social i mplications. To address their functional , vocational , and recreational needs , 
people with lower limb amputation (LLA) are often provided with a prosthesis or 
artificial leg . While use of a prosthesi s can allow an individual to achieve a basic 
level of f unctional mobility , absence of an anatomical foot and ankle still impairs 
their physical performance . As a result , people with LLA regularly exhibit decreased 
walking speeds , dimi nished endurance, a nd restricted ability to participate in desired 
life situations. 
Over the past three decades, increas ingly soph isticated prosthetic foot designs have 
been deve loped by the prosthetics industry to replace amputa ted structures in the leg . 
Contemporary, energy storing fee t 
(ESF) employ advanced materials and uni que geometric 
designs to improve walking performance and endurance of their users. Although prosthetic 
limbs with ESF allow people with LLA the po tential to r eturn to an active lifestyle , 
even the most advanced ESF do not significantly reduce the increased energy demands 
required for walking when compared to conventional prosthetic feet . 
Commercially- available running-specific fee t 
(RS F) like the Ossur Cheetah (Ossur, 
Reykjavik , Icela nd) allow people with LLA to participate in athletic activities and 
sporting events . RSF provide s i gnificantly enhanced pe r formance , compared to t raditional 
ESF , by extending the length and increasing the stiffness of the prosthetic keel 
(forefoot) . RSF also do not include a hee l , as they are used only for running 
activities. Although transtibial runners wi th RSF exhibit endurance levels similar to 
non - ampu t ees , the RSF design does not allow the biomechanical movements or provide the 
stability needed to use the foot for walking (over leve l or uneven terrain) . 
A Seattle- area prosthetist, Greg Davidson , currently provides many of his active LLA 
patients wi th a modified running-specific foot (mRSF). The mRSF combines the running 
keel (forefoot) of a RSF with the walking heel of a ESF . The mRSF can then be used for 
walking, run ning , and other routi ne daily ac t ivities . Mr. Davidson has fit a nd provided 
this prosthetic foot on over 100 of his patients. Preliminary feedback suggests that 
users experience improved overall function and high satisfaction with the device . 
However , empirical evidence i s needed to support prescript ion of this prosthetic foot at 
other clinical facilities . The goal of this study is therefore to evaluate endurance, 
walking performance , mobility , and perceived exertion of transtibial prosthesis user s 
(i . e ., study participants) walking with a conventional ESF and the mRSF . Results will be 
compared to determine if the mRSF provide s superior performance to the ESF, which is 
commonly prescribed to most active individuals with LLA . 
Hypotheses: 
la. Participants with LLA will exhibit signi ficantly increased endurance (as evidenced 
by an ability to walk s ignificant ly fur ther in a t imed walking test) wearing the 
mRSF compared to the ESF. 
lb. Participants will report significantly reduced levels of exerti on after performing a 
timed wal king test in the mRSF , compared to the ESF . 
2a. Participants will report significantly increased mobili ty , balance confidence , and 
health and significantly decreased fatigue when using the mRSF, compared to the ESF . 
3a . Use of the mRSF will significantly reduce participants ' net energy cost of walking 
(ECW) at slow , comfortable , and fa s t walking speeds, compared to the ESF. 
8. RESEARCH PROCEDURES INVOLVED. 
I. Provide a complete description of: a. the study design, and b. sequence and timing of all study procedures that will be 
performed, e.g., volume of blood, size of biopsy, drug administration, questionnaire, name of psychological test. Provide this 
information for each phase of the study (pilot, screening, intervention and follow-up). Use lay language. Attach study flow 
sheet, if available. 
APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee (Rev. 11/26/2014) 

PAGE 8 
We will conduct a study to compare endurance , walking performance , mobility , and 
perceived exertion of participants with transtibial amputation wearing two different 
prostheses : (1) a prosthesis with a modified Running Specific Foot (mRSF) , and (2) a 
prosthesis with a Energy Storing Foot (ESF) . To maximize study resources, we will 
recruit participants who will be receiving from their prosthetist the mRSF prosthesis 
as part of their normal clinical care. We will fabricate a duplicate prosthesis with 
the ESF as part of this study to be used as a comparison . 
Note: Both the mRSF and ESF included in this study are devices that people with LLA use 
daily in their normal lives o utside of this study. 
These feet (and o ther components 
included in the prostheses created for this study) are class I devices and e xempt from 
U. S . Food and Drug Administration premarket notification procedures. 
We will conduct a randomized crossover study to compare endurance , energy expenditure , 
and reported health of participants with transtibial ampu tation wearing prostheses with 
the mRSF and ESF described above . Study participants will be randomly assigned to the 
first foot condition (i. e . ESF or mRSF) . To standardi ze test conditions , the 
participant ' s prosthetist (Greg Davidson) will fabricate two comparable prostheses with 
identical (i . e . duplicated) prosthetic sockets, inter faces , and suspension mechanisms. 
The same socket cannot be used for both prostheses because of the unique , direct -
lamination attachment of the mRS F to the socket. The duplicate socket will be fitted 
with common ESF, the Ossur Vari - flex foot. We have obtained written commitments from 
Ossur to donate prosthetic components and from Davidson Prosthetics to donate time and 
materials needed to fabricate the duplicate sockets and test prostheses. Participants 
will be asked t o wear the same athletic shoes for all sessions in order to standardized 
footwear between tests . 
Participants will be recruited from their local prosthetist ' s o ffice (Davidson 
Prosthetics , Federal Way , WA ) . Davidson Prosthetic s is the sole locati on f or 
recruitment as this is the only provider of the mRSF in the Northwestern United States. 
Partici~ants will be asked to come to the University of Washington Assessment and 
Training Laboratory (ATL) for three test sessio ns. Participation in the study will 
require participants attend three visits over the course of about three months , 
totaling approx i mately 7 . 5 hours. 
Sessio n i: At the first session , we will screen participants , explain the study t o 
them, and obtain informed c onsent (Appendix 1 ) . Participants who agree will then be 
administered a baseline survey and perform initial speed testing . The baseline survey 
will inc lude non - identifiabl e , medical , and demographic questions we will use t o 
characterize the study sample (Appendix 2 ). Participants will then be asked t o walk on 
a treadmill for 6 minutes to determine their c·omfortable walking speed . The treadmill 
is equipped with full - length handrails that allow the participant to steady him/ herself 
as needed. A researcher will be next to the sub ject at all times to assist the sub j ect 
if he or she were to become distressed. 
Participants will be given blinded control of the treadmill speed for the first 30 
seconds of testing in order to select their preferred speed . Each participant ' s 
comfortable speed will be noted and used as a reference for the metabolic testing (see 
Session 2 and 3, described below) . 
Slow and fast speeds will be self- selected using an 
identical method (blinded control of the treadmill adj us tment) . Participants will be 
asked to perform a 6 minute practice trial at their self - selected fast speed to ensure 
the participant is capable of sustaining the speed without undo stress. If a 
participant is unable t o sustain the set speed f o r the entire 6 minutes , he / she may 
reduce speed as desired, and a weighted average o f the start and end fast speeds will 
be used for treadmill testing in Sessions 2 and 3. We will also give participants a 
step activity monitor to wear on their prosthesis . The activity monitor is a small, 
unobtrusive senso r about t he size o f a pa ger that i s worn on t he prosthesis and 
measures steps taken by the participant while they are away fr om the lab. Participants 
will be shown how to attach the activity monito r t o their prosthesis by study 
investigators . Session 1 is expected to take about 1.5 hours . 
Session 2 : The second sessi on will be performed after participants use the randomly-
assigned ESF or mRSF prosthe sis for a period o f 1 month. Upon arri val at the lab , study 
APPLICATION: Human Subjects Review (13-11 ), Full Board or Subcommittee (Rev. 11/26/201 4) 

PAGE9 
staff will remove the activity monitor and ask the participant to complete a self-
report survey (Appendix 2 ) to evaluate their perceived performance, health , and 
satisfaction with their prosthesis . The survey will be administered on a tablet 
computer (iPad) and includes the following standardized instruments selected to measure 
participants' mobility, fatigue , balance confidence, activity restrictions, and 
satisfaction: 
• 
Prosthetic Limb User s Survey of Mobility -
PLUS-M measures respondents' self -
reported mobility with a prosthesis. The PLUS - M was developed by the 
investigators in a prior study to address methodological limitations present in 
existing mobility measures. We will administer the PLUS - M computer adaptive test 
(CAT) to achieve the greatest precision of measurement and ease respondents ' 
burden (i.e. , CAT requires participants answer fewer questions than would taking 
the entire survey) . 
• 
PROMIS -
Fatigue -
PROMIS-F measures symptoms and effects of fatigue on 
respondents' ability to execute daily activities over a 1-week recall period . We 
will also administer PROMIS-F by CAT . 
• 
Activities Specific Balance Confidence Scale -
ABC measures respondents' 
confidence in performing basic ambulatory activities . We will administer a 
version of the ABC recommended to ease administration and improve scoring. All 16 
questions of the ABC will be administered (CAT not available). 
• 
Trinity Amputation and Prosthesis Experience Scales - Revised -
TAPES-Risa 
multidimensional health instrument that measures activity restrictions and 
satisfaction with a prosthesis. We will administer 19 TAPES-R questions (CAT not 
available) . 
We will next assess participants' walking performance and endurance using the 6- minute 
walk test (6MWT). The 6MWT is a sub- maximal test of aerobic capacity and endurance that 
exhibits good test - retest reliability in transtibial prosthesis users. The 6MWT will be 
conducted using a 100ft unobstructed indoor hallway , in accordance with recommended 
administration guidelines . During the 6MWT, participants will walk back and forth over 
a pressure- sensitive instrumented mat placed in the middle of the hallway . The mat will 
collect outcomes associated with walking such a s step length , step width , walking 
speed. Upon conclusion of the 6MWT, participants will self-report their exertion using 
the Borg Rating of Perceived Exertion (RPE) . The Borg RPE measures participants' 
perceived exertion after completing a standardized physical test . Note , participants 
will perform the 6MWT after evaluation of resting 02 consumption (see below) but be fore 
the treadmil l testi ng so as to ensure baseline 02 consumption is not adversely affected 
by the 6MWT . 
To assess the effect s of the studied prosthetic feet on energy cost of walking , we will 
measure participants ' real-t ime metabolic energy expenditure (i . e. , 02 consumption) 
across three walking speeds (slow , comfortable, fast) . The gold standard method for 
determining energy cons umptio n is measurement of the amount of oxygen a person intakes 
(VO2) and carbon dioxide that a person expires (VCO2 ). We will measure VO2 and VCO2 
using a portable Cosmed K4b2 monitor. The K4b2 monitor continuously samples the 
participant' s expiration and inspiration using a mask that fits over their nose and 
mouth. Plastic tubes convey the gases to sensors tha t are located in a small , 
lightweight (1 lb) backpack system . 
Breath- by-breath measurements of the expired gases 
are stored in the system until they are uploaded by the researcher to a laptop after 
the experiment is completed . 
Participants will be fitted with the K4b2 monitor upon conclusion of the self-report 
survey (described above) . 
They will sit quietly for 5 minutes to achieve steady-state 
resting VO2 consumption rate (ml/min) . Res t ing VO2 rate will be quantified as an 
average over the final minute of resting. Participants will then stand for 5 minutes to 
achieve a standing VO2 consumption rate (ml / min ) , again averaged over the final minute 
o f standing . 
Participants will remove the K4b2 monitor and conduct the 6MWT according to the 
protocol described above . After completing the Borg RPE , the participan t will re-don 
the K4b2 monitor and sit quietly in order to return to their resting VO2 rate. 
APPLICATION: Human Subjects Review (13- 11 ), Full Board or Subcommittee (Rev. 11/26/20 14) 

PAGEIO 
Participants will begin the treadmill testing once they have returned to their resting 
V02 rate. 
Participants will walk for 6 minutes on the t readmill at comfortable, slow, and fa st 
walking speeds (as determined in Session 1). 
The order of the speeds will be 
randomized within-subjects to control for fatigue . This randomized order . will be 
carried over into the third session so that par ticipant s are tested in the same order 
both times . Walking V02 consumption rate (ml/min) wil l be averaged over the final 1 
minute period of each activity . Participants will rest at least 5 minutes between each 
walking trial in order to return to their resting V02 rate . 
Session 2 will require about 3.0 hours to complete. Upon conclusion of Session 2 , 
participants will transition to the second prosthe sis (ESF o r mRSF, depending upon 
randomization) and wil l be asked to use it exclusively for 1 month before returning for 
Session 3 . 
Session 3: The third session will be identica l to the Session 2, but wil l be conducted 
with participants using the al t ernate prosthesis (e . g ., ESF if t hey were previously 
tested in the mRSF) . 
2. Would subjects undergo these or similar procedures (medical, psychological, educational, etc.) if they were not taking part in 
this research? ~ No D Yes lf "Yes," describe how the study procedures differ from what subjects would otherwise 
undergo. 
The study procedures include outcome measure s (survey measure s, 6MWT, or Borg RPE) 
that a prosthetist might perform in a clinic to evaluate a patie n t 's performance with a 
new prosthesis . However , the Cosmed K4b2 portable metabolic analysis system and 
treadmill walking are unlikely to occur in normal prosthetic clinical practice . These 
procedures are more likely to be conducted as part of a physical therapy treatment plan 
and would not be c onsidered unusual procedures at a phys ical the rapy clinical visit. 
3. Check all of the boxes below that apply to your research: 
Drug administration 
D Administration ofa drug (either FDA-approved or investigational) for research purposes to a subject-patient during general 
or regional anesthesia. 
D Administration of a drug (either FDA-approved or investigational) for research purposes to a subject-patient during the 1.5 
hours preceding general or regional anesthesia. 
Blood lines 
D Inserting an intravenous (central or peripheral) or intra-arterial line for research purposes in a subject-patient during 
general or regional anesthesia. 
Sample collection 
D Obtaining samples of blood, urine, or cerebrospinal fluid for research purposes while a subject-patient is under general or 
regional anesthesia. 
D Obtaining a research sample from tissue or organs that would not otherwise be removed during surgery, while the subject-
patient is under general or regional anesthesia. 
Radio-isotopes 
D Administration of a radio-isotope for research purposes during the 3 hours prior to anesthesia or while a subject-patient is 
under general or regional anesthesia. 
If you checked this box, you are responsible for informing in advance all appropriate clinical personnel (e.g., 
nurses, technicians, anesthesiologists, surgeons) about the administration and use of the radio-isotope, to ensure that 
any personal safety issues (e.g., pregnancy) can be appropriately addressed. This is a condition of !RB approval. 
Experimental devices 
D Implantation of an experimental device while a subject-patient is under general or regional anesthesia. 
Other experimental manipulations or procedures 
D Other manipulations or procedures performed solely for research purposes while a subject-patient is under general or 
regional anesthesia ( e.g., experimental liver dialysis, experimental brain stimulation) 
APPLICATION : Human Subjects Review (13-11 ), Full Board or Subcommittee (Rev. I 1/26/2014) 

PAGE 11 
None of the above 
[8J None of the above apply to my_ research 
4. If you checked any box in question #3 except "none of the above", answer the following questions: 
a. Provide the name and institutional affiliation of the physician anesthesiologist who is a member of your research team or who 
will serve as a safety consultant about the interactions between your research procedures and the general or regional 
anesthesia of the subject-patients. If your procedures will be performed at a UW Medicine facility or affiliate, the 
anesthesiologist must be a UW faculty member. 
N/A 
b. If you have not yet consulted with an appropriately qualified person about this issue, describe in detail your plans to do so. 
The IRB will not approve your application without this consultation. IfUW Department of Anesthesiology approval has been 
obtained, please provide the Department's letter of support. 
N/A 
5. Required application supplements. Complete and attach the indicated SUPPLEMENT, as appropriate 
a. 
SUPPLEMENT: Drugs. Biologics. Botanicals - for research involving the use of any of the following: 
• 
Drugs regulated by the FDA (prescription, over-the-counter, approved, or investigational) 
• 
Biologics regulated by the FDA (prescription, over-the-counter, approved, or investigational) 
• 
Botanicals 
• 
Dietary Supplements 
b. SUPPLEMENT: Devices - for research involving the use of any medical device (approved or investigational; 
including software used with a medical device, and including mobile medical applications). 
See attached (Appendix 3 ) . 
c. 
SUPPLEMENT: Genetic Research - submit this supplement when your research involves genetics. Genetic 
research is defined as research involving the analysis of any of the following: DNA; RNA; chromosomes; 
mitochondria; any or all parts of the human genome; or biomarkers such as proteins or metabolites which may be 
implicated in, associated with, or cosegregated with a disorder, syndrome, condition, or predisposition to disease or 
behavior. Usually genetic research involves the collection and/or use of human biological specimens such as blood, 
skin, or other tissues, nail clippings, or hair. Genetic research may also include the construction of pedigrees 
("maps" of the distribution ofa particular trait or condition among related individuals) or family medical histories. 
d. SUPPLEMENT: Department of Defense - for research involving any component of the federal Department of 
Defense (DOD). "Involvement" means funding; collaboration or cooperative arrangements; use of facilities, 
resources, or personnel; use of military or civilian members of the DOD (or their records/specimens) as subjects. 
e. 
SUPPLEMENT: Department of Justice - for research involving the federal Department of Justice (DOJ) or any 
of its components (such as the National Institute of Justice, or any facilities/personnel of the Bureau of Prisons). 
"Involvement" means funding; collaboration or cooperative arrangements; use of facilities, resources, or personnel; 
use of records or specimens from DOJ employees or from prisoners in any Bureau of Prisons facility . 
f. 
SUPPLEMENT: GWAS dbGaP - for research that will involve submitting data to the federal Database of 
Genotyped and Phenotyped (dbGaP) information. 
g. 
For research involving the Department of Energy (DOE), researchers should consult the CHECKLIST 
Department of Energy to ensure that they have addressed all DOE requirements. However, the Checklist does not 
need to be completed and submitted unless the researcher believes it would be a useful attachment. 
C. DECEPTION: If any deception or withholding of complete infonnation is required for this activity, explain why this is 
necessary and attach a protocol explaining if, how, when, and by whom subjects will be debriefed. 
No decept i on is required for thi s study. 
D. SUBJECTS 
The IRB reviews the number of subjects you plan to study in the context of risks and benefits. If your research is approved for a 
specific number of subjects, the data from any "extra" subjects cannot be described as having been obtained with IRB approval. 
APPLICATION: Human Subjects Review (13-1 I), Full Board or Subcommittee (Rev. I 1/26/2014) 

PAGE 12 
See the HSD website for the definition of"human subject" http://www.washington.edu/research/hsd/docs/l 253. Before answering the 
questions below, be sure that you are familiar with the definition. 
1. 
Subject groups/categories and numbers. Complete this table by listing: 
• 
Your groups or categories of subjects. "Group" should be defined as appropriate for your research. 
o 
"Units" within a group. For most research, a group will consist of individuals, such as children aged 8-12, or 
individuals with high blood pressure. However, this will not be true for all research. Examples of groups with 
"units" that are not individuals: 
• 
Dyads such as Alzheimer's-patient-and-caregiver, with one group of the dyads assigned to one intervention 
(e.g., behavioral modification) and another group of the dyads assigned to a comparison intervention(e.g., 
drug treatment). 
• 
Families. For example, a study of mental health interventions for homeless families might have one group 
of30 families assigned to one intervention and another group of30 families assigned to a different 
intervention. 
• 
Other. For example, the "units" in autism research might be an autistic individual and all his/her living 
blood relatives. The units in an academic excellence study might be a student-parents-teacher unit, 
o 
Types of groups. There are many ways in which subjects might be grouped. Examples: 
• 
By intervention. Example: research comparing two different drugs for high blood pressure. 
• 
By subject population. Example: research comparing the incidence of domestic violence in families living 
in urban settings versus families living in rural settings. 
• 
If you have only one group, fill in only one line in the table. Add more lines if needed. 
• 
The age range of each group. 
• 
The upper limit/number of completed subjects you need for each group. Completed means that all research procedures 
involving the subjects or the obtaining of specimens/records/data have been completed as far as is possible (or each rnbiect, 
including any follow-up (such as follow-up access to medical records.) In some cases, such as an online survey, it is not 
possible to predict the number of subjects 1Vho will complete the research. ff you cannot predict or describe the maximum 
number of subjects you need in each group. check the appropriate box and provide your rationale in the space provided 
below the table. 
Group name/description 
Age range of subjects 
Maximum desired 
Cannot provide a 
number of individuals 
number.** 
( or other group unit, 
such as families) who 
will complete the 
. 
research.• 
People wi th l ower limb l oss 
>18 
2 4 
• *"' 
• *"' 
• ** 
• ** 
*This is the number of subjects (individuals, dyads, families, etc., as appropriate) in each group that will be considered for 
approval by the IRB. 
**If you cannot predict or describe the maximum number of subjects you need in each group: 
Provide your rationale and description of research scope here. Include any information or estimates you might have about the 
number of subjects, so that the /RB has a sense of the scope of your research. For example, your research might be a small pilot 
study of all patients presenting IVith a rare disease at UW Medicine in the next year. Or, it might involve a survey posted on Craig 's 
List for two weeks that could result in thousands of responses. 
N/A 
APPLICATION: Human Subjects Review (13-1 I), Full Board or Subcommittee (Rev. 11/26/2014) 

PAGE 13 
NOTE: In your periodic Status Report, you will be asked to complete the table below with your subject numbers. While 
developing your research protocol, please plan ahead so that you will have an accurate record of the subject numbers above. 
This is for illustration onl . Do not com lete this table. 
#Com letions 
# 
# Withdrawals dro s lost 
' 
Grou Name / Descri tlon 
Total 
approved 
b IRB 
-- + -
A 
At time 
of last 
Status 
Re 
rt 
A+B 
Totai' to 
date 
-t------ -
Ongoing, 
C 
' 
(subjects .. At tlme of 
still ' 
• last 
involved) , Status 
Re 
rt 
. D 
Since last 
Status 
Re ort 
C+D ' 
Total to• 
· date. 
2. Explain how you will achieve equitable subject representation in the following categories. If not applicable,justify exclusions. 
a. Age (minors, elderly): 
We will not be recruiting minor participants for this pilot study . At p r esent , the mRSF 
i s not r egularly provided to children , so we will not be recruiti ng participants under 
the age of 18 for t h i s study. 
b. 
Gender: 
We will not exclude participation based on gender. Both males and fe males are welcome 
to participate in this study. 
c. 
Ethnic and racial minority populations: 
We will not exclude participation based on ethnicity or race . 
3. What characteristics (inclusion criteria) must subjects have to be in this study? (Answer for each subject group, if different.) 
Inclusion criteria include: 18 or more years of age , non-dys vascular unilateral 
transtibial amputation , prosthetic user for >l year , are scheduled to receive a 
prosthesis with a mRSF , able to walk continuously for at least 6 minutes with or 
without an assistive device, able to read and write English . 
4. What characteristics (exclusion criteria) would exclude subjects who are otherwise eligible from this study? (Answer for each 
subject group, if different.) 
Exclusion criteria include any health condition that would limit use of a prosthesis 
(e . g. , skin breakdown), ability to safely walk for a t l east 6 minutes (e.g ., heart 
disease) , o r participation (current or planned over t he study period) in another 
research study that may affect the fit or function of his/her prosthesis. 
5. Describe the subject recruitment strategies you will use for each group of subjects. ( You should obtain letters of cooperation from 
agencies, institutions, or others involved in subject recruitment for your research records. Do not send these to HSD or the IRB.) 
Study pa rticipant s will be exclus ively recruited from Davidson Prosthetics , the only 
local prosthetics facility that routinely provide s prostheses with ESF and mRSF to 
people wit h LLA. Informed consent will be obtained from all participants . 
6. Explain who will approach subjects to take part in the study and how this will be done to protect subjects' privacy. (Attach letters 
of cooperation from agencies, institutions or others involved in subject recruitment.) 
Flyers will be posted at Davidson Prosthetics with study information and the phone 
number of the study coordinator (Appendix 4). In addition , Mr . Davids on will l et 
potential participants know about the study and provide the phone number of our study 
coordinator. Potential participants can call our study coordinator to get more 
information about the study , decide if they are interested i n participating, and 
schedule their fir st study session (Appendix 5 ) . 
7. Explain what steps you will take during the recruitment process to minimize potential coercion or the appearance of coercion. 
APPLICATION: Human Subjects Review ( 13-11), Full Board or Subcommittee (Rev. 11/26/2014) 

PAGE)4 
Their prosthetic care provider (Mr. Davidson) will only inform potential participants 
about the study. All recruitment and e nrollment procedures will be conducted by study 
investigators/coordinators. All interested participan t s will be i nformed that 
participation (or not) is completely voluntary and will in no way affect the clinical 
care they receive . No members of our study team are or will be involved in the clinical 
care of potential participants o r participants. 
8. Will you give subjects gifts, payments, services without charge, or extra course credit? 0 No [8J Yes If yes, explain: 
Subjects will receive $30 for every hour of part i cipation in the screening session 
(Session 1) . Participants will receive $50 for every hour of participant in data 
collection sessions (Session s 2 & 3). Participants will be paid after each session. 
9. Will any of the subjects or their third-party payers be charged for any study procedures? [8J No D Yes If yes, explain: 
NIA 
10. UW Locations and research sites. Provide the following information in list or table format for all UW locations at which any 
research procedures will occur. Be sure to consider: screening, recruiting, consenting, observation, intervention, data collection, 
data analysis, specimen analysis, and location of any consultants and collaborators. 
• 
Geographical location and/or address 
• 
Name of organization, agency, group, site, institution 
• 
What procedures will occur at each location (how the location is involved in the research) 
• 
Whether subject contact or interaction will occur at each site 
• 
Whether consenting of subjects will occur at each site 
• 
Whether each site, or individuals at the site, will obtain, use, or have access to coded or individually identifiable private 
information about subjects for research purposes 
Site 1 : 
Site 2 : 
Univers ity of Washington 
Davidson Pros t hetics , LLC 
Depar t ment of Rehabilitation 
812 39t h Avenue SW Suite D 
Medici ne 
Puyallup , WA 98373 
Health Sciences Buildi ng , BB 
tower , 8th floor 
Scr eening 
X (Screening wil l be done by 
study i nvestiga t ors/staff over 
telephone) 
Recruiting 
X (The study will be described to 
X (Mr . Davids on will post flyers 
potential participant s by study 
and let potential participants 
i nvestigators /s taff. Potentia l 
know about the study) 
participants wil l have the 
opportunity to ask questions and 
decide if they would like to 
schedule a data collection 
se ssion at this time) 
Consenting 
X (Study inve s tigators , Dr . 
N/A 
Hafner and Ms. McDonald , will 
obtain informed consent at the 
data collection appointment, 
prior to data collection 
activities) 
Observation 
N/A 
NIA 
Intervention 
N/A 
N/ A 
Data 
X (S tudy investigators , Dr . 
N/A 
Collection 
Hafner and Ms . McDonald , will 
perform al l da ta collection 
activities ) 
Data Analysis 
X (Study investigators , Dr. 
N/A 
Hafner and Ms. McDonald , will 
APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee (Rev.11 /26/2014) 

PAGE 15 
perform all data a nalysis 
activities) 
E. RISKS AND BENEFITS 
In order to approve the research the IRB must find that risks are reasonable in relation to anticipated benefits, if any, to 
subjects, and the importance of the knowledge that may reasonably be expected to result. 
I. Describe nature and degree of risk of possible i.n.i.YrY, stress, discomfort, invasion of privacy, and other side effects from all study 
procedures, drugs and devices (standard and experimental), interviews and questionnaires. Include psycho-social risks as well as 
physiological risks. Include risks of withholding standard care or procedures if this is the case .. Do not reference the consent form. 
Participants will be a s ked to walk for about 70 minutes total for this study (a maximum 
of 6 minute s at a time , and 30 mi nutes maximum per se s sion ) . Because they are being 
asked to walk , the r e is the risk that they c ould become fatigued during the study 
procedures . I n addit i on , the r e is a risk o f f a l ling . However , the s e ri s ks are no larger 
than the risks that study par ticipa nt s generally under t ake when walking ou tside of t his 
study . 
2. Explain what steps you will take to minimize risks of harm and to protect subjects' rights and welfare. (If you will include 
protected groups of subjects (minors; fetuses in utero; prisoners; pregnant women; unviable neonates; neonates of uncertain 
viability; decisionally impaired or economically or educationally disadvantaged subjects) please identify the group(s) and answer 
this question for each group. Please also complete the SUPPLEMENT: Prote,cted and/or Vulnerable Populations.) 
This study will not require part icipants to pe rform a c t ivities at a leve l of endurance 
tha t they would not typically do outside o f t he study session . To minimize risks of 
fatigue and falling du r ing the study session , the part i cipants will be asked to take 
breaks af t e r each walking measure is collected. The maximum time that each participant 
wi ll be asked to walk continuously i s 6 minutes. They are also i nstructed to take a 
break , including a sitting break , at any time during the data collection session, 
including i n the middle of walking measures . If at any time it appears that the 
participant is at risk of falling or o ther harm, the data collection session will be 
stopped . 
3. Is it possible that you will discover a subject's previously unknown condition (disease, suicidal intentions, genetic predisposition, 
etc.) as a result of study procedures? 0 No O Yes If yes, explain how you will handle this situation. 
4. Describe the anticipated benefits of this research for individual subjects in each subject group. If none, state "None." 
None 
5. Describe the anticipated benefits of this research for society. 
The rnRSF is a promising advancement in prosthetic technology . However , currently, Mr . 
Davidson is one of few prosthetists in the United Sta t e s that is p roviding t his foot . 
Empirical evidence that support s its provi s ion for people with LLA will help the rnRSF 
become available to others who may benefit from its use . 
F. ADVERSE EVENTS OR EFFECTS 
I. Who will handle adverse events? r8] Investigator D Referral D Other, explain: 
N/ A 
2. Are your facilities and equipment adequate to handle possible adverse events? r8]Yes O No, explain: 
A first aid kit will be available , if needed , to address minor injuries (e.g ., scrapes 
o r minor cuts). The investigators wil l cont act emergency services ( 911) if a serious 
adverse event occurs . 
The UW Medical Cente r emergency room is located 5 floors below 
the researchers ' labora tory . 
G. CONFIDENTIALITY OF RESEARCH DATA 
I. Will you record any direct subject identifiers (names, Social Security numbers, patient, hospital, laboratory or claim numbers, 
addresses, telephone numbers, locator information, etc.) 0 No r8] Yes If yes, explain why this is necessary and describe the 
coding system you will use to protect against disclosure. 
APPLICATION: Human Subjects Review ( 13-1 I), Full Board or Subcommittee (Rev. 11 /26/2014) 

PAGE16 
Subject identifiers will be recorded (name , telephone number, social security number). 
Name and contact informa tion are needed to schedule participant data collection 
sessions. Social security information is requ i red by UW when payments of more tha n $50 
are made to study subjects. I dentifying information will be l i nked to a 5- digit numeric 
study code . The file conta i ning identifying information and the linked s ub ject code 
will be stored s eparatel y from all other study data in a secure and password protected 
computer only accessible to study r e searchers. 
2. Will you retain a link between study code numbers and direct identifiers after the data collection is complete? D No [8J Yes If 
yes, explain why this is necessary and for how long you will keep this link. 
This resea r ch is a pilot study in a new line of i nvestigat ion for our research lab 
(i.e. , same PI and research team) . We are c urren t l y purs uing fund i ng for parallel 
studies of prosthetic foot technologies. We wish to combine data from related studies 
to maximize our ability to recrui t from the small loca l population of people with lowe r 
l i mb loss. Combining data from mu l tiple studi es would i ncrease our power to de t ect 
differences and avoid participa t ion of indivi dual s in both studies (participation in 
both studies would lead to i ncluding a participant's d a ta twice i n the same dataset). 
To al low for accurate l ongi tudinal tracki ng of partici pants, we will re t ain the link 
between identi fie rs and study code numbers until 2026. 
Part i cipants may r equest that 
we destroy their link at any point during the study , or any time thereafter. 
3. Describe how you will protect data against disclosure to the public or to other researchers or non-researchers. Explain who (other 
than members of the research team) will have access to data (e.g., sponsors, advisers, government agencies, etc.). 
Data will be stored on a s tudy specifi c pas sword protected compute r which will be 
s tored in a locked cabinet in the PI ' s offi ce . Only membe rs of t he research t eam will 
have access to the information . 
4. Will you place a copy of the consent form or other study information in the subject's medical or other personal record? 
[8J No D Yes. If yes, explain why this is necessary. 
N/A 
5. Do you anticipate using any data (information, specimens, etc.) fro!TI this study for other studies in the future? D No [8J Yes 
lf "Yes," explain and include this information in the consent form. 
As noted above , this research i s a pil ot study in a new line of investigation for our 
research lab . We are c urrently pursuing funding for similar (parallel) studies of the 
pro s thetic foot technologies included in this study . To maximize available resources 
and address larger research questions , we will combine data from this study with data 
obtained in subsequent studies . We have added this information to the consen t form . 
H. ADDITIONAL INFORMATION 
I. If the study will involve radiation exposure to subjects, e.g., X-rays, radioisotopes, what is status of review by the UW Radiation 
Safety Committee (RSC): D Pending D Approved (Attach one copy of approval.) [8J NA 
2. Does this research require approval from the UW Institutional Biosafety Committee (!BC) for recombinant/synthetic DNA human 
Gene transfer or vaccines? 
[8J No D Yes. Ifyes, what is the status of review by !BC? D Pending D Approved (Attach one copy of approval.) DNA 
3. Protected Health Information (PHI}. Will you or any member of your research team obtain, access, or use a subject's protected 
health information by any method, and for any purpose including "pre-screening"? 
''Methods" may include but are not limited to: directly looking at a medical record (electronic or paper), requesting medical 
record information from a service such as the UW Center for Health Excellence, or viewing surgery schedules, clinic records, 
appointment books, etc. 
Examples of where PHI may be located include: medical records. dental records, clinical lab tests that you will have performed on 
subject samples, pharmacy records, medical billing records, clinical databases, etc. 
D No [8J Yes. lf "yes": 
a. Describe the type of records/data, location and how you will obtain the information: 
APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee (Rev. I 1/26/2014) 

PAGE17 
We will collect infor ma tion on the participant s' prostheses , including 
delivery s chedule , components , and p roblems experienced by the part icipants 
(related to fit and function of their pro s thes e s ) while they are pa rt of t h e 
study . Inf ormation will be collected direc tly from the participant ' s 
practitioner (Mr. Davidson ). Participants will be asked to complete a HIPAA 
au thorization to allow us to col l ec t ion information about their pro s thesis 
d i rectly fro'm their practitioner (Appendix 6 ) . 
b. Will you obtain any of the information without HIPAA authorization from each subject? 
r8J No O Yes. lf "yes": Complete and attach the SUPPLEMENT: Waiver Request. Hf PAA Authorization, and the 
SUPPLEMENT: Waiver Request. Consent Requirements. If the records are owned by the University of Washington or 
a state agency, complete and attach a UW Confidentiality Agreement. 
c. Will you obtain HIPAA authorization from subjects for any of the information? 
0 No r8J Yes. lf "yes", attach the Hf PAA Authorization form you propose to use 
See a t tac hme nt 
(Appendix 6). 
d. Will you be obtaining any of the data as a Limited Data Set? 
r8J No O Yes 
4. Other Records. Will you or any member of your research team obtain, access, or use academic, employment, or any other type of 
records about subjects, by any method, and for any purpose including "pre-screening"? 
"Methods " may include but are not limited to: directly looking at a record (electronic or paper). requesting records.from 
offices such as Payroll or the UW Registrar's Office, obtaining records from the state Department of Health, etc. 
r8J No O Yes. lf "yes": 
a. Describe the type of records/data, location, and how you will obtain the information. 
N/A 
b. Will you obtain any of the information without the subject's consent? 
0 No O Yes. 
If the records are owned by the University of Washington, complete and attach a UW Confidentiality Agreement. 
5. Will you use the Clinical Research Center (CRC) at the UW or Seattle Children's for any of your research activities? 
r8J No O Yes. 
If you answered "yes": 
A medical record will be created for your subjects at UW Medicine and CRC staff may need to access those medical records for 
you. This may be because they are performing procedures or collecting data for you. It may also be required if an event happens 
on the CRC that requires treatment (such as fainting during a blood draw). This means that you must obtain a signed Hf PAA 
Authorization form from each subject and give a copy of it to the CRC. Complete and attach the UW research HIPAA 
Authorization template, available on the HSD Forms webpage. There is guidance in the template about how to describe the 
information that the CRC staff may access and disclose to you. 
6. Does your research involve any of the following: 
• 
Students age 21 or younger who may be participants in your research? 
• 
Access to, or use of, personally identifiable information from student (current or past) education records from any 
institution or agency of education (including, but not limited to, pre-elementary, secondary, post-secondary, job training, 
adult education, career and technical education, special education)? 
• 
Conducting any research procedures in an educational setting? 
r8J No O Yes. 
If you answered "yes": 
Your research may be subject to the requirements of the Protection of Pupil Rights Amendment (PPRA) and/or the Family 
Education Rights and Privacy Act (FERPA). 
Consult with the SOP Research Involving Students to determine whether PPRA or FERPA regulations apply to your research. 
APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee (Rev. I 1/26/2014) 

PAGE18 
Check the appropriate box. 
D PPRA reguiations apply to my research 
D FERPA regulations apply to my research 
D Both PPRA and FERPA regulations apply to my research 
D Neither set of regulations apply to my research 
7. Will you make audio-visual or tape recordings or photographs of subjects? D No ~ Yes. If yes, explain what type of 
recordings you will make, how long you wil I keep them, and if anyone other than the members of the research team will be able to 
see them. 
With participant 's consent, we will take video and/or photographs of study procedures 
for use in grant applications, presentations, or publications (Appendix 7 ). Consent for 
photos/videos is not required to participate in the study. We will not destroy photos 
and/or videos. 
8. Will your study involve use of equipment involving energy input to the subjects (EMG, EKG, MRI, ultrasound, etc.)? 
~ No D Yes. If yes, attach documentation that all equipment will be tested regularly _by the Scientific Instrument Division (call 
(206) 543-5580 for information) or describe safety testing procedures you will use. 
N/A 
9. Confirm by checking the box that the principal investigator on this IRB application has ensured that all investigators (as defined 
by UW policy GIM 10) are aware of policy GIM 10 and their responsibility for complying with its relevant requirements. 
~ Confirmed 
I 0. Does the individual who is the principal investigator on (I) this IRB application or (2) any grants or contracts supporting this 
research have a financial conflict of interest with respect to this research? 
~ No D Yes. 
If yes, has it been disclosed to the University? (Since August 24, 2012, all disclosures are made through the University's 
online Financial Interest Disclosure System.) Final review of this application cannot occur until the disclosure has been made 
and reviewed by the University, and the outcome has been incorporated into the IRB 's review. 
D No D Yes D Not 
applicable, because there is no financial conflict of interest. 
11 . Is your research: 
• 
Clinical research that will bill subjects or their health insurance for UW Medicine professional or facility services, items, or 
tests*, AND/OR 
• 
An "applicable clinical trial" as defined below" •• 
0No ~ Yes 
If you selected ''yes", you must register your research at the federal site ClinicalTrials.gov 
See the HSD document titled: ClinicalTrials.gov - Instructions for Registering Your Trials for step-by-step instructions 
about how to register your research. 
*New Requirement 
As of January I, 2014, a new federal requirement will require you to provide the clinical trials registration number assigned 
to your research in order to bill most UW medicine professional or facility services, items, or tests to research participants 
or their health insurance. This new billing requirement applies to some clinical research, such as Phase I studies, that don't 
meet the federal registration definition of"applicable clinical trials". See also: Clinical Research Budget & Billing Support 
(CRBB) 
**Applicable clinical trial is defined as: 
(/) a pediatric pas/market surveillance study required by the FD/I OR 
(2) an interventional study (ivith one or more arm) of an FDA-regulated drug, biological product, or device that involves 
health outcomes and meets one or more of the fo//oiving conditions: 
• 
The trial has at least one site in the United states; or 
• 
The trial is conducted under an FDA investigational neiv drug application or investigational device 
exemption; or 
APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee (Rev. 11 /26/2014) 

PAGE19 
• 
The trial involves a drug, biologic, or device that is manufactured in the United States or its territories and 
is exported for research 
The source of funding (e.g. , industry.federal, nonprofit) is irrelevant. 
See this website for additional information: h11p:l/prsin(o.clinicaltrials. gov/ElaborationsOnDefinitions. pd( 
I. CONSENT 
Obtaining informed consent is a process that involves more than obtaining a signature on a form. It is a process of information 
exchange that may include subject recruitment materials, verbal instructions, question-and-answer sessions, and measures of 
participant understanding. Obtaining voluntary informed consent is one of the central protections required by all human subjects 
regulations and ethical principles. The key features of the consent process include: 
• 
Disclosure of the information needed to make an informed decision about participation 
• 
Facilitation of comprehension by the potential participant 
• 
Promotion of the voluntariness of the potential participant's decision 
Refer to the SOP Consent and SOP Consent Documentation for more information. 
I. Description of consent process for adult subjects. How are you going to obtain informed consent from your adult subjects? 
Describe in detail your consent methods, process, and settings. Identify who will provide the information to subjects and who 
will interact with them during the consent process. If there is more than one consent process, describe each one separately. 
For subjects who do not speak English: Describe the process that will be used, and whether anyone on the research team will 
speak the subjects' language. Complete this section if you will obtain consent from any subjects for any aspect of the 
research. 
Potential pa rticipants will provide informed c o nse nt at t heir s c heduled study 
s e ssion, but before a ny da t a c ollec t ion procedures. A stud y i nvestigato r wil l 
descri be the study t o the participan t using the wri t te n cons ent form (Appendix 1 ) 
as 
gu i de, a l l ow time fo r the poten t i a l partic ipant to read through t he consent 
form, as k if the participants have a ny ques tions, and as k them t o s i gn the form if 
t hey a r e inte r e sted in p artic i pa t i ng. If the potent i al pa r tic ipant is no t 
i nterested, t he y will no t be as ked to perform a ny study procedures . 
2. Description of assent process for children subjects. Describe in detail how you will obtain assent from children subjects, 
following the instructions provided in the question above. Also, describe how these processes will differ based on 
age/cognitive ability. Finally, describe how you will determine whether a child is assenting or dissenting throughout the 
research (if applicable). * Assent means a child's affirmative agreement to participate in the research. Mere failure to object 
should not be interpreted as assent. 
N/A 
3. Special issues or considerations. The standard concept of consent is based on the Western ethical tradition of individual 
autonomy and privacy. This may not apply well to your research. Your research may be subject to specific cultural or other 
contextual issues that affect the consent process. Describe any special issues and considerations about obtaining consent for 
your research. If none, state: "Not Applicable". 
Example issues: 
• 
Who is the appropriate person(s) for providing consent? 
• 
The desirability of a group consent process, or a surrogate consent process 
• 
Research that occurs in a setting with a blurred sense of what is public versus private 
• 
The cultural acceptability of the consent process (or documentation) 
• 
Cultures or groups in which it is considered impolite to refuse a request and/or in which people are fearful of refusing 
requests that they regard as coming from authorities 
N/ A 
4. Undue influence. Describe how you will minimize any undue influence on your subjects' decision about participating in your 
research. If this is not an issue for your research, describe why. This is an important consideration when persons recruiting or 
consenting subjects are in a position of authority or influence - for example, the subject 's teacher, doctor, or employer. 
Potenti a l participan t s will be identified via flyers (Appendix 4 ) posted in their 
pro s t het i c office. However, all o t he r rec r uitmen t and consenti ng procedu r e s will be 
APPLICATION : Human Subjects Review ( 13-11), Full Board or Subcommittee (Rev. 11/26/2014) 

PAGE 20 
done by study investigators who are not involved in potential participant 's health 
care . Study i nve stigators will stress that participation is voluntary and in no way 
will participat i on (or non-participation) in the study affect t heir prosthetic (or 
other health ) care . 
5. Subject comprehension. Describe anything that you will do to facilitate or verify your subjects' comprehension of the 
information you provide them during the consent process. 
Potential participants will be encouraged to ask questions throughout the consent 
process . 
6. Do you expect that all of your participants will be fluent in spoken and/or written English? D No ~ Yes. 
lf "No", please answer the following questions. 
6.1. In what language(s) will they be fluent? 
NI A 
6.2. Translation of documents into another language. Federal regulations require that consent, assent, and authorization 
documents must be presented to participants in a language that is understandable to them. The UW !RB expects that 
translated documents will be: 
• 
Linguistically accurate; 
• 
At an appropriate reading level for the subject population; and 
• 
Culturally sensitive for the locale in which they will be used. 
Describe how you will obtain translations of relevant documents, and how you will ensure that the translations meet 
these requirements. 
NI A 
6.3. Interpretation. Describe how you will provide interpretation, and when. Specifically: 
a. 
For what situations will you provide interpretation? (At a minimum, an interpreter should be available for the 
consent process, unless the !RB has waived consent.) 
NI A 
b. 
Who will be the interpreter? 
NI A 
c. 
Describe the qualifications of the interpreter - for example, background, experience, language proficiency in 
English and in the other language, native language fluency, certification, other credentials, familiarity with the 
research-related vocabulary in English and the target language. 
NI A 
d. How will you ensure that the subjects will understand ongoing study-related communication? If the subject has 
questions, complaints, or adverse events, how will that be communicated to the researchers? 
NI A 
7. Check all that apply: 
~ Written A /tach copies of all consent forms for each subject group. Include a footer identifying the version date of each form 
and a header or title that identifies each differentfo,-m. If you propose to delete one or more of the required elements of 
consent from a consent form, a/tach and complete the form called SU!'PLEAIENT: Wail'er Request, Consent Requirements. 
Se e attachment (Appendix 1 ) . 
~ Waiver of written documentation of consent This means that you are requesting a waiver of the requirement to 
obtain wri//en documentation of consent. Complete and altach the form called SUPPLEMtN T: Waiver Request, Consent 
Requirements. . Also, a/tach the Information Statement, oral consent or assent protocol and script, or other materials you 
iv ill use to communicate the necessary elements of consent to the subjects. 
See attachment (Appendix 8 ) . 
D Waiver of consent This means that you are requesting a waiver of the requirement to obtain consent. Complete and a//ach 
the form called SUPPLEMENT: Waiver Request, Consent Requirements. . 
APPLICATION: Human Subjects Review ( 13-1 I), Full Board or Subcommittee (Rev. 11/26/2014) 

PAGE 21 
D Assent Attach copies of any writ/en materials or scripts you will use with minor subjects (individuals under the age of 18) 
to obtain their assent to being in your research. 
D Parental permission Allach copies of any written materials or scripts you will use with parents, to obtain their permission 
to enroll their minor children in your research. See also SUPPLEMENT: Protected and1or Vulnerable Populations/or 
waivers or alterations of consent requirements. 
APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee (Rev. 11/26/2014) 

UNIVERSITY OF WASHINGTON 
SEATTLE, WASHINGTON 98105-6613 
Human Subjects Division, Box 3594722 
Office of Research 
February 19, 2015 
PI: 
Associate Professor Brian Hafner, PhD 
Rehabilitation Medicine/Prosthetics & Orthotics 
Contact: 
Cody McDonald 
Re: Human Subjects Application #49150, "Evaluation of a Modified Running Prosthesis" 
Dear Dr. Hafner, 
The Human Subjects Division received your application on 7/29/2014. Subcommittee E/A has reviewed 
this application under "expedited" minimal risk category #5 and #7. Thank you for your responses and for 
forwarding the revised materials. The above Human Subjects Application has been approved by 
Subcommittee E/A. The researcher copy of the approved application will be sent to you through campus 
mail. 
The dates of the initial approval period are from: 2/19/2015 -2/18/2016. 
The approved number of subjects is: 24. In the event you want to enroll additional subjects for this study, 
please submit 2 copies of an APPLICATION: Modification, Approved Project form (available on the 
HSD website, under Forms). 
Waiver of documentation of consent 
The IRB has waived documentation of consent for researchers to ask screening questions during the 
recruitment process according to the stamped "approved" recruitment script. 
IRB - approved consent forms 
Located at the back of the approval packet are the stamped "approved" recruitment materials and consent 
forms. Per HSD policy, it is necessary for you to make copies of the stamped "approved" consent form to 
use with potential subjects. 
The researcher copy of the approval packet will be sent through campus mail. It is the PI's responsibility 
to maintain all IRB materials. 
• 
In the event you will revise the purpose, procedures and/or population of this application, be sure 
to send 2 copies of a Modification for review and approval prior to implementing the changes. 
• 
Be sure to close the study upon completion of the study (or alternatively, renew the study) by 
sending 2 copies of a Status Report. 
Be sure to reference the Human Subjects Application number and investigator on all materials sent to the 
Human Subjects Division, Box 359470. 
Best wishes for your study -
Geri C. Faris, HSR Administrator 
Human Subjects Division 
(206) 616-2345 

UNIVERSITY OF WASHINGTON 
CONSENT FORM 
Evaluation of a Modified Running Prosthesis 
RECEIVED 
Human Subjects Division 
FEB 12 2015 
uw 
Researchers: Brian Hafner, PhD, Associate Professor, Division of Prosthetics and Orthotics, 
Department of Rehabilitation Medicine, 206-685-4048 
Patricia Kramer, PhD, Associate Professor, Department of Anthropology, 206-
616-2449 
Cody McDonald, UCPO, Graduate Research Assistant, Division of Prosthetics 
and Orthotics, Department of Rehabilitation Medicine, 206~221-6347 
Researchers' statement 
We are asking you to be in a research study. The purpose of this consent form is to give you the 
information you will need to help you decide whether to be in the study or not. Please read the 
form carefully. You may ask questions about the purpose of the research, what we would ask 
you to do, the possible risks and benefits, your rights as a volunteer, and anything else about the 
research or this form that is not clear. When we have answered all your questions, you can 
decide if you want to be in the study or not. This process is called "informed consent." We will 
give you a copy of this form for your records. 
PURPOSE OF THE STUDY 
The purpose of the study is to evaluate walking in people who use different types of prosthetic 
feet. In this study, we will compare people's ability to walk in a typical "energy storing" foot to 
their ability to walk in a modified running foot. 
STUDY PROCEDURES 
If you choose to take part in this study, the study procedures will take place across three study 
sessions over approximately a three month period. The first session will occur before you receive 
the first of the two prostheses that will be provided to you during the course of this study. The 
second session will occur one month after you receive the first prosthesis. The third session will 
occur one month after you receive the second prosthesis. The sessions are expected to each take 
between 1.5-3 hours to complete. 
Session 1: Session 1 is expected to take about 1.5 hours. At the first session, you will be asked to 
complete a survey and walk on a treadmill using your current prosthesis. The survey will ask 
your age, ethnicity, income, military status, education, and height and weight. We will also ask 
questions about the date and cause of your amputation. You do not have to answer every 
question. 
Next, you will be asked to walk on a treadmill at three speeds: comfortable, slow, and fast. You 
will be allowed to choose these three speeds by increasing and/or decreasing the speed on 
PROVED 
FEB 19 2015 
Appendix 1: Consent form 
02/12/2015 

. treadmill. You will then be asked to walk for 6 minutes at your preferred fast speed. You may 
reduce the speed as needed to ensure that you can continue at this pace for 6 minutes. 
You will also be informed about the prosthetic foot that you will receive first (the energy storing 
foot or the modified running foot). You will receive this prosthesis from Greg Davidson at 
Davidson Prosthetics at a time that you schedule with his office. You will be asked to wear this 
prosthesis in place of your current prosthesis for a period of one month. Please adhere to your 
normal wear schedule, as recommended by your prosthetist. 
You will also be given an activity monitor to attach to your study prosthesis. This device 
measures the number of steps you take throughout the day. We will show you how to attach the 
monitor to your prosthesis. We request that you leave the monitor on your prosthesis until we 
remove it. 
Session 2: Session 2 is expected to take about 3 hours. You will come to this session wearing the 
first prosthesis you were assigned. At this session, you will be asked to complete a survey that 
will ask you questions about your ability to move around with your prosthesis, tiredness, 
balance, activities that you engage in, and satisfaction with your prosthesis. Throughout this 
session, you will be able to rest when you feel like it and we will give you water to drink. 
You will be asked to wear a lightweight oxygen mask and waist pack during the some of this 
session. The oxygen mask helps us determine how much energy you use when you walk. You 
will be asked wear the mask while you sit for 5 minutes and then to stand for 5 minutes so we 
can measure your breathing while you are not active. You will then temporarily remove the 
oxygen mask. 
You will next be asked to complete a walking test called the Six-Minute Walk Test. For this test, 
you will be asked to walk back and forth between two cones for 6 minutes. While walking back 
and forth between the cones, you will be asked to walk across a mat. This mat records the steps 
you take while walking. You may rest at any point and a chair will be brought to you if you 
would like to sit during the test. You will be instructed to walk as quickly as possible during this 
test. You may use an assistive device, such as a cane or walker, when performing this test. We 
will record the total distance you walked during the test. Following the Six-Minute Walk Test, 
we will ask you to report your level of exertion on a scale from 0-100. A rating of 0 indicates no 
exertion at all and a rating of 100 indicates maximal exertion. This test will take under one 
minute. 
You will next be asked to put the oxygen mask on again. You will wear this mask while walking 
at your comfortable, slow, and fast walking speeds for a total of 18 minutes (6 minutes at each 
speed). You will be asked to rest for at least 5 minutes between each period of walking to make 
sure your breathing returns to normal. You will be able to rest when you feel like it and we will 
give you water to drink. 
Following this session, you will return to Davidson Prosthetics to receive your second prosthesis 
at a time that you schedule with his office. You will be asked to leave your first prosthesis at the 
office and wear the second prosthesis as your primary prosthesis for an additional month. 
Session 3: Session 3 is expected to take about 3 hours. You will come to this session wearing the 
second study prosthesis. Study activities for Session 3 will be identical to those in Session 2 
(above). 
You may choose not to complete any of these tests at any time during the session. 
Appendix 1: Consent form 
02/12/2015 
Page 2 of 5 

We would like your permission to take photographs and videos of you during this study so that 
we have an accurate record. Please indicate below whether or not you give your permission. 
We may ask for your additional permission to use the photographs and recordings outside this 
research study. We may want to use them publicly and keep them indefinitely. We will give you 
opportunity to review the photographs and recordings before giving your permission. 
RISKS, STRESS, OR DISCOMFORT 
We ask you to walk for about 30 minutes during the study session. Some people may become 
tired. The risk of falling is about the same as walking in your daily activities. You can take a 
break or sit down whenever you like. If the researchers notice fatigue or risk of falling, they will 
end the study session. 
ALTERNATIVES TO TAKING PART IN THIS STUDY 
The alternative to taking part in this study is to not take part in this study. 
BENEFITS OF THE STUDY 
You will not directly benefit from participating in this study. However, the Modified Cheetah is 
a promising prosthetic foot. Research involving this foot will help make it available to others 
who may benefit from its use. 
SOURCE OF FUNDING 
The study team is receiving financial support for this research from the University of 
Washington Royalty Research Fund. 
CONFIDENTIALITY OF RESEARCH INFORMATION 
The information you provide to us during the study is confidential. We will protect the 
information we collect about you using a unique code. The link between your name and this 
code will be kept in a safe place apart from the information we collect about you. We will keep 
this link until 2026 so that we contact you if we have any questions. You may request that we 
destroy this link at any point during or after the study. 
Government or university staff sometimes review studies such as this one to make sure they are 
being done safely and legally. If a review of this study takes place, your records may be 
examined. The reviewers will protect your privacy. The study records will not be used to put 
you at legal risk of harm. 
The U.S. Food and Drug Administration (FDA) reserves the right to review study data that may 
contain identifying information. 
A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 
Appendix 1: Consent form 
02/12/2015 
Page 3 of 5 

OTHER INFORMATION 
Taking part in this study is voluntary. You can stop at any time. You may refuse to participate 
and you are free to withdraw from this study at any time without penalty or loss of benefits to 
which you are otherwise entitled. 
You are responsible for your transportation to and from the study session. 
You will be offered payment for your participation in this study. You will receive $30 per hour 
for the first session and $50 per hour for the second and third sessions. 
It is UW policy that we record your name and address for any participant payments made to you. 
We will give you a sticker that will pay your parking costs while you are attending study 
sessions. 
You will also be allowed to keep both prostheses at the end of the study. Warranty terms for your 
modified running prosthesis will be provided by Davidson Prosthetics. The energy storing 
prosthesis is yours to keep, but does not include a warranty of any kind. 
We may combine information we collect from you in this study with information from similar 
studies in the future. We may use your study information in the future for related studies. 
We may ask you to keep photographs or video_recordings indefinitely and to use them publicly. 
We will give you an opportunity to review the photographs and video_recordings before giving 
your written consent. 
RESEARCH-RELATED INJURY 
If you think you have a medical problem or illness related to this research, contact Brian Hafner 
at 206-685-4048 or Cody McDonald at 206-221-6347 right away. They will refer you for 
treatment. 
Printed name of study staff obtaining consent 
Signature 
Date 
Appendix 1: Consent form 
02/12/2015 
Page 4 of 5 

Subject's statement 
This study has been explained to me. I volunteer to take part in this research. I have had a 
chance to ask questions. If I have questions later about the research, or if I have been harmed by 
participating in this study, I can contact one of the researchers listed on the first page of this 
consent form. If I have questions about my rights as a research subject, I can call the Human 
Subjects Division at (206) 543-0098. I will receive a copy of this consent form. 
D 
I give my permission for the researchers to photograph the study procedures as described 
above in this consent form. 
D 
I give my permission for the researchers to videotape the study procedures as described 
above in this consent form. 
Printed name of subject 
Copies to: 
Researcher 
Subject 
Appendix 1: Consent form 
Signature of subject 
Date 
02/12/2015 
Page 5 of 5