Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients?
Phase: NA
Conditions: Ankle Osteoarthritis, Healthy Ankles
Sponsor: VA Office of Research and Development

Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle 
Osteoarthritis Patients?
MIRB # 01601
Funding Agency: Department of Veterans Affairs
Principal Investigator: Bruce Sangeorzan, MD
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Abstract
Background and Purpose: Ankle osteoarthritis (OA) is a painful, progressive condition that can 
severely limit physical activity and reduce quality of life. Rocker bottom (RB) shoes and ankle-foot 
orthoses (AFO; a type of ankle brace), are common non-surgical treatments to manage ankle OA, but 
their ability to reduce pain and increase mobility has not been fully evaluated. One way ankle OA pain 
can be managed is by reducing the ankle’s range of motion (ROM), the less the joint has to move 
during activities (like walking) the less load it has to carry/process. RB shoes have curved soles, front-
to-back, that may alleviate joint pain by reducing the ankle’s front-to-back ROM. RB shoes may allow 
the body’s weight to rollover the curved sole of the shoe during activities (like walking) with less 
effort and movement needed from the ankle joint. Similarly, AFOs may reduce joint motion by 
securing the foot and ankle within the AFO structure. 
The purpose of this study is to evaluate the ability of RB shoes and AFOs to improve mobility, by 
alleviating pain and reducing joint motion when compared to a standard shoe. This study has three 
specific aims (SA):
SA 1: Compare the daily step count, self-selected walking speed (SSWS), and self-reported outcomes 
from a set of questionnaires assessing pain and mobility before and after wearing a control shoe, RB 
shoe and a AFO. Each footwear condition will be worn over a three-week period (one-week 
acclimation, two-week trial period). This will indicate how subjects respond to these treatment 
conditions – what their pain levels are compared to baseline, how they self-report functional change, 
and from their step count, a quantitative measure of their mobility in the treatment footwear.
SA 2: Evaluate the effect of a control shoe, a RB shoe and a AFO on the front-to-back ROM of the foot 
and ankle. This will determine how these devices shield the ankle from motion – potentially 
protecting it, and if they impose abnormal motion on adjacent foot joints – potentially exposing them 
to additional wear and increasing their risk for long term OA development.
SA 3: Compare the ankle OA clinical and biomechanical outcome measures for the control shoe, RB 
shoe, and AFO to a healthy control group wearing control shoes. This will determine the difference in 
clinical and biomechanical outcomes related to the presence of OA. 
Methods: We will enroll 100 participants with ankle OA and 50 control participants without lower 
limb pain. Three study groups will participate in this project. Study group 1 is a single day study and 
have images taken using our biplane fluoroscopy system. Study group 2 is a three month take home, 
and Study group 3 is a three month take home and will have images taken using our biplane 
fluoroscopy system. At visit-1 all participants will do baseline measures (questionnaires and 
functional assessments, including SSWS) and have a CT scan. During the initial visit, group 1 will 
participate in a biplane assessment. Participants in Study group 2 & 3 will be assigned to a randomly 
selected order of footwear (RB shoe, control shoe or an AFO). Each footwear condition will be worn 
for a three-week trial period at-home/in-community (one-week acclimation, two-weeks continuous 
wear). Participants will complete brief weekly pain assessments and wear a step counter. At visit-2 
participants will do a pain rating, repeat the questionnaires and SSWS test, and group 3 will have 
images taken using our biplane fluoroscopy system. Participants will continue wearing the step-
counter during a one week washout period. For the next three weeks, participants will repeat the at-
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home/in-community procedures (step counter, weekly pain rating) and come to the VA to repeat the 
visit-2 procedures. The same process will be repeated for the third footwear condition. 
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List of Abbreviations
Provide a list of all abbreviations used in the protocol and their associated meanings.
AE – adverse event
AFO – ankle-foot orthosis
CT – computed tomography
mSv - millisievert
OA – osteoarthritis
RB – rocker bottom
ROM – range of motion
ROP – report of other problem
SAE – serious adverse event 
SSWS – self-selected walking speed
UW/HMC – University of Washington/Harborview Medical Center
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Contents
Protocol Title: Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility 
for Ankle Osteoarthritis Patients?..........................................................................................................6
1.0
Key Study Personnel..................................................................................................................6
2.0
Introduction................................................................................................................................6
3.0
Specific Aims and Hypotheses...................................................................................................7
4.0
Resources and Personnel..........................................................................................................8
5.0
Study Procedures.......................................................................................................................8
5.1
Study Design..........................................................................................................................8
5.2
Recruitment Methods and Initial Screening.............................................................................8
5.3
Informed Consent Procedures..............................................................................................11
5.4
Inclusion/Exclusion Criteria...................................................................................................11
5.5
Study Visits, Data Collection, and Risk Management...........................................................12
5.6 Data Analysis............................................................................................................................24
5.7 
Withdrawal of Participants....................................................................................................27
6.0
Reporting..................................................................................................................................27
7.0
Information Security, Privacy and Confidentiality......................................................................28
8.0
Communication Plan................................................................................................................29
9.0
References...............................................................................................................................29
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Protocol Title: Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and 
Improve Mobility for Ankle Osteoarthritis Patients?                                                                 
1.0
Key Study Personnel
Principal Investigators: 
Bruce J Sangeorzan, MD, VA Puget Sound, bruce.sangeorzan@va.gov, 206-277-3223
Co-Investigators: 
William R. Ledoux, PhD, VA Career Research Scientist, william.ledoux@va.gov, 206-768-5347
Joseph Iaquinto, PhD, VA Puget Sound, joseph.iaquinto@va.gov, 206-277-1738
2.0
Introduction
Ankle osteoarthritis (OA) is a debilitating condition associated with severe pain, dysfunction, and 
reduced quality of life. In the end stage of the disease, many patients are unable to walk 100 meters 
or up a single flight of stairs1, and the reduction in quality of life is similar to that of end-stage hip 
arthritis or congestive heart failure1,2. Ankle OA affects about 6% of the population3 and is thus less 
common than hip or knee arthritis. However, ankle OA differs from hip or knee arthritis because most 
cases are post-traumatic2 and consequently affect a younger demographic4,5. Data from the Health 
Care Utilization Project online indicate that hospital charges for the treatment of ankle arthritis 
exceed $370 million per year.
Ankle OA is an important health care concern for the Veterans Health Administration. Veterans are at 
greater risk of developing ankle OA than non-veterans due to the rigorous physical demands 
associated with training and combat during military service6.  Traumatic OA from injury is also higher 
in the military population (up to seven times greater7). Data from the National Health Interview 
Survey of 1990 show a higher prevalence of foot and ankle OA among veterans of the pre- Gulf War 
era than corresponding non-veterans8, and studies of Operation Enduring Freedom/Operation Iraqi 
Freedom (OEF/OIF) have shown both an increase in extremity injury and an increase in ankle OA 
compared to previous conflicts9,10. This increase in ankle OA has resulted in severe disability for many 
veterans. A recent study of 126 wounded warriors with OA as an unfitting condition that led to a 
medical separation from the military, found that those with ankle OA had higher disability ratings 
than those with knee or hip OA11. VA Medical Centers treat a significant number of veterans with 
ankle OA. A VHA Support Service Center (VSSC) database search for FY2014 of local (Seattle VA), VISN 
20, and national outpatients yielded the following table of ankle OA populations, showing several 
thousand national cases in a single year.
End-stage ankle OA is defined as when all non-surgical treatment options (nonsteroidal anti-
inflammatory drug therapy, other oral therapy, corticosteroid injections, bracing, etc.) for ankle OA 
have failed. The most common surgical treatments are talocrural arthrodesis and total joint 
arthroplasty. However, the long-term results are mixed, with most ankle arthrodesis patients 
developing arthritis of the subtalar or midfoot joints within 3-22 years of operation12,13 and many 
ankle arthroplasty patients have a higher failure rate than the knee or hip14. These late effects suggest 
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that a longer delay in surgical treatment is desirable. Yet there are very few publications on efficacy 
of orthotic management.
The risks, the cost, and the time-limited outcomes are compelling reasons to explore non-surgical 
treatments options for ankle OA. Conservative interventions thought to limit joint range of motion 
(ROM) may delay or prevent the progression of arthritis, reduce pain, improve comfort and function, 
and thus improve quality of life. Two such treatment types are rocker bottom (RB) shoes and ankle-
foot orthoses (AFOs). These devices are commonly prescribed to manage ankle OA; however, their 
ability to reduce joint motion and thus alleviate pain and increase mobility has not been scientifically 
evaluated. Towards that end, we aim to compare two conservative treatments (RB shoes and AFOs) 
in OA subjects by measuring mobility and pain during and after the completion of three-week trial 
periods. We will use biplane fluoroscopy to measure hindfoot and midfoot joint motion at the 
conclusion of each period. This study will provide evidence to support clinical decision making.
3.0
Specific Aims and Hypotheses
The purpose of this study is to evaluate the ability of RB shoes and AFOs to improve mobility, by 
alleviating pain and reducing joint motion when compared to a standard shoe. This study has three 
specific aims (SA):
SA 1: Compare the daily step count, self-selected walking speed (SSWS), and self-reported outcomes 
from a set of questionnaires assessing pain and mobility before and after wearing a control shoe, RB 
shoe and a AFO. Each footwear condition will be worn over a three-week period (one-week 
acclimation, two-week trial period). This will indicate how subjects respond to these treatment 
conditions – what their pain levels are compared to baseline, how they self-report functional change, 
and from their step count, a quantitative measure of their mobility in the treatment footwear.
Hypothesis 1.1: For ankle OA subjects, the RB shoe and AFO will exhibit increased step count, 
self-selected walking speed, improve physical function, and reduced pain when compared to a 
control shoe.
Hypothesis 1.2: For ankle OA subjects, the AFO will increase step count, self-selected walking 
speed, improve physical function, and reduce pain more than the RB shoe or control shoe.
SA 2: Evaluate the effect of a control shoe, a RB shoe and a AFO on the front-to-back ROM of the foot 
and ankle. This will determine how these devices shield the ankle from motion – potentially 
protecting it, and if they impose abnormal motion on adjacent foot joints – potentially exposing them 
to additional wear and increasing their risk for long term OA development.
Hypothesis 2.1: For ankle OA subjects, the sagittal ROM of the talocalcaneal, talocrural, 
talonavicular, naviculocuneiform, and first cuneometatarsal joints will be less when wearing 
the AFO than the RB shoe, which will be less than OA subjects wearing the control shoe.
SA 3: Compare the ankle OA clinical and biomechanical outcome measures for the control shoe, RB 
shoe, and AFO to a healthy control group wearing control shoes. This will determine the difference in 
clinical and biomechanical outcomes related to the presence of OA.
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Hypothesis 3.1: For ankle OA subjects, daily step count, self-selected walking speed, PROMIS 
physical function, and FAOS will be less, while the PROMIS pain interference, AAOS-FAM, and 
numeric pain rating will be greater than the control subjects wearing the control shoes.
Hypothesis 3.2: For ankle OA subjects, the sagittal ROM of the talocalcaneal, talocrural, 
talonavicular, naviculocuneiform, and first cuneometatarsal joints when wearing RB shoes or 
AFOs will be less than the [sagittal] ROM of the control subjects wearing the control shoes.
4.0
Resources and Personnel
Data collection procedures for this study will be conducted at the VA Puget Sound in Seattle, 
WA. See Study Staff Sheet attachment for listing of personnel, ability to obtain consent, and 
access to PHI. 
Under the supervision of the PI, designated study staff will be responsible for conducting 
recruitment, consent and scheduling study procedures. The PI, Investigators, and/or Research 
Engineers and assistants will conduct procedures with participants. The PI, Investigators, and 
the Biostatistician will be primarily responsible for data analysis and interpretation; Research 
Engineers and assistants may also assist with this. Under the supervision of the PI, the 
Program Coordinator is responsible for IRB related matters.
5.0
Study Procedures
5.1
Study Design
Participants in this research study will be men and women, age 18 and over, who can walk without 
difficulty for about an hour. People with and without ankle OA, will be enrolled. Targeted enrollment 
by ankle OA status is listed in the table below. Vulnerable populations will not be specifically targeted 
for enrollment. See inclusion/exclusion criteria below in section 5.4. 
Study Groups
Total: 150
Controls, no ankle OA
50
People with Ankle OA
100
See section 5.5 below for data collection procedures and risk management.
5.2
Recruitment Methods and Initial Screening 
Up to 3000 individuals may be approached during recruitment and enrollment procedures. Please 
note that all references in this section to in-person contact/initial-screening will follow the Screening 
Script attachment, all references to approach letters and postcards refer to the Recruitment Letter 
attachment.
Recruitment activities at the VA
Medical Record/Database: Letter/Phone/In-person (Seattle and American Lake)
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Designated research staff will screen relevant clinic lists in CPRS to identify potential participants with 
a qualifying ankle OA diagnosis. After review, designated staff will go to the clinic or contact providers 
on the phone or on VA encrypted email to ask if a patient might be a good fit for the study. If the 
clinician agrees that the study may be a good fit for a patient, during an appointment the clinician will 
inform patients of the availability of the study and ask if they are interested in speaking with 
designated study staff; patients will be given a chance to opt out. For patients who are interested, 
designated study staff will speak to potential participants directly and/or use CPRS to obtain potential 
participants’ contact information (i.e., name, address, telephone number). For potential participants 
who learned about the study in person and were introduced to us but may not have time to complete 
the eligibility screening, designated study staff may give them a flyer and/or business card, and make 
a follow-up approach phone call, arrange a time to meet later in-person, and/or send an approach 
letter to them. If potential participants are unable to meet with designated study staff in-person, then 
we will send an approach letter.
We may also search CPRS and the Corporate Data Warehouse (CDW) to identify individuals with a 
qualifying diagnosis and mail them the approach letter. 
If potential participants have not spoken with us within 14 days of the first call and/or mailing the 
approach letter, designated study staff will contact them by phone up to two more times (three times 
total) about this study. The approach letter will also include an “opt out” postcard. The opt-out 
postcard will have a unique study recruitment identification code, e.g., “RBS-AFOd1”, “RBS-AFOd2”. If 
an individual returns the postcard to opt out they will not be approached about this study again. 
Clinician Referral
Designated staff will inform providers working in relevant clinics about the study and 
inclusion/exclusion criteria, so they can refer potential participants to contact the study team. Flyers 
and business cards may be provided to clinicians (or their support staff) to give to patients that are 
interested in learning about the study. Clinicians may also provide us (via VA encrypted email/in-
person/on the phone) with the names of patients that they are aware of who may be a good fit for 
the study and we will look up their contact information to send an approach letter. If a clinician 
informs patients about the study and the patient agrees to be contacted about it, the clinician may 
provide us with the patient’s name (via encrypted email/in-person/on the phone). We will look up 
the patient’s contact information in CPRS and make an approach call (in this instance – we will obtain 
printable documentation from the clinician, via encrypted email or a note in the medical record, that 
the patient agreed to be contacted on the phone).
Print/Text/Online/Flyers/Newsletter
Flyers may be posted in designated areas at the VA Puget Sound (Seattle and American Lake) on the 
CCTV system and in publicly accessible locations in the community (e.g., public libraries, community 
centers, coffee shops). The flyers may also be re-sized to be used in print publications or as a 
complete image in online ads. We may post classified ads in print and online publications. We may 
also post the classified ad text to our Center’s webpage. We may also post recruitment information in 
our center newsletter.
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VA Puget Sound Center Registry: Letter/Phone
Designated study staff may also identify potential participants using the VA Center for Limb Loss 
Prevention and Prosthetic Engineering Subject Registry (PI: Klute, #00433). The Registry contains 
contact information for participants who were screened for and/or participated in previous studies 
with our research group and consented to be contacted (via phone call and/or letter) for future 
studies. Designated study staff may make an approach phone call and/or send an approach letter to 
potential participants asking whether they are interested in the study. If potential participants have 
not spoken with us within 14 days of the first call and/or of the mailing the approach letter, 
designated study staff will contact them by phone up to two more times. The approach letter will also 
include an “opt out” postcard. The opt-out postcard will have a unique study recruitment 
identification code, e.g., RBS-AFOd1”, “RBS-AFOd2. If an individual returns the postcard to opt out 
they will not be approached about this study again. Designated study staff may also speak with these 
potential participants in-person if they have an upcoming clinic visit.
Eligibility Screening
Interested individuals will be screened for eligibility in-person or over the phone.
Recruitment Activities at UW/Harborview 
A confidentiality agreement will be obtained for this activity. The UW is engaged in all aspects of this 
study. Also, we spoke with Leah Miller at UW HSD and confirmed that Dr. Bruce Sangeorzan is not 
engaged as a UW agent for the purposes of this study or its recruitment activities.
Medical Record/Database: Letter/Phone/In-person (UW/Harborview)
Designated study staff will screen relevant UW/Harborview clinic lists, appointment calendars and 
patient medical records to identify potential participants with a qualifying ankle OA diagnosis. Study 
staff may also attend clinic at these facilities to identify and/or contact potential participants. Study 
staff will discuss with the clinician(s) (in-person or on the phone) any patients that might be 
appropriate candidates. If the clinician agrees that the study may be a good fit for a patient, the 
clinician will inform patients of the availability of the study and ask the patient if she/he is interested 
in speaking with study staff. For interested patients, study staff will speak to them directly to tell 
them more about the study, give them a study flyer, business card, and/or request their permission 
to screen them for initial eligibility (via the VA IRB approved screening script) and provide this 
information to the VA. If VA staff are not available in the clinic, the clinician or their support staff may 
provide the study flyer and/or VA research coordinator’s business card. 
If potential participants are screened in person, study staff will label the noted responses with an id 
code and no HIPAA identifiers or sensitive health information will be noted on the form. Study staff 
will transport the forms to the VA for storage. Study staff will use their VA remote access to add PHI 
to the screening log that is maintained on the VA server, or they will call other approved staff to 
provide the PHI, and the information will be added to the VA screening log.
For potential participants who learned about the study in person and were introduced to us but may 
not have time to complete the eligibility screening, staff may give them a flyer and/or business card, 
look up their contact information to make a follow-up approach phone call, arrange a time to meet 
later in-person, and/or send an approach letter to them. If potential participants are unable to meet 
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designated study staff in-person, then we will send an approach letter (the VA IRB approved letter 
with VA contact information would be sent per the process described above).
Staff may also search/access UW medical records to identify individuals with a qualifying ankle OA 
diagnosis, obtain their contact information (i.e., name, address, telephone number) and mail them 
the approach letter.
Clinician Referral
Designated staff will inform providers working in relevant clinics about the study and 
inclusion/exclusion criteria, so they can refer potential participants to contact the study team. Flyers 
and business cards may be provided to clinicians (or their support staff) to give to patients that are 
interested in learning about the study. Clinicians may also provide us (via in-person/on the phone) 
with the names of patients that they are aware of who may be a good fit for the study and we will 
look up their contact information to send an approach letter.
For potential participants who were initially contacted via letter and/or in-person but have not yet 
completed the initial screening, study staff may provide the potential participants’ contact 
information and limited pre-screening criteria over the phone to other study staff at the VA who will 
enter it into the screening log for tracking and follow up. This information may also be added (via VA 
remote access) to the screening log maintained on the VA server. Study staff will follow up with 
potential participants based on the VA approved protocol.
5.3
Informed Consent Procedures
A waiver of informed consent and HIPAA authorization will be used for recruitment and screening 
purposes. A waiver of documentation of consent and HIPAA authorization will be used to in order to 
retain the preliminary eligibility screening responses (see Screening Script). Informed consent will be 
obtained prior to enrollment in the study.
Designated study staff and/or the PI will conduct the informed consent process. All study personnel 
will complete the necessary human subjects’ protections training per VA policy. For study group 4 
(remote study) informed consent will be conducted remotely. The consent document will be mailed/ 
delivered to the participant. Designated study staff and/or the PI will conduct the informed consent 
process via phone. The participant will then mail (or researcher will pick up) the consent from and 
return back to the VA.  
5.4
Inclusion/Exclusion Criteria
Our targeted range for the total number of study completions is up to 150.
Inclusion Criteria:
Participants with ankle OA: 
1. radiographic evidence of tibiotalar OA 
2. age 18 years or older
3. able to stand and walk for about an hour (with breaks) and at least 15m (about 50ft) at a time 
without difficulty
4. minimum pain 3+/ 10
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Control participants without OA:
1. age 18 years or older 
2. able to stand and walk for about an hour (with breaks) and at least 15m (about 50ft) at a time 
without difficultly
Exclusion Criteria: all participants
1. subtalar joint arthritis 
2. prior ankle joint replacement or fusion on the foot of interest, or recent (<1 year) surgical, 
neurological, rheumatologic, or lower limb musculoskeletal problem (e.g., current foot ulcer, 
severe hip/knee OA, terminal illness, etc.) that impairs an individual’s ability to do the walking 
tests 
3. current user of AFO or rocker bottom shoe and has either been prescribed by doctor or is not 
willing to stop using the device for three months
4. plans to undergo surgical treatment for ankle OA within three months 
5. inability to walk unassisted during short, repeated walking trials 
6. rheumatoid arthritis 
7. inadequate cognitive or language function to consent or to participate 
8. no phone number or stable mailing address
9. currently incarcerated 
10. currently pregnant
11. open wounds on the foot or ankle
12. below- knee surgery in the past 60 days
Additional Exclusion Criteria, Controls only:
1. Ankle pain or ankle OA in addition to the above exclusionary criteria
5.5
Study Visits, Data Collection, and Risk Management 
Participants can be enrolled in one of three study groups for this project. The specific procedures for 
each item are outlined below. 
Visits at the VA Puget Sound may last up to 4 hours each. Particpant schedules and the accessibility of 
facility resources may extend the study timeframe beyond these estimates. Study visits will be 
scheduled by contacting the participants on phone, or during in-person contacts. We may contact 
participants with appointment and/or at home activity reminders via email or phone.
Study 
 
 group 1: One day visit
 
 
Participaton will be at the VA Puget Sound and last up to 4 hours wearing the participants own 
or study provided footwear during the activities. Activities may include a Screening, Functional 
assessments, CT scan with pregnancy test, Qualitative questions, Brief Pain Rating, and a Biplane 
assessment with one or more interventions including barefoot, their own footwear, a modified shoe 
(such as a rocker bottom shoe), an orthotic device (such as an AFO), or a control shoe provided by the 
researchers.
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Study group 2: Take home portion only (~3 months)
Participants with ankle OA will conduct a initial visit that will include a Screening, Functional 
assessments, CT scan with pregnancy test, Questionnaires, Qualitative questions, and Brief Pain 
Rating followed by a 3 month intervention at home intervention, that will include three additional 
visits to the VA. Timeline and assessments during those visits is described below.
Study group 3: Take home portion with Biplane (~3 months)
This study group is simlar to Study group 2, however it does include three biplane assessments 
over the three additional visits.
Study group 4: Remote take home only (~ 3 months)
This study group is similar to Stuy group 2, however all procedurse ill be done remotley. 
Participants with ankle OA will conduct a initial assessemnt that will include a Screening, Functional 
assessments, Questionnaires, Qualitative questions, and Brief Pain Rating followed by a 3 month at 
home intervention, that will include three additional assessemnts. Timeline and assessments during 
those assessments is described below. In addition, we will ask you to wear a StepWatch Activity 
Monitor (a step counter) and to do brief weekly pain ratings, and daily pain rating and pain 
medication use over the course of the entire study.
Photos and video
We will take video and photos of participants during portions of this study for documentation and use 
in research publications. All videos and photos will be anonymized (to avoid facial or voice 
identification) and and tattoos and other distinguishing marks will be covered before images are 
captured or obscured during processing to protect the identity and privacy of our participants.
During study sessions, visitors and observers will not be allowed in the lab unless the participant 
agrees to their presence; the participant can change her/his mind at any time. 
Study Footwear 
Over the course of the study (one day or ~3 months participants will be asked to wear up to three 
different footwear conditions: control shoes (a typical walking shoe, such as the New Balance 928), 
RB shoes (walking shoes with a front-to-back curved sole, such as the New Balance 928 with a rocker 
sole), and an orthotic device (such as an AFO, an ankle brace, such as the Toeoff® AFO) with control 
shoes. Participants will wear each footwear condition, in a randomized order. For all footwear 
conditions a fitbit zip may be clipped or taped to the shoe. This will record steps taken in the 
footwear. The fitbit will be synced during the VA visits and will only record number of steps.  A 
separate account for each fitbit will be created and the account number will be recorded on the 
participant crosswalk. There will be no additional methods to link the data to the participant. 
Additional assessements on the initial day may include barefoot and own shoe as footwear condtions. 
Screening /
 
 Eligibility Verification
 
 
Participants will have been preliminarily screened during recruitment, then during the first visit, after 
informed consent, we will make a final elibility determination. This will include verifying that the 
information collected during recruitment is accurate and current.
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If a participant cannot continue in the study, they will be compensated $50 for the visit.
Demographic Data collection
Participants’ age, sex, race/ethnicity and Veteran status will be recorded. 
Anthropometrics
Participants’ weight, waist circumfrence, and height will be measured.
Pain/health screening 
Short survery which will include questions regarding trauma history in the lower limbs,  joint 
replacments, OA, and pain throughout the body.
Functional Assessments
Self-selected Walking Speed (SSWS)
Participants wear either their own footwear or resaercher provided footwear. Participants will be 
asked to walk 20 meters in a straight line, at their own pace, in the hallway while a researcher times 
how long each walk takes. This will be used to determine the participants’ self-selected walking speed 
(SSWS). This assessment will be conducted up to three times and averaged.
Timed Up and Go (TUG)
Participants wear either their own footwear or resaercher provided footwear. Participants will start 
seated in a chair with arm rests, stand up, walk to a line 3 mters away, turn anround, walk back to the 
chair, then sit down. Time to complete this will be recorded. This assessment will be conducted up to 
three times and averaged.
10 m fast walking test (10 m walk)
Participants wear either their own footwear or resaercher provided footwear. Participants will be 
instructed to walk as fast as they are comfortable for 10 meters. Participants will start walking before 
the 10 meter line and continue past the finish line. Time to complete the 10 meter walk will be 
recorded. This assessment will be conducted up to three times and averaged.
Qualitative Assessment
Participants will be asked several questions and responses will be recorded. 
1.
Do you like the device? Why/ why not?
2.
Would you continue to wear the device if you were not part of the study? Why/why not?
3.
Do you have a preference to one of the treatments? Which one? Why?
Questionnaires
Participants will be asked to complete a series of questionnaires about their pain and physical 
function. This will include the Patient Reported Outcomes Measurement Information System 
(PROMIS) pain interference v1.1, PROMIS physical function v1.2, and the Foot Ankle Ability Measure 
(FAAM).
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The PROMIS measures will be completed on a mobile tablet and the data is saved locally by the 
application. The participant will enter their responses or it may be conducted as an interview with 
staff entering responses. The PROMIS measures are computer adaptive tests – the responses to the 
items determine which question path the user is taken through. Only a study assigned ID code (e.g., 
RBAFO_OA_001) will be associated with the PROMIS data. The other measures will be administered 
on paper or as an interview and will also be labeled with the study ID code. See section 10 for 
additional Privacy and Information Security details.
Daily Pain Rating and Pain Medication Use
We may ask you to rate (on a scale of 1-10) what your pain level is now, what your average pain level 
was in the past 24 hours, and what your maximum pain level was in the past 24 hours. We may also 
ask you what if any pain medication you took.
Brief Pain Rating (BPR)
A brief three item pain rating (1) what is your pain level now (0-10)?, 2) what has been your average 
pain level this week (0-10)?, and 3) what was your maximum pain level this week (0-10)?).
StepWatch Activity Monitor
A StepWatch Activity Monitor and instruction sheet will be provided to the participants. The 
StepWatch Activity Monitor is a step-counter placed around the ankle and is to be worn at home and 
in the community.
Pregnancy test
At each visit that involves exposure to radiation female participants of child-bearing potential (under 
age 50) will undergo a pregnancy test (urine test) so we can verify that they are not pregnant. 
Designated study staff will escort female partipants to the bathroom and provide them with a 
specimen cup, pregnacy test strip, and a disposable container on which to place the used test strip. 
Staff will go over the test instructions, and verify the test result. Staff will not handle urine specimens, 
we will tell particpants how to handle and dispose of the materials. Pregnancy tests may also be 
conducted by the lab at the VA Puget Sound. If the test indicates that the participant is pregnant she 
will be not be able to participate in the study and we will advise her to see her regular clinical care 
provider.  
CT Scan
CT scans will be done at the VA Puget Sound, however, if needed, CT scans may be collected by a 
third-party vendor on a fee for service basis as explained below. We hope to do the CT scan during 
the first visit, however the scan may be taken during any of the study visits depending on scheduling 
needs.
If participants have a VA or UW medical record(s) we will access them to collect information 
related to participants’ foot/ankle diagnosis, related clinical treatment, and check to see if they 
have already had a CT scan that can be used for this study. If participants report that they have had 
a CT scan(s) at a different medical facility, we may request copies of them. If possible, we will use 
the previously collected images for our data set and analyses so that participants do not have to be 
exposed to additional radiation. We will search for CT scans that took place within the last 5 years. 
If participants’ medical records are not at the VA they will be asked to sign a release form so that 
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we can obtain copies of these records. The CT scans and any other requested clinical notes from 
outside the VA will be delivered via the following methods:
The images and other clinical treatment information may be burned to CD(s) or DVD by HMC or 
other facility and mailed to us via traceable shipping.
A designated study staff member will pick up the CD(s) or DVD from HMC/UW or other facility 
and transport it to the VA.
Information about lower extremity diagnoses and clinical treatment may be provided to 
designated study staff over the phone – the information will be labeled with the participants’ 
study code and added to study records
 
(B) If scheduling a CT scan at the VA Puget Sound proves to be difficult, we may schedule the CT scan 
at a third-party vendor (i.e., a fee for service CT scanner). The vendor will use the Study Staff’s name 
and a study ID code for scheduling purposes. We will provide participants with the address of the 
vendor. A study ID code (e.g., RBAFO_OA_01) will be entered in the name field of the CT scan file 
along with age in years (if 89 or younger). The vendor will not store subjects’ PHI in their files and 
they will not have access to or create a study ID crosswalk. The vendor will make a copy of the CT 
scan with the study ID code and age. Study staff will pick up the CD and transport the scan to the VA 
and/or the vendor mail it to us via traceable shipping.
Additionally, a low lose CT scan of participants may be taken using our Center’s LineUP system 
(http://www.curvebeam.com/products/lineup/) and/or using clinical resources at the VA Puget 
Sound. The scan will start at the mid-tibia (lower leg) and extend down to include the subject’s feet. 
The CT scan will be used to generate a computational model of the participant’s bony anatomy – a 
necessary step for generating results with the fluoroscopy system. 
Paticipants will be instructed to perform up to 15 scans in various positions including: barefoot partial 
weight-bearing neutral position, barefoot partial weight-bearing maximum ankle dorsiflxion, barefoot 
partial weight-bearing maximum plantarflexion, full weight-bearing bearfoot in neurual position, and 
partial weight-bearing with 3 different footwear in a secured manner to sustain the posture while 
scaning. Repeated procedure may be necessary as the the scan requires the partipant to maintain the 
static position for less than one minute. 
Biplane Fluoroscopy Laboratory
These procedures are utilized in study groups 1 and 3. Participants will be escorted to the Biplane 
Fluoroscopy Lab per our SOPs. While wearing shorts (their own or ones we provide) and the assigned 
footwear (barefoot, own shoe, rocker bottom (RB) shoes, control shoes, or an ankle-foot orthosis 
(AFO) with the control shoes) the participants will step onto an elevated walkway, which is flat, about 
3 feet wide, level, and has handrails on both sides. Participants will walk freely up and down the 
walkway to get comfortable with the test environment. 
While standing still on the platform, a force plate will capture ground reactions forces and two 
fluoroscopes will capture simultaneous X-ray images of the participant’s foot of interest to record the 
standing position of the bones. These dual fluoroscopes allow for tracking of the bone motion in 
three dimensions while the participant is walking. Next, participants will walk along the platform 
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while simultaneous X-ray images of the foot of interest are taken; each X-ray exposure is expected to 
last about 0.5 seconds, and will image from about 3 inches above the ankle to below the bottom of 
the shoe or foot. Participants will do up to 26 walking trials with each footwear condition during 
which images of their foot are taken. For some participants, we may take images of both feet during 
the standing and walking X-ray procedures. Rest breaks will be provided as needed. 
Over the course of the study, participants with ankle OA will repeat the biplane fluoroscopy session 3 
times (once for each footwear condition). Participants in study group 1 will complete the biplane in 
one session while barefoot, or wearing their own shoes, the control shoes, RB shoes, and/or the AFO. 
Each participant will receive no more than 80 total biplane imaging trials as part of the study.
Participants enrolled in study group 3 will continue wearing the StepWatch. Those in study group 1 
have completed their participation and will return the study footwear and StepWatch.
Take home study 
Length of participation 
For participants with ankle OA, study procedures will occur over ~3 months (11 weeks). Four study 
visits will be done at the VA Puget Sound where three at-home/in-community study footwear 
(control shoes, RB shoes, an AFO) condition periods will be conducted. 
Visits at the VA Puget Sound may last up to 4 hours each. Particpant schedules and the accessibility of 
facility resources may extend the study timeframe beyond these estimates. Study visits will be 
scheduled by contacting the participants on phone, or during in-person contacts. We may contact 
participants with appointment and/or at home activity reminders via email or phone.
Assessment 1
During this initial assessment participants will complete the, Screening, Functional assessments, 
LineUP with pregnancy test (not Study group 4), Questionnaires, and Brief Pain Raiting. Participants 
will be given a StepWatch and the first footwear condition. At the first assessment, participants who 
elect to use Ilumivu will be assigned a randomized username for the ilumivu mobile application. The 
link between this unique ID and the Veteran’s identity will not be stored in the mobile application, 
but rather, stored locally at the Seattle VA. Further information about data security can be found in 
the Data Security section of this application. Ilumivu, is an app downloaded onto your phone. This 
app and its developers do not have any information that can be linked back to the participant. Only 
the researchers will know the Ilumivu participant ID. The Ilumivu participant ID will be recorded on 
the participant crosswalk in the research folder on the R drive. There will be no additional methods to 
link the data to the participant.
In Home/Community – Footwear Condition 1: Acclimation and Continuous Wear Period (3 weeks)
On day-1 of the first at home period, participants will wear the study footwear for one hour, then for 
two hours on day-2, three hours on day-3, then continue adding one hour of wear per day until the 
seventh day is reached. For the next two weeks, participants will wear the study footwear 
thoroughout the day during their normal daily activities. Participants will wear the StepWatch 
throughout this 3-week period. Each day participants will receive two messages either via email or 
with Ilumivu from the study staff, one in the morning, reminding the participant to wear the selected 
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footwear for the suggested number of hours, and one in the evening, reminding the participant to 
record the number of hours he/she has worn the selected footwear. 
Once per week we will call/email/ message through Ilumivi (which ever the participant prefers) 
participants to check in and complete the Brief Pain Rating and Qualitative assessment. 
Participants will be instructed to contact us if they have questions or if the study footwear is 
painful/uncomfortable. We will address any issues on an as needed basis, which may require 
additional visits to the VA. 
If a proper and comfortable fit cannot be achieved with a footwear condition, then participants may 
wear their own shoes for a one-week washout period (while contiuing other study procedures) and 
we will move them to the next footwear condition if they wish to continue their participation. If we 
determine that it is not in the participant’s interest to continue in the study he/she will be withdrawn.
Assessment 2
After the 2-week continuous wear period, participants will come to the VA Puget Sound with the 
StepWatch and study footwear. The StepWatch data will be downloaded and participants will 
complete the Brief Pain Rating, Qualitative assessment, Questionnaires, and Functional assessments. 
For those enrolled in Study group 3, the Biplane assessment will be conducted during this visit using 
the current footwear condition. 
Participants will be given instructions for the second footwear condition.
In Home/Community Footwear Condition 1 Washout Period (1 week)
For the next week, participants will be asked to wear their own self-selected footwear, continue 
wearing the StepWatch and complete the weekly pain rating over the phone. 
In Home/Community – Footwear Condition 2: Acclimation & Continuous Wear Period (3 weeks)
Participants be asked to follow the same 1-week acclimation procedure, followed by 2-weeks of 
continuous wear that they did with Footwear Condition 1. Participants will be asked continue wearing 
the StepWatch and complete the weekly pain ratings. 
Assessment 
 
 3  
The procedures described in Assessment 2 will be repeated.
In Home/Community Footwear Condition 2 Washout Period (1 week)
Participants will repeat the procedures described under In Home/Community Footwear Condition 1 
Washout Period. 
In Home/Community Footwear Condition 3: Acclimation & Continuous Wear Period (3 weeks)
Participants be asked to follow the same 1-week acclimation procedures, followed by 2 weeks of 
continuous wear that they did with Footwear Conditions 1 and 2. Participants will also continue 
wearing the StepWatch and completing weekly pain ratings. 
Assessment 
 
 4   
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The procedures described under Assessment 2 will be repeated. Participants will return the study 
footwear and the StepWatch. 
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Registry (optional)
Participants will be asked if they are interested in joining our Center’s Subject Registry (MIRB# 
00433). This registry is used to recruit for studies being conducted by our Center. If participants 
choose to join the registry they will sign a separate consent form. Data about their foot type that is 
collected under this study will be added to the Subject Registry; this will help us determine which 
studies may be a good fit for participants in the future.
Repository (optional)
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Participants will be asked if they are interested in allowing their study data to be added to our de-
identified data repository so that it may be used for additional research in the future. Participants 
who are interested will be asked to sign a separate consent form for the repository (MIRB# 00493). 
Once the consent form is signed, a copy of the data will be added to the repository on an ongoing 
basis throughout the course of the study.
Additional use of de-identified data
Throughout the course of the study we will place a copy of all de-identified data  in publicly accessible 
online data repositories. Once posted, the de-identified data will publicly accessible to search, 
retrieve, and analyze for any purpose. Participants will be made aware of this use of de-identified 
data during the consent process and it will be described in the consent form. If participants do not 
wish to have a copy of their de-identified data placed in online repositories they can choose not to 
participate in the study.
Payment to Participants
Participants will be paid once at the end of the study. Participants in study group 1 will receive 
$30/hour after they complete all of the study procedures. Participants in study groups 2  and 3 will 
receive $400 and $500 respectively, participants in study group 4 will receive $300, after they 
complete all of the study procedures. If participants are withdrawn early they will be paid based on a 
daily prorated amount for the length of time they were expected to be in the study. 
Checks will be mailed by the fiscal department about 6-8 weeks after each study visit or participants 
can pick up their check at the VA Puget Sound in approximately the same time frame. Participants 
that are screened out after consent will be compensated $50 for their good faith effort.
Risks and Risk Management
Procedures Involving Radiation Exposure
Biplane Fluoroscopy and CT scans: There is a very small increased risk of cancer due to the amount of 
radiation exposure involved in this study. Based on previous Radiation Safety Applications by our 
research group, and using conservative estimates, the estimated radiation exposure is from up to 
three sources the CT scans of subject anatomy (a) traditional CT, (b) LineUP CT and (3) three visits to 
the biplane fluoroscopy laboratory. For risk (a) the traditional CT imaging is conservatively estimated 
to expose participants to 0.20 mSv of ionizing radiation (b) the LineUP CT imaging is conservatively 
estimated to expose participants to 0.10 mSv of ionizing radiation and for the fluoroscopic exposure 
(c) an estimate (again conservative) of 0.21 mSv for 80 biplane trials. The total estimate of exposure 
for the whole study is 0.51 mSv. The upper limit of radiation exposure involved in this study is 
approximately ~16.5% of the estimated naturally occurring background radiation exposure (of 3.1 
mSv) (http://hps.org/documents/) “Background Radiation Fact Sheet.” For additional comparison, the 
EPA (https://www.epa.gov/radiation/radiation-sources-and-doses) estimates of annual radiation 
exposure is 6.20 mSv (3.1 mSv from naturally occurring background radiation and 3.1 mSv man-made 
sources such as equipment used in medical procedures), this study will therefore expose participants 
to ~8.2% of the annual background radiation. Please note that this is the maximum anticipated 
exposure, in practice we find that participants normally complete their walking trials in well under 80 
attempts (45 trials would be the minimum required), but we wish to be conservative with our 
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estimate. We will minimize the risk due to radiation by taking the minimum number of traditional CT 
scans, LineUP CT scans, and fluoroscope trials needed to obtain the necessary data. This means that 
some participants may only require 1 traditional CT scan, 8 LineUP CT scans (vs. up to 15), and 45 
trials (vs. up to 80). It is anticipated that most participants, particularly controls, will be well under the 
maximum of 1 CT scan, 15 LineUP scans, and 80 exposures we have budgeted for in our radiation 
estimate.
Participants may be exposed to loud noises (like a heavy door slamming) when they are inside the 
building that houses the biplane fluoroscopy lab; this may startle some individuals. The building 
where lab is located also houses a blast machine. The blast machine is located in a separate lab, 
diagonally across the building from the biplane fluoroscopy lab. The blast machine can be quite loud 
when standing directly outside of the door of the lab where it is located, however when walking to or 
when inside the fluoroscopy lab the noise sounds like a muted bang/door slamming. We have a set of 
standard operating procedures that will be followed in order to minimize the risk that participants 
will be exposed to noises from the blast machine. The SOPs  include escorting participants at all times 
and informing them of the potential noises prior to entering the building.
Biplane Trip and Fall: There is a risk of tripping and falling while walking on the Biplane imaging 
walkway. The the biplane imaging walkway is clear of obstacles and is level, dry, and rigid. Thus, 
walking on the biplane walkway is akin to walking on a well-maintained sidewalk. The biplane 
walkway also has support railings on both sides; these railings will be within easy reach of participants 
at all times. Participants will also have time to familiarize themselves with the shoes and the area in 
which they will be asked to walk.
Stress and Inflicted Insight: Participants may feel a mild level of emotional stress if they find it 
inconvenient to travel to the VA for study visits, or if they have difficulty sitting or standing still during 
the CT scan. It is possible that we could discover that female participants are pregnant. It is also 
possible that the imaging procedures (CT scans, and fluoroscopic images) could reveal that a 
participant has a serious health problem or anatomical abnormality (e.g., bone cancer). Potential 
participants will be screened during the telephone call, or in person screening, regarding their 
willingness to be made aware of the pregnancy test result and/or potential health problems 
discovered by the imaging procedures. Those who are not willing to be told about this information 
will be excluded from the study. Additionally, in the consent form, participants will again be made 
aware of this possibility and given the option to decline participation in the study if they choose. If a 
participant is determined to be pregnant and/or if we see an unexpected abnormality in a 
participant’s radiological images we will advise them to follow up with their regular health care 
provider.
Wearing Study Assigned Footwear and the StepWatch
At Home Trip and Fall: There is a risk of tripping and falling while wearing the study assigned 
footwear at home and in the community, but this risk is not greater than that of daily life. 
Increased Foot or Ankle Pain, Soft Tissue Irritation: There is a risk that the study assigned footwear 
could increase foot or ankle pain. There is a risk of minor discomfort, soft tissue irritation or skin 
break down (e.g. skin blister) in response to wearing the study assigned footwear and the SAM. 
Participants will be instructed to inform us if they feel discomfort or pain when wearing the control 
shoes, RB shoes, or AFO for the first time. Participants will have the opportunity to walk around to 
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confirm the shoe or orthosis fits them well and is comfortable before taking them home. Participants 
can change the size of the shoe or orthosis to achieve the best fit. The acclimation periods will give 
participants time to adjust and respond to the footwear which will minimize the risk of soft tissue 
irritation or discomfort. If proper fit and comfort cannot be achieved the participant will have the 
option to wear their own preferred footwear for a period of time or they can withdraw from the 
study. We may opt to move the participant to the next footwear condition after a washout period, if 
the participant wishes to continue in the study. Participants will be instructed to either drop out of 
the study or follow up with their regular clinician if they experience an increase in foot/ankle pain 
that concerns them (vs. their typical pain level) while wearing the study footwear. We will be 
regularly monitoring pain ratings throughout the study so participants will be aware of their pain and 
if it is changing significantly. If proper fit and comfort cannot be achieved the subject will have the 
option to wear their own preferred footwear for a period of time or they can withdraw from the 
study. 
Quality Control
The PI will ensure the study procedures are being properly followed by keeping the research staff well 
informed of the current study procedures through regular/ongoing contact and meetings. The PI and/
or designated research staff will verify visually that the data are sufficient and accurate as soon as 
possible after each data collection visit is complete.  
Privacy and Confidentiality
See section 7.0 below for Information Security, Privacy and Confidentality related procedures. 
5.6 Data Analysis
Means and SDs of daily step count, numeric pain rating, self-selected walking speed, PROMIS, AAOS-
FAM, and FAOS survey scores will be calculated in MATLAB for each intervention (control shoe, RB 
shoe, AFO). Sagittal, frontal, and transverse plane ROM for the talocalcaneal, talocrural, talonavicular, 
naviculocuneiform, and the first cuneometatarsal joints will be defined as the difference between the 
maximum and minimum angular joint position in the sagittal, frontal, and transverse planes during 
the stance phase of gait. Means and SDs of ROMs will be calculated in MATLAB.
Anatomical Coordinate Systems for ROM Calculation:
In order to determine joint motion, we first must assign anatomical coordinate systems to the bones. 
To accomplish this in a repeatable manner, we employ a template-matching algorithm to embed 
anatomical landmarks onto each bone. This is done by “morphing” a standard foot geometry 
template onto a given subject’s bony anatomy. The selected template foot was verified to be free of 
bone deformities and image/object artifacts by a group consisting of engineers and an orthopedic 
surgeon. Using a custom graphical user interface (GUI), the landmarks were located and embedded 
with digital markers to determine the spatial positions. The template foot can then be registered to 
all of the feet in the study.
Example – Talocrural Coordinate Systems for ROM Calculation:
Three landmark points (𝑃1, 𝑃2, and 𝑃3) are used in defining the coordinate systems for the 
tibia/fibula (the tibia and fibula are grouped together) and talus. The first directional unit vector ⃗𝑛⃗1 is 
computed from the vector between 𝑃1 and 𝑃2. A dummy vector ⃗𝑛⃗𝑑 is calculated from 𝑃2 and the 
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last point 𝑃3. The cross product between ⃗𝑛⃗1⃗ and ⃗𝑛⃗𝑑 yields the second directional unit vector, ⃗𝑛⃗2 . 
Finally, the cross product between ⃗𝑛⃗2⃗ and ⃗𝑛⃗1 yields the final directional unit vector ⃗𝑛⃗3 . 
Talar landmarks: Landmark points for the talus 
were located at the lateral point of the talar 
head (𝑃1), posterolateral (trigonal) process of 
the talus (𝑃2), and medial point of talar head 
(𝑃3). The direction unit vectors were calculated 
in the y, z, x order (Figure 8).
Tibia/Fibula Landmarks: Landmarks are placed 
on both bones to define their coordinate 
system. The landmarks are placed at the: lateral 
superior point of the Fibula (𝑃1), lateral 
malleolus (𝑃2), and medial malleolus (𝑃3) 
while the order of
calculation of the direction unit vectors were z, 
y, x (⃗𝑛⃗1 , ⃗𝑛⃗2 , ⃗𝑛⃗3 .) (Figure 8).
Figure 8: Template talus (left images, lateral view for top image, 
superior view for bottom image) and template tibia/fibula (right 
image pair, lateral view for left image, posterior view for right 
image). Landmark points are shown as black dots on the bone 
surface. Anatomical axes derived from landmark point locations 
are also shown (red, blue, green arrows).
Template Matching:
To register the template bones onto a study subject’s bones, the template bone is first
aligned to the subject bone by a rigid body registration and an affine transformation (i.e.,
uniform volumetric scaling to the template bone). The principal axes, obtained from a principal 
component analysis, and center of volume (COV) for both the template and subject bone are used to 
estimate the initial transformation parameters for the registration of the template bone to the 
subject bone. That is, the two bones are initially aligned along their principal axes, and isometrically 
scaled to have the same volume. At this point the template is roughly aligned and a similar size as the 
subject bone. To further match the template with the target, non-rigid B-spline registration was used 
to deform the template further onto the subject bone. This registration yields a deformation field of 
three-dimensional vectors defining the displacement of points on the template to the corresponding 
points on the subject bone.
Landmark Transformation:
The final step uses the registration results to perform a point mapping from the template to the 
subject bone. Using the affine transformation matrix (T) and the deformation field (d) points, points 
(x, y, z) on the template can be mapped directly to corresponding points (x’, y’, z’) on the subject. This 
formula is applied to the key anatomic landmark points on the template bone (i.e., points 𝑃1, 𝑃2, 
and 𝑃3 above), to determine their corresponding location on the subject bone. These transformed 
landmarks thus define the bone-embedded coordinate system
This process establishes a tibial anatomical coordinate system and a talar coordinate system for 
measuring talocrural joint ROM. These same methods will be used to measure talonavicular, 
naviculocuneiform, and the first cuneometatarsal kinematics. By performing this template 
matching algorithmically, we can ensure consistency in post processing of anatomical coordinate 
systems between subjects.
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Statistical Methods:
For Specific Aim 1, linear mixed effects regression will be carried out to test for differences in mean 
step count, self-selected walking speed, physical function or pain (the dependent variables) by 
intervention, (control shoe vs. RB shoe vs. AFO, the independent fixed effect) with study subject as a 
random effect. If the omnibus test for the association between outcome variables and intervention is 
significant, pairwise comparisons will be carried out to assess differences in mean outcomes between 
the RB shoe or the AFO and the control shoe (Hypothesis 1.1) and between the RB shoe and the AFO 
(Hypothesis 1.2).
For Specific Aim 2, linear mixed effects regression will be used as above to examine differences in 
mean [sagittal plane] ROM (the dependent variable) by intervention (control shoe, RB shoe, AFO; the 
independent fixed effect) with subject and subject by intervention interaction as random effects. If 
the omnibus test for association between [sagittal plane] ROM and foot intervention is significant, 
pairwise comparisons will be carried out to assess differences in mean [sagittal plane] ROM between 
the RB shoe, the AFO, and the control shoe (Hypothesis 2.1). Secondary analyses will be carried out 
using methods similar to those described above to determine if the interventions affect frontal and 
transverse plane joint ROM.
For Specific Aim 3, hypotheses 3.1 and 3.2, the above model will be modified with the definition of 
the independent fixed effect, foot intervention, having an additional category representing the 
healthy control group. Post-hoc comparisons will focus on differences in mean step count, self-
selected walking speed, physical function, pain or [sagittal plane] ROM between RB shoe or AFO and 
the healthy control subjects wearing the control shoes. Additional secondary analysis will be carried 
out using linear mixed effects regression to determine if pain (the dependent variable) correlates with 
[sagittal plane] ROM (the independent fixed effect, averaged over trial) and step count (the 
dependent variable) correlates with pain (the independent fixed effect) with study subject as a 
random effect in both sets of models. To determine if the mean differences in outcome by 
intervention (AFO vs. RB shoe) varies by OA severity, the regressions described above will be modified 
by adding two additional independent co-variates: OA severity and OA severity X intervention. The 
significance of the latter interaction term suggests that OA severity may influence outcome 
differences by intervention.
Power Analysis:
Ten thousand datasets were generated using mean [sagittal] ROM for the control foot of 15.3
degrees, between subject SD of 2.0 degrees, and within subject SD of 2.4 degrees.84 Power was 
estimated for sample sizes of 15 and 20 subjects and for a 1.5 degrees and 2.0 degrees difference in 
[sagittal] ROM between the control shoe and the RB shoe or AFO. Hypothesis testing for each 
bootstrapped sample for the reduction in ROM was carried out using a linear mixed effects regression 
of [sagittal] ROM (the dependent variable) on foot (ROM or AFO vs. control) with study subject and 
subject by intervention interaction as random effects. Power was estimated by determining the 
number of tests that were significant at the 0.05 level using the likelihood ratio test. The analysis 
indicated that if the footwear induces a 1.5 degrees change in ankle [sagittal] ROM then a sample size 
of 20 or 15 subjects results in 94% or 84% power, respectively. If the change in ROM is 2.0 degrees, 
then even with only 15 subjects the study has 98% power (Table 2). Note that we expect the change 
in [sagittal] ROM to be significantly more than 1.5 degrees but even for this small difference our study 
is adequately powered with 25 subjects. Based on these results, we plan to enroll 30 subjects into the 
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study and expect several to drop out leaving a sample size of at least 25 subjects and the study power 
greater than 94% (Table 2).
5.7 
Withdrawal of Participants
This is not a treatment study; withdrawing or being terminated from this study will not have an 
impact on participant safety. A study clinician or the PI may withdraw a participant without their 
consent if he or she feels that it is not in a participant’s best interest to continue in the. All data 
previously collected from participants who withdraw, or are withdrawn, or lost to follow-up will be 
kept and may be used in the study data analysis. If participants choose to withdraw, miss multiple 
visits or their participation is terminated, we will contact them to request that they return the study 
provided footwear; a mailer will be provided if needed. We will make up to three contact attempts to 
recover the study equipment. Participants may withdraw at any time by informing the Research 
Coordinator and/or the PI.
6.0
Reporting
All safety information on Adverse Events (AEs), Serious Adverse Events (SAEs), unanticipated events 
or problems, and protocol deviations will be collected. This information will be collected at study 
visits and whenever participants call to report a problem. It will be collected on VA IRB forms (Report 
of a SAE and/or Problem Form), or Report of Problems (ROP) Form. Safety data will be collected on an 
as-needed basis and will begin upon enrollment into the study. Any anticipated AEs will be recorded 
on a log sheet and reported annually with the CRQ. Although the risks identified in this study are 
relatively minimal, we will tabulate a list of any such reports that occur during the study and compare 
it with corresponding data available in the literature. Participant pain ratings will be collected weekly which 
will help us to monitor any significant changes. This will allow us to analyze how much of an increased risk 
was due to the administered protocol. Also please note, the anticipated maximum radiation dosage 
(0.40 mSv) is far below any dose that would have a measurable effect on participants. After each 
report of an AE, SAE or an unanticipated problem, we will evaluate study procedures for previously-
assessed risks, and will determine whether any changes to the protocol are necessary to minimize 
risks. The study will be suspended until these changes have been fully implemented and approved by 
the IRB. 
If we become aware of relevant findings or information that may affect participants’ health or welfare 
we will contact participants by phone and/or a letter to notify them.
7.0
Information Security, Privacy and Confidentiality
As with most studies, it is possible that a loss of privacy or confidentiality could occur. Given the 
impresonal nature of the majority of the data that will be collected, the risk of harm is minimal. 
Electronic data with PHI/sensitive information will be stored on the secure server at the VA Puget 
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Sound. These data will only be accessed by authorized study personnel. Hardcopies of VA sensitive 
data and documents with PHI will be stored in a locked file cabinet in a locked office at the VA Puget 
Sound (Seattle). Study files/data with PHI or sensitive information will not be sent off-site. This is a 
locked facility to which only study investigators have access. Identifiable data will not be transmitted, 
transported, or stored on portable media or laptops outside of the VA, and the data will only be 
accessed by authorized VA study staff.  We will notify the Information Security Officer of the location 
of the hardcopy data/files via the Data Inventory form. If study data is improperly used or disclosed 
we will notify the ISO and Privacy Officer within one hour of becoming aware of the issue.
Study data will be labeled with a study assinged code and de-identified data sets (data without any of 
the 18 HIPAA identifiers) will be created/used when data is made publically available and transmitted 
without restriction. The key to the code will be stored seperately from the study data and only 
designated study staff will have access to it. The key will be stored in a permissions restricted folder 
on the VA network. Study records with PHI/PII will be destroyed using VA approved procedures and in 
accordance with the records retention schedule after the study is completed; this will be a minimum 
of 6 years after the study has been completed. De-identified data with study assigned codes will be 
stored indefinitely.  If participants choose to participate in the Subject Registry information about 
their foot type will be stored indefinitely in the Registry.
If the CT scan is obtained through a clinical service at the VA, it will contain the participant’s name in 
the header, and it will be stored in the participant’s medical record (CPRS). The CT data will be 
downloaded onto CD(s), and hand-transported by study staff to our data processing computers at the 
VA. Pre-existing CT scans released to the VA from the UW, or any other facility, via a Release of 
Information Form will be transported from the UW by study staff and/or mailed to the VA. Prior to 
any analysis of the CT data, all patient and institution identifiers will be removed from the headers of 
the radiograph files, and replaced with the study-unique code. When the de-identified copy of the CT 
data is properly created, it will then be uploaded from the CD(s) to our computer workstation for 
further analysis. The CDs/DVDs will be stored in a locked cabinet in a locked office when not being 
processed. We will take the CD containing PHI to our VA IT manager to be destroyed. At no time, will 
copies of any medical image data containing patient identifiers be placed on any computer. CT scans 
taken at a third-party vendor will be burned to CD and hand delivered by study staff, or sent via 
traceable mail, to the VA. The CT scan files will include a study ID code, age (if 89 or younger), but no 
PHI. The third-party vendor will not collect any PHI from subjects. CT scans obtained by our in-house 
LineUP system will be labeled only with the study assigned ID code.
Ilumivu: After participants complete mobile assessment, the data will be stored with the unique ID on 
ilumivu’s main storage database in the USA. The ilumivu-based site may only be accessed after 
supplying a verified user ID and password. The core system implements a hierarchical, roles-based 
security model that determines access to information and system capabilities. Data are encrypted 
using TLS encryption 1.2 or greater before being transmitted to the database, while on the servers, 
and when being transmitted to the VA local site.
Electronic transmission of de-identified fluoroscopy images will occur between the Biplane 
Fluoroscopy Laboratory data collection computer and the data processing computers in a different 
room at the VA. The de-identified images/data will also be kept indefinitely. 
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De-identified, non-sensitive electronic data with the study assigned codes (described above) and all 
18 HIPAA identifiers removed or converted to de-identified format, may be stored on non-networked 
equipment at the VA Puget Sound (computers/laptops/tablets/sd cards) and/or on the VA network 
and/or on non-VA owned computers. These devices are stored in locked areas. No mobile devices will 
be used to collect or house PHI/sensitive data. Mobile devices (tablets) will be used to collect de-
identified data (PROMIS measures). No HIPAA identifiers will be entered into the PROMIS. The data 
will be labeled with study assigned ID codes and be stored by the PROMIS application on the tablet. A 
copy of the PROMIS data will be exported to an database file and emailed to the research team. 
StepWatch Activity Monitors will be used to collect step data during the study. The device itself will 
not contain any PHI, it will be associated with the study assigned ID code. StepWatch data will be 
downloaded to a computer during study visits at the VA. If needed, we will send a new StepWatch to 
participants using a trackable mail service and provide participants with a 
pre-paid/addressed/trackable envelope to return a StepWatch. 
De-identified data files will be sent via email and/or other electronic media (CD/DVD, usb drive via 
hand delivery or trackable mail) to our biostatistician and off-site collaborators. De-identified 
electronic data will not be encrypted. These non-sensitive files may also be transported on usb drives 
or non-networked laptops by staff working at both the VA and UW. De-identified data may be 
transmitted by email between study investigators and collaborators and will not be secured. These 
data will be stored and used on electronic media outside of the VA. 
De-identified data (as described above) will be stored and publicly accessible to search, retrieve, and 
analyze. Participants will be informed, via the consent form, about this additional use of data.
Any consented photography or video will protect participatnts’ identity because they will be 
anonymized/edited during data collection or processing to remove or obscure any identifying 
features (such as scars and tattoos); and then the original file will be deleted. The video camera and 
the recording media (e.g., SD cards, optical disks) will be stored in a locked office at the VAPSHCS. 
Photos and videos that do not contain identifiable information may also be stored on password-
protected computers/laptops for future use in scientific presentations and publications. These de-
identified data will not be encrypted.
If participants choose to enroll in our data repository, a copy of their de-identified data will be placed 
in the repository and kept indefinitely. 
8.0
Communication Plan
Students or staff at the University of Washington are participating as study staff at the VA.  UW IRB 
approval has been obtained from the UW Human Subjects Division.
9.0
References
1. Glazebrook M, Daniels T, Younger A, et al. Comparison of health-related quality of life between
patients with end-stage ankle and hip arthrosis. The Journal of Bone & Joint Surgery 2008;90:499-
505.
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2. Saltzman CL, Zimmerman MB, O'Rourke M, Brown TD, Buckwalter JA, Johnson R. Impact of 
comorbidities on the measurement of health in patients with ankle osteoarthritis. The Journal of 
Bone and Joint Surgery 2006;88-A:2366-72.
3. Huch K, Kuettner KE, Dieppe P. Osteoarthritis in ankle and knee joints. Semin Arthritis Rheum
1997;26:667-74.
4. Saltzman CL, Salamon ML, Blanchard GM, et al. Epidemiology of ankle arthritis: report of a
consecutive series of 639 patients from a tertiary orthopaedic center. Iowa Orthop J 2005;25:44-6.
5. Patzkowski JC, Owens JG, Blanck RV, Kirk KL, Hsu JR. Management of posttraumatic 
osteoarthritiswith an integrated orthotic and rehabilitation initiative. Journal of the American 
Academy of Orthopaedic Surgeons 2012;20:S48-S53.
6. Dominick KL, Golightly YM, Jackson GL. Arthritis prevalence and symptoms among US non-
veterans, veterans, and veterans receiving Department of Veterans Affairs Healthcare. The Journal of
rheumatology 2006;33:348-54.
7. Waterman BR, Owens BD, Davey S, Zacchilli MA, Belmont PJ, Jr. The epidemiology of ankle sprains 
in the United States. J Bone Joint Surg Am 2010;92:2279-84.          
8. Shibuya N, Jupiter DC, Ciliberti Jr LJ, VanBuren V, La Fontaine J. Prevalence of podiatric medical
problems in veterans versus nonveterans. Journal of the American Podiatric Medical Association
2011;101:323-30.
9. Rivera JC, Wenke JC, Ficke JR, Johnson AE. Post-traumatic OA: Unique implications for the military.
10. Belmont P, Schoenfeld AJ, Goodman G. Epidemiology of combat wounds in Operation Iraqi 
Freedom and Operation Enduring Freedom: orthopaedic burden of disease. J Surg Orthop Adv 
2010;19:2-7.
11. Rivera JC, Wenke JC, Buckwalter JA, Ficke JR, Johnson AE. Posttraumatic osteoarthritis caused by 
battlefield injuries: the primary source of disability in warriors. Journal of the American Academy of
Orthopaedic Surgeons 2012;20:S64-S9.
12. Coester LM, Saltzman CL, Leupold J, Pontarbelli W. Long-term results following ankle arthrodesis 
for post-traumatic arthritis. The Journal of Bone and Joint Surgery 2001;83-A:219-28.
13. Fuchs S, Sandmann C, Skwara A, Chylarecki C. Quality of life 20 years after arthrodesis of the 
ankle. A study of adjacent joints. Journal of Bone and Joint Surgery British Volume 2003;85:994-8.
14. Labek G, Thaler M, Janda W, Agreiter M, Stockl B. Revision rates after total joint replacement:
cumulative results from worldwide joint register datasets. J Bone Joint Surg Br 2011;93:293-7.
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