walk2Wellness: Long-term Use Effects of Walkasins® Wearable Sensory Prosthesis on Gait Function, Balance-Confidence, and Social Participation
Phase: NA
Conditions: Sensory Peripheral Neuropathy, Balance; Distorted, Sensation Disorders
Sponsor: RxFunction Inc.

walk2Wellness:  Long-term Use Effects of 
Walkasins® Wearable Sensory Prosthesis on Gait 
Function, Balance-Confidence, and Social 
Participation 
NCT03538756
7576 Market Place Drive 
Eden Prairie, MN 55344 
July 30, 2019 

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• 
I have read this protocol, appendices, and amendment(s), if applicable, and agree to 
adhere to its requirements.  
• 
I will provide copies of this protocol and all pertinent information to the study personnel 
under my supervision.  
• 
I will discuss this material with study personnel and ensure they are fully informed 
regarding the device and the conduct of the study. 
• 
I will conduct the study in accordance with the protocol and Good Clinical Practice 
guidelines, as well as local regulations, and I accept respective revisions to the protocol 
approved by authorized personnel of the Sponsor and by regulatory authorities.  
 
 
Principal Investigator (print)  
 
 
 
Principal Investigator (signature)   
 
 
 
 
Date 
 
 
 
Institution Name/Location (print)  
 
 
 

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Sponsor:   
 
 
 
 
 
 
 
RxFunction, Inc. 
 
 
 
 
 
 
 
 
 
 
 
7576 Market Place Drive 
Eden Prairie, MN 55344 
 
Sponsor Contact:   
 
 
 
 
Yvonne Rumsey 
RxFunction, Inc. 
7576 Market Place Drive 
Eden Prairie, MN 55344 
 
Scientific Contact:   
 
 
 
 
Lars Oddsson, PhD 
 
Study Sites:  
A list of study sites is maintained separately. 
 
Protocol Number: 
 
 
 
 
 
CIP-002 
 
Protocol Short Title:  
 
 
 
 
walk2Wellness Study 
 
Date of Issue:   
 
 
 
 
 
July 30, 2019 
 

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TABLE OF CONTENTS 
1 
INTRODUCTION AND BACKGROUND .......................................................................................... 5 
1.1 
RATIONALE FOR THE STUDY ........................................................................................... 5 
1.2 
STUDY PURPOSE ........................................................................................................... 5 
2 
STUDY SUMMARY AND HYPOTHESIS ......................................................................................... 6 
2.1 
STUDY DESIGN SUMMARY .............................................................................................. 6 
2.2 
HYPOTHESES ................................................................................................................ 6 
2.3 
SECONDARY OUTCOMES ................................................................................................ 7 
2.4 
RATIONALE FOR THE SELECTION OF FUNCTIONAL OUTCOME MEASURES ............................. 7 
2.5 
JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION ...................................... 8 
3 
INVESTIGATIONAL DEVICE .......................................................................................................... 8 
3.1 
DESCRIPTION ............................................................................................................... 8 
3.2 
REGULATORY CLASSIFICATION........................................................................................ 9 
3.3 
CLINICAL DATA PUBLISHED TO DATE ..............................................................................10 
3.4 
RISKS TO SUBJECTS .....................................................................................................13 
3.5 
APPROACHES TO MINIMIZE RISKS ..................................................................................13 
3.6 
DEVICE LABELING ........................................................................................................13 
3.7 
DEVICE ACCOUNTABILITY, STORAGE, AND RETURN .........................................................13 
4 
STUDY POPULATION .................................................................................................................. 14 
4.1 
SUBJECT SELECTION ....................................................................................................14 
4.1.A 
INCLUSION CRITERIA ....................................................................................................14 
4.1.B 
EXCLUSION CRITERIA ...................................................................................................14 
4.2. 
SUBJECT RECRUITMENT PLANS .....................................................................................15 
4.3 
EARLY WITHDRAWAL OF SUBJECTS................................................................................15 
4.4 
DATA COLLECTION AND FOLLOW-UP FOR WITHDRAWN SUBJECTS .....................................15 
4.5 
SUBJECT COMPLIANCE MONITORING ..............................................................................16 
4.6 
PRIOR AND CONCOMITANT THERAPY ..............................................................................16 
5 
STUDY PROCEDURES ................................................................................................................. 16 
5.1 
TELEPHONE SCREENING ...............................................................................................16 
5.2 
INFORMED CONSENT PROCESS ......................................................................................16 
5.3 
SCREENING VISIT .........................................................................................................16 
5.4 
BASELINE VISIT: 1A ......................................................................................................17 
5.5 
BASELINE VISIT: 1B ......................................................................................................18 
5.6 
SCHEDULE OF ASSESSMENTS ........................................................................................20 
5.7 
FOLLOW-UP VISITS .......................................................................................................21 
6 
STATISTICAL PLAN ..................................................................................................................... 22 
6.1 
SAMPLE SIZE DETERMINATION AND POWER.....................................................................22 
6.2 
EXPECTED DROP-OUT RATE ..........................................................................................22 
6.3 
CONTROL OF SYSTEMATIC ERROR/BIAS..........................................................................22 
6.4 
INTERIM ANALYSIS ........................................................................................................23 
6.5 
ANALYSIS PLAN ............................................................................................................23 
6.6 
SPECIFICATION OF SUBGROUPS FOR ANALYSIS ...............................................................23 
6.7 
EXPLORATORY ANALYSIS OF MRI DATA ..........................................................................23 
6.8 
MISSING OUTCOME DATA ..............................................................................................23 
7 
DATA MANAGEMENT .................................................................................................................. 24 
7.1 
CONFIDENTIALITY AND SECURITY ...................................................................................24 
7.2 
CASE REPORT FORMS AND SOURCE DOCUMENTS ...........................................................24 

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7.3 
RECORDS RETENTION...................................................................................................25 
8 
SAFETY AND ADVERSE EVENTS ............................................................................................... 25 
8.1 
DEFINITIONS ................................................................................................................25 
8.2 
CLASSIFICATION OF THE EVENT’S RELATIONSHIP TO THE DEVICE ......................................26 
8.3 
SAFETY AND COMPLIANCE MONITORING .........................................................................27 
8.4 
REPORTING PROCEDURES ............................................................................................27 
8.5 
REPORTING TO REGULATORY AUTHORITIES BY SPONSOR ................................................28 
9 
QUALITY CONTROL AND QUALITY ASSURANCE ..................................................................... 28 
9.1 
STUDY MONITORING PLAN.............................................................................................28 
9.2 
AUDITING AND INSPECTING ............................................................................................28 
9.3 
PROTOCOL DEVIATIONS ................................................................................................29 
9.4 
CRITERIA FOR SUSPENDING/TERMINATING A STUDY CENTER ............................................29 
10 ETHICAL CONSIDERATIONS ...................................................................................................... 29 
10.1 
DECLARATION OF HELSINKI ...........................................................................................29 
10.2  
INSTITUTIONAL REVIEW BOARD APPROVAL ......................................................................29 
10.3 
INFORMED CONSENT FORM ...........................................................................................30 
10.4  
PROTOCOL AMENDMENTS .............................................................................................30 
10.5 
EMERGENCY ACTIONS ..................................................................................................30 
10.6 
CONFLICTS OF INTEREST ...............................................................................................31 
11 STUDY ADMINISTRATION ........................................................................................................... 31 
11.1 
PARTICIPATING SITES ...................................................................................................31 
11.2 
INVESTIGATOR RESPONSIBILITIES ...................................................................................31 
11.3 
TRAINING .....................................................................................................................32 
11.4 
PRE-STUDY DOCUMENTATION REQUIREMENTS ................................................................32 
11.5 
SUBJECT STIPENDS OR PAYMENTS .................................................................................32 
11.6 
STUDY TIMETABLE ........................................................................................................32 
11.7 
CRITERIA FOR TERMINATION OF THE STUDY ....................................................................33 
12 PUBLICATION PLAN .................................................................................................................... 34 
13   REFERENCES ............................................................................................................................... 35 
 
 
 
 
 
 
 

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1 Introduction and Background 
1.1 
Rationale for the Study 
Approximately 4.8 to 6.4 million Americans, comprising 30-40% of the U.S. diabetic 
population, exhibit symptomatic diabetic peripheral neuropathy (PN) (Harris, Eastman et 
al. 1993; Martyn and Hughes 1997; Apfel 1999). The prevalence may be as high as 50% 
in diabetics over 60 years of age. Up to 20% of the elderly population may be affected by 
peripheral neuropathies (PN) (Harris, Eastman et al. 1993; Richardson and Ashton-Miller 
1996); and epidemiological evidence has linked PN patients to an increased risk of falling 
(Richardson, Ching et al. 1992; Richardson and Hurvitz 1995) and decreased stability 
while standing (Geurts, Mulder et al. 1992) as well as when exposed to external postural 
perturbations (Inglis, Horak et al. 1994). Consequently, there is a need for developing 
cost-effective interventions for improving mobility and balance to manage fall risk in the 
elderly (Rubenstein, Robbins et al. 1990; Studenski, Duncan et al. 1991; Province, Hadley 
et al. 1995) and other clinical populations (Richardson, Ching et al. 1992; Richardson and 
Hurvitz 1995). Walkasins®, a lower limb sensory prosthesis that replaces lost foot pressure 
sensation with vibrotactile feedback around the lower calf, can address this need. 
 
A growing body of research has investigated the use of vibrotactile feedback to enhance 
balance control following short-term use. Vibrotactile displays have been used 
successfully by the U.S. Navy to provide navigational cues that allow blindfolded pilots to 
control their aircraft (Rupert 2000; Rupert 2000). Sensory substitution devices to aid 
balance have provided auditory (Chiari, Dozza et al. 2005; Dozza, Chiari et al. 2005; 
Dozza, Chiari et al. 2005; Dozza, Horak et al. 2007), electrotactile (Tyler, Danilov et al. 
2003), and vibrotactile feedback (Wall, Weinberg et al. 2001; Wall, Merfeld et al. 2002; 
Wall and Weinberg 2003; Wall, Oddsson et al. 2004).  
 
More recent work has demonstrated the utility of vibrotactile feedback to improve postural 
control in patients (Horak, Dozza et al. 2009; Wall, Wrisley et al. 2009; Horak 2010; Wall 
2010; Wall and Kentala 2010). None of these technologies, however, have been based 
on the measurement of foot pressure, nor have they been intended to be worn on a 
continuous basis as a balance prosthetic device (Statler, Wrisley et al. 2007, Wall 2012). 
In addition, current devices typically require a lab engineer on hand to ensure functionality.  
1.2 
Study Purpose 
The purpose of this study is to investigate the long-term effects of Walkasins use on clinical 
and subject-reported outcomes of balance and gait function, quality of life, social 
activity/participation, pain, and medication use in persons with peripheral neuropathy who 
experience balance problems. The intent is to pool data from up to six sites for use in 
submission to CMS for Walkasins HCPCS code application.  
 
In addition, because peripheral nerve deterioration diminishes the quantity and quality of 
afferent feedback to the spinal cord and brain, this chronic progressive disease process 
is associated with structural changes in the brain that include reduced cortical grey matter 
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somatosensory cortices (S1 and S2) and their connected neural networks (Selvarajah et 
al. 2014). Rocca et al. (2014) further demonstrated that individuals with mild-to-moderate 
PN, as compared to healthy controls, exhibit less resting-state functional connectivity 
within the somatosensory network as well as between the somatosensory network and 
other brain networks, including those responsible for attention and motor planning. Long-
term use of Walkasins, which increase movement-related afferent feedback from the 
lower-extremity to the central nervous system, thus hold great promise to induce beneficial 
changes to brain structure and function. We will, therefore, conduct an exploratory study 
in which up to ten subjects who are interested and eligible for MRI brain scans will 
complete such scans at baseline and after 26 weeks of Walkasins use.   
 
2 Study Summary and Hypothesis 
2.1 
Study Design Summary 
This study involves an assessment of Walkasins through a randomized cross-over study, 
including pre- and post-assessments as well as periodic follow-ups. Up to six sites will 
participate with approximately 25 subjects per site.  
2.2 
Hypotheses 
Subjects who receive tactile sensory balance information when wearing Walkasins every 
day will improve outcomes of gait, balance function, physical activity, and participation. 
The study should reflect expected realistic everyday use of Walkasins.  
 
Over a 10-week period of continuous Walkasins use, subjects will show a sustained 
improvement of their Functional Gait Assessment (FGA) of at least 4 (the Minimally 
Clinically Important Difference or MCID, Beninato et al. 2014) compared to their initial 
assessment. We will specifically examine whether a linear multiple regression model and 
discriminant analysis based on initial baseline assessment data can help predict those 
patients who show a sustained long-term improvement of their FGA≥4. 
 
Over the extended long-term use reflected at 26 and 52 weeks, we expect to see clinical 
outcomes plateau across subjects at levels not different from those found after 10-weeks 
of use. 
 
Furthermore, we expect that subjects who show a short-term improvement in their FGA 
(≥4) with Walkasins on during the initial assessment session (“responders”) will have a 
statistically significant sustained long-term improvement in their FGA scores compared to 
subjects who don’t show a short-term benefit (“non-responders”). We hypothesize that 
“non-responders” will require longer exposure to the Walkasins sensory stimulus and that 
they will show an improvement of their FGA by at least 4 at the 10-week assessment 
compared to baseline testing.    

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2.3 
Secondary Outcomes 
Secondary outcomes include gait speed, 4-Stage Balance Test results, Timed Up and Go 
(TUG) results, and patient-reported outcomes that will be examined for trends over time. 
We expect to see trends of increasing gait speed, increased 4-Stage Balance Test times, 
and lower times in the Timed Up and Go assessment. We also expect to see trends of 
improvement in subject-reported outcomes that reflect comments from a recent case study 
of a patient using Walkasins on a long-term basis (>12 months), including increased 
participation in social and physical activities, higher self-confidence in balance-related 
activities, and less interference of pain in activities of daily living. 
2.4 
Rationale for the Selection of Functional Outcome Measures 
• 
Functional Gait Assessment (FGA): The FGA is a reliable and valid measure of gait 
function related to postural stability and has been shown to be effective in classifying 
fall risk in older adults and predicting unexplained falls in community-dwelling older 
adults (Wrisley, Marchetti et al. 2004; Wrisley and Kumar 2010). It has also been 
validated in stroke survivors (Lin, Hsu et al. 2010) and patients with Parkinson’s 
disease (Leddy, Crowner et al. 2011); and it has less floor and ceiling effect than the 
Dynamic Gait Index (Lin, Hsu et al. 2010). The FGA includes a 10-item scale where 
each item is scored from 0 to 3 (3 = normal, 2 = mild impairment, 1 = moderate 
impairment, 0 = severe impairment). The maximum score is 30. An increase ≥4 is 
considered the MCID for community-dwelling elderly individuals (Beninato et al. 2014). 
• 
10-Meter Walk Test (10MWT): The 10m-walk (Perera, Mody et al. 2006) is routinely 
done in rehabilitation and has excellent reliability in chronic stroke patients 
(Hiengkaew, Jitaree et al. 2012). In addition, gait speed has been found to be an 
important predictor of survival in older adults (Hardy, Perera et al. 2007), further 
emphasizing its importance as a clinical outcomes measure. Gait speed (10-meter 
walk using the middle 6 meters) will be assessed under two conditions: 1) instructed 
to walk at normal speed and 2) instructed to walk as fast as they can. A difference of 
0.10m/sec is defined as the MCID (Perera, Mody et al. 2006). 
• 
4-Stage Balance Test: The 4-Stage Balance Test is part of the CDC-recommended 
test protocol for balance function (STEADI, http://www.cdc.gov/steadi/pdf/4-
stage_balance_test-a.pdf). It includes four gradually more challenging postures the 
subject is exposed to:  
1) Stand with feet side by side.  
2) Stand with feet in semi-tandem stance.  
3) Stand with feet in tandem stance.  
4) Stand on one leg.  
Subjects pass each level if they can hold the stance for 10 seconds and then move on 
to the next stance. A fail of 1, 2, or 3 indicates at risk of falling. In addition, the 
researchers will record the time for each of the tests.  

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• 
Timed Up and Go (TUG): The TUG is also part of the CDC-recommended STEADI 
test 
protocol 
for 
balance 
function 
(https://www.cdc.gov/steadi/pdf/STEADI-
Assessment-TUG-508.pdf). From a seated position in a standard armchair, the subject 
is asked to do the following:  
1) Stand up from the chair.  
2) Walk to a line on the floor 10 feet away normal pace.  
3) Turn.  
4) Walk back to the chair at normal pace.  
5) Sit down again. 
The tester will record the time taken from the command “Go” until the subject sits down 
again.  
2.5 
Justification for the Design of the Clinical Investigation 
In a recent study at the Minneapolis VA Health Care System (MVAHCS) on short-term 
(a few hours) use effects of Walkasins in individuals with peripheral neuropathy (PN) and 
balance problems, the study team found an average increase in Functional Gait 
Assessment (FGA) score of 4.4±3.7 when subjects used Walkasins versus an increase of 
1.5±1.2 when they did not.  
 
The main objective of the current study is to show a long-term (10 weeks) sustained 
improvement in FGA score ≥4 following Walkasins use as compared to initial baseline 
assessment and to examine a potential relationship between initial baseline assessment 
data and long-term outcome. We believe our finding of a short-term FGA change >4 during 
Walkasins use justifies a pre-post study design to investigate the long-term effects of 
Walkasins use. We also intend to extend our observations of the short-term effects of 
Walkasins by replicating the randomized cross-over design of our previous short-term 
study during the initial assessment session. This study will help us further refine the 
prescription criteria for Walkasins and understand whether the presence of a short-term 
response is indicative of long-term improvements.  
 
3 Investigational Device 
3.1 
Description  
Walkasins consist of two parts for each leg: the leg unit and the foot pad (Figure 1). The 
leg unit wraps around the lower leg of the user and contains electronics for reading foot 
pad pressure signals, a microprocessor, and four vibrating motors that provide gentle 
tactile sensory cues to the front, back, medial, and lateral surfaces of the user’s leg. These 
cues reflect real-time foot pressure information at a location above the ankle where skin 
sensation is still present. The leg unit has a power button, two status LEDs, and a reset 
button (not shown in Figure 1). Power is supplied by a rechargeable internal battery. The 
foot pad is a thin consumable sole insert that can be cut to size to fit into a regular shoe. 
The foot pad connects to the leg unit through a physical cable.  
 

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Figure 1. 
3.2 
Regulatory Classification 
Walkasins meet the regulatory definition of a non-significant risk device because they do 
not meet the definition for a significant risk (SR) device.  
 
Under 21 CFR 812.3(m), an SR device means an investigational device that:    
• 
Is intended as an implant and presents a potential for serious risk to the health, safety, 
or welfare of a subject;  
• 
Is purported or represented to be for use supporting or sustaining human life and 
presents a potential for serious risk to the health, safety, or welfare of a subject;  
• 
Is for a use of substantial importance in diagnosing, curing, mitigating, or treating 
disease, or otherwise preventing impairment of human health and presents a potential 
for serious risk to the health, safety, or welfare of a subject; or  
• 
Otherwise presents a potential for serious risk to the health, safety, or welfare of a 
subject. 
(https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ 
UCM126418.pdf) 
 
As a non-significant risk device, Walkasins . . .  
• 
Are worn on the foot and leg and are not intended as an implant, and they do not 
present a potential for serious risk to the health, safety, or welfare of a subject; 
• 
Are not purported or represented to be for use in supporting or sustaining human life, 
nor do they present a potential for serious risk to the health, safety, or welfare of a 
subject; 
• 
Are not for a use of substantial importance in diagnosing, curing, mitigating, or treating 
disease, or otherwise preventing impairment of human health, nor do they present a 
potential for serious risk to the health, safety, or welfare of a subject in this regard; 

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• 
Do not otherwise present a potential for serious risk to the health, safety, or welfare of 
a subject. (In the case study described below, the subject reported no adverse events 
during his long-term use of Walkasins.)  
3.3 
Clinical Data Published to Date  
The following data from a study at the Minneapolis Veterans Affairs Health Care System 
(MVAHCS) were recently published by a peer-reviewed journal.  Thirty-one subjects met 
inclusion criteria and were included for allocation. Twenty-seven of these subjects had a 
diagnosis of PN in their medical record, described as diabetic neuropathy (n = 14), 
idiopathic/unspecified neuropathy (n = 8), or neuropathies possibly related to alcohol 
dependence (n = 4) or b12 vitamin deficiency (n = 1). Exposure to agent orange was noted 
in the medical record of eight subjects. 
 
No significant carryover effect based on sum of FGA scores across the three assessments 
was found (p = 0.92, [62]). Fig 2 shows consecutive changes in FGA scores across the 
three different assessments for each of the two groups, either using the device first ON-
then-OFF or first OFF-then-ON. Larger changes in FGA score were seen when the device 
was turned ON, i.e., from Assessment #1 to Assessment #2 for the ON-then-OFF group 
and from Assessment #2 to Assessment #3 for the OFF-then-ON group. The ON-then-
OFF group maintained their FGA score during their device OFF treatment at Assessment 
#3 (Fig 4). The OFF-then-ON group showed an improved FGA score during their device 
OFF session at Assessment #2. 
 
 
 
At Assessment #2, 10 of 15 subjects (67%) in the group wearing the device turned ON 
improved their FGA score by at least four points compared to 5 of 16 (31%) in the group 
wearing the device turned OFF. The difference in proportion between the groups was 
statistically significant (p<0.05). At Assessment #3, 7 of 16 subjects (44%) in the group 
wearing the device turned ON improved their FGA score by at least four points from the 
prior treatment compared to 2 of 15 subjects (13%) in the group wearing the device turned 
OFF. The difference in proportion between the groups was not statistically significant (p = 
0.063). 
 

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Overall, there were 24 observations of increases in FGA score of at least four points from 
the prior treatment across both ON and OFF treatments. These 24 observations 
represented 23 different subjects, i.e., one subject showed an FGA improvement of four 
points for both test treatments. Seventeen of the 24 observations occurred during device 
ON treatments and seven during device OFF treatments. Eight of the 31 subjects did not 
improve their FGA score by at least four points during either of the two test treatments. 
Consequently, 17 of the 31 subjects (55%) improved their FGA score by at least four points 
with the device turned ON as compared to 7 of 31 subjects (23%) when the device was 
OFF. The difference was statistically significant (p<0.001) and the effect size was near 
large (Hedges’ gav = 0.79, [67]). 
 
All outcomes showed statistically significant improvements after ON treatments with large 
effect size for FGA scores, medium for 4-Stage Balance and small for gait speed [67]. The 
average change in FGA score after ON treatment was 4.4 points versus 1.5 points during 
the OFF treatment. The difference was statistically significant (p<0.01) and the effect size 
was large (Hedges’ gav = 0.82). After OFF treatment, only the FGA score showed a 
statistically significant increase although the effect size was small (Hedges’ gav = 0.24) 
compared to the ON treatment (Hedges’ gav = 0.82). No statistically significant changes 
were seen for gait speed or 4-Stage balance test after OFF treatment. 
 
The table below shows the overall effects on outcomes following both the ON and OFF 
treatments combined for all subjects (i.e., between Assessment #1 and Assessment #3) 
following exposure to two balance training sessions, one with the device turned ON and 
one with the device turned OFF. After Assessment #3, 16 of the 31 subjects showed an 
increase of at least 0.13 m/s of their normal gait speed compared to Assessment #1. 
Fourteen of the 31 subjects performed the 4-Stage Balance Test for longer than 30 s after 
Assessment #3 compared to 5 subjects at Assessment #1. The change in proportion was 
statistically significant (p<0.05) and the effect size was large (Hedges’ gav = 0.80). The 
mean within-subject FGA score changed from 15.2 at Assessment #1 to 21.1 at 
Assessment #3. The change was statistically significant (p<0.001) and the effect size was 
large (Hedges’ gav = 1.14). 
 
 

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Sixteen of the subjects ended the third test session with an FGA score higher than 22, i.e., 
in the normal fall risk range. Their mean FGA score at Assessment #1 was 18.3 compared 
to 25.1 at Assessment #3, respectively. The difference was statistically significant 
(p<0.001) and the effect size was large (Hedges’ gav = 2.51). The remaining 15 subjects 
who were still at high fall risk (FGA<23) after Assessment #3 did increase their FGA score 
from an average of 11.9 to 16.8. The change was statistically significant (p<0.001) and 
the effect size was also large (Hedges’ gav = 1.11) although less than half the magnitude 
of the normal fall risk group’s effect size. Mean normal gait speed increased from 0.93 m/s 
at Assessment #1 to 1.02 m/s at Assessment #3 (p<0.005). The effect size was medium 
(Hedges’ gav = 0.41). Fast gait speed increased from 1.35 m/s to 1.42 m/s (p<0.05) 
representing a small effect size (Hedges’ gav = 0.22). The 4-Stage Balance test 
performance increased from 22.2 s at Assessment #1 to 27.6 s at Assessment #3 
(p<0.001), a medium effect size (Hedges’ gav = 0.70). 
 
A majority of patients in the current study improved their clinical outcomes of gait and 
balance function after a brief session with a physical therapist. These findings suggest 
new sensory balance cues provided to the lower limb can modulate the activity of relevant 
nerve afferents and become integrated into sensorimotor control of balance and gait within 
a single therapy session. 
 
Figure 4 shows data that were recently presented at the American Physical Therapy 
Combined Sections Meeting in New Orleans by Dr. Diane Wrisley of a patient case study. 
It represents the first long-term Walkasins use data available where a patient is wearing 
the device as a sensory prosthesis on a continual/chronic basis. Most of the improvement 
noticed in the FGA score had occurred after 2-3 months of daily use. This patient continues 
to use the device and has nearly maxed out in several clinical outcomes including the FGA 
(maximum score is 30). 
  
 
 
Figure 4. Long-term Change in FGA Score in One Subject. 

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3.4 
Risks to Subjects 
• 
Use of device/administration of physical stimuli: The device being tested may distract 
the subject while walking and increase the risk of falling. To prevent falling during the 
testing in the clinic/research site, a spotter will walk next to the subject to help him/her 
regain balance if a fall starts to occur.  
• 
There is a very low chance that the subject will find the vibration uncomfortable. If this 
occurs, the subject can decide if he/she wishes to end participation in the trial.  
• 
Use of medical records: The Sponsor and/or research site personnel may use the 
medical records to obtain information related to the cause of subjects’ peripheral 
neuropathy or other medical history relevant to the study. There is a risk that study 
personnel may inadvertently see other information in subjects’ medical records. The 
researchers will obtain HIPAA authorization for use of subjects’ medical records. 
• 
There may be other unknown side effects that could occur. 
3.5 
Approaches to Minimize Risks 
All efforts will also be made to minimize potential risks by the following means: 
• 
Investigators and study personnel will include individuals who are experienced in 
research and trained in the study assessments. 
• 
Clearly defined inclusion/exclusion criteria ensure only appropriate subjects are 
enrolled. 
• 
Maintaining subject safety through practices such as spotting the subject during study 
assessments will help to ensure subjects’ physical safety. 
• 
Regular monitoring and onsite visits to investigational sites will help to maximize 
consistency among the sites. 
3.6 
Device Labeling 
Each Walkasins leg unit and foot pad carry a label comprised of the item serial number 
and company details as required by law. In addition, the plastic bags in which the devices 
are packaged bear the following label: 
Caution: Investigational Device. Limited by Federal Law (USA) to Investigational 
Use. 
3.7 
Device Accountability, Storage, and Return  
The Sponsor will ship the investigational device (Walkasins) only to the Principal 
Investigator (PI) or designee at each site. The Principal Investigator will maintain adequate 
records of the disposition of the investigational devices in the Device Accountability Log.  
 
Device accountability records must be maintained at the study site and made available to 
RxFunction personnel or designees. The devices returned to the Sponsor and those 
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Investigator must explain in writing the reasons for any discrepancy noted in device 
accountability. 
 
When the study is complete, any unused investigational devices will be returned to the 
Sponsor, and a completed Inventory Accountability Report (or equivalent) will be 
generated for the site. The Inventory Accountability Report (or equivalent) will document 
the disposition of all investigational devices including those that have been returned to the 
Sponsor. Use of any investigational device outside of the protocol without prior IRB, 
Sponsor, and/or regulatory authority approval is strictly forbidden and may constitute 
grounds for removal of the Investigator/site from the study. 
 
All unused investigational devices must be returned to the Sponsor when the study is 
complete. All investigational devices or any remaining components that are associated 
with a clinical device malfunction/failure must be returned to the Sponsor. 
 
4 Study Population  
4.1 
Subject Selection  
This study will recruit individuals who have been diagnosed with peripheral neuropathy 
and who have self-reported balance problems. Potential subjects must meet all the 
inclusion criteria and will be excluded if any of the exclusion criteria apply. 
4.1.a Inclusion Criteria  
• 
Age: 18-90 years, male or female 
• 
Formal diagnosis of sensory peripheral neuropathy prior to participating in the 
study 
• 
Self-reported balance problems 
• 
Ability for transfers or ambulation on level surfaces at fixed cadence as 
assessed by trained study personnel during the FGA 
• 
FGA <23, the cut-off score for high fall-risk and/or <8 on the Short Gait 
Assessment  
• 
Ability to understand and provide informed consent   
• 
Foot size that allows the Walkasins to function appropriately  
• 
Must be able to complete all functional outcome measures without the use of 
an assistive device 
4.1.b Exclusion Criteria 
• 
Inability to perceive vibration from Walkasins leg unit 
• 
Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins 

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• 
Acute thrombophlebitis including deep vein thrombosis 
• 
Untreated lymphedema 
• 
Untreated lesion of any kind, swelling, infection, inflamed area of skin or 
eruptions on the lower leg near product use 
• 
Untreated fractures in the foot and ankle 
• 
Severe peripheral vascular disease  
• 
Musculoskeletal or other neurological conditions that prohibit use of Walkasins 
as determined by clinician 
• 
Weighs more than 300 pounds 
• 
Plans to begin balance physical therapy (PT) during the first ten weeks of the 
trial (Ongoing or previous balance PT is not an exclusionary criterion.) 
4.2. 
Subject Recruitment Plans 
The study team will post fliers at various locations to advertise the study, and information 
about the study will be provided to clinicians who may provide patient referrals. Site 
personnel will provide an overview of the study to potential subjects and screen them over 
the phone to determine their eligibility for and interest in the study. Research sites may 
use other recruitment methods, subject to IRB review and approval.  
4.3 
Early Withdrawal of Subjects  
Each enrolled subject will remain in the study until completion of the required follow-up 
period; however, a subject’s participation in any clinical study is voluntary, and the subject 
has the right to withdraw at any time without penalty or loss of benefit. Reasons for 
withdrawing subjects include, but are not limited to, the following:  
• 
Subject’s death  
• 
Subject’s voluntary withdrawal  
• 
Subject’s withdrawal by study personnel as clinically indicated  
• 
Subject lost-to follow-up  
 
The reason for subject discontinuation will be documented on the CRF and source 
documents as appropriate. The Principal Investigator must also report all subject 
withdrawals to his/her IRB as defined by the IRB’s procedure. 
4.4 
Data Collection and Follow-up for Withdrawn Subjects  
If a subject decides to withdraw from the trial, a member of the research team will ask the 
subject to clarify whether he/she wishes to withdraw from all components of the trial or 
only from the primary interventional component of the trial (i.e., wearing the Walkasins 
device). If the latter, research activities for which the subject previously gave consent may 
continue (e.g., follow-up data collection activities for adverse events such as falls).  

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4.5 
Subject Compliance Monitoring  
The researchers will provide a calendar on which subjects can mark the days they wear 
their Walkasins to help determine the degree of subject compliance with study 
requirements. They will be asked at each visit to provide the calendar or an 
account/estimate of the number of days they wear/have worn their Walkasins to help 
ensure compliance with the study protocol. In addition, researchers will also ask subjects 
to mark falls on the same calendar to facilitate collection of this data point. 
4.6 
Prior and Concomitant Therapy 
Individuals enrolled in this study may have received or be receiving physical therapy. This 
treatment will be noted as part of their medical history. Potential subjects who plan to 
initiate physical therapy for balance problems during the first 10 weeks of the trial will be 
excluded from participation. 
 
5 Study Procedures  
5.1 
Telephone Screening 
To help ensure that potential subjects will meet the eligibility requirements for the study, 
study staff will screen them over the phone prior to arranging their screening visit. 
5.2 
Informed Consent Process 
The Principal Investigator, sub-investigator, or designee who has been trained on the 
protocol will explain the nature and scope of the study as well as risks and potential 
benefits of participation. The consent process will occur in a private room or space at the 
research sites. Study staff will answer any questions related to the study and will ask the 
subject to answer questions to verify that he/she understands the study.  
 
After the consent discussion, all subjects will sign and personally date the Institutional 
Review Board (IRB) approved forms indicating their consent to participate in the study and 
to allow the study team to use their data (explained in the consent and HIPAA documents). 
The signed consent document will be stored in the subject’s medical record, per local site 
requirements, and a copy of the signed consent form will be given to the subject. 
 
When a consent form is not signed or properly dated before the procedure, the Investigator 
must inform the local IRB and the Sponsor of this deviation, per the IRB’s requirements. 
The Sponsor has the responsibility to inform the regulatory authorities as required. 
5.3 
Screening Visit 
Subjects will be considered enrolled in the trial at the time they sign the consent form and 
HIPAA authorization. After enrollment into the study, subjects will be tested to determine 
whether they can perceive vibration from the Walkasins leg unit. (Subjects who are unable 
to feel the vibration of the device will be excluded from continued participation in the study.) 
 

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Subjects who can feel vibration from the Walkasins leg unit will then complete a medical 
history form to assess common health issues related to neurological, musculoskeletal, 
and cardiopulmonary disorders as well as other systemic diseases and information on 
falls. 
 
They will also undergo a brief assessment of their functional gait that includes the following 
tasks: 
• 
Gait with Narrow Base of Support: Subjects will walk on the floor with arms folded 
across the chest, feet aligned heel to toe in tandem. The number of steps taken in a 
straight line are counted for a maximum of 10 steps. 
• 
Gait with Eyes Closed: Subjects will walk at their normal speed for 20 feet with their 
eyes closed. 
• 
Gait Level Surface: Subjects will walk 20 feet at their normal speed (time for 20’). 
• 
Gait with Horizontal Head Turns: Subjects will walk 20 feet while turning their heads. 
 
Subjects who pass the screening criteria will be asked if they would be willing to participate 
in an optional MRI protocol. If so, they will be assessed for MRI eligibility at the end of this 
visit using a standard screening form. Subjects who are interested and eligible for the MRI 
will be scheduled for an MRI visit (Visit 1A) as well as a separate visit to assess the acute 
effects of Walkasins (Visit 1B). Subjects who are eligible for the study but uninterested 
and/or ineligible for an MRI will be scheduled only for the visit to assess the acute effects 
of Walkasins. 
5.4 
Baseline Visit: 1A 
Structural and functional MRIs will be acquired using the following sequences:  
 
Structural MRI Acquisition: We will acquire three-dimensional 1 mm isotropic T1 MPRAGE 
(TR=2530 ms, TE=3.04 ms, TI=800 ms, flip angle=10°, FOV=256x256x220 mm) that will 
be averaged during post-processing and 1 mm isotropic T2 (SPACE) images (TR=4000 
ms, TE=406 ms, flip angle=90°, FOV=260x228x176 mm). T1 and T2 images will be used 
for co-registration of individual participant functional magnetic resonance imaging (fMRI) 
data into a standard stereotaxic space and for ascertaining changes in cortical thickness, 
cortical and sub-cortical brain volumes using Freesurfer (Patenaude et al. 2011). 
 
Functional MRI Acquisition: Functional network organization will be evaluated with resting-
state functional magnetic resonance imaging (rs-fMRI). Echo planar imaging data will be 
acquired with slices in an oblique 30-degree orientation relative to main magnetic field to 
optimize signal in ventral frontal regions (TR=2000 ms, TE=30 ms, flip angle=90°, 
FOV=220x220 mm, 3.4x3.4x3.5 mm2 voxels). We will collect one 13-minute scan to 
maximize test-retest reliability (Birn et al.). During resting-state scans, participants will be 
instructed to keep their eyes open, relax, and remain awake. Preprocessed time-series 
data will be extracted from spherical regions of interest (10 mm) and cross-correlated with 
every voxel in the brain to establish functional connectivity maps for relevant neural 

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networks. Within and between subject differences will be generated via ordinary least 
squares in FSL with thresholding set at Z=2.33 and cluster correction of p<0.05. 
5.5 
Baseline Visit: 1B 
Subjects who meet all the eligibility requirements during the screening visit will return for 
the baseline visit. 
 
They will begin by completing the following measures: 
• 
Concomitant Medications Log: Study staff will review the subject’s current medication 
list and record the medication names, indications, dosages, etc. in REDCap Cloud. 
• 
Activities-Specific Balance Confidence (ABC) Questionnaire: Powell and Myers (1995) 
developed the Activities-specific Balance Confidence (ABC) Scale to detect levels of 
balance confidence in elderly persons. The ABC scale is a one-page questionnaire 
that asks questions about balance confidence when performing 16 different tasks. 
• 
Vestibular Activities of Daily Living Scale (VADL): The VADL was developed to assess 
self-perceived disability in individuals with vestibular impairment. It evaluates the 
effects of vertigo and balance disorders on independence in everyday activities of daily 
living. (https://www.sralab.org/rehabilitation-measures/vestibular-disorders-activities-
daily-living-scale) 
• 
Falls Efficacy Scale-International (FES-I): The Falls Efficacy Scale International (FES-
I), a 16-item questionnaire, measures an individual’s “fear of falling” or “concerns about 
falling.” It is suitable for use in research and clinical practice. (https://sites. 
manchester.ac.uk/fes-i/) 
 
Next, subjects will be assessed using the monofilament test and vibration (tuning fork) 
test. Then subjects will don the Walkasins device, and their baseline scores on the FGA, 
10MWT, TUG, and 4-Stage Balance Test will be assessed. (If subjects score >22 on the 
FGA, the accepted cut-off score for high risk fallers, they will be excluded from continued 
participation.)  
 
Then subjects will complete the following self-reported outcome measures: 
• 
Patient Health Questionnaire (PHQ-9): The PHQ-9 is a concise, self-administered tool 
for assessing depression. It incorporates DSM-IV depression criteria with other leading 
major depressive symptoms into a self-report instrument that is commonly used for 
screening 
and 
diagnosis. 
(http://www.apa.org/pi/about/publications/caregivers/ 
practice-settings/assessment/tools/patient-health.aspx)  
• 
Pain Interference Short Form 6b: The PROMIS Pain Interference instruments (adult 
and child) measure the self-reported consequences of pain on relevant aspects of a 
person’s life and may include the extent to which pain hinders engagement with social, 
cognitive, emotional, physical, and recreational activities. The Pain Interference short 
form is universal rather than disease-specific. (https://cde.drugabuse.gov/instrument/ 
0a47fbff-5f72-2281-e050-bb89ad4358ae)  

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• 
Pain Intensity Form 1a: The PROMIS Pain Intensity instrument assesses how much a 
person hurts. The Pain Intensity short form is universal rather than disease specific. 
(https://www.assessmentcenter.net/documents/PROMIS%20Pain%20Intensity%20S
coring%20Manual.pdf) 
• 
Ability to Participate Short Form 8a: The PROMIS Ability to Participate in Social Roles 
and Activities assesses the perceived ability to perform one’s usual social roles and 
activities. Items are worded negatively in terms of perceived limitations, but responses 
are reverse-coded so that higher scores represent fewer limitations (better abilities). 
The measure does not use a time frame (e.g. over the past seven days) when 
assessing ability to participate in social roles and activities. (https://www.assessment 
center.net/documents/PROMIS%20Ability%20to%20Participate%20in%20Social%20
Roles%20and%20Activities%20Scoring%20Manual.pdf) 
• 
Satisfaction with Participation in Social Roles Short Form 8a: The PROMIS 
Satisfaction with Social Roles and Activities items assess satisfaction with performing 
one’s usual social roles and activities (e.g., “I am satisfied with my ability to participate 
in 
family 
activities”). 
(https://www.assessmentcenter.net/documents/PROMIS% 
20Satisfaction%20with%20Participation%20in%20Social%20Roles%20Scoring%20
Manual.pdf 
 
Subjects will then be randomized by minimization (Han et al. 2009) to one of two study 
groups to balance the two groups during the baseline assessment with respect to the FGA 
score, age, and use of an assistive device. (Normal use of an assistive device is permitted, 
but not during any clinical assessment.) 
 
Subjects randomized to Group A will initially be trained on the Walkasins Learning Protocol 
(a set of standardized standing and walking balance exercises) and tested with Walkasins 
turned on; then following a 60-minute break, Group A subjects will be trained on the 
Walkasins Learning Protocol and tested with Walkasins turned off. The second group 
(Group B) will initially be trained on the Walkasins Learning Protocol and tested with the 
Walkasins turned off; then following a 60-minute break, Group B subjects will be trained 
and tested with the Walkasins turned on. (See Figure 5 below for protocol design.) 
 
During testing, subjects will complete trials of the FGA, 10MWT, TUG, and the 4-Stage 
Balance Test. (A trained member of the study team will conduct these assessments at the 
research sites.) 
 
When subjects have completed the clinical assessments and subject-reported outcome 
measures, the researchers will train the subjects on how to use the device at home (e.g., 
how to charge the device and what to do if they encounter any problems). The subjects 
will then leave the site with the device for use at home and a calendar on which to mark 
their daily use of Walkasins as well as any fall events.  
 
 

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Figure 5. 
5.6 
Schedule of Assessments 
Clinical Measures 
Baseline Week  
2 
Week 
6 
Week 
10 
Week 
26 
Week 
52 
FGA 
X 
X 
X 
X 
X 
X 
10MWT 
X 
X 
X 
X 
X 
X 
TUG 
X 
X 
X 
X 
X 
X 
4-Stage Balance 
X 
X 
X 
X 
X 
X 
Monofilament 
X 
 
 
X 
X 
X 
Vibration Assessment 
(128Hz and Walkasins leg 
unit) 
X 
 
 
X 
X 
X 
 
Assessed for Eligibility  
Baseline Functional Gait Testing #1 
Exclusion 
Randomization 
Matched-Subject Based on FGA, Age, Assistive Device 
Enrollment 
Standardized Balance Training 
Device ON  
Standardized Balance Training 
Device OFF 
Functional Gait Testing #2 
Device ON 
Functional Gait Testing #2  
Device OFF 
One Hour Break 
One Hour Break 
Functional Gait Testing #3 
Device ON 
Functional Gait Testing #3 
Device OFF 
Standardized Balance Training 
Device OFF 
Standardized Balance Training 
Device ON 
Wear Device Home for 52 Weeks 

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Subject-Reported Outcomes 
Baseline Weeks 
2 & 10 
Weeks  
6, 26, 52 
Subject Medical History Form 
X 
 
 
Activities-Specific Balance Confidence Score 
X 
X 
X 
Vestibular Activities of Daily Living Scale 
X 
X 
X 
Falls Efficacy Scale-International 
X 
X 
X 
PHQ-9 
X 
X 
X 
PROMIS Pain Interference Short Form 6b 
X 
X 
X 
PROMIS Pain Intensity Form 1a 
X 
X 
X 
PROMIS Ability to Participate Short Form 8a 
X 
X 
X 
PROMIS Satisfaction with Participation in 
Social Roles Short Form 8a 
X 
X 
X 
Concomitant Medication Use Form  
X 
X 
X 
User Experience Survey 
 
X 
 
5.7 
Follow-up Visits  
Subjects will be assessed at the research site at Weeks 2, 6, 10, 26, and 52, following the 
assessment schedule above. (Subjects will wear their Walkasins devices [turned on] for 
all functional assessments during the follow-up visits.) All the assessments are the same 
as those completed during the baseline visit, except that at Weeks 2 and 10, subjects will 
also take the User Experience Survey. This RxFunction survey collects information 
concerning the subjects’ experience with their Walkasins. 
 
Between in-person visits, study sites will contact subjects via telephone periodically 
between Weeks 10 and 26 (e.g., Weeks 14, 18, 22) and between Weeks 26 and 52 (e.g., 
Weeks 30, 35, 40, and 45) to remind them of study requirements and to collect follow-up 
information regarding health changes, adverse events, pain scores, device usage, and 
device functioning. If subjects report adverse events and/or falls during these contacts, 
site personnel will record the details on the appropriate CRFs in REDCap Cloud.  
 
Subjects’ levels of physical activity or inactivity while wearing the device will also be 
measured through an internal step counter in Walkasins. At each scheduled follow-up visit, 
the step data will be directly downloaded from the Walkasins. (This is a hardwired 
connection with the processor in the device and downloading counters in the memory for 
“load-cycles” [steps] and how many times the vibrator motors have been active. It will be 
downloaded to a company laptop and later entered in REDCap Cloud. There will be no 
subject identifiers on the laptop other than the subjects’ ID numbers and the corresponding 
counts.) 
 
If subjects encounter any issues with their Walkasins during the at-home trial, they may 
call the customer service number at RxFunction, Inc. (Subjects will receive a contact card 
with RxFunction’s customer service number on it.) They will be instructed to call the 
number and tell the RxFunction representative that they are participating in a research 

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study. (They will not be required to give their name or any personally identifiable 
information.) RxFunction, Inc., will assist subjects in troubleshooting their devices and may 
ask for the subject’s ID number or a serial number for the device. If the problem cannot be 
resolved during the phone call, RxFunction, Inc. will inform the study designee at the site 
and provide the serial number; the designee will ship or provide new Walkasins devices 
to the subject. If acceptable to the participating institution, RxFunction may also ship the 
device directly to the subject with his or her permission. 
 
Subjects who complete an MRI at baseline will be scheduled for an additional MRI visit at 
Week 26. Unscheduled visits may occur for device replacement or other reasons as 
needed.  
 
6 Statistical Plan 
6.1 
Sample Size Determination and Power 
The primary endpoint of the study will be changes in the FGA score from initial baseline 
assessment to 10 weeks of Walkasins use. The baseline average FGA score in a recent 
study was 15.2 with a standard deviation of 4.8. The data was normally distributed 
according to Shapiro-Wilk Test. To detect a mean difference in pre- and post-FGA score 
>4, we need to study at least 20 subjects using a significance level of 0.01 and a power 
of 0.8.  
 
 
 
Significance level is set to 0.01 and the power at 0.8. 
6.2 
Expected Drop-out Rate 
The expected ~20% drop-out rate is based on the Study Quality Assessment Tools 
available on the website of the National Heart, Lung, and Blood Institute 
(https://www.nhlbi.nih.gov/health-topics/study-quality-assessment-tools). Therefore, we 
plan to recruit up to 25 subjects (at each site) who must pass the eligibility criteria to enter 
the study (20/0.8=25). 
6.3 
Control of Systematic Error/Bias 
Potential subjects may be recruited from the Investigators’ usual patient load or from 
individuals who initiate contact with the researchers after seeing a recruitment flier or being 
referred by a clinician. All individuals having signed the Informed Consent Form and 
meeting the inclusion/exclusion criteria will be eligible for randomization in the study. The 
reasons for exclusion (i.e., for subjects who sign an informed consent form but are not 
randomized) will be indicated on the appropriate CRF in REDCap Cloud. Thus, 
consecutively eligible subjects will be randomly allocated into the study, minimizing 
selection bias. 
 
To control for inter-observer variability, the Sponsor will provide training to the research 
teams.  

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6.4 
Interim Analysis  
No formal interim analyses are planned for stopping this trial early for efficacy. 
6.5 
Analysis Plan 
The outcome measures of this study include changes in subjects’ FGA scores and 
10MWT, TUG, and 4-Stage Balance Test times. Using a within-subject parametric 
statistical model, we will compare baseline measures from the first study visit to post-
training outcomes.  
 
We expect that subjects who show a short-term improvement in their FGA (>4) with 
Walkasins on during the initial assessment session will also have a statistically significant 
sustained long-term improvement in their FGA scores compared to subjects who do not 
show a short-term benefit. We will use regression analysis to investigate trends in changes 
over time in the different outcomes.  
6.6 
Specification of Subgroups for Analysis 
A separate post-hoc analysis will be conducted at 10 weeks on clinical outcomes between 
short-term “responders” vs. “non-responders.” The recent short-term study found that 17 
of 31 subjects immediately improved their FGA score by at least 4 (responders) when 
using Walkasins. We hypothesize that “non-responders” who do not show immediate 
short-term improvement of their FGA score require longer exposure to the Walkasins 
sensory stimulus and that they will show an improvement of their FGA by at least 4 at the 
10-week assessment compared to baseline testing.  
6.7 
Exploratory Analysis of MRI Data  
Statistical analysis related to MRI data will be performed using IBC SPSS Statistic 19 for 
Windows with alpha set at p<0.05. Repeated-measures analysis of variance with time 
(baseline, 24-week follow-up) will be used to examine potential changes in brain structure 
and function associated with long-term Walkasins usage. Separate models will be used 
for each dependent variable, which will include cortical volume and cortical thickness of 
the somatosensory network, as well as the strength of resting-state functional connectivity 
within this network. Effects of covariates, including age, sex, and average daily Walkasins 
use, will also be explored. Using linear regression analysis, we will also investigate 
whether observed changes in structural and functional brain outcomes are predictive of 
functional improvements associated with Walkasins usage over the same time period.  
6.8 
Missing Outcome Data 
No imputation methods will be used to infer missing values of any outcome measures.  
 

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7 Data Management  
7.1 
Confidentiality and Security 
The Investigator and the associated institution will permit direct access to source 
data/documents for study-related monitoring, audits, IRB review, and regulatory 
inspections. 
 
Subjects providing informed consent agree to allow the Sponsor or designee access and 
copying rights to pertinent information in their medical records (e.g., diagnosis and 
adverse events) concerning their participation in this study. The Investigator will obtain, as 
part of the informed consent process, permission for study monitors or regulatory 
authorities to review, in confidence, any records identifying the subjects in this study. This 
information may be shared with regulatory agencies; however, the Sponsor undertakes to 
make every effort to protect the subject’s privacy by eliminating any information permitting 
identification of the subject. 
 
The Sponsor and all research team members will observe standard data confidentiality 
and security measures including, but not limited to, the following: 
• 
Research staff will collect only the minimum identity information needed. (See CRFs 
for information to be collected.)   
• 
Identifiers should be removed from data files whenever possible and must be 
encrypted if stored electronically. Identifiers will be stored in a physically separate and 
secure location from the data files and the key to the code.  
• 
If it is necessary to use portable devices for initial collection of identifiers, the data files 
will be encrypted, and the identifiers will be moved to a secure system as soon as 
possible. Any portable devices will be stored in secure locations when they are not in 
use.  
• 
Physical and electronic access to identifiers will be limited to authorized research 
personnel only. 
• 
Identifiers and contact information will not be distributed without the specific consent 
of research participants.  
7.2 
Case Report Forms and Source Documents 
Subject data will be collected in REDCap Cloud, a secure Electronic Data Capture (EDC) 
system. The Investigator’s electronic signature for specific Case Report Forms/Events will 
be documented in compliance with FDA Regulation 21 CRF: Part 11 – Electronic Records: 
Electronic Signatures. Each study user will have a unique login to access the REDCap 
Cloud system and perform data entry. 
 
For the duration of the study, the Investigator will maintain complete and accurate 
documentation including but not limited to medical records, study progress records, case 
report forms, signed consent forms, device accountability records, correspondence with 

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the IRB and Sponsor, adverse event reports, and information regarding subject 
discontinuation or completion of the study. 
 
Source documents are defined as original documents, data, and records. Regulations 
require that the Investigator maintain source documents in the subject’s medical records, 
which confirm the data entered on the electronic case report forms. 
7.3 
Records Retention 
The Investigator/Site will maintain all records pertaining to this study for a minimum of two 
(2) years following study completion or as otherwise instructed by the Sponsor or per local 
requirements, if longer. ICH guidelines require that essential documents be retained until 
at least two (2) years after the last approval of a marketing application in an ICH region 
and until there are no pending or contemplated marketing applications in an ICH region or 
at least two (2) years have elapsed since the formal discontinuation of clinical 
development of the investigational product.  
 
To comply with these requirements, the Investigator will not dispose of any records 
relevant to this study without either 1) written permission from the Sponsor or 2) providing 
an opportunity for the Sponsor to archive the records with an external vendor. The 
Investigator shall take responsibility for maintaining adequate and accurate source 
documents of all observations and data generated as required during this study. Such 
documentation is subject to inspection by the Sponsor or its agents, the IRB, or other 
regulatory agencies.  
 
The Sponsor will notify the Investigator of the date of marketing approval or 
discontinuation of the study. The Investigator will obtain permission from the Sponsor in 
writing before destroying or transferring control of any study records. 
 
8 Safety and Adverse Events 
8.1 
Definitions 
Adverse Event (AE): Any untoward medical occurrence in a subject administered a study 
product and which does not necessarily have a causal relationship with this treatment. An 
adverse event (AE) can, therefore, be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease temporally associated with the use of 
an investigational product whether it is related to the study product. Elective procedures 
for a pre-existing condition are not considered AEs. 
 
Serious Adverse Event (SAE):  An important medical event that may not result in death, 
be life-threatening, or require hospitalization but may be considered serious when, based 
upon appropriate clinical judgment, may jeopardize the subject and/or may require 
intervention to prevent one of the outcomes listed in this definition.  

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If the adverse event meets any of the criteria below, it is regarded as a serious adverse 
event.  
• 
Results in death  
• 
Is life threatening  
• 
Requires inpatient hospitalization or prolongation of existing hospitalization  
• 
Results in a persistent or significant disability/incapacity  
• 
Results in medical or surgical intervention to prevent permanent impairment to body 
structure or a body function  
• 
An important medical event that may not result in death, be life-threatening, or require 
hospitalization but may be considered serious when, based upon appropriate medical 
judgment, it may jeopardize the subject and/or may require intervention to prevent one 
of the outcomes listed in this definition.  
 
Adverse Device Effect (ADE):  An adverse device effect is defined as any adverse effect 
that is related or whose relation to the study device is unknown. 
 
Serious Adverse Device Effect (SADE): Adverse device effect that has resulted in any of 
the consequences characteristic of a serious adverse event or that might have led to any 
of these consequences if suitable action had not been taken or intervention had not been 
made or if circumstances had been less opportune. 
 
Unanticipated Adverse Device Effect (UADE): Unanticipated adverse device effect 
includes any serious adverse effect on health or safety or any life-threatening problem or 
death caused by or associated with a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational plan 
or application (including a supplementary plan or application), or any other unanticipated 
serious problem associated with a device that relates to the rights, safety, or welfare of 
subjects. 
8.2 
Classification of the Event’s Relationship to the Device 
Determination of whether there is a reasonable possibility that an investigational product 
or device caused or contributed to an AE is primarily determined by the Investigator and 
recorded on the CRFs per the categories in the table below. Determination should be 
based on assessment of temporal relationships, biologic plausibility, association (or lack 
of association) with underlying disease, and presence (or absence) of a more likely cause. 
  
Definitions for determination of the relationship include the following: 
 

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Relationship of Adverse Event and Study Device 
CATEGORY 
DEFINITION 
Highly 
Probable  
The AE is related to the study device. There is objective evidence 
establishing a cause and effect relationship between the AE and the 
study device.  
Probable  
The AE is likely related to or caused by the study device. There is no 
other likely explanation for the event.  
Possible  
The AE could be related to or caused by the study device; however, 
there is no evidence establishing a link/relationship. The subject’s 
condition or concomitant therapy could have caused the AE.  
Unlikely  
It is improbable that the AE is related to the study device. There is no 
evidence that the study device caused the reported event (e.g., the AE 
can reasonably be explained by the subject’s condition or other 
cause/concomitant therapy or the temporal sequence between the 
study intervention and the AE is such that the relationship is 
improbable).  
Unrelated  
There is no relationship between the study device and the AE.  
8.3 
Safety and Compliance Monitoring 
The Investigator will monitor the occurrence of adverse events for each subject during the 
study. All adverse events (AEs) reported by the subject, observed by the Investigator, 
and/or documented in medical records will be recorded on the adverse event CRF, 
whether believed by the Investigator to be related or unrelated to the investigational 
device. Beginning with study enrollment, any new event/experience that was not present 
at baseline or worsening of an event present at baseline is considered an adverse event.  
 
All adverse events will be followed until they are adequately resolved or stabilized. Serious 
adverse events and unanticipated adverse device effects will be collected and monitored 
throughout the entire course of the study.  
 
Unchanged, chronic conditions are not adverse events and should not be recorded on the 
adverse event CRF. 
8.4 
Reporting Procedures 
Investigators will report each adverse event or complication that meets the definition of a 
serious adverse event or serious adverse device effect to the Sponsor within two (2) 
business days upon discovery. The investigators will complete the Adverse Event Form 
(and any related form) and will report the event to the Sponsor within two business days 
of the Investigators’ knowledge of the event. The Investigators will further report the event 
to the IRB according to the overseeing IRB’s reporting requirements. The subject’s course 
must be monitored until the event has subsided or, in a case of permanent impairment, 
until the event stabilizes, and the overall clinical outcome has been ascertained. 

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If the Investigator believes that an adverse event meets the definition of an unanticipated 
adverse device effect, the Investigator must report the event to the Sponsor within two 
business days of the Investigator’s knowledge of the effect. The Sponsor will make the 
final determination whether an adverse event meets the definition of an unanticipated 
adverse device effect. The Principal Investigator must report any UADE to the reviewing 
IRB according to the institution’s IRB reporting requirements. If the relationship of the 
unanticipated effect to the device is unknown, the Investigator is also required to follow 
these reporting obligations. 
 
The Sponsor will ensure that all UADE reporting requirements are followed.  
8.5 
Reporting to Regulatory Authorities by Sponsor 
The Sponsor or designee will be responsible for reporting adverse events to the 
appropriate regulatory authorities per local regulations. 
 
9  Quality Control and Quality Assurance 
9.1 
Study Monitoring Plan  
The Sponsor’s designee will monitor the study over its duration according to the pre-
specified monitoring plan. RxFunction will employ centralized monitoring as often as 
feasible to verify site compliance with the study protocol as well as Good Clinical Practice 
(GCP) standards. Although centralized monitoring will be the company’s primary method 
of site monitoring, RxFunction will conduct onsite monitoring visits as necessary and will 
notify sites at least one week in advance of an onsite visit.  
 
The study monitor may inspect all study documents and records that are maintained by 
the Investigator/site, including medical records (office, clinic, or hospital), for the subjects 
in this study. The Investigator/site will permit access to such records. Source 
documentation must be available to substantiate proper informed consent procedures, 
adherence to protocol procedures, adequate reporting and follow-up of adverse events, 
accuracy of data collected on case report forms, and device information.  
 
The Investigator and/or research coordinator will be available for monitoring visits. It is 
expected that the Investigator will provide the study monitor with a suitable working 
environment for review of study-related documents. 
9.2 
Auditing and Inspecting 
The study site may also be subject to a quality assurance audit by RxFunction, Inc. or its 
designees as well as inspection by appropriate regulatory authorities.  
 
The Investigator and research coordinator must be available to respond to reasonable 
requests and queries made during the quality assurance assessment process or 
regulatory inspections. 

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9.3 
Protocol Deviations 
It is the Investigator's responsibility to ensure that there are no deviations from the protocol 
in full compliance with all established requirements of the IRB. The Investigator will not 
deviate from the protocol for any reason except in cases of medical emergencies when 
the deviation is necessary to protect the life or physical well-being of the subject. 
 
All deviations must be reported to the Sponsor within five business/working days of their 
discovery. In subject-specific deviations from the protocol, the Protocol Deviation CRF will 
be completed. The occurrence of protocol deviations will be monitored by the Sponsor or 
designee. Investigators will inform their IRB of all protocol deviations in accordance with 
their IRB’s reporting policies and procedures.  
 
If an Investigator does not comply with the Investigator Agreement or protocol, the 
Sponsor will notify the Investigator of the site’s non-compliance. Continued non-
compliance may result in further escalation in accordance with the Sponsor’s or its 
designee’s standard operating procedure (SOP). 
9.4 
Criteria for Suspending/Terminating a Study Center 
RxFunction reserves the right to stop the enrollment of subjects at a study site at any time 
after study initiation if enrollment is significantly slower than expected or if the center has 
multiple or severe protocol violations without justification or fails to follow remedial actions. 
 
Possible reasons for suspending/terminating a study center include: 
• 
Failure to obtain IRB approval 
• 
Failure to obtain written Informed Consent 
• 
Failure to report SAEs/UADEs to RxFunction within two business days of knowledge 
• 
Failure to complete case report forms in a timely manner 
• 
Loss of (or unaccounted for) investigational product inventory 
 
10  Ethical Considerations 
10.1 Declaration of Helsinki 
The Investigator will ensure that this study is conducted in full conformity with the current 
revision of the Declaration of Helsinki and with the regulations and guidelines of FDA (all 
state/local regulations), whichever affords the greater protection to the subject. 
10.2  Institutional Review Board Approval 
A copy of the protocol, proposed consent form, other written subject information, and any 
proposed advertising material must be submitted to the IRB for written approval. The 
Sponsor must receive a copy of the written IRB approval of the protocol and consent form 

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before the Sponsor will ship investigational devices to the site and before the site may 
recruit subjects into the study. 
 
When the Investigator is under the oversight of a local IRB, the Investigator must submit 
and, when necessary, obtain approval from the IRB for all subsequent protocol 
amendments and changes to the consent form. The Investigator should notify the IRB of 
deviations from the protocol or SAEs/UADEs occurring at the site and other SAE/UADE 
reports received from RxFunction in accordance with local IRB procedures. 
 
The Investigator will be responsible for obtaining IRB approval and annual renewal 
throughout the duration of the study when he/she is under the oversight of a local IRB. 
Copies of the Investigator’s reports and the IRB’s written approval of continuance must be 
submitted to RxFunction, Inc. 
10.3 Informed Consent Form 
A sample consent form may be provided for the Investigator to prepare for use at his/her 
site. The written Informed Consent documents should be prepared in the language(s) of 
the potential subject population and will be administered according to local requirements. 
 
The reviewing IRB and the Sponsor must first approve the consent forms that are used. 
The consent forms used in this study will be in accordance with the current guidelines as 
outlined by the GCP guidelines, Declaration of Helsinki, and the International Conference 
on Harmonization (ICH) as well as local requirements and FDA regulations. 
 
Prior to participation in the clinical trial, each subject must give written informed consent 
after the context of the study has been fully explained to him/her. The subjects must also 
be given the opportunity to ask questions and to have those questions answered to their 
satisfaction. 
 
Written informed consent must be recorded appropriately by means of the subject’s dated 
signature. The subject will receive a copy of the consent form. 
10.4  Protocol Amendments 
This protocol will be followed exactly and altered only by written amendments. 
Administrative changes that do not affect the risk/benefit ratio to the subject (e.g., editorial 
changes for clarity) may be made without any further approvals. Any change that would 
require alteration of the consent form must receive approval from the sites’ IRBs prior to 
implementation. Following approval, the protocol amendment(s) will be distributed to all 
sites with instructions to append them to the protocol. 
10.5 Emergency Actions 
RxFunction, Inc., accepts the right of the Investigator to deviate from the protocol in an 
emergency when necessary to safeguard the physical well-being of a study subject. The 
Investigator must give notice of any emergency deviations and justification for the 

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deviation to RxFunction and the IRB as quickly as possible after the episode, in any event 
no later than 24 hours after the emergency. 
10.6 Conflicts of Interest 
“A conflict of interest exists when two or more contradictory interests relate to an activity 
by an individual or an institution. The conflict lies in the situation, not in any behavior or 
lack 
of 
behavior 
of 
the 
individual” 
(https://ori.hhs.gov/education/products/ucla/ 
chapter4/default.htm). 
 
The Investigator is responsible for submitting information regarding potential conflicts of 
interest to the IRB and/or the appropriate oversight committee at his/her institution. In 
addition, the Investigator must provide assurance to the Sponsor that he/she or any 
member of his/her research team is not a member of the IRB or that he/she did not 
participate in the review of this study. 
 
11  Study Administration 
11.1 Participating Sites 
The Sponsor will select Investigators who are qualified by training and experience and are 
legally entitled to perform clinical research and to participate in the investigation of the 
study device. Sites will be selected based on the qualifications of the Principal Investigator. 
All Investigators must be trained to the protocol and study procedures prior to enrolling 
subjects. 
11.2 Investigator Responsibilities 
The Principal Investigator at each site will do the following: 
• 
Agree to, sign, and adhere to the Investigator Agreement (or a contract/clinical trial 
agreement). 
• 
Agree to participate in Investigator meetings as scheduled by RxFunction, Inc. 
• 
Be willing to perform and capable of performing treatment procedures as outlined in 
this protocol. 
• 
Comply with all required elements of this protocol (e.g., perform testing and follow-up 
as specified, especially during personnel transitions). 
• 
Agree to obtain written informed consent before any study-specific procedures are 
performed in accordance with GCP. 
• 
Complete all case report forms (CRFs) in a timely manner. 
• 
Agree to comply with all applicable national and local laws, regulations, and guidelines, 
including Good Clinical Practices. 

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11.3 Training  
In addition to providing documentation of their human subjects protection training (e.g., 
CITI), all Investigators and study personnel are required to attend Sponsor training 
sessions, which may be conducted at a site initiation visit or other appropriate training 
sessions. Phone or web-based training will take place as required. Training of 
Investigators and study personnel will include, but is not limited to, the investigational plan, 
investigational device usage, protocol requirements, randomization instructions, case 
report form completion, and study personnel responsibilities. All Investigators and study 
personnel must sign a training log upon completion of the training. The Investigators and 
study personnel must not perform any study-related procedures prior to being trained. 
11.4 Pre-Study Documentation Requirements 
Prior to shipment of investigational product, the site must provide the following documents 
to RxFunction: 
• 
Signed and dated Investigator Agreement 
• 
A copy of the written IRB approval of the protocol 
• 
A copy of the written IRB approval of the consent form 
• 
A copy of the curriculum vitae of the Principal Investigator and sub-investigator(s), if 
applicable 
11.5 Subject Stipends or Payments  
Subjects will receive compensation for their participation in the study based on the 
schedule below.  
 
Visits 
Compensation Amount 
Screening 
$25  
Baseline 
$50 for Randomized Subjects 
Follow-up Visit 1:  Week 2 
$25 
Follow-up Visit 2:  Week 6 
$25 
Follow-up Visit 3:  Week 10 
$25 
Follow-up Visit 4:  Week 26 
$25 
Follow-up Visit 5: Week 52 
$50 
Baseline MRI Visit 
$50 
Week 26 MRI Visit 
$50 
 
RxFunction will also provide reimbursement for parking fees, if applicable, and/or bus or 
cab fare for subjects who are unable to secure other means of transportation to and from 
the research sites. 
11.6 Study Timetable 
The screening visit will last about 1.5 hours; the baseline visit will take approximately four 
(4) hours, and subsequent visits will last about 1.5 hours for a total of 13 hours over the 

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course of the study. The seven scheduled follow-up visits by telephone will last 10-15 
minutes each—about 2 hours. 
 
The study will be considered complete (regarding the primary endpoint) after all subjects 
have completed the 52-week follow-up period or ended their participation in the study. 
 
Study Procedures 
Baseline 
Week 2 
Week 6 
Week 10 
Week 26 
Week 52 
Informed Consent & HIPAA 
X 
 
 
 
 
 
Subject Medical History Form  
X 
 
 
 
 
 
FGA 
X 
X 
X 
X 
X 
X 
10MWT 
X 
X 
X 
X 
X 
X 
TUG 
X 
X 
X 
X 
X 
X 
4-Stage Balance Test 
X 
X 
X 
X 
X 
X 
Filament & Vibration Assessment 
X 
 
 
X 
X 
X 
ABC Score 
X 
X 
X 
X 
X 
X 
Vestibular Activities of DLS 
X 
X 
X 
X 
X 
X 
Falls Efficacy Scale--International 
X 
X 
X 
X 
X 
X 
PHQ-9 
X 
X 
X 
X 
X 
X 
Pain Interference Form 6B 
X 
X 
X 
X 
X 
X 
Pain Intensity Form 1a 
X 
X 
X 
X 
X 
X 
Ability to Participate Form 8a 
X 
X 
X 
X 
X 
X 
SPSR Form 8a 
X 
X 
X 
X 
X 
X 
Concomitant Medication Use 
X 
X 
X 
X 
X 
X 
Fall Events Form (if needed) 
X 
X 
X 
X 
X 
X 
User Experience Survey 
 
X 
 
X 
 
 
11.7 Criteria for Termination of the Study  
RxFunction, Inc., reserves the right to terminate the study but will exercise this right only 
for valid scientific or administrative reasons and/or reasons related to protection of 
subjects. Investigators and their associated IRBs will be notified in writing in the event of 
termination. 
 
Possible reasons for study termination include the following: 

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• 
The discovery of an unexpected, significant, or unacceptable risk to the subjects 
enrolled in the study. 
• 
A decision on the part of RxFunction to suspend the study or discontinue development 
of the device. 
12  Publication Plan  
Recognizing the importance of this investigation, Rx Function, Inc., as the sponsor of this study, 
is committed to the dissemination of the results. At the study’s conclusion, a multicenter abstract 
to be presented at a scientific meeting and/or a manuscript to be submitted to a peer-reviewed 
journal will be prepared by the Scientific Advisor together with the leads of each site. The 
publication of the principal results from any single center experience within the study can occur 
following the preparation and publication of the multicenter results. 
 
Submission of all abstracts and publications regarding the primary and secondary endpoints from 
the study requires approval by the Sponsor. 
 
 

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