A Pilot Study to Explore the Effects of Lower-Leg Mechanical Tactile Sensory Stimulation on the Gait Speed of Mildly Cognitively Impaired Individuals
Phase: NA
Conditions: Mild Cognitive Impairment, Cognitive Decline, Gait Disorders in Old Age
Sponsor: RxFunction Inc.

 
A Pilot Study to Explore the Effects of 
Lower-Leg Mechanical Tactile Sensory Stimulation  
on the Gait Speed of  
Mildly Cognitively Impaired Individuals 
 
NCT05723822 
 
 
 
7576 Market Place Drive 
Eden Prairie, MN 55344 
March 7, 2023 

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Sponsors:   
 
 
 
 
 
 
Innovative Design Labs, Inc. 
 
 
 
 
 
 
 
 
 
 
 
861 E Hennepin Ave, Suite 450 
 
 
 
 
 
 
 
 
 
 
 
Minneapolis, MN 55414 
 
RxFunction, Inc. 
 
 
 
 
 
 
 
 
 
 
 
7576 Market Place Drive 
Eden Prairie, MN 55344 
 
Sponsor Contact:   
 
 
 
 
Yvonne Rumsey 
RxFunction, Inc. 
7576 Market Place Drive 
Eden Prairie, MN 55344 
 
Principal Investigator: 
 
 
 
John Condon 
 
Protocol Number:  
 
 
 
 
CIP 0007 
 
Protocol Short Title:  
 
 
 
MCI Pilot Study 
 
Date of Issue:   
 
 
 
 
 
March 7, 2023 
 
 
 

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Table of Contents 
 
LIST OF ABBREVIATIONS.......................................................................................................................... 4 
INTRODUCTION ........................................................................................................................................... 5 
BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ............................................................. 5 
DESCRIPTION OF WALKASINS ................................................................................................................... 5 
SUMMARY OF PREVIOUS WALKASINS RESEARCH.................................................................................... 6 
DESCRIPTION OF PHYSENS™-IMM .......................................................................................................... 7 
RATIONALE FOR THE PILOT STUDY ........................................................................................................... 9 
PILOT STUDY AIM AND HYPOTHESIS .................................................................................................... 10 
PILOT STUDY DESIGN .............................................................................................................................. 10 
RESEARCH DESIGN .................................................................................................................................. 10 
STUDY SITE .............................................................................................................................................. 10 
PARTICIPANT SELECTION ...................................................................................................................... 10 
INCLUSION CRITERIA ................................................................................................................................ 11 
EXCLUSION CRITERIA .............................................................................................................................. 11 
PILOT STUDY PROCEDURES .................................................................................................................. 12 
SPECIFIC TRAINING .................................................................................................................................. 12 
CONSENT PROCEDURES .......................................................................................................................... 12 
DOCUMENTATION OF INFORMED CONSENT PROCESS ............................................................................ 13 
STUDY VISIT PROCEDURES ..................................................................................................................... 13 
PILOT STUDY DURATION ......................................................................................................................... 14 
DATA MANAGEMENT AND QUALITY PLAN .......................................................................................... 16 
DATA DEIDENTIFICATION ......................................................................................................................... 16 
DATA CONFIDENTIALITY, STORAGE, AND RETENTION ........................................................................... 16 
DATA QUALITY ......................................................................................................................................... 16 
DATA SHARING ........................................................................................................................................ 16 
SHARING OF RESULTS WITH PARTICIPANTS ........................................................................................... 17 
STATISTICAL ANALYSIS PLAN ............................................................................................................... 17 
RISKS AND POTENTIAL BENEFITS ........................................................................................................ 17 
POTENTIAL BENEFITS .............................................................................................................................. 17 
PILOT STUDY RISKS AND THEIR MITIGATION .......................................................................................... 17 
PROVISIONS TO PROTECT THE PRIVACY INTEREST OF STUDY PARTICIPANTS ...................................... 18 
EARLY WITHDRAWAL OF PARTICIPANTS ............................................................................................ 18 
RXFUNCTION’S WITHDRAWAL OF PARTICIPANTS ................................................................................... 18 
PARTICIPANTS’ REQUESTS FOR WITHDRAWAL FROM THE PILOT STUDY .............................................. 18 
ADVERSE EVENTS AND UNANTICIPATED PROBLEMS ...................................................................... 19 
DEFINITIONS ............................................................................................................................................. 19 
RECORDING OF AND RESPONDING TO ADVERSE EVENTS ...................................................................... 21 
NOTIFICATION OF ADVERSE EVENTS AND UPIRTSOS .......................................................................... 21 
ETHICAL CONSIDERATIONS ................................................................................................................... 21 

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PARTICIPANT STIPENDS OR PAYMENTS ............................................................................................. 21 
PUBLICATION PLAN ................................................................................................................................. 21 
REFERENCES ............................................................................................................................................ 22 
 
 
 
 
 

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List of Abbreviations 
 
The following abbreviations appear in this protocol. 
 
AE 
Adverse Event 
CITI 
Collaborative Institutional Training Initiative (CITI Program) 
FES 
Falls Efficacy Scale 
GCP 
Good Clinical Practice 
IDL 
Innovative Design Laboratories 
IRB 
Institutional Review Board 
MCI 
Mild Cognitive Impairment 
NSR 
Nonsignificant Risk 
RA/QA 
Regulatory Affairs/Quality Assurance 
SAE 
Serious Adverse Event 
SLUMS Exam 
Saint Louis University Mental Status Exam 
SPN 
Sensory Peripheral Neuropathy 
SPPB 
Short Physical Performance Battery Protocol 
SR 
Significant Risk 
TUG 
Timed Up and Go 
TUG-COG 
Timed Up and Go Cognitive 
UPIRTSO 
Unanticipated Problem Involving Risks to Subjects or Others 
 
 
 

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Introduction 
 
This protocol describes the procedures for a pilot study to evaluate the use of 
Walkasins, a sensory prosthesis currently indicated for use in patients with sensory 
peripheral neuropathy (SPN), in individuals with mild cognitive impairment (MCI). The 
pilot study will be developed and conducted according to U.S. standards of Good 
Clinical Practice (GCP) and in accordance with applicable federal regulations.  
 
 
Background Information and Scientific Rationale  
 
Description of Walkasins 
Walkasins consist of two parts for each leg: the Haptic Module and the Receptor Sole  
(Figure 1). The Haptic Module wraps around the lower leg of the user and contains 
electronics for reading Receptor Sole 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 Haptic Module 
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 Receptor Sole is a thin consumable 
insert that fits in a regular shoe. The Receptor Sole connects to the Haptic Module 
through a physical cable. (Walkasins are commercially available by prescription.) 
 
 
Figure 1. 

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In previous studies, three Institutional Review Boards (IRBs) have determined that 
Walkasins meet the regulatory definition of a non-significant risk (NSR) 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. 
 
As a non-significant risk device, Walkasins . . .  
• Are worn on the feet and legs 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; 
• Do not otherwise present a potential for serious risk to the health, safety, or welfare 
of a subject.  
 
Summary of Previous Walkasins Research 
The role of plantar cutaneous sensory afferent information for balance has been studied 
for more than two decades and is well-documented in peer-reviewed study literature.1,2,3 
Lars Oddsson, Ph.D., a scientist and widely published investigator on topics related to 
balance, co-invented Walkasins with Ph.D. student Peter Meyer during his tenure at 
Boston University’s Neuromuscular Research Center. Their early work on the role of 
plantar cutaneous sensation for balance control,2,3 combined with promising pilot data,4 
led to the NIH-funded development of Walkasins for patients presenting with gait and 
balance impairments related to SPN.  
 

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A randomized cross-over study of short-term, in-clinic effects of Walkasins use, 
conducted at the Minneapolis Veterans Affairs Medical Center (VAMC) and published in 
PLOS ONE, found clinically meaningful and statistically significant improvements in gait 
speed and functional balance in patients with SPN using Walkasins.5 The authors 
stated that “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.”5  
 
In 2020 a multi-site clinical trial of the long-term effects of daily Walkasins use 
(walk2Wellness, ClinicalTrials.gov #NCT03538756) was published in Frontiers in Aging 
Neuroscience.6 The trial sites included Baylor College of Medicine, Hebrew Senior Life 
(a Harvard Medical School Affiliate), Johns Hopkins Medical Center, M Health Fairview, 
and Minneapolis Veterans Affairs Health Care System. After 10 weeks of Walkasins 
use, this long-term study demonstrated clinically meaningful improvements in Functional 
Gait Assessment (FGA) and gait speed, which is associated with a lower fall risk. The 
authors concluded that “a wearable sensory prosthesis may provide a new way to treat 
gait and balance problems and manage falls in high fall-risk patients with PN.”6 
 
Most recently, an analysis of data from 26 weeks of Walkasins use in the 
walk2Wellness trial showed that “participants who reported falls over 6 months prior to 
the study had a 43% decrease in fall rate during the study as compared to self-report 6-
month pre-study (11.8 vs. 6.7 falls/1000 patient days, respectively, p <0.004), similar to 
the 46% decrease reported after 10 weeks of use.”7 
 
Description of PhySens™ IMU Shoe Clip 
In addition, participants will wear the PhySens™ Intelligent Motion Module (PhySens-
IMM), Innovative Design Lab’s (IDL) compact motion sensing and processing platform. 
The PhySens-IMM is designed to sense motion information using its onboard MEMS 
accelerometer, gyroscopes, magnetometers, and barometer and to process this 
information in real-time using its onboard processors. Results are wirelessly transmitted 
via Bluetooth Low Energy (BLEv5) and stored on a local micro-SD card. To function 
across a wide variety of applications, the PhySens-IMM was designed to securely and 
repeatably attach to application specific, 3D printable, mounting clips. Uses for the 
PhySens-IMM range from exercise recognition to camera orientation estimation to 
wheelchair performance monitoring. 
 
A photograph of the device appears below. 

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Figure 2. 
 
This device is part of the PhySens™ ecosystem that includes a variety of sensor types 
designed to monitor important aspects of daily life such as sleep, exercise, cognitive 
state, gait, etc. The data obtained from the PhySens-IMM will be used to inform and 
complement the data collected from the Walkasins device and the functional 
assessments. (See IDL’s website for more detailed information regarding this device.) 
 
Ultra-Wideband (UWB) Real Time Location System 
As a truth source, subject position will be tracked using the MDEK1001 Ultra-Wideband 
Real Time Location System, manufactured by Qorvo (formerly Decawave). This system 
uses a set of static “Anchor Nodes” positioned around the testing area to determine the 
relative position of “Tag Nodes” as seen in the figure 3 below. 
 
Figure 3. 

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The Anchor and Tag Nodes include a rechargeable battery and communicate wirelessly 
with each other, creating a mesh network. An additional node is attached to a laptop 
computer over USB to log the position of the Tag Node (subject) in real time. Both the 
Anchor and Tag Nodes are physically similar, as seen in figure 4 below—the Anchor 
node mounted on a tripod and the Tag Node attached to a clip to be worn on the 
subject’s belt or pocket. 
 
Figure 4. 
 
The system has a maximum location rate of 10Hz and a typical accuracy <10cm. The 
maximum distance between nodes for reliable ranging is 25m. The ultra-wideband 
signal is compliant with IEEE802.15.4-2011 and complies with FCC & ETSI UWB 
spectral masks in the 3.5-6.5GHz range. These devices are commonly used in industry 
for real time location of equipment, people, and products in healthcare, warehousing, 
and industrial applications. 
 
Rationale for the Pilot Study 
The Walkasins system is one of a growing number of wearable devices that use various 
modalities of neuromodulation, defined as “the alteration of nerve activity through 
targeted delivery of a stimulus, such as electrical stimulation or chemical agents, to 
specific neurological sites in the body.”8 Because these technologies are relatively new, 
innovative applications of their use in various patient populations may lead to 
improvements in the care and quality of life of individuals who suffer from these life-
altering diagnoses. 
 
We have previously shown that individuals with peripheral neuropathy who have gait 
and balance problems walk faster with the Walkasins device.5-7 This increase may be 
related to an improved automaticity of gait function, thereby decreasing the need for 
cognitive attention to the walking task, which is known to slow down gait.9 Individuals 

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with mild cognitive impairment commonly show slow gait speeds,10 likely due to a 
decline in executive function. There is a reason to think that sensory stimuli from the 
Walkasins device can improve the automaticity of gait in these individuals and thereby 
enhance gait speed. 
 
 
Pilot Study Aim and Hypothesis 
 
The primary aim of this pilot study is to investigate the effect of lower-leg mechanical 
tactile sensory stimulation on the gait speed and balance function of participants with 
mild cognitive impairment as measured by the SLUMS Examination. We hypothesize 
that participants will increase their gait speed and improve clinical outcomes, suggesting 
less reliance on compensatory executive control9 when their Walkasins are turned on. 
 
 
Pilot Study Design 
 
Research Design  
This pilot study will collect data from individuals with mild cognitive impairments who 
consent to participate in one assessment session. It will employ a pre- and post-test 
study design to evaluate whether wearing active Walkasins (i.e., Walkasins turned on) 
improves the participants’ gait speed and other clinical outcomes of gait and balance 
function. 
 
Study Site 
The Pillars at Prospect Park, a senior living community located in Minneapolis-St. Paul, 
has agreed to allow RxFunction to recruit its residents and to use space at its facility to 
conduct this pilot study. The Pillars will not receive any funds for this project, and its 
employees will not be engaged in any research-related activities aside from potentially 
informing prospective participants about the availability of the research, providing 
prospective participants with the study team’s contact information, and/or obtaining the 
prospective participants’ permission for the study team to contact them. 
 
 
Participant Selection 
 
Up to 20 study participants will be enrolled in this pilot study. To participate, individuals 
must meet the following inclusion and exclusion criteria. 
 

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Inclusion Criteria 
• Ambulatory person who is at least 65 years of age 
• Ability to understand and provide informed consent: For this study we will assume 
participants are able to consent if they can satisfactorily answer the following 
questions: 
o How would you describe your brain health right now?  
o What is this study about? 
o If you decide to be in this study, what harm (risks) might occur?  
o Will this study mainly help you or others? 
o If you want to stop being in the study, when can you do this? 
o Can you please explain how you decided to participate in this study? 
• Ability to perceive vibrations from the Walkasins Haptic Module 
• Ability to complete the functional outcome measures without the use of an assistive 
device 
• Foot size that allows the Walkasins to function appropriately 
• Mild Cognitive Impairment (MCI) as measured by the Saint Louis University Mental 
Status (SLUMS) Exam (scores between 20 and 24 + or -2 for those with less than a 
high school education and scores between 21-26 + or -2 for those who graduated 
from high school, which indicate mild cognitive impairment) and/or a diagnosis of 
MCI (or related term) in the person’s medical record 
• Slow gait speed (<1m/second or slightly faster, provided all other criteria are met) 
 
Exclusion Criteria 
• Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins 
• Self-reported 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 
• Self-reported severe peripheral vascular disease  
• Other neurological conditions that impact walking (e.g., peripheral neuropathy) 
• Weighs more than 300 pounds 
 

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Pilot Study Procedures 
 
Specific Training 
In addition to completing human subjects research training (e.g., CITI training), the 
RxFunction study team and any collaborators who assist with the pilot study will receive 
training on the protocol and procedures as well as their responsibilities and functions 
prior to their participation in study-related tasks. 
 
Recruitment of Participants 
Upon IRB approval of the study, participants may be recruited by flier, personal 
invitation, and/or referral. Study staff will inform interested individuals about the study 
and screen individuals for eligibility before inviting them to participate if they are eligible. 
(See Telephone Screening attachment.)  
 
Consent Procedures  
A qualified study team member will conduct the consent discussions in a private space. 
He/she will provide an overview of the pilot study, its purpose, risks and benefits, etc. 
Potential participants may take as much time as they need to read the consent form and 
to ask any questions they may have.  
 
Before the potential participant signs the consent form, the study team member will ask 
the questions listed below. If the potential participant cannot answer the questions, the 
study team member may review the relevant points with him/her. If further review does 
not result in satisfactory responses, the study team member will advise the potential 
participant that he/she will not be able to take part in the study. (Consent will not be 
sought from a legally authorized representative or surrogate.) 
• How would you describe your brain health right now?  
• What is this study about? 
• If you decide to be in this study, what harm (risks) might occur?  
• Will this study mainly help you or others? 
• If you want to stop being in the study, when can you do this? 
• Can you please explain how you decided to participate (or not participate) in this 
study? 
 
If the person consents to participate in the pilot study, he/she will sign the consent form 
and receive a copy for his/her records. 
 

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Documentation of Informed Consent Process 
Documentation of the informed consent process will be maintained in study records. A 
study team member will note the date consent was obtained and affirm that consent 
was obtained prior to initiating any study-related procedures. 
 
Study Visit Procedures 
After subjects have signed the appropriate forms indicating their consent to participate 
in the study and to allow the study team to use their data (explained in the consent 
form), study staff will collect the following data points:  
• Assigned identifying code for the participant  
• Age 
• Sex 
• Race and ethnic demographics 
• Height and weight 
• Assistive device used if any 
• Level of education (high school graduate or not) 
 
The study team member will then check the inclusion and exclusion criteria to verify that 
participants meet the eligibility criteria and will enroll them into the study if they meet all 
criteria. As part of the eligibility verification, study staff will administer the SLUMS Exam, 
“an assessment tool for mild cognitive impairment and dementia.”11  
 
Participants will remain eligible if they score as follows:  
• High School Education: 21-26 
• Less Than High School Education: 20-24 
 
The final assessment for eligibility is a four-meter timed walk excluding an initial two 
meters to allow for acceleration. Participants will remain eligible for the pilot study if their 
gait speed is less than 1m/second. (At their discretion the investigator[s] may enroll 
individuals whose gait speed is slightly faster than 1m/second, provided they meet all 
other eligibility criteria.) This test may be repeated if necessary. 
 
Participants who meet all eligibility criteria will then don a pair of Walkasins and the 
PhySens-IMM System. They will perform some brief balance exercises (i.e., sensory 
integration exercises) and then complete the following assessments with their 
Walkasins turned off and without the use of an assistive device: 

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• Short Physical Performance Battery (SPPB): The SPPB “is a composite measure 
assessing walking speed, standing balance, and sit-to-stand performance.” 
Research has shown it to be “predictive of an increased risk of falling” among other 
outcomes associated with older populations.12 (Complete instructions for the SPPB 
are available at https://geriatrictoolkit.missouri.edu/SPPB-Score-Tool.pdf.) 
• Timed Up and Go (TUG): The TUG is part of the Centers for Disease Control-
recommended STEADI test protocol for balance function.13 From a seated position 
in a standard armchair, the participant 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 participant sits 
down again.  
• Timed Up and Go Cognitive (TUG-COG): The TUG-COG is performed as described 
above; in addition, the participant is asked to count “backwards by threes from a 
randomly selected number between 20 and 100.”14 To standardize the assessment 
for this pilot study, the study team member who conducts the TUG-COG will use the 
same starting number for all participants (e.g., the same odd number for the first 
TUG-COG assessment and the same even number for the second TUG-COG 
assessment). 
 
After a five-minute break, study staff will then guide the participants through the same 
sensory integration exercises they performed before the first set of assessments. 
Participants will then retest participants on the same assessments with Walkasins 
turned on and without the use of assistive devices. Upon completion of the 
assessments with their Walkasins turned on, participants will remove their Walkasins 
and the PhySens-IMM System and complete the Falls Efficacy Scale (FES).15 The 
subjects’ participation in the study will then be over. 
  
Pilot Study Duration 
The pilot study will involve one visit that may last 1 to 1-1/2 hours. (A flow chart of the 
study visit appears on the following page.) We anticipate that all data collection will be 
completed within three months after study initiation. 

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Data Management and Quality Plan  
 
Data Deidentification 
Study staff will assign identification numbers to the participants’ data, and they will use 
those numbers when analyzing the collected data. 
 
Data Confidentiality, Storage, and Retention 
All research team members will observe standard data confidentiality and security 
measures including, but not limited to, the following: 
• Study staff will collect only the minimum identity information needed.  
• Any portable electronic devices utilized in the study will be stored in secure locations 
when they are not in use.  
• Physical and electronic access to the pilot study data will be limited to authorized 
personnel only. 
• No information that can identify individual participants will appear in any publications 
or presentations that may result from analysis of the pilot study data. 
 
Pilot study data will be retained indefinitely in a limited-access spreadsheet or 
spreadsheets. Any printed materials (e.g., consent forms) will be confidentially shredded 
when the period for their retention has passed (i.e., two years after study completion).  
  
Data Quality  
Data entry will occur directly as the study visits are conducted. Quality control measures 
to ensure data accuracy and integrity procedures for this pilot study include the 
following measures:  
• Validation checks will be incorporated into cells as much as possible to help ensure 
that data entries are logically consistent with questions asked or tasks performed. 
• No imputation methods will be used to infer missing values of any outcome 
measures. 
• Data collection forms will be reviewed for completeness and consistency. Errors will 
be corrected, following standard GCP procedures. 
 
Data Sharing  
RxFunction may share information from the pilot study with researchers at other 
companies or institutions in accordance with standard data sharing agreements that 

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protect the confidentiality of study participants. Only RxFunction company officers may 
approve data sharing agreements. 
 
Sharing of Results with Participants 
At its discretion RxFunction may share information from the study with participants, 
providing only their own data or via reports summarizing results on all participants if 
requested (e.g., through a newsletter or RxFunction website posting).  
 
 
Statistical Analysis Plan 
We will use descriptive statistics as well as regression analysis to investigate trends in 
changes for the various outcomes measured. Walkasins on versus off conditions will be 
compared using paired t-test as well as Wilcoxon Signed Rank Test for non-normally 
distributed data. Test of normality will be conducted using the Shapiro–Wilk test. In 
addition, we may conduct qualitative analyses on participants’ comments to answer 
research questions. 
 
 
Risks and Potential Benefits  
 
Potential Benefits 
There are no direct benefits to individuals who participate in this pilot study; however, 
we hope that the information gleaned through their participation will enhance our 
understanding of Walkasins’ potential role in the treatment of gait difficulties 
experienced by individuals with mild cognitive impairments. 
 
Pilot Study Risks and Their Mitigation 
• The device being tested may distract the participants while they are walking and 
increase the risk of falling. To help prevent falling during the testing at the research 
site, a spotter will walk next to the participants to help them regain balance if a fall 
starts to occur.  
• There is a very low chance that participants may find the device stimulations 
uncomfortable. If this occurs, the participants can decide if they wish to end 
participation in the pilot study.  
• RxFunction personnel may request participants’ medical information relevant to the 
study, but they will limit the data collected to the minimum necessary to conduct the 
study. 
• There may be other unknown side effects that could occur. 
 

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Every effort 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 will help to ensure that only appropriate 
participants are enrolled. 
• Maintaining participant safety through practices such as spotting the participants 
during study assessments will help to ensure their physical safety. 
 
Provisions to Protect the Privacy Interest of Study Participants 
RxFunction study personnel will exercise all standard precautions to ensure that only 
authorized individuals will access pilot study records. The collection of sensitive 
information about participants is limited to the amount necessary to achieve the aim of 
the pilot study.  
 
 
Early Withdrawal of Participants  
 
RxFunction’s Withdrawal of Participants 
Study personnel may end a subject’s participation in the study without the participant’s 
consent if they feel that it is in the participant’s best interest. They may also end a 
subject’s participation if he/she experiences a study-related injury or unacceptable side 
effects. 
 
Participants’ Requests for Withdrawal from the Pilot Study 
Participants wishing to withdraw from the pilot study may advise the principal 
investigator or study staff of their wish to withdraw at any time during their participation. 
From the point of withdrawal, RxFunction will not collect further data from the participant 
for inclusion in the pilot study; however, any data collected up to the point of withdrawal 
will remain in the pilot study to protect its integrity. The consent form will advise 
participants of their right to withdraw and the limitations on data removal from the pilot 
study. 
 
 

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Adverse Events and Unanticipated Problems  
 
Given the short duration of subjects’ participation in this pilot study, we do not anticipate 
that any adverse events will occur; however, in the unlikely event such an incident 
should occur, RxFunction and its study team will evaluate the event according to the 
definitions and procedures described below. 
 
Definitions  
 
Adverse Event (AE): The FDA defines “an adverse event [as] any undesirable 
experience associated with the use of a medical product in a patient.”16 An adverse 
event (AE) can, therefore, be any unfavorable and unintended sign, symptom, or 
disease temporally associated with the use of an investigational product whether or not 
it is related to the study product. 
 
Serious Adverse Event (SAE):  If the “patient outcome” of the adverse event meets any 
of the criteria below, it is a serious adverse event that must be reported to the FDA.16 
• Results in death  
• Is life threatening  
• Requires inpatient hospitalization or prolongation of existing hospitalization  
• Results in a persistent or significant disability/incapacity  
• Requires medical or surgical intervention to prevent permanent impairment to body 
structure or a body function  
• An “important medical event” that “does not fit the other outcomes, but [which] . . . 
may jeopardize the patient and may require medical or surgical intervention 
(treatment) to prevent one of the other outcomes”16 
 
Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSOs): The Office 
of Human Research Protections (OHRP, 45 CFR 46.108[a][4]) and FDA (21 CFR 
56.108[b]) require that researchers report the occurrence of any unanticipated problem 
involving risks to subjects or others (UPIRTSO) to their institutional officials, the IRB, 
and FDA for FDA-regulated research and/or to OHRP for other types of research 
(depending on funding source and IRB reporting requirements). For an incident to be 
classified as a UPIRTSO and for it, therefore, to be reportable, it must meet all three 
criteria described in OHRP guidance: 
1. unexpected (in terms of nature, severity, or frequency) given (a) the research 
procedures that are described in the protocol-related documents, such as the 

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IRB-approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied; 
2. related or possibly related to participation in the research (in this guidance 
document, possibly related means there is a reasonable possibility that the 
incident, experience, or outcome may have been caused by the procedures 
involved in the research); and 
3. suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized.17  
UPIRTSOs may be either adverse medical events or non-medical events (e.g., a data 
breach), but only those events that meet the criteria listed above will be classified as 
UPIRTSOs.  
 
Classification of the Event’s Relationship to the Device 
The principal investigator and/or the clinician conducting the assessments will 
determine whether there is a reasonable possibility that Walkasins caused or 
contributed to an AE, and he/she will record the determination on the Adverse Event 
Log per the categories in the table below. Determinations should be based on 
assessment of temporal relationships, 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: 
 
Study Intervention’s Relationship to the Adverse Event 
CATEGORY 
DEFINITION 
Definitely 
Related 
The AE is related to the device. There is objective evidence 
establishing a cause and effect relationship between the AE and the 
device.  
Possibly 
Related  
The AE could be related to or caused by the device; however, there 
is no clear evidence establishing a link/relationship. The participant’s 
condition or concomitant therapy could have caused the AE.  
Definitely Not 
Related 
There is no evidence that the study device caused the reported 
event. The AE can reasonably be explained by the participant’s 
condition and/or another cause or concomitant therapy. Alternatively, 
the temporal sequence between the device and the AE is such that 
the relationship is improbable or clearly unrelated.  
 

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Recording of and Responding to Adverse Events 
If an adverse event (or unanticipated problem) occurs, study staff will document it on the 
appropriate log within five business days of its occurrence or of study staff becoming 
aware of the event. If the event is serious, staff will report the event within 24 hours of 
its occurrence or of becoming aware of its occurrence. They will also take appropriate 
actions to help ensure the participant’s safety.  
 
Notification of Adverse Events and UPIRTSOs 
Adverse events will be reported internally to RxFunction’s director of RA/QA according 
to the relevant quality policy; he will report the event to the FDA if the event meets FDA 
medical device reporting requirements. UPIRTSOs and AEs will be reported according 
to IRB guidelines.  
 
 
Ethical Considerations 
The research team will obtain and maintain IRB approval for the pilot study throughout 
its duration. 
 
 
Participant Stipends or Payments 
Participants will receive $50 in compensation for taking part in the study. (For 
accounting purposes, they will sign a form, indicating receipt of the gift card. This form 
will not be linked to linked to their study data.)  
 
 
Publication Plan 
Rx Function, Inc., as the pilot study sponsor, is committed to dissemination of significant 
findings that may result from the pilot study. The study team will observe International 
Committee of Medical Journal Editors (ICMJE) guidelines when determining author 
contributions. 

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References 
 
 1  
Strzalkowski N, Peters RM, Inglis JT, and Bent LR (2018). Cutaneous afferent 
innervation of the human foot sole: what can we learn from single-unit recordings? 
Journal of Neurophysiology, 120(3), 1233–1246. 
https://doi.org/10.1152/jn.00848.2017  
 2  
Meyer PF, Oddsson LI, De Luca CJ. Reduced plantar sensitivity alters postural 
responses to lateral perturbations of balance. Exp Brain Res. 2004;157(4):526-
536. doi:10.1007/s00221-004- 1868-3  
 3  
Meyer PF, Oddsson LI, De Luca CJ. The role of plantar cutaneous sensation in 
unperturbed stance. Exp Brain Res. 2004b;156(4):505-512. doi:10.1007/s00221-
003-1804-y  
 4 
Wall C 3rd, Wrisley D, Oddsson L. Vibrotactile feedback of mediolateral trunk tilt or 
foot pressure increases locomotor performance in healthy older adults—a pilot 
study. Annual Int Conf IEEE Eng Med Biol Soc. 2012;2012:6145-6148. 
doi:10.1109/EMBC.2012.6347396  
 5  
Koehler-McNicholas SR, Danzl L, Cataldo AY, Oddsson LIE. Neuromodulation to 
improve gait and balance function using a sensory neuroprosthesis in people who 
report insensate feet - A randomized control cross-over study. PLoS One. 
2019;14(4):e0216212. Published 2019 Apr 30. doi:10.1371/journal.pone.0216212  
 6  
Oddsson LIE, Bisson T, Cohen HS, et al. The Effects of a Wearable Sensory 
Prosthesis on Gait and Balance Function After 10 Weeks of Use in Persons with 
Peripheral Neuropathy and High Fall Risk – The walk2Wellness Trial. Front Aging 
Neurosci. 2020;12:592751. Published 2020 Nov 9. doi:10.3389/fnagi.2020.592751 
 7 
Oddsson LIE, Bisson T, Cohen HS, Iloputaife I, Jacobs L, Kung D, Lipsitz LA, 
Manor B, McCracken P, Rumsey Y, Wrisley DM and Koehler-McNicholas SR 
(2022) Extended effects of a wearable sensory prosthesis on gait, balance function 
and falls after 26 weeks of use in persons with peripheral neuropathy and high fall 
risk—The walk2Wellness trial. Front. Aging Neurosci. 14:931048. doi: 
10.3389/fnagi.2022.931048 
 8 
The International Neuromodulation Society. Home page. Accessed September 30, 
2022. https://www.neuromodulation.com/. 
 9 
Clark DJ. Automaticity of walking: functional significance, mechanisms, 
measurement and rehabilitation strategies. Front Hum Neurosci. 2015 May 
5;9:246. doi: 10.3389/fnhum.2015.00246. PMID: 25999838; PMCID: 
PMC4419715. 

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10 
Pedersen MM, Holt NE, Grande L, Kurlinski LA, Beauchamp MK, Kiely DK, 
Petersen J, Leveille S, Bean JF. Mild cognitive impairment status and mobility 
performance: an analysis from the Boston RISE study. J Gerontol A Biol Sci Med 
Sci. 2014 Dec;69(12):1511-8. doi: 10.1093/gerona/glu063. Epub 2014 May 5. 
PMID: 24799356; PMCID: PMC4296116. 
11 
SLU Mental Status Exam. Saint Louis University. Accessed September 30, 2022. 
https://www.slu.edu/medicine/internal-medicine/geriatric-medicine/aging-
successfully/ assessment-tools/mental-status-exam.php. 
12 
Treacy D, Hassett L. The Short Physical Performance Battery. J Physiotherapy 
2018;64(1):61. ISSN 1836-9553. https://doi.org/10.1016/j.jphys.2017.04.002. 
13 
Assessment: Timed Up & Go. Centers for Disease Control and Prevention. 
Published 2017. Accessed November 17, 2022. https://www.cdc.gov/steadi/ 
pdf/STEADI-Assessment-TUG-508.pdf  
14 
Timed Up and Go Dual Task; Timed Up and Go (Cognitive); Timed Up and Go 
(Motor). Timed Up and Go (Manual). Shirley Ryan Ability Lab. Updated January 
19, 2014. Accessed September 30, 2022. https://www.sralab.org/rehabilitation-
measures/timed-and-go-dual-task-timed-and-go-cognitive-timed-and-go-motor-
timed-and-go-manual. 
15 
Tinetti, M., D. Richman, Powell L. (1990). "Falls efficacy as a measure of fear of 
falling." J Gerontol 45(6): P239. Accessed November 17, 2022. 
https://www.sralab.org/sites/default/files/2018-08/Falls-Efficacy-Scale.pdf. 
16 
Food and Drug Administration. What is a Serious Adverse Event? Published 
February 1, 2016. Accessed April 7, 2022. https://www.fda.gov/safety/reporting-
serious-problems-fda/what-serious-adverse-
event#:~:text=An%20adverse%20event%20is%20any,medical%20product%20in%
20a%20patient.  
17 
Office of Human Research Protections. Reviewing and Reporting Unanticipated 
Problems Involving Risks to Subjects or Others and Adverse Events: OHRP 
Guidance. Published January 15, 2007. Accessed November 17, 2022. 
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-
unanticipated-
problems/index.html#:~:text=OHRP%20considers%20adverse%20events%20that,
greater%20risk%20of%20physical%20or.