LifeWalker Upright Walker Versus Conventional Rollator Walker and Predicate Device
Phase: NA
Conditions: Back Pain
Sponsor: Shirley Ryan AbilityLab

PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
Device
Page 1 of 15
Revised Template: November 10, 2014
PROTOCOL TITLE:  Life Walker vs. Conventional Rollator and Predicate 
Mobility Device
PRINCIPAL INVESTIGATOR:
Arun Jayaraman, PT, PhD
Department of Physical Medicine & Rehabilitation
Northwestern University
Rehabilitation Institute of Chicago
345 E. Superior
Chicago, IL 60611
Ph: (312) 238-6875
Fax: (312) 238-2081
Email: a-jayaraman@northwestern.edu
VERSION NUMBER:
Version 4
VERSION DATE:
10/11/2016
IRB #: STU00202634 Approved by NU IRB for use on or after 3/9/2018 through 3/8/2019.

PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
Device
Page 2 of 15
Revised Template: November 10, 2014
Table of Contents
1.0
Objectives .................................................................................................................3
2.0
Background...............................................................................................................3
3.0
Inclusion and Exclusion Criteria ..............................................................................3
4.0
Study-Wide Number of Subjects..............................................................................4
5.0
Study-Wide Recruitment Methods........................................................................4-5
6.0
Study Timelines........................................................................................................5
7.0
Study Endpoints........................................................................................................6
8.0
Procedures Involved............................................................................................6-10
9.0
Data Management...................................................................................................11
10.0
Withdrawal of Subjects*.........................................................................................11
11.0
Risks to Subjects* .............................................................................................12-13
12.0
Potential Benefits to Subjects .................................................................................13
13.0
Setting.....................................................................................................................13
14.0
Resources Available..........................................................................................13-14
15.0
Recruitment Methods..............................................................................................13
16.0
Local Number of Subjects ......................................................................................13
17.0
Confidentiality ........................................................................................................13
18.0
Provisions to Protect the Privacy Interests of Subjects ..........................................13
19.0
Compensation for Research-Related Injury............................................................14
20.0
Process to Document Consent in Writing...............................................................14
21.0
Drugs or Devices...............................................................................................14-15
IRB #: STU00202634 Approved by NU IRB for use on or after 3/9/2018 through 3/8/2019.

PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
Device
Page 3 of 15
Revised Template: November 10, 2014
1.0
Objectives
The primary objective of this study is to determine the efficacy of the Life 
Walker versus a standard rollator walker and predicate assistive device 
on gait function in adults between 18 to 89 year of age and using a walker 
with or without back pain 
1.1
Hypothesis’s:
Aim 1: Perform in-laboratory training on the Life Walker and testing to 
compare functional gait outcomes with the Life Walker compared 
to a conventional rollator and predicate assistive mobility device. 
We expect that participants will be able to walk longer and will 
perform more efficiently on measures of gait function when using 
the Life Walker. 
Aim 2: Perform in-laboratory testing to compare self-reported pain with 
the Life Walker compared to a conventional rollator and predicate 
assistive mobility device. We expect that participants will report 
less pain because they will have a more efficient and upright 
posture when using Life Walker. 
Aim 3: Perform in-laboratory testing to compare measures of quality of 
life with the Life Walker compared to a conventional rollator and 
predicate mobility device. We expect that participants will report 
better outcomes on quality of life measures because they will 
experience better self-esteem due to better mobility when using 
Life Walker.
2.0
Background
More than 6 Million people in the United States use assistive devices such as canes, 
crutches, or walker to move independently and to improve their balance. Over 1.5 million 
of these use walkers (Hamid Bateni) (H. Stephen Kaye). Independent movement is one of 
the most important factors to uphold quality of life for elderly or people with and patients 
with gait disorder, muscle weakness and musculoskeletal pain.
Mobility devices, especially rollators are used for improving the endurance, increasing 
the walking distance and the walking time (Zorica Suica).  Due to the bilateral 
stabilization the base of support allows a bigger tolerance for the body mass center till 
losing balance. Up to 100% are load on the walker, depending on using which allows a 
decrease lower limb loading and compensate weakness and decrease fatigue. Wheeled 
Walker (rollator) need less effort for lifting and moving thereby decrease the energy cost 
up to 50%. (Ko CY; H. Stephen Kaye) Arm-rest can increase the comfort of the walkers 
and reduce the weight bearing on lower limbs and on hand and wrists additionally (Ko 
CY). The Life Walker is an ergonomically designed walker with forearm supports at a 
position which is meant to relieve pressure on important loading parts of a person’s body 
IRB #: STU00202634 Approved by NU IRB for use on or after 3/9/2018 through 3/8/2019.

PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
Device
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Revised Template: November 10, 2014
leading to better mobility. Thus the study aims at understanding the true utility of the 
walker.
3.0
 Inclusion and Exclusion Criteria
3.1
We will recruit 30 subjects. Most subjects will be recruited through 
RIC recruitment flyers and from the RIC pain clinic. 
Inclusion:
• Individuals using a walker with or without back pain for 
ambulation. 
• Ages from 18 to 89 years old
• Medically stable for therapy
Exclusion
• Patient weight exceeds 300 lbs
• Patient height is below 5’0” or exceeds 6’3”
• Inactive, physically unfit to fit into the device.
• Cognitive deficits or visual impairment that would impair 
their ability to give informed consent or to follow simple 
instructions during the experiments.
• MMSE score below 17 
• Pregnant women
• Co-morbidity that interferes with the study (e.g. stroke, 
pace maker placement, severe ischemia cardiac disease, 
etc.)
4.0
Study-Wide Number of Subjects
This study will enroll up to 30 older adults who use walkers as a primary 
mode of transportation, and 30 individuals who use a walker due to low 
back pain.  
5.0
Study-Wide Recruitment Methods
This study will enroll up to 30 eligible subjects.  RIC approved flyers will 
be posted at RIC in-patient, out-patient, day rehabilitation and fitness 
facilities, as well as pain clinic offices, providing contact information of 
study recruiters. Authorized research personnel will identify potential 
subjects from RIC’s Cerner Information Systems. Patients will be 
IRB #: STU00202634 Approved by NU IRB for use on or after 3/9/2018 through 3/8/2019.

PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
Device
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considered enrolled into the study after they have signed the Consent 
Form and HIPAA Authorization for Research.
6.0
Study Timelines: 1-2 days of training
7.0
Study Endpoints
7.1
7.0 Study Endpoints: 
Gait Assessment: 
•
6 minute walk test
•
10 m walk test
•
Outdoor ambulation
•
GaitRite 
•
EMG (lower limb &spine 
load during ambulation)
•
Hand & forearm gripping 
load
•
Talking while walking 
with dual tasking 
•
Dynamic Gait Index
Metabolic testing:
•
V02 Max
•
Heart Rate
•
Blood Pressure
•
Blood oxygenation
Self-Report:
•
Quebec back pain scale
•
Brief pain inventory
•
Borg Rate of perceived 
exertion
•
Rosenberg’s Self-Esteem
•
Fatigue 
•
Visual Analog Pain Scale
•
QUEST
•
MFES
•
User functional rating 
Scale
Participants (n=60)
30  Adults (without back pain), 30  Adults (with  back Pain)
Training to use Walker
Randomize order of testing conditions for 
each participant
Condition B: 
Predicate Mobility 
Device
Condition A: Life 
Walker
Condition C:  
Rollator Walker
Testing Protocol (3 trials/for each condition):
-Gait assessment
-Metabolic testing
- Self report measures
-Video taping
IRB #: STU00202634 Approved by NU IRB for use on or after 3/9/2018 through 3/8/2019.

PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
Device
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Achievable benchmarks include: (1) recruitment of 30 subjects who use a 
walked with low back pain and 30 subjects older adults who use a walker; 
(2) appropriate functional training of the LifeWalker Upright for all of the 
enrolled participants ; (3) completed clinical, performance outcome and 
self report measures for all of the of subjects. 
8.0
Procedures Involved
Participants will come to the laboratory for a screening and informed 
consent. Once written consent is obtained, participants will be screen for 
inclusion eligibility.
Screening/Baseline Procedures
•
Informed Consent
•
Medical history-Complete medical and surgical history, medications
•
Demographics-Age, gender, race, ethnicity
•
Review subject eligibility criteria
•
Testing sessions will take place over the course of 1-32 days and 
include the following clinical objective outcome measures, subjective 
self-report measures and metabolic measures listed.
Overall Sessions:
•
Session 1 will include, (i) Consent (ii) Some Self reported measures (baseline) 
and (iii) Indoor Gait assessment tests with or without metabolics (depending 
on equipment availability)
•
Session 2 will include, (i) Outdoor ambulation, (ii) Indoor gait assessment with 
or without metabolics (depending on equipment availability), and (iii) Self 
reported measures
•
Session 3 will include, any items that were not completed in session 1 or 2.

Life Walker Upright Training Procedures
8.1
Walker Training procedures 
All participants will be trained on the use of the Life Walker and 
standard Rollater for a time of 15 min. After training all the testing 
will be begin. 
8.2
Walker Testing procedures: Experimental order of which walker is 
used first, second and third during the testing will be randomized 
using a random number generator. 
IRB #: STU00202634 Approved by NU IRB for use on or after 3/9/2018 through 3/8/2019.

PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
Device
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8.3
Overview: Participants will first complete a series of gait testing. 
Gait testing will include metabolic testing using the K4B2, load and 
grip testing using load sensors and upper extremity and spine muscle 
electromyography (EMG) testing. Participants will also be asked to 
be videotaped during their training sessions. After all the testing is 
complete, participants will be asked to complete a set of self-report 
questionnaires.  During each device session, participant heart rate, 
blood pressure and blood oxygenation will be measured. All of these 
procedures will be repeated with each device.
8.4
Equipment
• Cosmed K4B2 Metabolic unit.  Cosmed K4B2 (K4B2 Cosmed, 
Italy) is a portable gas analysis system that measures oxygen 
consumption (VO2) and Carbon-dioxide production (VCO2 ) in a 
breath by breath fashion. K4B2 system consists of a portable unit 
and battery pack that weight about 2.4 lbs (1100 gm). The portable 
unit has O2 and CO2 analyzers that are bi-directionally connected 
to a flowmeter and turbine attached to a rubber facemask that is 
tightly strapped over subject’s nose and mouth.  K4B2 requires 
calibration before every testing session due to usage of heated 
sensors for measurements. Manufacturer’s recommend at least 45 
minutes warm up time for unit under ambient temperature (ideally 
at 20˚C) before calibration. K4B2 calibration involves verifying 
flowmeter and concentrations of gases with labeled concentrations. 
K4B2 acquires heart rate using a telemetric heart rate sensor that is 
strapped over subject’s thorax. The K4B2 and battery pack can be 
securely placed in slots on a standard harness worn by subject. 
This harness allows access to buttons on the unit on upper back 
and minimal interference to activities like walking. Data extraction 
and processing is carried using K4B2 custom software.
• Electromyography (EMG): Muscle activity will be 
collected from subjects by electrodes placed upon the skin 
over lower extremity muscles and also on the lower back 
muscles. This will be collected during the six-minute walk 
test. 
• Postural measurement (using EMG):  Muscle activity 
will be collected from subjects by electrodes placed upon 
the lower back muscles , upper extremities and lower 
extremities to measure the posture with each device.
• Grip and forearm strength load – Specialty gloves and 
load cells will be used to measure to amount of load 
participants are using when using each device on the hands 
IRB #: STU00202634 Approved by NU IRB for use on or after 3/9/2018 through 3/8/2019.

PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
Device
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and also on the forearm. This will be collected during the 
six-minute walk test.
• Activity monitors will be placed on the body or walker to collect 
body movement data.
• HR/BP: Subjects will wear a heart rate monitor during the study 
and blood pressure will be taken periodically with a standard BP 
cuff.
8.5
Clinical Testing
• 10 METER TIMED WALK (10mWT): This test will 
examine the patient’s gait speed. Patients will be directed to 
walk at a self-selected speed and at their preferred 
maximum but safe speed. Patients will be positioned 1 
meter before the start line and instructed to walk the entire 
distance and past the end line approximately 1 meter. The 
distance before and after the course are meant to minimize 
the effect of acceleration and deceleration. Time will be 
recorded using a stopwatch and recorded to the one 
hundredth of a second (ex: 2.15 sec). The test will be 
recorded 3 times each, with adequate rest in between. The 
average of the 3 times should be recorded. Participants will 
complete the 10mWT 6 times with each device: 3 times 
Self-selected; 3 times Fast-walking
• 6 MINUTE WALK TEST (6MWT): The 6 minute walk 
test is performed as an objective evaluation of functional 
exercise capacity. The 6minute walk test is easy to 
administer, well tolerated, and typically reflective of 
activities of daily living. The test measures the distance that 
the patient can walk on a flat, hard surface, indoors, in a 
period of 6 minutes. The walk test is patient self-paced and 
assesses the level of functional capacity. Patients are 
allowed to stop and rest during the test, however, the timer 
does not stop. If the patient is unable to complete the time, 
the time stopped is noted and reason for stopping 
prematurely is recorded. We will record the number of 
stops and stumbles during the test. This test will be 
administered while wearing a mask to measure oxygen 
consumption in addition to blood pressure, heart rate and 
oxygen saturation.
• TALKS WHILE WALKING TEST (TWWT Dual Task 
Test) : The TWWT is used to determine the effects of 
cognitive attentional demands during walking by 
IRB #: STU00202634 Approved by NU IRB for use on or after 3/9/2018 through 3/8/2019.

PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
Device
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introducing a secondary thinking and talking task, while 
walking. Participants will perform the following tasks, 
timed walking up to 50 meters, performing a thinking and 
talking (numerical and/or vocabulary) task while sitting and 
a dual task while walking (i.e. performing a thinking and 
talking task while walking). Participants voice will be 
recorded when performing all the thinking and talking tasks 
.
• GAITRITE DATA CAPTURE: The GAITRite system 
automates measuring temporal and spatial gait parameters 
via an electronic walkway connected to a computer. The 
GAITRite electronic walkway contains sensor pads 
encapsulated in a carpet to collect gait information. The 
system can be laid over any flat surface. The GAITRite 
electronic walkway for the study shall be a minimum of 14 
feet long. The GAITRite data capture was chosen as 
measurement of the patient’s overall gait quality. Patients 
will be asked to walk at a self-selected speed across the 
GAITRite electronic walkway. GAITRite. Participants will 
complete the GAITRite 6 times with each device: 3 times 
Self-selected; 3 times Fast-walking
• OUTDOOR AMBULATION: All participants will 
complete a structured outdoor course of straight walkway, 
ramps, and a standard side walk with curbs as well as a 
crosswalk. Time and RPE will be measured.
• DYNAMIC GAIT INDEX (DGI). The DGI is clinical test 
that assesses the individual’s ability to modify balance 
while walking with the walkers in the presence of external 
demands (i.e. demands like, level walking, look up amd 
down, left and right while walking, stepping over and 
walking around obstacles and cones). 
8.6
Self-Report Questionnaires
•
MODIFIED FALLS EFFICACY SCALE (mFES): The mFES 
is self-report questionnaire consisting of 14 items which is 
designed to measure fear of falling in the elderly. It assesses an 
individual’s perception of balance during activities of daily living 
by asking “how confident are you that you can do the following 
activities without falling.” 
•
MODIFIED FATIGUE IMPACT SCALE (mFIS): The mFIS is 
a 21-item short version of perceived impact of fatigue on the 
subscales of physical, cognitive, and psychosocial functioning.
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PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
Device
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•
THE QUEBEC USER EVALUATION OF SATISFACTION 
WITH ASSISTIVE TECHNOLOGY (QUEST) was designed to 
measure the level of satisfaction attribute to assistive technologies. 
It does so using 27 variables which are scored in terms of 
perceived importance and satisfaction.
•
VISUAL ANALOG PAIN SCALE (VAS): The Visual Analog 
Scale Pain Scale is a measure of perceived pain intensity. It 
consists of a horizontal line that is 10 centimeters long. On either 
side of the line is a description of pain- to the left the description 
will read “No pain,” and to the right the description will read 
“worst pain imaginable.”  The individual is instructed to mark a 
point on the continuum which represents his/her pain.
•
QUEBEC BACK PAIN DISABILITY Scale: The back pain 
scale is a self-report measure that evaluates a patient’s functional 
status related to back pain. 
•
BORG RATE OF PERCEIVED EXERTION: 6-20 item scale 
that measures perceived exertion during activity.
•
USER FUNCTIONAL RATING SCALE: Is specifically to 
assess the user’s perception of difficulty in performing the 
functional tasks when using the different assistive devices. The 
scale is similar to the patient specific functional scale wherein 
functional tasks are rated in level of their difficulty from “0” 
(“inability to perform the task”) to “10” (“no difficulty in 
performing the task.”). 
•
Brief Pain Inventory: This scale is a 9-item self-report measure of 
measure of perceived pain intensity at different body parts in the 
past 24 hours.
•
Rosenberg’s Self-Esteem Scale :
The Rosenberg Self-Esteem Scale is a 10-item self-report measure of global 
self-esteem. It consists of 10 statements related to overall feelings of self-
worth or self-acceptance. The items are answered on a four-point scale 
ranging from strongly agree to strongly disagree
9.0
Data Management
IRB #: STU00202634 Approved by NU IRB for use on or after 3/9/2018 through 3/8/2019.

PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
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9. 1       Subjects’ records will be kept completely confidential: Every possible 
precaution will be taken to protect the privacy interests of subjects. To 
begin with participation in this is completely voluntary. Trained research 
personnel will explain the purpose of the study and intended use of 
subject’s personal health information and precautions taken to keep the 
study information and data confidential. Data will be collected and kept 
confidential and compliant with HIPPAA requirements. Research data will 
be de-identified and stored in locked cabinets in the lab with access only 
to research staff. Electronic data will be de-identified and kept on secure, 
password protected files and password protected computers of RIC. Only 
authorized research personnel will have access to the study related data.
9.2        Record Retention: Study documentation will be collected and kept 
confidential and compliant with HIPPAA requirements. Data will be held 
for 3 years after the study is completed and published.
10.0
Withdrawal of Subjects*
10.1     Patient voluntarily withdraws 
10.2     Patient withdraws consent (termination of treatment and follow-up);
10.4
Patient is unable to comply with protocol requirements
10.5
Patient demonstrates change in medical condition
10.5     Patient experiences adverse event that makes continuation in the protocol 
unsafe;
10.6     PI judges continuation in the study would not be appropriate;
11.0
Risks to Subjects*
11.1 There is a risk of falling during training and testing. The risk of 
falling will be reduced by having each participant supervised during 
training and testing by a trained research professional in all testing 
procedures and fully trained in device use. During testing and 
training, the participant will use a gait belt for safety. Each 
participant will be educated in the safe use of the device and will 
demonstrate safe use with assistive devices, as necessary. The risk is 
similar to that during any clinical outpatient physical therapy 
session.
11.2 There is a risk of muscle soreness due to increased physical activity 
during training and testing sessions. All subjects will work with 
trained research staff. Adequate rest will be given and subjects will 
be monitored by the researchers for verbal or visual signs of fatigue 
or discomfort.
IRB #: STU00202634 Approved by NU IRB for use on or after 3/9/2018 through 3/8/2019.

PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
Device
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11.3 There is a risk of skin irritation from using the EMG electrode patches. The 
adhesive is hypo-allergenic. All subjects will be educated in signs and 
symptoms of skin irritation and we will remove the patches if irritation 
occurs. 
12.0
Potential Benefits to Subjects
12.1 There will likely be no direct benefit by participating in this research 
study. The participants might feel the differences between the devices and be better 
informed on devices that they may have better preferences for. 
13.0
Setting
13.1 Procedures will be performed in the clinical laboratory housed in a 
Rehabilitation inpatient and outpatient hospital.
14.0
Resources Available
14.1 Staffing: The RIC houses the Center for Bionic Medicine (CBM) 
which is an internationally recognized research center focused on the 
design, control, and evaluation of multi-function technologies for 
individuals with disabilities. The CBM is a large, fully equipped 
facility with a research team of more than 35 staff members 
including physicians, therapists, neuroscientists, engineers, software 
developers, graduate students, post-doctoral researchers, and 
administrative staff that facilitates integration of teaching, research, 
and clinical knowledge. 
All training will involve trained research staff, and will occur in compliance 
with standard clinical training methods. Subject safety will be paramount at 
all times; harness systems and clinical oversight will be in place when 
necessary.
14.2 Facilities:  The PI of this study, Arun Jayaraman, PT, PhD, is 
Director of the Max Nader Center for Rehabilitation Technologies 
and Outcomes (MN Center), within CBM at the RIC Hospital. The 
MN Center has laboratory space of 1000 sq. ft. for clinical 
evaluation of patients and assessment of ambulation and functional 
activities. This includes ramps, stairs, parallel bars, and other clinical 
evaluation equipment. This area is covered by an overhead support 
system such that a patient can move throughout the room and over 
obstacles while being safely harnessed in case of a stumble or fall. 
Adequate dedicated office space is available for private meetings 
with potential subjects, performing physical evaluations, explaining 
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PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
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the study protocol and obtaining study consent, performing data 
analysis, and writing manuscripts.
15.0
Recruitment Methods
15.1
Subjects will be recruited from the pain clinic at RIC. Furthermore, 
flyers, or the RIC. Interested participants will be directed to research staff 
who will inform them of the time commitment required and questioned 
regarding the inclusion/exclusion criteria. Once subjects have agreed to 
participate in the study, they will come to RIC for further participation 
instructions.
15.2    Subjects will be paid through the Clincard system if enrolled past the 
consenting and screening phase of the study. If subjects only come in for 
one visit they will be paid through petty cash. . Subjects will be 
compensated up to $100 for completing the study. Subjects will be 
compensated $50 for the first session and $50 for the second session. 
However, in the event that protocol needs to be spread across three 
sessions, subjects will be paid $50 for the first session and $25 for the 
second and third session.
16.0
Local Number of Subjects
The total number of subjects to be enrolled will be 30. We will enroll 30 
participants who use a walker due to back pain and 30 older adults who 
use a walker. 
17.0
Confidentiality
All personal information (names, addresses, email or phone numbers, etc.) 
gathered for this study that can identify participants will be kept secure to protect 
their privacy and will never be shared at any time with any person or entity. Data 
collected during the study and shared with others will reference participants only 
by an alphanumeric code. The “master list” linking personal information to the 
alphanumeric code will not be shared, and will be kept by the study PI in a secure 
location. All personal information linking participants to their data will be 
destroyed after three years (or according to RIC compliance procedures) 
following the completion of the study. De-identified information gathered from 
participants will be used by RIC.
18.0
Provisions to Protect the Privacy Interests of Subjects
Every possible precaution will be taken to protect the privacy interests of subjects. 
Participation in this study is completely voluntary. Trained research personnel 
will explain the purpose of the study and intended use of subject’s personal health 
information and precautions taken to keep the study information and data 
confidential.
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PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
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19.0
Compensation for Research-Related Injury
If the research involves more than Minimal Risk to subjects, describe If the 
subject gets an injury or illness as a result of study, subject is required to promptly 
notify the PI of the study about the illness or injury. The hospital [Researchers, 
RIC, Northwestern University and all affiliated clinical sites] will provide the 
basic immediate clinical care needed, however, any advanced or long-term 
clinical care will not be provided. Furthermore, any costs related to medical care 
required because of a bad outcome resulting from participation in this research 
study will not be compensated by the study PI or associated 
organization. However, this does not keep subject from seeking to be paid back 
for care required because of a bad outcome.
20.0
Process to Document Consent in Writing
20.1 Informed consent will take place at RIC’s Rehabilitation 
Technologies and Outcomes Lab in room 1771. 
20.2 Trained research personnel will guide the subject through consenting 
process. Subject will be given detailed explanation of the purpose, 
time line, commitment, procedures, data handling and privacy and 
confidentiality of information pertaining to the study.
21.0
Drugs or Devices
21.1
Classification - type of device: Rolling Walker
21.2
Storage and stability: Device is stored at RIC Flagship hospital-Room 
#1771. The device is accessible only to research staff.
21.3
Availability: Property of the Rehabilitation Technologies and Outcomes 
Research Lab at RIC.
IRB #: STU00202634 Approved by NU IRB for use on or after 3/9/2018 through 3/8/2019.

PROTOCOL TITLE: Life Walker vs. Conventional Rollator and Predicate Mobility 
Device
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IRB #: STU00202634 Approved by NU IRB for use on or after 3/9/2018 through 3/8/2019.