CONSENT TO PARTICIPATE IN RESEARCH

Collecting and Analyzing Floor Vibration Sensor Data During Human Gait

INTRODUCTION

You are invited to take part in a research study led by Dr. Sriram Malladi from the
Mechanical Engineering Department at Michigan Technological University, Dr. Smitha Rao
from the Biomedical Engineering Department at Michigan Technological University, and Dr.
Caroline Gwaltney from the Doctor of Physical Therapy Program at Central Michigan
University. Additionally, Central Michigan University Doctor of Physical Therapy students Chad
Garton and Erin Buckeridge will be actively involved in the research and data collection process.
You have the option to participate voluntarily in this study. Before deciding, please review the
information below and ask questions to ensure thorough understanding.
The primary aim of this research is to study a new method for assessing walking patterns.
We are seeking data from individuals with no recent history of muscle or joint injuries and no
neurological diagnosis affecting their walking. Approximately five people will be involved in
this study. If you choose to participate, you will be asked to walk along a path three times in one
day. You can participate in the study if you do not have any problems with your walking. You
and/or your insurance company will not incur any charges for your participation in this study.
This study does not provide compensation for data collection.

Thank you for considering participation in our study.

PURPOSE OF THE STUDY

The purpose of this study is to understand if using sensors on the floor can give clinicians
like physical therapists reliable information about walking patterns. Physical therapists currently
use observation skills to measure changes in walking after injury, which isn’t as precise as a
system that can measure walking objectively. This study aims to address these challenges by
providing accurate data of walking patterns.
Recognizing the critical role of walking speed and other variables as references for
community participation, our goal is to demonstrate the proof of concept with this device. By
doing so, we aim to pave the way for a more precise and clinically relevant understanding of
patient walking cycles. The limitations of subjective analysis underscore the need for objective
data in clinical decision-making and treatment planning, and this study seeks to bridge that gap.
Exploring the potential integration of this technology into routine clinical practice will lay the
foundation for future investigations into the clinical utility of gathering objective data on walking
cycles and its possibility of improving quality of care.
We want to show that this special device can help us learn more about how people walk.
This is important for the community. Right now, when doctors decide how to help someone walk
better, they mostly use their judgment. We think it's better to use facts and numbers to make
those decisions. This study is the first step to prove that our device works. If it does, it might be
used by doctors to make better plans for helping people walk. This could lead to better care for
patients. We hope that in the future, more research will be done to see if this device can really
make a big difference in how we help people improve their walking patterns resulting in a better
quality of life.
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PROCEDURES

If you volunteer to participate in this study, you will be asked to fill out a brief
questionnaire that includes questions about your age, sex, height, weight, and leg length. The
researchers will help you measure weight and leg length if you do not know that information.
You will also fill out a brief health history questionnaire to make sure you do not have a medical
problem that will affect your walking.

You will be asked to walk along a () foot platform situated on a raised platform. You will
wear a pair of athletic shoes provided for the study so that everyone in the study wears the same
kind of shoe. The trial will then be recorded by using floor sensors and computer-based
technology to track different aspects of your walking. You will be asked to walk starting with
your dominant foot following a hammer strike on the platform to signal the start of the trial.
When the trial is over, a hammer will strike the platform again to signal the end. We will ask
each participant to repeat walking over the platform two more times to total up to three trials of
walking on the platform. Dr. Sriram Malladi will look at different aspects of the walking trials to
determine if the technology is accurate enough to track how hard your foot strikes the ground,
distance between steps, how fast you are walking, and how far apart your feet are from side to
side when taking a step.

RISKS/DISCOMFORTS:

Potential to Trip
When we collect data on a platform that's a bit higher, there's a chance people might trip
when they step onto it because it's not the same level as the ground. To help with this, there will
be brightly colored tape on the platform edges. We will also give you a warning to make sure
the foot stepping onto the platform is lifted high enough to handle the difference in height. Also,
we'll allow you to walk across the platform before the three trials so you feel good about walking
on the slightly higher surface. A licensed physical therapist and/or student physical therapist will
be present for the trial. This way, we make sure you will be safe and comfortable when doing the
trials.

Injury Resulting from Risks/Discomforts

In the event of physical and/or mental injury resulting from participation in this research
project, Michigan Technological University does not provide any medical, hospitalization or
other insurance for participants in this research study, nor will Michigan Technological
University provide any medical treatment or compensation for any injury sustained as a result of
participation in this research study, except as required by law.

POTENTIAL BENEFITS TO SUBJECTS AND/OR TO SOCIETY

This study does not aim to improve your quality of life or health. You have the right to
refuse to participate in this study. Although participation in this study will not directly benefit
you, we hope to learn how this new technology tracks different walking patterns. This study will
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hopefully provide evidence to further investigate the accuracy of the platform so it can be tested
with people who have trouble walking. In the future, the system could be used in physical
therapy clinics and rehabilitation centers to improve clinicians’ ability to accurately measure
walking, which could improve access to physical therapy services for people who need them.

CONFIDENTIALITY

Any information obtained in connection with this study and that can be identified with
you will remain confidential and disclosed only with your permission or as required by law.
Confidentiality will be maintained using a unique code to your research study information
instead of using your name. The people who process data for each participant will not be able to
identify you. A second researcher who will not meet you will analyze the collected data and have
no connections to identifiable information that could link your data points to you.

Federal IRB regulations require records retention for three years after the final report is
completed. Your private information will be kept and stored on a computer. The computer is
password protected and is in a locked room requiring key access. Only the research team
members will have access to the information.

PARTICIPATION AND WITHDRAWAL

You can choose whether to be in this study. If you volunteer to be in this study, you may
withdraw at any time without consequences of any kind or loss of benefits to which you are
otherwise entitled. You may also refuse to answer any questions you do not want to answer.

IDENTIFICATION OF INVESTIGATORS

If you have any questions or concerns about this research, please contact:

Dr. Sriram Malladi

Phone Number: (906) 487-3503
Mailing address: 1400 Townsend Drive, MEEM 933, Houghton MI 49931
Email Address: smalladi@mtu.edu

Dr. Caroline Gwaltney

Phone Number: 906-487-3244
Mailing Address: 1402 E Sharon Ave Ste 300, Houghton MI 49931
Email Address: gwalt1c@cmich.edu

RIGHTS OF RESEARCH SUBJECTS

The Michigan Tech Institutional Review Board has reviewed my request to conduct this project.
If you have any concerns about your rights in this study, please contact the Institutional Review
Board, Michigan Tech-IRB at 906-487-2902 or email IRB@mtu.edu.
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I fully understand the study being done. My questions have been answered to my satisfaction,
and I confirm that I am age 18 years or older and I agree to participate in this study. I have been
given a copy of this form.

________________________________________
Printed Name of Subject

________________________________________ _________________________
Signature of Subject Date