Use of a Robotic Walking Device to Improve Home and Community Mobility in People With Parkinson's Disease
Phase: NA
Conditions: Parkinson Disease
Sponsor: Ohio State University

Cover Page 
Study Title: Use of a robotic walking device to improve home and community mobility in people 
with Parkinson’s disease 
Study ID: 2018H0397 
NCT number: NCT03751371
Date of Document: 10/17/2018 

 
1 
 
Use of a robotic walking device to improve home and community mobility in people with 
Parkinson’s disease 
 
Anne Kloos, Deb Kegelmeyer, Sandra Kostyk, Raquel Minarsch, David Kline 
 
BACKGROUND  
Individuals with Parkinson’s disease (PD) experience difficulty participating in meaningful activities in 
their homes and communities due to slowing and increased energy expenditure of walking. Exercise that 
involves repetitive practice of stepping like treadmill walking, tango dancing or use of external cueing to 
facilitate larger steps improve walking performance in the PD population.1-3 However, many individuals 
have difficulty adhering to regular exercise due to barriers including lack of access to exercise facilities, 
physical, cognitive, and psychologic (i.e., depression) impairments, and lack of motivation and/or self-
efficacy.4  To promote optimal functional recovery, rehabilitation interventions that encourage 
neuroplastic changes must provide high repetition, task-oriented movement training that promotes 
learning and sensory input.5 Robotic devices have incited high interest among researchers and clinicians 
in the neurorehabilitation field because they can deliver high repetition task-specific training, while 
reducing the manual labor burden on therapists during delivery of the rehabilitation.6  Clinical trials of 
robot-assisted treadmill training in individuals with PD demonstrate significant improvements in 
functional mobility, gait speed, walking endurance, freezing of gait, and quality of life.7-11 While these 
studies showed that people with PD accept and benefit from the use of robots, the robots used in these 
studies were large, heavy, complex robots (i.e., Lokomat, G-EO) that are cost prohibitive for most people 
and require months of training before they can be used independently. Recently, Honda Research and 
Development (R&D) developed a robotic exoskeleton called the Honda Walking Assist device (Honda 
R&D Co. Ltd., Wako, Japan) that is lightweight and portable with a goal of affordability and ease of use 
for therapists and patients.12 The HWA facilitates walking in people with gait deficits with little robotic 
interference while providing repetitive training of a symmetrical gait pattern in the home environment 
(Figure 1).  The device is worn around the 
user’s waist and thighs, and assists with hip 
flexion during swing initiation and hip 
extension during stance. The robot 
automatically calibrates leg movements to  
spatial and temporal cadence targets.13 The 
device does not interfere with sitting and is 
not active during sit to/from stand 
transfers. Variable device settings allow for 
personalized, specific assistance. 
Advantages of wearable robotics such as 
the HWA include easy donning and doffing, 
and greater ease of use and free movement 
in the home and community, all of which 
yield greater walking practice.14  By allowing high repetition task-based exercise in the home and 
community, the use of the HWA has the potential to overcome exercise/activity barriers, thereby 
leading to improved gait parameters to prevent or slow functional decline and improve quality of life 
in individuals with PD.  Previous laboratory-based studies have examined the effects of HWA device 
usage on gait spatiotemporal parameters and efficiency in healthy adult and neurological populations.14-
18 Healthy elderly and middle-aged adults showed temporary improvements in stride length, gait speed, 
and energy costs wearing the HWA compared to unassisted walking.15,16 Long-term HWA usage in 
patients with stroke improved gait parameters during unassisted walking.14,17 Preliminary findings in 12 
Figure 1. Honda Walking Assist Device 

 
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individuals with PD showed improved gait speed and walking endurance during unassisted walking after 
10-12 sessions of HWA training in a clinic.18 These preliminary findings of gait improvements in PD with 
HWA training warrant further study within home and community environments, and within a larger 
population of individuals with PD. Importantly, HWA training may be a useful intervention to overcome 
exercise barriers and improve mobility for daily life and warrants an innovative Phase II randomized 
controlled trial of real-world use over an extended period of time. 
 
Project Objectives. This study will determine the impact of HWA usage on mobility in the home and 
community in individuals with PD. It will also examine feasibility and safety of HWA usage in the PD 
population. As mobility limitations are highly associated with poor quality of life in people with PD,19-21 
any benefits of HWA usage to improve mobility are likely to positively impact the health and well-
being of individuals with PD. Specific Aim 1: Determine the short-term impact of mechanical gait 
assistance on efficiency and ease of walking in individuals with PD. With disease progression, individuals 
with PD develop gait impairments (e.g., slower gait velocity, shorter step lengths, increased step-to-step 
variability, and freezing of gait), that interfere with their abilities to perform daily living tasks and 
participate in work, home, and social activities and predispose them to falls.22  We hypothesize that 
wearing the HWA device will improve gait efficiency, gait parameters, and perceived ease of walking in 
individuals with PD compared to unassisted walking over a one session period. Positive findings of 
immediate improved walking efficiency and perceived ease of walking will suggest that HWA usage can 
ameliorate gait impairments in individuals with PD, and thereby possibly allow them to more easily 
perform daily tasks, participate in work, home, and social activities, and reduce their fall risk. Specific 
Aim 2: Determine the effect of long-term HWA device usage on the ease and ability to walk unassisted 
in the home and community in individuals with PD. Angular sensors embedded in the HWA monitor the 
cadence, angular velocity, and degree of hip extension and flexion of the device user.14 When the user 
initiates walking, the HWA automatically adjusts leg movements to reach target walk ratios (step 
length/cadence) by increasing the amount of hip flexion and/or extension using power supplied by the 
device. Thus, the HWA applies continuous, step-by-step cueing to individuals with PD to take bigger and 
more symmetrical steps, thereby producing a faster and more efficient walking pattern. By wearing the 
HWA device over an extended period of time, individuals with PD will repetitively practice walking with 
a more “normal” gait pattern, possibly driving neuroplastic changes that will translate to improve 
unassisted walking. We hypothesize that an 8-week intervention of HWA device usage will improve gait 
efficiency, gait parameters, perceived ease of walking, self-confidence, and daily physical activity in the 
home and community in individuals with PD with and without the use of the device. Positive findings 
would justify larger clinical trials to determine the efficacy of HWA device usage to encourage adherence 
to rehabilitation programs and to promote maintenance of an active lifestyle in individuals with PD.  
 
METHODS 
 
Participants: Adults aged 50-80 (n=46) who ambulate without assistance (Hoehn & Yahr stages 1-3) with 
diagnosed idiopathic PD and on stable doses of Parkinson’s medications for at least 4 weeks prior to the 
study will be recruited from the Ohio State Movement Disorders Clinic and community support groups. 
Exclusion criteria will be: presence of other significant cardiac, neurological or orthopedic problems that 
affect gait, weight more than 220 pounds and height greater than 6’8”, electronic medical devices 
embedded in the body, participating in any physical therapy, and inability to understand instructions 

 
3 
 
required by the study.  Study Design: Proof-of-concept of the HWA device has already been established 
in prior single arm studies.14-18 This study will be a prospective Phase II randomized controlled trial to 
assess preliminary efficacy.  HWA Device: The HWA device weighs 5.95 lbs and has two motors that run 
on a single rechargeable battery (Figure 2). The device is equipped with angle and established in prior 
single arm studies.14-18 This study will be a prospective Phase II randomized controlled trial to assess 
preliminary efficacy.  HWA Device: The HWA device weighs 5.95 lbs and has two motors that run on a 
single rechargeable battery (Figure 2). The device is equipped with angle and current sensors to monitor 
hip joint angle and torque output respectively. The assist torque is transmitted to the user’s thighs via 
thigh frames. A trained healthcare 
professional, who operates the device, can 
remotely change assist settings through 
software that runs on a mobile device. Honda 
will provide the researchers with a minimum of 
3 HWA devices of different sizes for use in this 
study. The HWA devices have points of 
adjustability at the Waist Frame and Thigh 
Frames (Figure 2), such that the devices can 
accommodate ~75% of adult, United States 
(US) body sizes.  Randomization: After 
obtaining written informed consent, 
participants will be randomly assigned to 1 of 2 
groups (Trained – HWA group, Untrained – 
usual care group). Randomization allocation 
will be 1:1 and stratified by Hoehn & Yahr stage.  Each stratum randomization scheme will be generated 
in permuted blocks of varying size.  These techniques will help to ensure a balance in the randomization 
among stage. The randomization scheme will be prepared, uploaded and overseen by the study’s 
biostatisticians. Given the nature of the intervention proposed, participants will know the intervention to 
which they have been assigned. Therefore, it will only be possible to blind assessors in this study. 
Procedures: Demographic information will be collected (i.e., age, sex, disease duration, Parkinson’s 
medications, numbers of falls in past 6 months) and a neurologist with UPDRS motor rating certification 
will administer the Unified Parkinson Disease Rating Scale (UPDRS) Part III –Motor Scale 23 to assess 
motor impairments and determine the Hoehn and Yahr stage. A researcher who is blinded to the 
participants’ group allocation and trained on relevant assessments will perform all outcome assessments. 
Assessments will be collected with participants in the ON phase at around one hour after taking their 
usual Parkinson’s medications. The primary outcome measure, gait velocity, will be used to validate the 
effectiveness of the HWA to improve gait parameters for both Aim 1 and 2. Gait velocity (e.g., walking 
speed) correlates with functional ability and has been linked to clinically meaningful changes in quality of 
life and in home and community walking behavior.24  Aim 1: Only participants randomized to the Trained 
group (n=23) will complete this part of the study to eliminate exposure of the Untrained group to the 
HWA device. Gait assessments will be conducted first during unassisted walking followed by HWA-
assisted (i.e., wearing the HWA device) walking, with rest breaks allowed between tests. Prior to HWA-
assisted walking, the researcher will select the appropriate sized HWA device, assist the participants to 
correctly don the device, and adjust the HWA device settings to maximize the participants’ safety while 
walking. The PIs are experts in application and use of the HWA device (preliminary data and unshown 
pilot studies). Initial device settings will be symmetrical flexion and extension assist bilaterally. The 
research therapist will make adjustments as needed based on the response to the symmetrical assist 
setting. If the therapist is unable to adjust the HWA to provide a safe gait pattern the testing will be 
ended and the device removed. Safe gait is defined as one that results in no increase in incidence of 
Figure 4. Components of the HWA Device 
Figure 4. Components of the HWA Device 
Figure 2. Components of the HWA Device 

 
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stumbles and/or balance loss during HWA-assisted walking as compared to unassisted walking. 
Outcomes: Gait efficiency will be assessed with the six-minute walk test (6MWT),25 gait parameters (i.e., 
velocity, stride length, swing time, double support, and their coefficients of variability) using GAITRite, 26 
gait safety using counts of observed episodes of stumbles and/or loss of balance, and participants’ 
perceived ease of walking as indicated on a visual analog scale (100 mm line with anchors “Not at all 
easy” on the left end and “Extremely easy” on the right end).The GAITRite System® (CIR systems, Inc.: 
Havertown PA) is a 4.88 m electronic walkway with sensors arranged in a gridlike pattern to capture 
footfall contacts.  The application software (version 3.9) processes the raw data into footfall patterns and 
computes spatial and temporal parameters. Participants will walk at a normal, comfortable pace across 
the walkway for 4 trials. The first trial under each condition will be a practice trial and the data from the 
remaining three trials for each condition will be averaged. Aim 2: All individuals (n=46) will participate in 
this part of the study. Intervention: After undergoing the pre-assessment, participants randomized to the 
Trained group will be fitted with the HWA device in their home by a research physical therapist. They will 
be directed to walk with the device on and the therapist will adjust the settings until a safe gait pattern is 
obtained. The initial setting used will be the one that produced the safest walking at the pre-assessment. 
Adjustments will be made based on the response to this initial setting. Participants who achieve a safe 
gait pattern will receive physical therapist supervised home and community-based walking training 
wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking 
in and outside of the home while encouraging larger and more symmetrical steps with practice of 
activities (e.g., multi-directional stepping, turning, navigating around obstacles) that challenge the 
person’s balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to 
adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed. The 
Untrained group will continue their usual daily activities including any exercise regimen that they typically 
perform.  However, they will be asked not to start any new exercise program during the study period. 
Outcomes: All assessments will be performed within one week prior to and after the 8 week intervention 
in the researcher’s laboratory at the Ohio State University with the exception of the activity monitors. 
The Untrained group will only perform gait assessments without use of the HWA. The same outcomes 
will be used from Aim 1 with addition of the Stanford Self-Efficacy for Measuring Chronic Disease 6-Item 
Scale (SSE) 27 questionnaire to measure participants’ confidence in performing daily activities. The SSE has 
been found to have good reliability and validity in individuals with Parkinson’s disease.28 To determine 
changes in activity levels, all participants will wear activity monitors (e.g., Biosensics LEGSysTM and 
PAMSysTM system wearable accelerometers) to quantitatively measure physical activity (e.g., number of 
steps, time spent walking, gait parameters, number of falls) for 5 consecutive days and complete a diary 
recording their daily activities during weeks 1 and 8 of the intervention period. To monitor safety during 
the study period the participants will be asked to record any falls (i.e., an event which causes the person 
to rest inadvertently on the ground or floor) or other adverse events that occur in a diary. Sample Size:  
The primary outcome for Aim 1 is to compare gait velocity pre and post treatment.  For Aim 1, we will use 
the 23 patients randomized to the treatment arm and will have at least 80% power to detect a difference 
of 0.61 standard deviations in gait velocity using a two-sided paired t-test with type I error rate of 0.05.   
The primary outcome for Aim 2 is the gait velocity at 8 weeks. For Aim 2, we will have at least 80% power 
with 18 evaluable patients per group to detect a difference of 0.96 standard deviations in gait velocity at 
week 8 using a two-sided t-test with type I error rate of 0.05.  Assuming a loss to follow-up rate of 20%, 

 
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we will enroll 23 patients per group for Aim 2. Data Analysis: The 
primary outcome for Aim 1 is the change in gait velocity with and 
without the use of the HWA device.  This analysis will compare 
the difference in gait velocity using a paired t-test.  The test of 
the with/without HWA gait  change will be two-sided and at the 
0.05 level.  Exploratory analyses may consider associations of 
difference with patient characteristics such as Hoehn & Yahr 
stage.  Secondary outcomes for Aim 1 will be analyzed similarly 
using appropriate methods for paired data.  The primary 
outcome for Aim 2 is gait velocity at 8 weeks.  The primary 
analysis will follow intention to treat principles to preserve the 
balancing properties of randomization.29,30  The primary analysis 
will assess the effect of treatment on gait velocity at 8 weeks 
using a linear regression model that includes an indicator of 
treatment, stage, and baseline gait velocity.  The test of the 
treatment effect will be two-sided and conducted at the 0.05 
significance level.  Sensitivity analyses will examine the per 
protocol population (those who followed the assigned treatment 
correctly) and will utilize methodology for handling missing data 
(i.e., multiple imputation) to account for loss to follow-up.  
Exploratory analyses may explore differences in the treatment 
effect across baseline patient characteristics (such as Hoehn & 
Yahr stage).  Secondary outcomes for Aim 2 will be assessed 
similarly to the primary outcome using appropriate generalized linear models. Interim Monitoring We 
will conduct an interim analysis to ensure that the rate of patients in the treatment arm unable to attain 
a safe gait is not unacceptably high.  We will evaluate the failure rate after 10 patients in the treatment 
arm complete the study.  If 5 or more of the 10 patients fail to attain a safe gait with the device, the study 
will stop to determine if termination is warranted.  Assuming an acceptable failure rate is 20%, we would 
have a 62% chance of correctly stopping the study early with an observed failure rate of 0.5.  With the 
same assumptions, we also have a 3% chance of incorrectly stopping the trial. According to Honda R&D 
personnel, all participants who have met inclusion criteria during studies with the device have been able 
to safely use the device during walking. Therefore, the failure rate of 20% is an estimation and not based 
on preliminary findings. We will also conduct an interim analysis of data to ensure data quality and refine 
data analysis processes at the end of 12 months. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure3. Study Flowsheet 

 
6 
 
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Sale P, De Pandis MF, Le Pera D, et al. Robot-assisted walking training for individuals with Parkinson's 
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Furnari A, Calabro RS, De Cola MC, et al. Robotic-assisted gait training in Parkinson's disease: a three-
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Fundaro C, Giardini A, Maestri R, Traversoni S, Bartolo M, Casale R. Motor and psychosocial impact of 
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Young AJ, Ferris DP. State of the Art and Future Directions for Lower Limb Robotic Exoskeletons. IEEE 
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Shimada H, Kimura Y, Suzuki T, et al. The use of positron emission tomography and 
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Buesing C, Fisch G, O'Donnell M, et al. Effects of a wearable exoskeleton stride management assist system 
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Shimada H, Suzuki T, Kimura Y, et al. Effects of an automated stride assistance system on walking 
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Otsuki R, Matsumoto H, Ueki M, et al. Automated stride assistance device improved the gait parameters 
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Tu XJ, Hwang WJ, Ma HI, Chang LH, Hsu SP. Determinants of generic and specific health-related quality of 
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CONSENT & 
AUTHORIZATION 
IRB Protocol Number:  2018H0397 
IRB Approval date:  10/17/2018 
Version:  1 
 
Page 1 
Form date: 07/18/16  
 
 
 
The Ohio State University Combined Consent to Participate in 
Research and HIPAA Research Authorization 
 
 
Study Title: Use of a robotic walking device to improve home and community mobility
people with Parkinson’s disease 
Principal Investigator: Anne Kloos, PT, PhD 
 
Sponsor: Michael J. Fox Foundation 
 
 
• This is a consent form for research participation.  It contains important 
information about this study and what to expect if you decide to participate.  
Please consider the information carefully. Feel free to discuss the study with your 
friends and family and to ask questions before making your decision whether or 
not to participate. 
• Your participation is voluntary.  You may refuse to participate in this study.  If 
you decide to take part in the study, you may leave the study at any time.  No 
matter what decision you make, there will be no penalty to you and you will not 
lose any of your usual benefits.  Your decision will not affect your future 
relationship with The Ohio State University.  If you are a student or employee at 
Ohio State, your decision will not affect your grades or employment status. 
• You may or may not benefit as a result of participating in this study.  Also, 
as explained below, your participation may result in unintended or harmful effects 
for you that may be minor or may be serious depending on the nature of the 
research. 
• You will be provided with any new information that develops during the 
study that may affect your decision whether or not to continue to 
participate.  If you decide to participate, you will be asked to sign this form and 
will receive a copy of the form.  You are being asked to consider participating in 
this study for the reasons explained below.   
 
1.   Why is this study being done? People with Parkinson’s disease develop 
difficulties with walking over time that prevent them for doing their daily activities and put 
them at higher risk of falling.  There is some emerging evidence that the use of 
mechanical walking devices (also known as robotic devices) can improve the walking 
ability of people with Parkinson’s disease. The purpose of this research is to determine 
the immediate and long-term impact of using a light-weight mechanical walking assist 
device that is worn around a person’s waist and thighs and helps to move a person’s legs 
to take bigger steps on the walking ability of people with Parkinson’s disease.   

CONSENT & 
AUTHORIZATION 
IRB Protocol Number:  2018H0397 
IRB Approval date:  10/17/2018 
Version:  1 
 
Page 2 
Form date: 07/18/16  
 
 
 
 
2.   How many people will take part in this study? 
46 individuals with a diagnosis of mild to moderate Parkinson’s disease will be 
recruited to participate in this study. 
 
 
3.   What will happen if I take part in this study? 
If you elect to be in the study you will be assigned to one of two groups, either a 
treatment group or a usual care group.  You will be asked information about your age, 
time since diagnosis, Parkinson’s medications, and a falls history and a researcher will 
have you perform motor tests (e.g., finger tapping, alternating movements, backward pull, 
getting up from chair, walking) that are routinely done in the clinic. You will be asked to 
walk at a comfortable pace for 6 minutes and you will walk over a mat that has sensors 
that record your footsteps. If you are in the treatment group you will perform these 
walking tests first without using a mechanical walking assist device and then again 
wearing the device. A researcher will help you to put on the device and will make sure 
that you are able to safely walk with the device before doing the testing. After the 6 
minute walking tests you will be asked to rate how easy you feel your walking is. You will 
also be asked to fill out a questionnaire that asks 6 questions about your confidence to 
perform daily activities. All of the walking tests and questionnaires will be conducted in 
the researchers’ laboratory at the Ohio State University. During the first week and the 
eighth week after the initial laboratory testing, you will be asked to wear activity monitors 
attached to your trunk and both legs with straps during the day for 5 consecutive days 
and complete a diary of your daily activities during those days.  
 
If you are in the treatment group you will be asked to take part in a walking training 
program using the mechanical walking assist device for 45-60 minutes per session for 
two days a week for eight weeks under the supervision of a physical therapist.  The 
training will take place in your home and/or outside your home as you are doing walking 
activities.  If you are in the control group you will be asked to continue your usual care. 
 
After eight weeks you will go back to the laboratory at the Ohio State University where 
you  will undergo all of the same walking tests and questionnaires that you did at the first 
visit. 
 
4.   How long will I be in the study? 
The study will last for 8-10 weeks.  This includes 2 testing sessions and 8 weeks of 
walking training wearing the mechanical walking assist device for a total of 16 sessions. 
 
5. Can I stop being in the study? 
 
You may leave the study at any time.  If you decide to stop participating in the study, 
there will be no penalty to you, and you will not lose any benefits to which you are 

CONSENT & 
AUTHORIZATION 
IRB Protocol Number:  2018H0397 
IRB Approval date:  10/17/2018 
Version:  1 
 
Page 3 
Form date: 07/18/16  
 
 
otherwise entitled.  Your decision will not affect your future relationship with The 
Ohio State University.  
 
 
6.   What risks, side effects or discomforts can I expect from being in the study? 
There is a risk that you could become tired or have muscle soreness during or after the 
walking training. You will be allowed to rest whenever you need to rest. Muscle soreness, if 
it develops, usually resolves within 24 hours. There is a risk that you could fall during the 
walking training. The therapist will observe your walking with the mechanical walking assist 
device and make adjustments as needed to ensure that you are able to walk safely with the 
device. The therapist will also put a gait belt around your waist and will guard you at all 
times while you are walking.  
 
 
7.   What benefits can I expect from being in the study? 
You may obtain some physical conditioning from the walking training wearing the 
mechanical walking assist device. By participating in the study you will help us to 
know whether the device could potentially improve the walking ability of individuals 
with Parkinson’s disease in their homes and communities. 
 
 
8.   What other choices do I have if I do not take part in the study? 
 
You may choose not to participate without penalty or loss of benefits to which you 
are otherwise entitled. 
 
 
9. What are the costs of taking part in this study? 
You will have to drive to and from the Ohio State University 2 times eight weeks 
apart. There will be no cost for parking but you will incur costs for gasoline.  
 
 
10. Will I be paid for taking part in this study? 
 
By law, payments to subjects are considered taxable income. You may receive up to 
$75.00 for completing the study.  You will receive $25.00 if you complete the initial 
testing session and $50.00 if you complete the second testing session. 
 
 
11. What happens if I am injured because I took part in this study? 
 
If you suffer an injury from participating in this study, you should notify  Sandra 
Kostyk, MD, PhD at 614-685-1734, who will determine if you should obtain medical 
treatment at The Ohio State University Wexner Medical Center.   
 

CONSENT & 
AUTHORIZATION 
IRB Protocol Number:  2018H0397 
IRB Approval date:  10/17/2018 
Version:  1 
 
Page 4 
Form date: 07/18/16  
 
 
The cost for this treatment will be billed to you or your medical or hospital insurance. 
The Ohio State University has no funds set aside for the payment of health care 
expenses for this study.  
 
 
12. What are my rights if I take part in this study? 
 
If you choose to participate in the study, you may discontinue participation at any 
time without penalty or loss of benefits.  By signing this form, you do not give up any 
personal legal rights you may have as a participant in this study. 
 
You will be provided with any new information that develops during the course of the 
research that may affect your decision whether or not to continue participation in the 
study. 
 
You may refuse to participate in this study without penalty or loss of benefits to 
which you are otherwise entitled. 
 
An Institutional Review Board responsible for human subjects research at The Ohio 
State University reviewed this research project and found it to be acceptable, 
according to applicable state and federal regulations and University policies 
designed to protect the rights and welfare of participants in research. 
 
 
13. Will my study-related information be kept confidential? 
 
Efforts will be made to keep your study-related information confidential.  However, there 
may be circumstances where this information must be released.  For example, personal 
information regarding your participation in this study may be disclosed if required by state 
law.   
 
Also, your records may be reviewed by the following groups (as applicable to the research): 
• 
Office for Human Research Protections or other federal, state, or international 
regulatory agencies; 
• 
U.S. Food and Drug Administration; 
• 
The Ohio State University Institutional Review Board or Office of Responsible 
Research Practices; 
• 
The sponsor supporting the study, their agents or study monitors; and 
• 
Your insurance company (if charges are billed to insurance). 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. law.  This website will not include information that can identify you.  At 
most, the website will include a summary of the results.  You can search the website at any 
time.  
 

CONSENT & 
AUTHORIZATION 
IRB Protocol Number:  2018H0397 
IRB Approval date:  10/17/2018 
Version:  1 
 
Page 5 
Form date: 07/18/16  
 
 
14. HIPAA AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR 
      RESEARCH PURPOSES  
 
I. 
What information may be used and given to others? 
 
• Past and present medical records; 
• Research records; 
• Records about phone calls made as part of this research; 
• Records about your study visits; 
• Information that includes personal identifiers, such as your name, or a 
number associated with you as an individual; 
• Information gathered for this research about: 
Physical exams 
Diaries and questionnaires 
• Records about the study device. 
 
II. 
Who may use and give out information about you? 
 
Researchers and study staff.   
 
III. Who might get this information? 
 
• The sponsor of this research.  “Sponsor” means any persons or companies 
that are: 
• working for or with the sponsor; or  
• owned by the sponsor. 
• Authorized Ohio State University staff not involved in the study may be aware 
that you are participating in a research study and have access to your 
information; 
• If this study is related to your medical care, your study-related information 
may be placed in your permanent hospital, clinic or physician’s office record; 
• Others: Michael J. Fox Foundation  
 
IV. 
 Your information may be given to: 
  
• The U.S. Food and Drug Administration (FDA), Department of Health and 
Human Services (DHHS) agencies, and other federal and state entities; 
• Governmental agencies in other countries; 
• Governmental agencies to whom certain diseases (reportable diseases) must 
be reported; and  
• The Ohio State University units involved in managing and approving the 
research study including the Office of Research and the Office of Responsible 
Research Practices. 
 

CONSENT & 
AUTHORIZATION 
IRB Protocol Number:  2018H0397 
IRB Approval date:  10/17/2018 
Version:  1 
 
Page 6 
Form date: 07/18/16  
 
 
V. 
Why will this information be used and/or given to others? 
 
• To do the research;  
• To study the results; and  
• To make sure that the research was done right.   
 
VI. 
 When will my permission end? 
 
There is no date at which your permission ends. Your information will be used 
indefinitely. This is because the information used and created during the study may 
be analyzed for many years, and it is not possible to know when this will be 
complete. 
 
VII. May I withdraw or revoke (cancel) my permission? 
 
Yes. Your authorization will be good for the time period indicated above unless you 
change your mind and revoke it in writing. You may withdraw or take away your 
permission to use and disclose your health information at any time. You do this by 
sending written notice to the researchers. If you withdraw your permission, you will 
not be able to stay in this study. When you withdraw your permission, no new health 
information identifying you will be gathered after that date. Information that has 
already been gathered may still be used and given to others. 
 
VIII. What if I decide not to give permission to use and give out my 
health information? 
 
Then you will not be able to be in this research study and receive research-related 
treatment.  However, if you are being treated as a patient here, you will still be able 
to receive care. 
 
IX. 
 Is my health information protected after it has been given to 
others? 
 
There is a risk that your information will be given to others without your permission. 
Any information that is shared may no longer be protected by federal privacy rules. 
 
X. 
May I review or copy my information? 
 
Signing this authorization also means that you may not be able to see or copy your 
study-related information until the study is completed.   
 
 
15. Who can answer my questions about the study? 
 

CONSENT & 
AUTHORIZATION 
IRB Protocol Number:  2018H0397 
IRB Approval date:  10/17/2018 
Version:  1 
 
Page 7 
Form date: 07/18/16  
 
 
For questions, concerns, or complaints about the study, or if you feel you have been 
harmed as a result of study participation, you may contact Anne Kloos 614-688-
5942. 
 
For questions related to your privacy rights under HIPAA or related to this research 
authorization, please contact Frank White at 614-685-1734. 
 
For questions about your rights as a participant in this study or to discuss other 
study-related concerns or complaints with someone who is not part of the research 
team, you may contact Ms. Sandra Meadows in the Office of Responsible Research 
Practices at 1-800-678-6251. 
 
If you are injured as a result of participating in this study or for questions about a 
study-related injury, you may contact Sandra Kostyk, MD, PhD at 614-685-1734. 
 
 

CONSENT & 
AUTHORIZATION 
IRB Protocol Number:  2018H0397 
IRB Approval date:  10/17/2018 
Version:  1 
 
Page 8 
Form date: 07/18/16  
 
 
Signing the consent form 
 
I have read (or someone has read to me) this form and I am aware that I am being asked 
to participate in a research study.  I have had the opportunity to ask questions and have 
had them answered to my satisfaction.  I voluntarily agree to participate in this study.  
 
I am not giving up any legal rights by signing this form.  I will be given a copy of this 
combined consent and HIPAA research authorization form. 
 
Printed name of subject 
Signature of subject 
AM/PM 
Date and time 
Printed name of person authorized to consent for 
subject (when applicable) 
Signature of person authorized to consent for subject  
(when applicable) 
AM/PM 
Relationship to the subject 
Date and time 
 
 
 
Investigator/Research Staff 
 
I have explained the research to the participant or his/her representative before 
requesting the signature(s) above.  There are no blanks in this document.  A copy of this 
form has been given to the participant or his/her representative. 
 
Printed name of person obtaining consent 
Signature of person obtaining consent 
AM/PM 
Date and time 
 
Witness(es) - May be left blank if not required by the IRB 
 
Printed name of witness 
Signature of witness 
AM/PM 
Date and time 
Printed name of witness 
Signature of witness 
AM/PM 
Date and time