Reinforcing CP Robotic Training With Auditory Feedback
Phase: NA
Conditions: Cerebral Palsy
Sponsor: State University of New York at Buffalo

 
Title  
Novel Gait Training Paradigm to Promote Healthy Aging in Individuals 
with Cerebral Palsy 
IRB Institution 
University at Buffalo 
IRB Approval period 
3/7/22-3/6/23 

 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federalwide Assurance ID#: FWA00008824 
Page 1 of 34 
 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions ...................................................... Error! Bookmark not defined. 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives* .............................................................................................................. 4 
3.0 
Scientific Endpoints* ............................................................................................... 4 
4.0 
Background* ............................................................................................................ 5 
5.0 
Study Design* .......................................................................................................... 7 
6.0 
Study Intervention/Investigational Agent ................................................................ 8 
7.0 
Local Number of Subjects ..................................................................................... 10 
8.0 
Inclusion and Exclusion Criteria* .......................................................................... 10 
9.0 
Vulnerable Populations* ........................................................................................ 12 
10.0  Eligibility Screening* ............................................................................................ 13 
11.0  Recruitment Methods ............................................................................................. 13 
12.0  Procedures Involved* ............................................................................................. 14 
13.0  Study Timelines* ................................................................................................... 16 
14.0  Setting .................................................................................................................... 16 
15.0  Community-Based Participatory Research ............................................................ 17 
16.0  Resources and Qualifications ................................................................................. 17 
17.0  Other Approvals ..................................................................................................... 18 
18.0  Provisions to Protect the Privacy Interests of Subjects .......................................... 19 
19.0  Data Management and Analysis* .......................................................................... 19 
20.0  Confidentiality* ..................................................................................................... 20 
A. 
Confidentiality of Study Data.......................................................................... 20 
B. 
Confidentiality of Study Specimens ................................................................ 21 
21.0  Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 22 
22.0  Withdrawal of Subjects* ........................................................................................ 23 
23.0  Risks to Subjects* .................................................................................................. 24 
24.0  Potential Benefits to Subjects* .............................................................................. 25 
25.0  Compensation for Research-Related Injury ........................................................... 25 
26.0  Economic Burden to Subjects ................................................................................ 26 
27.0  Compensation for Participation ............................................................................. 26 
28.0  Consent Process ..................................................................................................... 26 
29.0  Waiver or Alteration of Consent Process ............................................................... 31 
30.0  Process to Document Consent ............................................................................... 31 
31.0  Multi-Site Research (Multisite/Multicenter Only)* ............................................... 32 
32.0  Banking Data or Specimens for Future Use* ........................................................ 33 
 
 
 

 
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PROTOCOL TITLE: 
Include the full protocol title. 
Response: Novel Gait Training Paradigm to Promote Healthy Aging in 
Individuals with Cerebral Palsy 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response:  
Jiyeon Kang, PhD 
Dept. of Mechanical and Aerospace 
Room 1011 Furnas Hall, Buffalo, NY 14260 
Phone: (716) 645 6063 
Fax: (716) 645 2883 
jiyeonk@buffalo.edu 
VERSION NUMBER/DATE: 
Include the version number and date of this protocol. 
Response: 1 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
10/7/2021 
Pre/post evaluation measures 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FUNDING: 
Indicate any funding for this proposal. This should match the Funding Sources 
page in Click IRB. 
Response: 2019-20 SUNY Research Seed Grant Program RFP #20-02-
RSG 
 
GRANT APPLICABILITY: 

 
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IRB Version: 1/23/19 
Indicate whether this protocol is funded by a grant (e.g. NIH, foundation grant). 
For a grant with multiple aims, indicate which aims are covered by this research 
proposal. 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission.   
Response: 2019-20 SUNY Research Seed Grant Program RFP #20-02-
RSG Aim 2 Investigate the potential of reinforcing the retention of cable-
actuated training by providing auditory feedback to eight adults with 
cerebral palsy   
RESEARCH REPOSITORY: 
Indicate where the research files will be kept, including when the study has been 
closed. The repository should include, at minimum, copies of IRB correspondence 
(approval, determination letters) as well as signed consent documents. This 
documentation should be maintained for 3 years after the study has been closed.  
Response: The copies of IRB correspondence or signed consent forms will be 
stored in a locked cabinet located in Furnas Hall Room 809. Only personnel 
related to the project will have access to the document. 
Location: Cabinet with key access 
Address: Room 809 Furnas Hall, Buffalo, NY 14260  
Department: Dept of Mechanical and Aerospace Engineering 
1.0 Study Summary 
 
Study Title 
Novel Gait Training Paradigm to Promote Healthy Aging in 
Individuals with Cerebral Palsy 
Study Design 
Adults with cerebral palsy will be recruited to conduct the 
feasibility testing of our hypothesis for multiple training 
sessions. 
Primary Objective 
The purpose of this study is to create a platform to prolong 
the adaption obtained from the cable-actuated gait training 
and encourage the individuals with CP to provide self-care at 
home. 
Secondary 
Objective(s) 
Investigate the potential of reinforcing the retention of cable-
actuated training by providing auditory feedback to adults 
with cerebral palsy   
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
This study includes cable-actuated strength training and 
auditory feedback to reinforce the feedback. 
IND/IDE #  
N/A 
Study Population 
Adults with Cerebral Palsy 
Sample Size 
20 

 
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Study Duration for 
individual 
participants 
2 Years 
Study Specific 
Abbreviations/ 
Definitions  
 sEMG: surface electromyography 
 DOF: degree of freedom 
 CP : cerebral palsy 
2.0 Objectives* 
2.1 Describe the purpose, specific aims, or objectives of this research. 
Response: (1) Investigate the benefit of the strength training of adults with 
cerebral palsy using a cable-actuated robot.  
(2) Investigate the potential of reinforcing the retention of cable-actuated training 
by providing auditory feedback to eight adults with cerebral palsy.   
 
2.2 
State the hypotheses to be tested, if applicable. 
NOTE: A hypothesis is a specific, testable prediction about what you expect to 
happen in your study that corresponds with your above listed objectives. 
Response:  
(1) We hypothesized that individuals with cerebral palsy will benefit from the 
cable-actuated strength training to improve their walking ability and posture.  
(2) We hypothesized that auditory feedback will reinforce the retention of cable-
actuated training.  
 
3.0 Scientific Endpoints* 
 
2.1  Describe the scientific endpoint(s), the main result or occurrence under 
study.  
 
NOTE: Scientific endpoints are outcomes defined before the study begins to determine 
whether the objectives of the study have been met and to draw conclusions from the data. 
Include primary and secondary endpoints. Some example endpoints are: reduction of 
symptoms, improvement in quality of life, or survival. Your response should not be a 
date.  
Response: The two primary outcome measures will be the motion and the muscle 
activation data of the lower body during walking. Motion trajectory will be used 
to detect the changes in the kinematics and sEMG data will present the muscle 
activation of the participants. Ground reaction force, center of pressure, and center 
of mass will be evaluated with the instrumented insole and treadmill. Before the 
first and after the last training, participants will be evaluated for functional gait 
assessment, 6-min-walk, leg strength using dynamometer, international physical 
activity questionnaire (short form), usability questionnaire, and Modified 
Ashworth test by a physical therapist. This will show the kinematic and kinetic 
changes of the participant after the training. 

 
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4.0 Background* 
4.1 Provide the scientific or scholarly background, rationale, and significance 
of the research based on the existing literature and how it will contribute to 
existing knowledge. Describe any gaps in current knowledge. Include 
relevant preliminary findings or prior research by the investigator.  
Response: Cerebral palsy is a neurological disorder that occurs around birth, 
impairing movement and posture which leads to critical limitations in their daily 
lives. About 3.6 children out of every 1000 school-aged children are diagnosed 
with cerebral palsy [1], and their life expectancy is significantly increased due to 
the advanced medical technology [2]. Past research has primarily focused on 
children with cerebral palsy to restore their motor function. Comparatively, 
attention to the adult with CP has been sparse and the evolution of the motor 
disorder through adulthood has not been well understood [3]. It is suggested that 
individuals with CP age prematurely, demonstrating early declines in physical 
function and mobility, presumably due to the changes in strength, flexibility, and 
endurance [3]. Therapeutic services have primarily been designed for children 
with CP without considering longer-term aging with a disability. There is a need 
to develop interventions that are adult-focused and can improve the motor 
function of individuals aging with CP.   
 
     Deterioration of locomotion skills is a major problem in persons with CP. This 
can lead to a sedentary lifestyle at an early age and a significant decrease in the 
quality of life [4]. A few studies have addressed progressive resistive strength and 
aerobic training in adults with CP which show significant strength improvements 
in their walking ability and gait parameters [5]. As an extension of these studies, 
we investigated the use of targeted gait training using a cable-actuated system 
over a treadmill that promoted strengthening during walking in children with CP 
[6]. This cable-actuated system provided downward force and participants had to 
extend their legs against the force while walking on a treadmill. This leads to a 
straighter walking posture, longer stride, and reduced toe-walking pattern in a 
supervised environment. Once the participants were taken out of the actuated 
cable system, they showed immediate improvement of knee extension and heel-
to-toe walking. This is because participants recalibrated their movement to walk 
against the downward force and its effect lasted for a while after the force was 
removed. This after-effect of adaptation may be used in physical therapy to let the 
patients experience a more normal movement pattern [7]. In the proposed study, 
we will introduce the use of instrumented insoles to provide feedback to sustain 
positive after-effects in unsupervised ecological environments. Sensory feedback 
has been shown to improve the gait features of individuals with cerebral palsy in 
the past [8, 9, 10]. We will use similar methods to assist adults with CP to retain 
the positive motor adaptation from using the cable-actuated system on the 
treadmill. We will collect pressure data, foot clearance, heel-to-toe pattern from 
smart insoles and provide feedback to the participant on their gait pattern. We 

 
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hypothesize that once participants have experienced gait in response to resisted 
gait training, the feedback from the insoles will assist them to maintain the 
improved gait. Furthermore, we hypothesize that the use of sensory feedback with 
minimal supervision will lead these individuals to take an active role in their gait 
training. It can foster collaboration between the therapist and participant in the 
shared goal of improved gait quality. These are essential components of self-
management, especially important for individuals with chronic conditions like 
cerebral palsy.  
The goal of the suggested work is to retain the positive after-effects of resistive 
gait training for longer periods using sensory feedback until it becomes the normal 
gait pattern by repeated and reinforced training. For the first time, we will examine 
the feasibility of using sensory feedback to reinforce the adaptation from the 
resisted gait training. Previous robotic devices focused on the adaption itself 
during the training, but methods on sustaining the adaptation after the training have 
not been well studied, despite the significance of maintaining the adaptation. 
Different types of auditory feedback will be explored using the data from smart 
insoles to extend the carry-over effect of motor adaption during training. The 
knowledge of this study can be widely used in other rehabilitation devices to 
sustain and maximize the training effect. Secondly, this approach creates a 
rehabilitation platform that includes both supervised and unsupervised training 
which can lead to the participant taking a more active role in their care. Once 
participants step off the treadmill, they will use the instrumented insoles and the 
sensory feedback to maintain positive gait changes from the gait-resisted training. 
By suggesting a training method collaborating in-clinic, we envision a successful 
therapeutic intervention that is tailored to the needs of an adult with CP. It provides 
in-clinic gait resisted training to safely provide a stimulus that can alter their gait. 
The proposed study would also create a rich biomechanical data set over the whole 
gait cycle of adults with CP. Since this is an understudied population, this 
information would be invaluable to clinicians and researchers. This data set will 
help to understand neuromechanical characteristics of the gait of adults with CP 
for future implications in physical and pharmacological interventions, and as the 
long-term mission to promote healthy aging in the population with cerebral palsy 
by improving their functional mobility. 
4.2 Include complete citations or references  
Response:  
[1] M. Yeargin-Allsopp, K. N. Van Braun, N. S. Doernberg, R. E. Benedict, R. S. 
Kirby, and M. S. Durkin, “Prevalence of cerebral palsy in 8-year-old children in 
three areas of the united states in 2002: A multisite collaboration,” Pediatrics, 2008, 
doi: 10.1542/peds.2007-1270. 
[2] D. Wilson-Costello, H. Friedman, N. Minich, A. A. Fanaroff, and M. Hack, 
“Improved survival rates with increased neurodevelopmental disability for 
extremely low birth weight infants in the 1990s,” Pediatrics, 2005, doi: 
10.1542/peds.2004-0221. 

 
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[3] P. Haak, M. Lenski, M. J. C. Hidecker, M. Li, and N. Paneth, “Cerebral palsy 
and aging,” Developmental Medicine and Child Neurology. 2009, doi: 
10.1111/j.1469-8749.2009.03428.x. 
[4] Jahnsen R, Villien L, Egeland T, Stanghelle JK, Holm I. Locomotion skills in 
adults with cerebral palsy. Clin Rehabil. 2004 May;18(3):309-16. doi: 
10.1191/0269215504cr735oa. PMID: 15137562. 
[5] D. Thorpe, “The role of fitness in health and disease: Status of adults with 
cerebral palsy,” Developmental Medicine and Child Neurology. 2009, doi: 
10.1111/j.1469-8749.2009.03433.x. 
[6] J. Kang, D. Martelli, V. Vashista, I. Martinez-Hernandez, H. Kim, and S. K. 
Agrawal, “Robot-driven downward pelvic pull to improve crouch gait in children 
with cerebral palsy,” Sci. Robot., 2017, doi: 10.1126/scirobotics.aan2634. 
[7] L. A. Malone and A. J. Bastian, “Thinking about walking: Effects of conscious 
correction versus distraction on locomotor adaptation,” J. Neurophysiol., 2010, doi: 
10.1152/jn.00832.2009. 
[8] van Gelder LMA, Barnes A, Wheat JS, Heller BW. The use of biofeedback for 
gait retraining: A mapping review. Clin Biomech (Bristol, Avon). 2018 
Nov;59:159-166. doi: 10.1016/j.clinbiomech.2018.09.020. Epub 2018 Sep 20. 
PMID: 30253260. 
[9] Ghai S, Schmitz G, Hwang TH, Effenberg AO. Auditory Proprioceptive 
Integration: Effects of Real-Time Kinematic Auditory Feedback on Knee 
Proprioception. Front Neurosci. 2018;12:142. Published 2018 Mar 8. 
doi:10.3389/fnins.2018.00142 
[10] M. Batavia, J. G. Gianutsos, A. Vaccaro, and J. T. Gold, “A do-it-yourself 
membrane-activated auditory feedback device for weight bearing and gait training: 
A case report,” Arch. Phys. Med. Rehabil., 2001, doi: 10.1053/apmr.2001.21931. 
5.0 Study Design* 
5.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response: The experiment protocol involves a maximum of ten sessions 
and will take two or three hours for each session. Baseline data will be 
collected before the first session for both overground and treadmill walking. 
During this session, the sound level will be adjusted based on the feedback 
received from the users. The researcher will ask the comfortable sound level 
to the participant before starting the experiment. Training will be conducted 
on the treadmill with the cable-actuated device for about 20 minutes. When 
the cables were removed, participants walked on the treadmill for 4 minutes 
during the post-training session. During training and post-training, 
participants will be exposed to feedback while walking on the treadmill. 
After treadmill walking, CP participants will be asked to take a ten-minute 
break and then practice overground walking for two minutes with auditory 
feedback (type A) and without it (type B). Effects of 3 different types of 

 
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auditory feedback will be explored namely, rhythmic sounds, movement 
sonification, and sound notifying erroneous gait. Group A participants will 
be further divided into groups depending on the type of auditory feedback 
that will be provided. Participants will participate in a maximum of 10 
sessions, two or three times a week. Before the first and after the last 
training, participants will be evaluated for functional gait assessment, 6-
min-walk, leg strength using a dynamometer, international physical activity 
questionnaire (short form), usability questionnaire, and Modified Ashworth 
test by a physical therapist. 
 
6.0 
Study Intervention/Investigational Agent 
1.1 Description: Describe the study intervention and/or investigational 
agent (e.g., drug, device) that is being evaluated. 
Response:  
A cable-actuated system that can apply a therapeutic force while walking was 
developed in our past study. The system consists of motorized cables, belt, and 
tension sensors to apply a downward force to strengthen the legs. During the 
training, participants powered soleus muscles more and changed the coordination 
of gastrocnemius muscles. Six children with crouch gait and diplegia participated 
in the experiment for 15 sessions. After 15 sessions, six children with CP presented 
better foot clearance, heel-toe pattern, and straighter walking posture during the 
stance. These children also showed immediate change when the cables were 
removed by recalibrating their CNS against the downward force. To walk against 
the resistance force, children provide feedforward control of their anti-gravity 
muscles to create larger upward force. When the cables were removed, they still 
kept the increased muscle force which resulted in stronger stride, heel-toe pattern, 
and foot clearance [1] 
Our smart insoles have shown the capability to provide a full gait monitoring 
strategy during daily life [2]. This system is fully portable and equipped with 
pressure sensors, an IMU, a microcontroller, a Bluetooth module, and a battery. An 
array of pressure sensors is integrated into the insole to measure the pressure 
distribution with an IMU to provide the posture of the foot. The device can provide 
spatiotemporal gait parameters, pressure distribution, the center of pressure, and 
foot clearance with a wireless system and mobile application. The unique design of 
the pressure sensor allows detecting abnormal foot contact with the ground which 
is typically found in patients with a neurological movement disorder. The shoe was 
tested on stroke patients and the elderly to monitor their gait patterns in real-time. 
Using the insole, we will measure the gait characteristics of the individuals such as 
gait parameters, ground reaction force, the center of pressure to provide auditory 
feedback [3]. An instrumented treadmill manufactured by Bertec will also be used 
as a backup in case we face technical issues with the smart insole [4]. The 
instrumented treadmill allows for highly accurate 6-axis load measurement for 
each lower limb.   

 
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Furthermore, using the data from the smart insole and Bertec Force plate 
instrumented treadmill, three different types of auditory feedback will be provided 
to the selected participants. The sound level of the auditory feedback is adjustable 
and will be determined based on the user’s feedback during the baseline trials. 
Rhythmic auditory feedback will be generated to provide participants information 
about the cadence which will help them synchronize their footsteps. Another type 
of auditory feedback consists of, an unpleasant sound which will be generated in 
case the gait characteristics such as knee flexion or ankle plantarflexion of the 
participants abnormal. The last type of auditory feedback will comprise modulating 
the characteristics such as pitch and tempo of the sound to reflect the motion of the 
lower limbs[5]. Analyzing the effects of these different types of auditory feedback 
will not only allow us to identify if auditory feedback aids in the retention of benefit 
from strength training for a longer duration but also identify the varying degrees of 
effects of different types of auditory feedback on retention of gait adaptations from 
cable actuated robot. 
[1] J. Kang, D. Martelli, V. Vashista, I. Martinez-Hernandez, H. Kim, and S. K. 
Agrawal, “Robot-driven downward pelvic pull to improve crouch gait in children 
with cerebral palsy,” Sci. Robot., 2017, doi: 10.1126/scirobotics.aan2634. 
[2] Yang, Zhuolin, et al. "A smart environment-adapting timed-up-and-go system 
powered by sensor-embedded insoles." IEEE Internet of Things Journal 6.2 (2018): 
1298-1305. 
[3] Yang, Zhuolin, et al. "A smart environment-adapting timed-up-and-go system 
powered by sensor-embedded insoles." IEEE Internet of Things Journal 6.2 (2018): 
1298-1305.  
 
[4] Instrumented 
Treadmills, URL:- https://www.bertec.com/products/instrumented-treadmills  
 
[5] Schaffert, Nina, et al. "A review on the relationship between sound and 
movement in sports and rehabilitation." Frontiers in psychology 10 (2019): 244.  
 
 
6.1 Drug/Device Handling: If the research involves drugs or device, 
describe your plans to store, handle, and administer those drugs or 
devices so that they will be used only on subjects and be used only by 
authorized investigators. 
 
If the control of the drugs or devices used in this protocol will 
be accomplished by following an established, approved 
organizational SOP (e.g., Research Pharmacy SOP for the 
Control of Investigational Drugs, etc.), please reference that 
SOP in this section. 
Response: N/A 

 
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6.2 If the drug is investigational (has an IND) or the device has an IDE 
or a claim of abbreviated IDE (non-significant risk device), include 
the following information: 
 
Identify the holder of the IND/IDE/Abbreviated IDE. 
 
Explain procedures followed to comply with sponsor 
requirements for FDA regulated research for the following: 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
Response: N/A 
 
7.0 Local Number of Subjects 
7.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response: 20 
 
7.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response:  
 
7.3 Justify the feasibility of recruiting the proposed number of eligible subjects 
within the anticipated recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit? 
Response: Cerebral Palsy is the most common of all childhood disabilities, 
affecting approximately three live births out of every thousand in the United 
States. With the population of Erie County being over 900,000, it is feasible 
to identify 20 adults with CP to participate in the study. 
 
8.0 Inclusion and Exclusion Criteria* 

 
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8.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE: This may be done in bullet point fashion. 
Response: The inclusion criterion for the study is adults with cerebral 
palsy (18-65 years old) who can ambulate a distance of 100 feet with or 
without the use of assistive devices. However, they shouldn’t need 
physical assistance from a caregiver while they walk 100 feet.  
8.2 Describe the criteria that define who will be excluded from your final study 
sample.  
NOTE: This may be done in bullet point fashion.  
Response: Recruited participants will be excluded if they have severe 
Equinovarus foot or Genu recurvatum of the knee. Participants who had surgery 
within 6 months will be excluded.  Individuals with pregnancy, lower limb 
prosthetics,  severe respiratory problems such as chronic obstructive pulmonary 
disease, heart disease, a loss of sensation, uncontrolled blood pressure, a seizure 
disorder, severe arthritis will be excluded from this study. 
8.3  Indicate specifically whether you will include any of the following special 
populations in your study using the checkboxes below.  
 
NOTE: Members of special populations may not be targeted for enrollment in 
your study unless you indicate this in your inclusion criteria. 
Response:  
☐ 
Adults unable to consent 
☐ 
Individuals who are not yet adults (infants, children, teenagers) 
☐ 
Pregnant women 
☐ 
Prisoners 
 
8.4 Indicate whether you will include non-English speaking individuals in your 
study. Provide justification if you will exclude non-English speaking 
individuals.  
In order to meet one of the primary ethical principles of equitable selection 
of subjects, non-English speaking individuals may not be routinely excluded 
from research as a matter of convenience. 
In cases where the research is of therapeutic intent or is designed to 
investigate areas that would necessarily require certain populations who 
may not speak English, the researcher is required to make efforts to recruit 
and include non-English speaking individuals. However, there are studies in 
which it would be reasonable to limit subjects to those who speak English. 
Some examples include pilot studies, small unfunded studies with validated 
instruments not available in other languages, studies with numerous 

 
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questionnaires, and some non-therapeutic studies which offer no direct 
benefit. 
Response: We will exclude non-English speaking individuals as we don’t have 
human resources for translation. All instructions should be equally provided to the 
user for consistency.  
 
9.0 Vulnerable Populations* 
If the research involves special populations that are considered vulnerable, 
describe the safeguards included to protect their rights and welfare.  
NOTE: You should refer to the appropriate checklists, referenced below, to ensure you 
have provided adequate detail regarding safeguards and protections. You do not, 
however, need to provide these checklists to the IRB. 
9.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: 
  
☒ 
N/A: This research does not involve pregnant women. 
9.2 For research that involves neonates of uncertain viability or non-viable 
neonates, safeguards include: 
NOTE CHECKLISTS: Non-Viable Neonates (HRP-413), or Neonates of Uncertain 
Viability (HRP-414) 
Response:  
 
☒ 
N/A: This research does not involve non-viable neonates or neonates of 
uncertain viability. 
9.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
 
☒ 
N/A: This research does not involve prisoners. 
9.4 For research that involves persons who have not attained the legal age for 
consent to treatments or procedures involved in the research (“children”), 
safeguards include:  
NOTE CHECKLIST: Children (HRP-416) 
Response:  
 
☒ 
N/A: This research does not involve persons who have not attained the 
legal age for consent to treatments or procedures (“children”). 

 
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9.5 For research that involves cognitively impaired adults, safeguards include: 
NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  
 
☒ 
N/A: This research does not involve cognitively impaired adults. 
9.6 Consider if other specifically targeted populations such as students, 
employees of a specific firm, or educationally or economically 
disadvantaged persons are vulnerable. Provide information regarding their 
safeguards and protections, including safeguards to eliminate coercion or 
undue influence. 
Response: Students may be recruited in this study, but cable actuated training  and 
observing their gait with sEMG sensors, reflective markers, or IMUs won’t create 
any risks. They are allowed to stop and take breaks during the study anytime if 
they need it. Students will be explicitly informed that their grades in any course 
will not be affected, positively or negatively, based on your participation in this 
study 
 
10.0 
Eligibility Screening* 
10.1 Describe screening procedures for determining subjects’ eligibility. 
Screening refers to determining if prospective participants meet inclusion and 
exclusion criteria.  
Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaire).  
Response: Dr. Langan is a licensed physical therapist. She will perform screening 
procedures for the patients. We will examine the individual’s ability to ambulate 100 feet 
with or without assistive devices but not with the assistance of a caregiver to ensure 
independent walking through the protocol. 
☐ 
N/A: There is no screening as part of this protocol. 
11.0 
Recruitment Methods 
☐ 
N/A: This is a records review only, and subjects will not be 
recruited. NOTE: If you select this option, please make sure that 
all records review procedures and inclusion/exclusion screening 
are adequately described in other sections. 
11.1 Describe when, where, and how potential subjects will be recruited.  
NOTE: Recruitment refers to how you are identifying potential participants and 
introducing them to the study. Include specific methods you will use (e.g. searching 
charts for specific ICD code numbers, Research Participant Groups, posted 
advertisements, etc.). 
Response: Extensive distribution of flyers through organizations such as 
WNY parent’s network, UB boards that allow study flyers, clinical 

 
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facilities in the greater Buffalo region, and clinicians that see patients with 
CP. The Buffalo Research Registry (BRR) is a database of people from 
Buffalo and Western New York who have shown interest in becoming 
research study volunteers. We will ask for a list of potential participants 
from the BRR. A flyer providing information on the study will be emailed 
or mailed to potential participants from this list. 
11.2 Describe how you will protect the privacy interests of prospective subjects 
during the recruitment process.  
NOTE: Privacy refers to an individual’s right to control access to him or herself.  
Response: Participants will self-select to respond to one of the flyers for the study. 
They need to choose to contact the researchers to participate in the study. The 
settings for the phone conversation and data collection will be private areas. The 
researcher will emphasize that participation in this study is voluntary and 
subjects may withdraw at any time with no consequences. 
11.3 Identify any materials that will be used to recruit subjects.  
NOTE: Examples include scripts for telephone calls, in person announcements / 
presentations, email invitations.  
For advertisements, include the final copy of printed advertisements with your 
submission. When advertisements are taped for broadcast, attach the final 
audio/video tape. NOTE: You may submit the wording of the advertisement prior to 
taping to ensure there will be no IRB-required revisions, provided the IRB also 
reviews and approves the final version. 
 Response: Flyers and follow-up phone conversations when participants 
demonstrate an interest in the study. 
 
12.0 
Procedures Involved* 
12.1 Provide a description of all research procedures or activities being 
performed and when they are performed once a subject is screened and 
determined to be eligible. Provide as much detail as possible.  
NOTE: This should serve as a blueprint for your study and include enough detail 
so that another investigator could pick up your protocol and replicate the research. 
For studies that have multiple or complex visits or procedures, consider the 
addition of a schedule of events table in your response. 
Response: Participants will be scheduled for an appointment to visit AWEAR 
(Assistive Wearable Robotics) lab which is located at University at Buffalo Furnas 
Hall Room 809 or Kimball 115. They will be asked to wear comfortable clothing 
which won’t restrict their natural movement. Participants are required to wear 
reflective markers on the whole body to record the motion by a Vicon motion 
capture system. Similarly, Delsys surface electromyography sensors will be 
attached to the skin of the participant to record the muscle activation during 
walking. The instrumented insole will also be added to the participant’s shoes. The 
participant will walk on the treadmill for 5 minutes as warming-up and 20-minutes 

 
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of training with a cable-actuated robot will be provided. The device will augment 
15% of their own body weight. While they are walking with the device, auditory 
feedback will be provided for the participants who are assigned to the auditory 
group. The auditory and non-auditory groups will be randomly assigned. 
Furthermore, one of the 3 different types of auditory feedback will be randomly 
assigned to participants from the feedback group. A break of 5 minutes will be 
provided after 10 minutes of walking with the device. After the robotic training is 
completed, the device will be taken off and the participant will walk without the 
device to monitor the immediate retention of the training. After every 10 minutes, 
the researcher will ask the participant questions as per the Borg exertion scale to 
check the fatigue of the participant. After finishing the treadmill session, 
participants will take a 10-minute break and walk 4 minutes with (or without 
auditory feedback) on the floor. The participant will repeat overground walking for 
a total of three sets. There will be a total of ten training sessions, two or three 
sessions a week and each session will last for a maximum of 3 hours. In addition, 
pre and post-training visits are required to evaluate functional gait assessment, 6-
min-walk, leg strength using a dynamometer, international physical activity 
questionnaire (short form), usability questionnaire, and Modified Ashworth test by 
a physical therapist. 
12.2 Describe what data will be collected.  
NOTE: For studies with multiple data collection points or long-term follow up, 
consider the addition of a schedule or table in your response. 
Response:  
• We will schedule the participants to visit the lab. We will make a table when the 
participants are available.  
• EMG data from the muscles  
• Vicon motion capture data   
• Photo and Video of the test  
• IMU sensor data  
• Smart insole data  
• Ground reaction force   
 
12.3 List any instruments or measurement tools used to collect data 
(e.g. questionnaire, interview guide, validated instrument, data collection 
form).  
 
Include copies of these documents with your submission. 
Response: Vicon motion capture system, Delsys Trigno sEMG system, and Bertec 
Force plate instrumented treadmill, Smart Insole 
12.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 

 
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Response: N/A 
 
12.5 Indicate whether or not individual subject results, such as results of 
investigational diagnostic tests, genetic tests, or incidental findings will be 
shared with subjects or others (e.g., the subject’s primary care physician) 
and if so, describe how these will be shared. 
Response: N/A 
 
12.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
Response: The data and study results will be not shared with the subject. 
 
13.0 
Study Timelines* 
13.1 Describe the anticipated duration needed to enroll all study subjects. 
Response: All data will be collected in two years of a time window. 
 
13.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response: Maximum of three hours will be used to collect the data 
 
13.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
Response: We expect to collect and analyze the data within three years. 
 
14.0 
Setting 
14.1 Describe all facilities/sites where you will be conducting research 
procedures. Include a description of the security and privacy of the facilities 
(e.g. locked facility, limited access, privacy barriers). Facility, department, 
and type of room are relevant. Do not abbreviate facility names.  
NOTE: Examples of acceptable response may be: “A classroom setting in the 
Department of Psychology equipped with a computer with relevant survey 
administration software,” “The angiogram suite at Buffalo General Medical 
Center, a fully accredited tertiary care institution within New York State with 
badge access,” or, “Community Center meeting hall.” 
Response: Dr. Kang’s laboratories are located in 809 Furnas and 115 Kimball. 
The laboratories are equipped with a Vicon motion capture system, Delsys sEMG 
system, smart insole, Kinect cameras, and Bertec Force plate instrumented 

 
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treadmill. A computer station can control Vicon, Delsys, Bertec system, and smart 
insole all together simultaneously. 
 
14.2 For research conducted outside of UB and its affiliates, describe: 
 Site-specific regulations or customs affecting the research 
 Local scientific and ethical review structure 
NOTE: This question is referring to UB affiliated research taking place outside 
UB, i.e. research conducted in the community, school-based research, 
international research, etc. It is not referring to multi-site research. UB affiliated 
institutions include Kaleida Health, ECMC, and Roswell Park Cancer Institute.  
Response:  
 
☒ 
N/A: This study is not conducted outside of UB or its affiliates. 
15.0 
Community-Based Participatory Research 
15.1 Describe involvement of the community in the design and conduct of the 
research.  
NOTE: Community-Based Participatory Research (CBPR) is a collaborative 
approach to research that equitably involves all partners in the research process 
and recognizes the unique strengths that each brings. CBPR begins with a research 
topic of importance to the community, has the aim of combining knowledge with 
action and achieving social change to improve health outcomes and eliminate 
health disparities. 
Response:  
 
☒ 
N/A: This study does not utilize CBPR. 
15.2 
Describe the composition and involvement of a community advisory 
board. 
Response:  
 
☒ 
N/A: This study does not have a community advisory board. 
16.0 
Resources and Qualifications 
16.1 Describe the qualifications (e.g., education, training, experience, expertise, 
or certifications) of the Principal Investigator and staff to perform the 
research. When applicable describe their knowledge of the local study sites, 
culture, and society. Provide enough information to convince the IRB that 
you have qualified staff for the proposed research.  

 
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NOTE: If you specify a person by name, a change to that person will require prior 
approval by the IRB. If you specify a person by role (e.g., coordinator, research 
assistant, co-investigator, or pharmacist), a change to that person will not usually 
require prior approval by the IRB, provided that the person meets the 
qualifications described to fulfill their roles. 
Response:  
The principal investigator has various experiences to collect biomechanical data 
of healthy individuals, Parkinson's disease, and cerebellar ataxia patients. PI has 
been published experiments that include motion capture systems and sEMG 
systems. All researchers who are working with PI will finish CITI program 
training to establish a basic knowledge of human subjects research. 
 
Describe other resources available to conduct the research.  
16.2 Describe the time and effort that the Principal Investigator and research 
staff will devote to conducting and completing the research. 
NOTE: Examples include the percentage of Full Time Equivalents (FTE), hours 
per week. The question will elicit whether there are appropriate resources to 
conduct the research. 
Response: We estimate that the PI will devote 20% of their time to the study. 
Other PIs will devote 5s% of their time to the study. The research assistance will 
devote 30% of their time to the study. 
 
16.3 Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if 
applicable. 
NOTE: One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Response: There will be a licensed physical therapist (Dr. Jeanne Langan or other 
physical therapist) when we conduct this study.  
 
16.4 Describe your process to ensure that all persons assisting with the research 
are adequately informed about the protocol, the research procedures, and 
their duties and functions. 
Response: PI will train all personnel who will conduct human subject studies. 
Their role will be assigned and informed about the protocol, procedures, and 
duties. Before starting this study, all staff members will run a dry-run test to 
practice their knowledge.  
 
17.0 
Other Approvals 

 
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17.1 Describe any approvals that will be obtained prior to commencing the 
research (e.g., school, external site, funding agency, laboratory, radiation 
safety, or biosafety). 
Response:  
 
☒ 
N/A: This study does not require any other approvals. 
18.0 
Provisions to Protect the Privacy Interests of Subjects 
18.1 Describe how you will protect subjects’ privacy interests during the course 
of this research. 
NOTE: Privacy refers to an individual’s right to control access to him or herself. 
Privacy applies to the person. Confidentiality refers to how data collected about 
individuals for the research will be protected by the researcher from release. 
Confidentiality applies to the data.  
Examples of appropriate responses include: “participant only meets with a study 
coordinator in a classroom setting where no one can overhear”, or “the 
participant is reminded that they are free to refuse to answer any questions that 
they do not feel comfortable answering.”  
Response: Participants will be assigned an unidentifiable code when analyzing the 
data. During the study, the participant can ask questions anytime or stop the study.  
18.2 Indicate how the research team is permitted to access any sources of 
information about the subjects.  
NOTE: Examples of appropriate responses include: school permission for review 
of records, consent of the subject, HIPAA waiver. This question does apply to 
records reviews. 
Response: All data collection occurs after the subject has signed the consent 
form.   
19.0 
Data Management and Analysis* 
19.1 Describe the data analysis plan, including any statistical procedures. This 
section applies to both quantitative and qualitative analysis.  
Response: The collected motion capture data will be labeled and filtered with a 4th 
order Butterworth filter. All sEMG data will be post-processed by bandwidth filter, 
enveloped, smoothed, and scaled. To define the beginning and the end of each 
repetition the speed of the markers is used as a threshold. The data will be time-
scaled and averaged over different trials.     
The analyses for CP subjects are carried out separately. Descriptive statistics will 
be obtained to compare the randomized groups on baseline factors including pre-
existing chronic conditions, underlying disease, demographics, and other potential 
confounders. When the numeric data are not normally distributed based on graphic 
inspection (e.g., normal quantile plots), we will consider the Box-Cox 
transformation. For numeric data, a mixed-effects model will be constructed, where 

 
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major factors include the effect of time within each day, the effect of feedback, the 
effect of the day as well as the effect of the random assignment. Major statistics to 
obtain will be improvement measures between baseline and the end of treatment. 
An appropriate covariance structure will be considered reflecting the correlations 
within subjects. Various contrasts will be tested to see an improvement by the major 
factors. Some other covariates such as demographic and other subjects 
characteristics can be included in the models if a significant difference is shown. 
Residual plots will be examined to check the normality of the residual. If not 
normally distributed, we will consider simpler nonparametric methods that 
compare specific factor combinations in a form of various contrasts. For categorical 
data, we will construct a similar model to the numeric data, except that we will use 
an appropriate link function based on the generalized linear model. The covariance 
structures will be incorporated into the analysis using a generalized structural 
equation modeling strategy. For this pilot study, we do not consider controlling 
family-wise Type I error as the purpose of the study is to see the viability of the 
treatment and potentially support the bigger clinical trials in the future. 
19.2 If applicable, provide a power analysis.  
NOTE: This may not apply to certain types of studies, including chart/records 
reviews, survey studies, or observational studies. This question is asked to elicit 
whether the investigator has an adequate sample size to achieve the study 
objectives and justify a conclusion.  
Response: A goal of this study is to test the feasibility and efficacy of the 
proposed intervention in the improvement of gait characteristics. Currently, no 
previous study is available to have the treatments both resistance training and 
sensory feedback. For CP subjects, we will have a sample size of 20 (10 each 
group), which requires an effect size of 0.5 to have a power of 80% with the size 
of the test 0.05 in the two-group comparison with 6 repeated measures under the 
assumption of compound symmetry with auto-correlation 0.1. 
 
19.3 Describe any procedures that will be used for quality control of collected 
data. 
Response: The post-processed data will be visually investigated whether all the 
procedures were properly applied. Outliers will be also detected during this 
investigation.  
 
20.0 
Confidentiality* 
 
A. Confidentiality of Study Data 
 
Describe the local procedures for maintenance of confidentiality of study data 
and any records that will be reviewed for data collection.  
 

 
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20.1 
A. Where and how will all data and records be stored? Include 
information about: password protection, encryption, physical controls, 
authorization of access, and separation of identifiers and data, as applicable. 
Include physical (e.g. paper) and electronic files. 
Response: The file linking subjects’ names to code will be in paper form and will 
be stored in a locked file cabinet inside PI’s laboratory along with signed consent 
forms. The rest of the data will be stored in a password-protected computer in 
Furnas 809 which does not have an internet connection. Password will be disclosed 
only to individuals who are related to this project. After the mandatory 3 years of 
data retention, the questionnaire will be shredded. Only coded data will be reported 
in research papers, conference presentations, and participating research lab 
meetings. 
20.2 
A. How long will the data be stored? 
Response: The file linking subjects’ name to ID will be retained until the end of 
the study. It will be destroyed afterward. All data will be stored for at least 3 years 
in a password-protected folder regarding this project. After the mandatory 3 years 
of data retention, the data can be deleted from the password protected computer in 
Furnas 809 
20.3 
A. Who will have access to the data? 
Response: Only researchers directly involved in the study will have access to this 
data. Access will only be available to those working on the project through 
password protection. 
 
20.4 
A. Who is responsible for receipt or transmission of the data? 
Response: Only the PI (Dr. Jiyeon Kang) will be responsible for receipt or 
transmission of the data. 
 
20.5 
A. How will the data be transported? 
Response: If data is transported, a password-protected hard drive will be used.  
 
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study 
specimens.  
 
☒ 
N/A: No specimens will be collected or analyzed in this research.  
(Skip to Section 19.0) 
 

 
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20.6 
B. Where and how will all specimens be stored? Include information 
about: physical controls, authorization of access, and labeling of specimens, as 
applicable.  
Response:  
 
20.7 
B. How long will the specimens be stored? 
Response:  
 
20.8 
B. Who will have access to the specimens? 
Response:  
 
20.9 
B. Who is responsible for receipt or transmission of the specimens? 
Response:  
 
20.10 B. How will the specimens be transported? 
Response: 
 
 
21.0 
Provisions to Monitor the Data to Ensure the Safety of 
Subjects* 
☐ 
N/A: This study is not enrolling subjects, or is limited to records review 
procedures only. This section does not apply. 
 
NOTE: Minimal risk studies may be required to monitor subject safety if the research 
procedures include procedures that present unique risks to subjects that require 
monitoring. Some examples include: exercising to exertion, or instruments that elicit 
suicidality or substance abuse behavior. In such cases, N/A is not an acceptable 
response. 
 
21.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 
Response: There will be extra personal in addition to the operator of the device to 
ensure the participant’s safety. We will collect the response of the Borg exertion 
scale and ask the participants if there is any adverse effect after each session. A 
licensed physical therapist will monitor the participants walking patterns. 
 
21.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 

 
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Response: For each week, the cable tension data will be monitored to ensure the 
proper operation of the device. Safety harness will be also tested before each 
operation.  
 
21.3 Describe any safety endpoints. 
Response: For each training session, researchers are asked to record any adverse 
effects electronically.  
 
21.4 Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
Response: We will ask the participants for any adverse effect/Borg exertion scale 
and all information will be recorded in a daily report form. And the cable tension 
data will be automatically saved in the computer that is controlling the device. 
Furthermore, the PI will have a weekly meeting with the team members to check 
for any adverse effects. 
 
21.5 Describe the frequency of safety data collection. 
Response: The cable tension data will be collected for every trial. Borg scale will 
be asked for every 10 minutes.  
 
21.6 Describe who will review the safety data. 
Response: PI will review the safety data by having a periodic meeting with the 
researcher. 
 
21.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response: N/A 
 
21.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response: N/A 
 
21.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response: N/A 
 
22.0 
Withdrawal of Subjects* 

 
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☐ 
N/A: This study is not enrolling subjects. This section does not apply. 
 
22.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Response: If the participant has difficulties walking for 6 minutes, we will 
automatically withdraw the participant as 6-min walk is included in one of our 
metrics. Though highly unlikely, if the participant cannot follow simple 
instructions to walk and stop he or she may be withdrawn from the study. 
 
22.2 Describe any procedures for orderly termination.  
NOTE: Examples may include return of study drug, exit interview with clinician. 
Include whether additional follow up is recommended for safety reasons for 
physical or emotional health. 
Response: The PI will inform the participant of early termination. The participant 
will be compensated for the hours that he/she participated in the study.  
 
22.3 Describe procedures that will be followed when subjects withdraw from the 
research, including retention of already collected data, and partial 
withdrawal from procedures with continued data collection, as applicable. 
Response: We destroy all the data and records related to the specific participant 
whom we withdraw from the study.  
 
23.0 
Risks to Subjects* 
23.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related to their participation in the research. 
Consider physical, psychological, social, legal, and economic risks. Include 
a description of the probability, magnitude, duration, and reversibility of the 
risks.  
NOTE: Breach of confidentiality is always a risk for identifiable subject data. 
Response: This research involves minimal risk to participants. Subjects will be 
explicitly informed the following “Some risks are unknown, so if you have 
experienced any shortness of breath or chest pain in the past while walking, you 
should not participate in this study.” Though highly unlikely, there can be fatigue 
by repeated walking tasks multiple times. If this is the case, the participant can 
request a break as much as he/she needs. Also attaching sEMG electrodes on the 
skin can cause mild skin irritation. Once the participant expresses discomfort, we 
will stop the experiment and remove the device.  
 
23.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 

 
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Response: Researchers who will perform this study will be trained to ask the 
participant if the participant feels fatigued every 10 minutes. There will be 
multiple emergency switches to stop the device immediately. The participant will 
wear a safety harness when walking with the cable-actuated robotic device. 
 
23.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response: We do not expect any risk in this experimental procedure. 
 
23.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response: We do not expect any risk in this experimental procedure. 
 
23.5 If applicable, describe risks to others who are not subjects. 
Response: We do not expect any risk in this experimental procedure. 
 
24.0 
Potential Benefits to Subjects* 
24.1 Describe the potential benefits that individual subjects may experience by 
taking part in the research. Include the probability, magnitude, and duration 
of the potential benefits. Indicate if there is no direct benefit.  
NOTE: Compensation cannot be stated as a benefit. 
Response: Our previous study with a cable-actuated system showed that cerebral 
palsy children showed increased walking ability in step length, walking speed, or 
single stance time [1]. We expect to see similar benefits in adults with cerebral 
palsy. 
[1] J. Kang, D. Martelli, V. Vashista, I. Martinez-Hernandez, H. Kim, and S. K. 
Agrawal, “Robot-driven downward pelvic pull to improve crouch gait in children 
with cerebral palsy,” Sci. Robot., 2017, doi: 10.1126/scirobotics.aan2634. 
25.0 
Compensation for Research-Related Injury 
☒ 
N/A: The research procedures for this study do not present risk of research 
related injury (e.g. survey studies, records review studies). This section 
does not apply.  
25.1 
If the research procedures carry a risk of research related injury, 
describe the available compensation to subjects in the event that such 
injury should occur.  
Response: 
 

 
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25.2 
Provide a copy of contract language, if any, relevant to compensation for 
research related injury. 
NOTE: If the contract is not yet approved at the time of this submission, submit the 
current version here. If the contract is later approved with different language 
regarding research related injury, you must modify your response here and 
submit an amendment to the IRB for review and approval. 
Response:  
 
26.0 
Economic Burden to Subjects 
26.1 
Describe any costs that subjects may be responsible for because of 
participation in the research.  
NOTE: Some examples include transportation or parking. 
Response: There will be no cost that subjects will be responsible for because of 
participation in the research. 
 
☐ 
N/A: This study is not enrolling subjects, or is limited to records review 
procedures only. This section does not apply. 
27.0 
Compensation for Participation 
27.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 
Response: The participant will be compensated for $20/hour. They will be 
compensated via cash at the end of each session before the participants leave the 
lab. 
 
☐ 
N/A: This study is not enrolling subjects, or is limited to records 
review procedures only. This section does not apply. 
☐ 
N/A: There is no compensation for participation. This section does 
not apply. 
28.0 
Consent Process 
28.1 Indicate whether you will be obtaining consent.  
NOTE: This does not refer to consent documentation, but rather whether you will 
be obtaining permission from subjects to participate in a research study.  
Consent documentation is addressed in Section 27.0. 
☒ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 27.0) 
 

 
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28.2 Describe where the consent process will take place. Include steps to 
maximize subjects’ privacy. 
Response: The consent form is obtained by PI or researchers in the laboratory 
located in 809 Furnas Hall or 115 Kimball.  
 
28.3 Describe how you will ensure that subjects are provided with a sufficient 
period of time to consider taking part in the research study.  
NOTE: It is always a requirement that a prospective subject is given sufficient time 
to have their questions answered and consider their participation. See “SOP: 
Informed Consent Process for Research (HRP-030)” Sections 5.5 and 5.6. 
Response: The participant will be informed before the consent that he or she can 
use as much time as he/she needs. Participants will be also informed to be allowed 
to ask questions or withdraw the study when she or he felt discomfort during the 
study.  
 
28.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.  
Response: We will provide compensation of $20/hr to the participants to 
encourage continuation of this study.  
 
28.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-030).” Pay particular attention to Sections 5.4-5.9. If not, 
or if there are any exceptions or additional details to what is covered in the 
SOP, describe: 
 
The role of the individuals listed in the application who are involved in 
the consent process 
 
The time that will be devoted to the consent discussion 
 
Steps that will be taken to minimize the possibility of coercion or 
undue influence 
 
Steps that will be taken to ensure the subjects’ understanding 
Response:  
 
☒ 
We have reviewed and will be following “SOP: Informed Consent Process 
for Research (HRP-030).” 
 
Non-English Speaking Subjects  
☒ 
N/A: This study will not enroll Non-English speaking subjects.  
(Skip to Section 26.8) 

 
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28.6 Indicate which language(s) other than English are likely to be 
spoken/understood by your prospective study population or their legally 
authorized representatives. 
 
NOTE: The response to this Section should correspond with your response to 
Section 6.4 of this protocol. 
Response:  
 
28.7 If subjects who do not speak English will be enrolled, describe the process 
to ensure that the oral and written information provided to those subjects 
will be in that language, how you will ensure that subjects are provided with 
a sufficient period of time to consider taking part in the research study, and 
any process to ensure ongoing consent. Indicate the language that will be 
used by those obtaining consent.  
NOTE: Guidance is provided on “SOP: Informed Consent Process for Research 
(HRP-030).” 
Response:  
 
 
Cognitively Impaired Adults 
☒ 
N/A: This study will not enroll cognitively impaired adults.  
(Skip to Section 26.9) 
28.8  Describe the process to determine whether an individual is capable of 
consent.  
Response:  
 
 
Adults Unable to Consent 
☒ 
N/A: This study will not enroll adults unable to consent.  
(Skip to Section 26.13) 
When a person is not capable of consent due to cognitive impairment, a legally 
authorized representative should be used to provide consent (Sections 26.9 and 
26.10) and, where possible, assent of the individual should also be solicited 
(Sections 26.11 and 26.12). 
28.9  Describe how you will identify a Legally Authorized Representative (LAR). 
Indicate that you have reviewed the “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)” for research in New 
York State.  

 
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NOTE: Examples of acceptable response includes: verifying the electronic medical 
record to determine if an LAR is recorded. 
Response:  
 
☐ 
We have reviewed and will be following “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).”  
28.10 For research conducted outside of New York State, provide information 
that describes which individuals are authorized under applicable law to 
consent on behalf of a prospective subject to their participation in the 
research. One method of obtaining this information is to have a legal 
counsel or authority review your protocol along with the definition of 
“legally authorized representative” in “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).” 
Response:  
 
28.11 Describe the process for assent of the adults: 
 
Indicate whether assent will be obtained from all, some, or none of the 
subjects. If some, indicate which adults will be required to assent and 
which will not. 
Response:  
 
 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 
Response:  
 
28.12 Describe whether assent of the adult subjects will be documented and the 
process to document assent.  
NOTE: The IRB allows the person obtaining assent to document assent on the 
consent document using the “Template Consent Document (HRP-502)” Signature 
Block for Assent of Adults who are Legally Unable to Consent. 
Response:  
 
 
Subjects who are not yet Adults (Infants, Children, and Teenagers) 
☒ 
N/A: This study will not enroll subjects who are not yet adults.  
(Skip to Section 27.0) 

 
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28.13 Describe the criteria that will be used to determine whether a prospective 
subject has not attained the legal age for consent to treatments or 
procedures involved in the research under the applicable law of the 
jurisdiction in which the research will be conducted (e.g., individuals under 
the age of 18 years). For research conducted in NYS, review “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013)” to be 
aware of which individuals in the state meet the definition of “children.”  
NOTE: Examples of acceptable responses include: verification via electronic 
medical record, driver’s license or state-issued ID, screening questionnaire. 
Response:  
 
28.14For research conducted outside of New York State, provide information 
that describes which persons have not attained the legal age for consent to 
treatments or procedures involved the research, under the applicable law of 
the jurisdiction in which research will be conducted. One method of 
obtaining this information is to have a legal counsel or authority review 
your protocol along the definition of “children” in “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013).” 
Response:  
 
28.15 Describe whether parental permission will be obtained from: 
Response:  
☐  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the 
child. 
☐ 
Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for 
the care and custody of the child. 
☐ 
Parent permission will not be obtained. A waiver of parent permission is 
being requested. 
NOTE: The requirement for parent permission is a protocol-specific determination 
made by the IRB based on the risk level of the research. For guidance, review the 
“CHECKLIST: Children (HRP-416).”  
28.16Describe whether permission will be obtained from individuals other than 
parents, and if so, who will be allowed to provide permission. Describe your 
procedure for determining an individual’s authority to consent to the child’s 
general medical care. 
Response:  
 

 
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28.17 Indicate whether assent will be obtained from all, some, or none of the 
children. If assent will be obtained from some children, indicate which 
children will be required to assent. 
Response:  
 
28.18 When assent of children is obtained, describe how it will be documented. 
Response:  
 
29.0 
Waiver or Alteration of Consent Process 
Consent will not be obtained, required information will not be disclosed, or the 
research involves deception. 
☒ 
N/A: A waiver or alteration of consent is not being requested. 
29.1 If the research involves a waiver or alteration of the consent process, please 
review the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-
410)” to ensure that you have provided sufficient information for the IRB to 
make the determination that a waiver or alteration can be granted.  
NOTE: For records review studies, the first set of criteria on the “CHECKLIST: 
Waiver or Alteration of Consent Process (HRP-410)” applies.  
Response:  
 
29.2 If the research involves a waiver of the consent process for planned 
emergency research, please review the “CHECKLIST: Waiver of Consent 
for Emergency Research (HRP-419)” to ensure you have provided sufficient 
information for the IRB to make these determinations. Provide any 
additional information necessary here: 
Response:  
 
30.0 
Process to Document Consent 
☐ 
N/A: A Waiver of Consent is being requested.  
(Skip to Section 29.0) 
30.1 Indicate whether you will be following “SOP: Written Documentation of 
Consent (HRP-091).” If not or if there are any exceptions, describe whether 
and how consent of the subject will be obtained including whether or not it 
will be documented in writing.  
NOTE: If your research presents no more than minimal risk of harm to subjects 
and involves no procedures for which written documentation of consent is normally 
required outside of the research context, the IRB will generally waive the 
requirement to obtain written documentation of consent. This is sometimes referred 

 
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to as ‘verbal consent.’ Review “CHECKLIST: Waiver of Written Documentation of 
Consent (HRP-411)” to ensure that you have provided sufficient information.  
If you will document consent in writing, attach a consent document with your 
submission. You may use “TEMPLATE CONSENT DOCUMENT (HRP-502)”. 
If you will obtain consent, but not document consent in writing, attach the script of 
the information to be provided orally or in writing (i.e. consent script or 
Information Sheet).  
Response:  
 
☒ 
We will be following “SOP: Written Documentation of Consent” 
(HRP-091). 
31.0 
Multi-Site Research (Multisite/Multicenter Only)* 
☒ 
N/A: This study is not an investigator-initiated multi-site study. This 
section does not apply. 
 
31.1 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 
Response:  
 
31.2 If this is a multi-site study where you are the lead investigator, describe the 
processes to ensure communication among sites, such as the following. See 
“WORKSHEET: Communication and Responsibilities (HRP-830).”: 
 
All sites have the most current version of the IRB documents, including 
the protocol, consent document, and HIPAA authorization. 
 
All required approvals have been obtained at each site (including 
approval by the site’s IRB of record). 
 
All modifications have been communicated to sites, and approved 
(including approval by the site’s IRB of record) before the 
modification is implemented. 
 
All engaged participating sites will safeguard data as required by 
local information security policies. 
 
All local site investigators conduct the study appropriately in 
accordance with applicable federal regulations and local laws. 
 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with local policy. 
Response:  
 
31.3 Describe the method for communicating to engaged participating sites (see 
“WORKSHEET: Communication and Responsibilities (HRP-830)”): 

 
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 
Problems (inclusive of reportable events) 
 
Interim results 
 
Study closure 
Response:  
 
31.4 
If this is a multicenter study where you are a participating 
site/investigator, describe the local procedures for maintenance of 
confidentiality. (See “WORKSHEET: Communication and 
Responsibilities (HRP-830).”) 
 
Where and how data or specimens will be stored locally? 
 
How long the data or specimens will be stored locally? 
 
Who will have access to the data or specimens locally? 
 
Who is responsible for receipt or transmission of the data or 
specimens locally? 
 
How data and specimens will be transported locally? 
Response:  
 
31.5 
If this is a multicenter study and subjects will be recruited by methods not 
under the control of the local site (e.g., call centers, national 
advertisements) describe those methods. Local recruitment methods are 
described elsewheres in the protocol. 
 
Describe when, where, and how potential subjects will be 
recruited. 
 
Describe the methods that will be used to identify potential 
subjects. 
 
Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For 
advertisements, attach the final copy of printed advertisements. 
When advertisements are taped for broadcast, attach the final 
audio/video tape. You may submit the wording of the 
advertisement prior to taping to preclude re-taping because of 
inappropriate wording, provided the IRB reviews the final 
audio/video tape.) 
Response:  
 
32.0 
Banking Data or Specimens for Future Use* 
☐ 
N/A: This study is not banking data or specimens for future use or 
research outside the scope of the present protocol. This section does not 
apply. 

 
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32.1 If data or specimens will be banked (stored) for future use, that is, use or 
research outside of the scope of the present protocol, describe where the 
data/specimens will be stored, how long they will be stored, how the 
data/specimens will be accessed, and who will have access to the 
data/specimens.  
NOTE: Your response here must be consistent with your response at the “What 
happens if I say yes, I want to be in this research?” Section of the Template 
Consent Document (HRP-502). 
Response: Data will be stored in a password-protected desktop computer in the 
AWEAR laboratory (Furnas Hall Room 809). It will be stored for additional three 
years after the analysis and only researchers listed in the present IRB will have 
access to identifiable private information. Individuals who are not on this IRB 
should get permission from PI and only the data without identifiable private 
information will be provided.  
 
32.2 List the data to be stored or associated with each specimen. 
Response: motion capture, surface EMG data, ground reaction force, shoe insole 
data, and instrumented treadmill data. 
 
32.3 Describe the procedures to release banked data or specimens for future 
uses, including: the process to request a release, approvals required for 
release, who can obtain data or specimens, and the data to be provided with 
specimens. 
Response: If identifiers are removed from identifiable private information or 
identifiable samples that are collected during this research, that information or 
those samples could be used for future research studies or distributed to another 
investigator for future research studies without additional informed consent. 
Motion capture data, surface EMG data, ground reaction force data, and shoe 
insole data will be provided as a text file format. The data will be shared by 
password protected external hard drive.