A Functional Upper Limb Training and Assessment Tool to Enhance Efficacy and Scalability of Rehabilitation in Ecological Environments
Phase: NA
Conditions: Stroke
Sponsor: State University of New York at Buffalo

 
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 43 
 
 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions.......................................................................................................... 2 
1.0 
Objectives ................................................................................................................ 4 
2.0 
Scientific Endpoints ................................................................................................. 4 
3.0 
Background ............................................................. Error! Bookmark not defined. 
4.0 
Study Design .......................................................................................................... 10 
5.0 
Local Number of Subjects ..................................................................................... 13 
6.0 
Inclusion and Exclusion Criteria ............................................................................ 13 
7.0 
Vulnerable Populations .......................................................................................... 15 
8.0 
Eligibility Screening .............................................................................................. 16 
9.0 
Recruitment Methods ............................................................................................. 17 
10.0 Procedures Involved............................................................................................... 18 
11.0 Study Timelines ..................................................................................................... 22 
12.0 Setting .................................................................................................................... 22 
13.0 Community-Based Participatory Research ............................................................ 23 
14.0 Resources and Qualifications ................................................................................. 24 
15.0 Other Approvals ..................................................................................................... 25 
16.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 25 
17.0 Data Management and Analysis ............................................................................ 26 
18.0 Confidentiality ....................................................................................................... 27 
A. 
Confidentiality of Study Data ............................................................................ 28 
B. 
Confidentiality of Study Specimens ................................................................... 28 
19.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 29 
20.0 Withdrawal of Subjects .......................................................................................... 31 
21.0 Risks to Subjects .................................................................................................... 31 
22.0 Potential Benefits to Subjects ................................................................................ 33 
23.0 Compensation for Research-Related Injury ........................................................... 33 
24.0 Economic Burden to Subjects ................................................................................ 34 
25.0 Compensation for Participation ............................................................................. 34 
26.0 Consent Process ..................................................................................................... 34 
27.0 Waiver or Alteration of Consent Process ............................................................... 39 
28.0 Process to Document Consent ............................................................................... 39 
29.0 Multi-Site Research (Multisite/Multicenter Only)................................................. 40 
30.0 Banking Data or Specimens for Future Use .......................................................... 41 
31.0 Drugs or Devices.................................................................................................... 42 
32.0 Humanitarian Use Devices .................................................................................... 42 
 
 
 

 
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IRB Version: JAN2016 
Template Instructions 
Sections that do not apply: 
• In several sections, the addition of checkboxes for Not Applicable have been 
added to the template as responses.   
o If an N/A checkbox is present, select the appropriate justification 
from the list.   
o If an N/A checkbox is not present, or if none of the existing 
checkboxes apply to your study, you must write in your own 
justification. 
• In addition: 
o For research where the only study procedures are records/chart 
review:  Sections 19, 20, 22, 23, 24, 25, 31, and 32 do not apply. 
o For exempt research:  Sections 31 and 32 do not apply. 
 
Studies with multiple participant groups: 
 
• If this study involves multiple participant groups (e.g. parents and children), 
provide information in applicable sections for each participant group. Clearly 
label responses when they differ.  For example: 
Response:  
Intervention Group:  
 
Control Group: 
 
Formatting: 
• Do not remove template instructions or section headings when they do not apply 
to your study. 
If you are pasting information from other documents using the “Merge Formatting” 
Paste option will maintain the formatting of the response boxes. 
Amendments: 
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Track Changes function in Microsoft Word. 
• Update the version date or number on Page 3. 
 
 

 
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IRB Version: JAN2016 
PROTOCOL TITLE: 
Include the full protocol title. 
A Functional Upper Limb Training and Assessment Tool to Enhance Efficacy and 
Scalability of Rehabilitation in Ecological Environments 
 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response:  
Jeanne Langan 
Rehabilitation Sciences 
716-829-2905 
jlangan@buffalo.edu 
 
VERSION: 
Include the version date or number. 
Response:June 14, 2019 
 
 
GRANT APPLICABILITY: 
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:  
 This protocol is funded by NIH grant 1 R21 HD09224301  
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:  

 
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IRB Version: JAN2016 
Location: PI’s office in a locking cabinet 
Address: 522 Kimball Tower 
Department: Rehabilitation Science 
1.0 Objectives 
1.1 Describe the purpose, specific aims, or objectives of this research. 
Response:  
Our overarching goal is to develop novel portable technology, affordable 
for home use and capable of quantifying quality of movement with the 
purpose of providing to provide objective feedback on performance 
of upper limb motor tasks to individuals with residual deficits following chronic 
conditions such as stroke. We assert that smartphones combined with 3 
dimensional printed objects can be used to create rehabilitation and assessment 
to that may be used in home environments. This creates a home-rehabilitation 
system that will promote self-management of upper limb rehabilitation efforts 
across the lifespan in chronic conditions such as stroke. 
Aim 1: Develop and validate a novel in-home rehabilitation system using 
3D printing technologies, smart devices and machine learning algorithms. 
Aim 2: Examine performance changes in trained ADLs when augmenting 
3D printed objects with smart technology to provide quantitative feedback 
on performance. 
1.2 
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:  
Aim 1 hypothesis- Smartphone measurements provide a valid assessment 
of upper limb kinematics 
Aim 2 hypothesis: We hypothesize that characteristics of performance 
including time to complete the task and normalized jerk score 
(smoothness/quality of movement) will improve with this home based 
training 
 
2.0 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.   

 
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Response: 
Aim 1- We will validate that data from a smartphone can be modeled to 
accurately identify human performance including task events, movement 
status detection, and performance-quality evaluation. 
Aim 2- We will examine kinematics of movement as well as time to completion of 
defined acts of daily living. 
2.1 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: Significance: Developing portable technology, affordable for 
home use, capable of quantifying quality of movement and providing user 
feedback on motor performance is significant as it advances the present 
standard of care in home-based rehabilitation for millions of individuals 
with motor deficits (1-4). The population in the US is aging, (5) and with 
increased age there is diminished motor control (6-9) in addition to higher 
risk for neurological insult such as stroke (10). Over 700,000 new cases of 
stroke occur each year (11,12). This number is projected to increase with 
the aging of the baby boomer generation. Rehabilitation services aimed at 
reducing limitation and improving functional mobility often focus on the 
early stages of recovery with specialized inpatient rehabilitation units for 
stroke (13). Despite evidence that improvements can still be made several 
years post stroke (14) rehabilitation options in chronic stages of stroke are 
not well established. Only 10-15% of stroke survivors had a follow-up 
with a physical therapist one year after their stroke (15) Written home 
exercise programs are commonly prescribed at the end of formal therapies. 
However, as practice is a key component to improvement (16), 
participation is imperative for a home exercise program to lead to motor 
performance benefits (17). Regaining as much upper limb function as 
possible is important, as even mild impairments are associated with 
limitations in daily function and lower health-related quality of life (18). 
Hence, developing approaches to better support clients with their home 
program is important. The proposed portable measurement system will 
have the potential to promote participation and refine practice by 
providing them with feedback. 
Creating automated systems that measure and give feedback on quality of 
movement will promote a more proactive approach to maximizing 
function across the lifespan of individuals with chronic conditions. With a 
robust body of research underscoring the importance of practice, (19-22) 
providing adequate practice in rehabilitation across the lifespan is central 
to efficacious interventions (19,23). Providing feedback can promote 
participation, refine practice and give individuals a better understanding of 
their abilities to then set goals for themselves (17,24,25) As demonstrated 
by previous research, exercise programs that include feedback from a 

 
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person through a home visit, telephone call or clinic appointment have 
resulted in better outcomes compared to programs without feedback 
(17,25) This feedback informs the participant of their progress to more 
specifically direct their rehabilitation efforts and potentially motivate them 
to continue. Feedback can encourage better self-management of ongoing 
rehabilitation. Herein it is proposed that coupling three-dimensional (3D) 
printing with smart technology provides a scalable option to provide 
feedback in long-term rehabilitation. Embedding smartphones in 3D 
printed objects tailored to the individual’s mobility needs harnesses the 
sensors and networking functions of smartphones to quantify quality of 
movement and provide timely feedback to the user. This offers a vast 
improvement compared to the typical written home program issued at 
discharge. With a static written home exercise program, patients have a 
limited capacity to evaluate their motor performance and no 
encouragement to refine their movement. As individuals with motor 
deficits following neurological insult are able to make improvements 
beyond the acute phase, (16,21,26) it is necessary to provide better options 
for home rehabilitation. 
Preliminary Work and Pilot Data: Focus groups held with individuals with 
stroke and local clinicians substantiate the need for better long-term 
options to promote home-based therapeutic practice. Individuals with 
stroke have positive comments when assessing this system: “I could see 
what I had to do to improve the graphs… after a couple of times I could 
see what worked and what didn’t… I would use this, I don’t know that I 
would call it fun, but it makes it interesting to do rather than sitting with 
an inanimate object like clay or an elastic strap”. Clinicians echo the need 
to engage individuals in rehabilitation in chronic stages of stroke. While 
time measurements are commonly provided as feedback to participants in 
clinical settings, this metric does not provide the user with information on 
quality of movement. With the portable devices, we can calculate a 
normalized jerk score, which is dimensionless, allowing comparisons of 
movements that vary in duration and/or amplitude (27,28) In a small 
sample of young and older adults as well as individuals with stroke we 
examined normalized cumulative jerk. In three separate tasks young adults 
show minimal variability in performance compared to older adults and 
individuals with stroke. In addition, young adults demonstrate minimal 
variability across repetitions while individuals with stroke demonstrate a 
greater change across trials (29). Interestingly, when individuals with 
stroke are familiarized with the concept of smoothness, they are able 
to decrease their normalized jerk score. Recording normalized jerk over 
time and across activities is a promising way to assess change in 
impairment (30-33) and has been used to demonstrate change in motor 
performance pre/postinterventions. An extended record of this assessment 
via a portable measuring device would provide information to the 
individual with stroke and healthcare providers. 

 
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2.2 Include complete citations or references.  
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Stroke Statistics-2012 Update A Report From the American Heart 
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2 Bushnell, C., McCullough, L. D., Awad, I. A., Chireau, M. V., Fedder, 
W. N., Furie, K. L., .Walters, M. R. Guidelines for the Prevention of 
Stroke in Women A Statement for Healthcare Professionals From the 
American Heart Association/American Stroke Association. Stroke 45, 
1545-1588, doi:10.1161/01.str.0000442009.06663.48 (2014). 
3 Christensen, D., Braun, K. V. N., Doernberg, N. S., Maenner, M. J., 
Arneson, C. L., Durkin, M. S., . . . Yeargin-Allsopp, M. Prevalence of 
cerebral palsy, co-occurring autism spectrum disorders, and motor 
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4 Thurman, D. J., Alverson, C., Dunn, K. A., Guerrero, J. & Sniezek, J. E. 
Traumatic brain injury in the United States: A public health perspective. 
Journal of Head Trauma Rehabilitation 14, 602-615 (1999). 
5 Wiemeyer, J., Deutsch, J., Malone, L. A., Rowland, J. L., Swartz, M. C., 
Xiong, J., & Zhang, F. F.. Recommendations for the Optimal Design of 
Exergame Interventions for Persons with Disabilities: Challenges, Best 
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doi:10.1089/g4h.2014.0078 (2015). 
6 Ortman, J., Velkoff, V. & Hogan, H. An Aging Nation: The Older 
Population in the United States, Population Estimates and Projections, 
Current Population Reports, <http://www.census.gov/prod/2014pubs/p25-
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7 Francis, K. L., Macrae, P. G., Spirduso, W. W. & Eakin, T. The effects 
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Current aging science 5, 2-12 (2012). 
8 Krampe, R. T. Aging, expertise and fine motor movement. Neuroscience 
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10 Howard, J. H. & Howard, D. V. Age differences in implicit learning of 
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11 Santalucia, P., Baviera, M., Cortesi, L., Tettamanti, M., Marzona, I., 
Nobili, A., . Roncaglioni, M. C. Epidemiologic Trends in Hospitalized 
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doi:10.1016/j.jstrokecerebrovasdis.2015.05.008 (2015). 
12 Rosamond, W., Flegal, K., Friday, G., Furie, K., Go, A., Greenlund, K., 
. . . Amer Heart, A. Heart disease and stroke statistics - 2007 update - A 
report from the American Heart Association Statistics Committee and 
Stroke Statistics Subcommittee. Circulation 115, E69-E171,  
doi:10.1161/circulationaha.106.179918 (2007). 
13 Winstein, C. J., Stein, J., Arena, R., Bates, B., Cherney, L. R., Cramer, 
S. C., . . . Council Quality Care Outcomes, R. Guidelines for Adult Stroke 
Rehabilitation and Recovery A Guideline for Healthcare Professionals 
From the American Heart Association/American Stroke Association. 
Stroke 47, E98-E169, doi:10.1161/str.0000000000000098 (2016). 
14 Duncan, P. W., Zorowitz, R., Bates, B., Choi, J. Y., Glasberg, J. J., 
Graham, G. D., . . . Reker, D..Management of adult stroke rehabilitation 
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15 Wolf, S. L., Thompson, P. A., Winstein, C. J., Miller, J. P., Blanton, S. 
R., Nichols-Larsen, D. S., . . . Sawaki, L. The EXCITE Stroke Trial 
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17 Wolf, S. L., Lecraw, D. E., Barton, L. A. & Jann, B. B. Forced use of 
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19 Lai, S. M., Studenski, S., Duncan, P. W. & Perera, S. Persisting 
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20 Lang, K. C., Thompson, P. A. & Wolf, S. L. The EXCITE Trial: 
Reacquiring Upper-Extremity Task Performance With Early Versus Late 

 
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23 Birkenmeier, R. L., Prager, E. M. & Lang, C. E. Translating Animal 
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24 Bell, J. A., Wolke, M. L., Ortez, R. C., Jones, T. A. & Kerr, A. L. 
Training Intensity Affects Motor Rehabilitation Efficacy Following 
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doi:10.1097/jcp.0000000000000277 (2015).  
3.0 Study Design 
3.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response:  
Aim 1: Develop and validate a novel in-home rehabilitation system using 
3D printing technologies, smart devices and machine learning algorithms. 
Part 1.1 Augment Smart Devices for Rehabilitation Use Through 3D 
Printing:  
The instrumented physical devices offer customization of on-demand 
functional objects enhanced by 3D printing augmentation and smart 
devices properly located for sensing movement and 
providing feedback. 3D printed objects can be personalized and adaptive 
to individual needs. Such design philosophy enables users with specific 
conditions (e.g., hand size, diminished strength) to experience fewer 
obstacles and achieve better outcomes. For example, a 3D printed mug 
design is flexible in handle size, body design, weight, and inside design. 
As shown in Fig. 5a, multiple slots were designed inside the mug to 
arrange for different types of smartphones. The same methodology is 
applied to augment smartphones into other functional rehabilitation 
objects, such as bowls and keys. Our team has considerable experiences 
on 3D printing design and fabrication.  
Part 1.2 Develop a Smartphone App for Analyzing Sensors Data and 
Providing User Feedback 
Sensor Data Analysis: The kinematic computation engine is implemented 
in the embedded smartphone, which primarily focuses on sensor data 
analysis and user feedback realization. In sensor data analysis, the 
collected acceleration and angular velocity data from a smartphone are 
used for task events counting (e.g. repetition, time), status detection 
(still/moving), and performance-quality evaluation (kinematic features 
extraction). The core part of the computation engine is a robust algorithm 
to detect and classify the occurrence of task events. To this end, we 
propose an occurrence-detection method to identify, index and classify the 
sensor patterns of task events. First, we will investigate a new presentation 

 
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method to characterize cross-channel sensor data. We can form a set of 
signal shape primitives to represent three channel signals. Then we can 
build the interval coincidence graph, representing the primitives in the 
motion sensor signal recordings. The thickness of edges shows higher 
coincidence between the primitives. Primitives with high coincidence are 
clustered. Our team has preliminarily evaluated this approach on human 
activity monitoring application. In addition, other existing machine 
learning methods will be compared with proposed approach for exercise 
activity recognition.  
User Feedback Interface: The sensor data analysis results serve as the 
source of user feedback. Our focus groups and pilot data demonstrate user 
feedback is important in rehabilitation it motivates participation and 
encourages better self-management of the rehabilitation program. User 
feedback in our system has two categories including instant user feedback 
and post-training feedback. Instant feedback is primarily acoustic and/or 
visual. For example, when a user is pouring water from a cup, the sound of 
water flowing will vary in different stages of pouring, providing an 
immersive experience for rehabilitation. Feedback such as applause, 
fireworks sound, or smiling faces are designed as rewards for achieving 
preset goals or reaching milestones. Post-training feedback emphasizes 
quantitative performance measurements at the end of the task training. 
Measurements include time to complete the task, normalized jerk score, 
total path length, and number of repetitions. We have developed an App 
on a smartphone to visualize the statistical results, and users can see their 
rehab performance across multiple trials. We adopted a two-layer 
feedback report design including a basic report  and detailed report. Users 
are provided with a basic report with the performance trend graphed. If the 
user clicks on a specific trial, then the detailed report of performance 
metrics for that trial will appear. 
Validation: We will validate that data from a smartphone can be modeled 
to accurately identify task events (repetition and time), movement status 
detection (moving or still), and performance-quality evaluation (kinematic 
measures. In a study (N=15 young adults) we will examine the ability of 
the smartphone to accurately identify the above listed components for the 
ADLs listed in Table 1. Each participant will be asked to perform five 
repetitions of each activity in three different testing sessions. We will 
qualify the performance of our activity recognition algorithms using 
accuracy and area under the receiver-operator characteristic (ROC) curve 
(AUC). We will perform an evaluation with random hold out and cross-
validation as well as leave-one-person-out evaluation. Particularly, we will 
compute sensitivity, specificity, and F-measure values. Then we will 
generate a learning curve that plots classification accuracy as a function of 
training set size and will add data collection time until the curve plateaus. 
Our previous research work has shown that it is critical to collect enough 

 
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sensor training data in building robust models. Similarly, we will consider 
recruiting new participants until the curve plateaus. The data collection for 
this study will take place in the Rehabilitation Lab at the University at 
Buffalo. The controlled environment will allow us to measure motion 
accuracy and thus calculate gold standard numbers for jerk score, task 
completion, total path length, and other qualitative metrics (i.e., the 
number of repetitions). 
Aim 2: Examine performance changes in trained ADLs when augmenting 
3D printed objects with smart technology to provide quantitative feedback 
on performance. Study Design: A single-subject experimental design with 
a multiple baseline, multiple probe testing setup is well suited to stroke 
rehabilitation research. With inherent variability between motor 
performance of individuals with stroke, there is an advantage to having 
participants serve as their own control. The level of stability of motor 
performance will be established during baseline by three different 
assessments (described in “Assessments” below). Each participant will 
have a varying length of the baseline period to establish that the 
intervention, rather than time, is the primary reason for any observed 
change in performance. For the intervention, all participants will be asked 
to complete a six-week in home training program as described in 
“Training Intervention” below. A follow-up phase, using the same 
assessments as in the baseline, will be repeated for the purpose of 
assessing carry-over post intervention. Training Intervention: Training will 
focus on upper extremity ADLs and manipulating or transporting the 3D 
printed objects instrumented with a smartphone, the smartphone will be 
supplied for the length of the training program (Table 1 in attached grant 
proposal). Participants will be cued to start their rehabilitation program by 
setting an alarm on the smartphone. The smartphone will be placed either 
in (e.g., the bowl) or on (e.g., the key) the 3D printed device. During the 
initial assessment, rehabilitation professionals will work with  participants 
to determine which tasks can be completed safely. Task modifications will 
be made as necessary to protect joint integrity and balance. Similar to 
previous research in stroke, training will be tailored to the participant’s 
ability. The majority of training ADLs give participants the opportunity to 
perform them in a seated position. However, some participants may prefer 
to stand as this position is more functional for many of the ADLs. 
Participants will be asked to complete a minimum of 10 repetitions of each 
task they are training once a day/ five days per week for six weeks. These 
common ADLs include general arm movement (horizontal transport), 
forearm pronation and supination (pouring) and fine motor (key). 
Participants will receive auditory feedback on count or speed of movement 
in real time. Feedback will be given as described previously. The goal is to 
perform tasks more smoothly and in less time than the previous session. If 
participants have increased pain with training, they will be asked to stop 
doing the training tasks and contact the PI. 

 
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4.0 Local Number of Subjects 
4.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response:  
We expect about 45 people in this research study.  Fifteen young adults 
(18-30) who have not experienced a stroke will be recruited. It is possible 
that we would need to recruit more than the anticipated 15 participants. 
Possibly 10 more. Our previous research has shown that it is critical to 
collect enough sensor training data in building robust models. Similarly, 
we will consider recruiting new participants until the curve plateaus. 
Twenty adults who have experienced a stroke are expected to participate 
in the study.   
4.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response:  
It is possible that approximately 25% of individuals with stroke will not qualify 
for the study. We anticipate that advertisements for the study emphasizing study 
criteria will keep the screening failure rate low.                        
4.3 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:  
The enrollment at The University at Buffalo is over 29,000. It is likely that we can find 
15 adults between the ages of 18-30 from the campus community to participate in the 
study 
Erie County has the highest rate of stroke in New York State (BCBS statistics). It is 
likely that we can recruit 20 participants for the proposed study. 
 
5.0 Inclusion and Exclusion Criteria 
5.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
Response:  
Aim 1 and Aim 2: Inclusion Criteria  
Both older adults and individuals with stroke need to be: 1) living in the 
community as an independent ambulator with or without an assistive device 
(orthosis, walker, cane, etc.). 2) able to hear well enough, with or without a 
hearing aid, to participate in a conversation 

 
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Aim 1 Criteria: adults: age 18-30 in good health 
Aim 2 Criteria in individuals with stroke must: 1.) have had no more than one 
non-cerebellar stroke. 2.) be 6+ months post stroke 3.) be 18 years or older 
 
5.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:   
Exclusion Criteria: 1.) Presence of cognitive impairment that would affect ability 
to participate as determined by the Mattis Dementia Scale (minimum of 124/144). 
2) Acute or chronic pain that would interfere with participation in testing or  
training. 3) Severely limited range of motion or contractures of the arms or 
hands. 4) Absence or severely impaired proprioception of upper limbs. 5) 
Musculoskeletal or circulatory conditions affecting the lower limb (vascular 
disease, tendonitis, cellulitis, Raynauds syndrome, severe osteoarthritis or 
rheumatoid arthritis, other orthopedic surgeries involving the lower limbs). 6) 
Severe spasticity interfering with function (3 or greater on the Modified Ashworth 
Scale). 7) Recent treatment (within 3 months) for spasticity including botulinum 
toxin injections or spasticity medications including intrathecal baclofen. 8) 
Hospitalization within 3 months of participation 
 
Exclusion Criteria specifically for Aim 2- Participants in Aim 2 will need to score 
greater than 42 on the Berg Balance Scale indicating they are not at a higher risk 
for falls. 
 
5.3 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 
 
5.4 Indicate whether you will include non-English speaking individuals in your 
study.  Provide justification if you will exclude non-English speaking 
individuals.  

 
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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 questionnaires, and some non-therapeutic studies which offer no 
direct benefit. 
Response:  
Participants with stroke involved in the intervention will need to be fluent in 
English to efficiently interact with the written/verbal feedback based on the 
Smartphone. Non-English speaking participants will be excluded in this initial 
study of the software guiding the gait rehabilitation program. 
6.0 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. 
6.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: It is possible that one of our participants may be pregnant. 
There is no reason to anticipate that the procedures used in this study 
would harm a pregnancy. 
 
  
☐ 
N/A:  This research does not involve pregnant women. 
6.2 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. 
6.3 
For research that involves prisoners, safeguards include: 

 
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NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
 
☒ 
N/A:  This research does not involve prisoners. 
6.4 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”). 
6.5 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. 
6.6 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:  
Flyers, advertisements and letters will be used to recruit participants. Participants 
will have the choice to contact the PI to participate in the study, thereby avoiding 
coercion or undue influence. 
7.0 Eligibility Screening  
7.1 
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: 
The PI or research assistants will be responsible for screening potential 
participants. Participants will be asked a series of questions over the phone (see 
phone scripts and questionnaires for young adults and individuals with stroke). 
When participants arrive for their first scheduled session, they will complete a 
cognitive assessment (Mattis Dementia Rating Scale- Dementia Rating Scale–2™ 
(DRS-2™) http://www4.parinc.com/Products/Product.aspx?ProductID=DRS-2, 
this trademark assessment will be purchased for the study information on the 

 
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assessment is found at the given website), The Montreal  Cognitive assessment 
may also be used.  A movement screen (range of motion and proprioception) and 
assessments for spasticity (Modified Ashworth Scale) will also be conducted prior 
to starting the testing. If the individual demonstrates severe limitations in 
movement, they will not complete the testing session. They will be paid for 
coming to the testing session on South Campus. 
☐ 
N/A:  There is no screening as part of this protocol. 
8.0 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. 
8.1 
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:  
Recruitment strategies for young adults will consist of flyers posted on UB 
campuses. Recruitment for individuals with stroke will be extensive 
including distribution of flyers through organizations such as Meals on 
Wheels, the Program of All-Inclusive Care for the Elderly (PACE), stroke 
support groups, senior centers and clinical facilities in the greater Buffalo 
region. In addition, advertisements will be placed in local papers and 
flyers at community centers. Final versions of the newspaper 
advertisements will be submitted to as an amendment to the IRB for 
approval prior to the printed ad. We will also ask the Buffalo Research 
Registry for a list of potential participants to contact and determine if they 
are interested in participating and if they are a good fit. 
 
8.2 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 advertisements 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. 
 
8.3 Identify any materials that will be used to recruit subjects.  
NOTE:  Examples include scripts for telephone calls, in person announcements / 
presentations, email invitations.  

 
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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, advertisements, and follow up phone conversations- see phone scripts will 
be used to recruit participants. The flyer will be used as the advertisements. 
 
 
9.0 Procedures Involved 
9.1 
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 in your response. 
Approach: Our goal is to develop portable technology capable of cueing a home 
training program, collecting data on upper limb motor performance and 
providing user feedback on performance.  
Response: Aim 1:Participants will be asked to come to Kimball Tower three times 
within a two week time span to demonstrate consistency of motor performance. 
An infrared motion monitor system will be used to track their movement and 
compare kinematics produced by the smartphone with kinematics produced from 
the infrared motion monitor system. Participants may be video taped during data 
collection to further assess mobility. 
Aim 2 
Wolf Motor Function Test (WMFT): examines functional abilities. It is a 
valid and reliable outcome measure following stroke  
9-Hole Peg Test: a timed test of manual dexterity which involves 
lifting/placing/removing 9 pegs into/out of holes. It is both valid and 
reliable in measuring arm function after stroke. 
Grip assessment: Grip strength is measured with a hand dynamometer.  
Berg Balance Scale: A 14-item scale designed to measure balance 
 
All clinical assessments are recommended Outcome Measures by the APTA for 
stroke (http://www.neuropt.org/professionalresources/neurology-section-
outcome-measures-recommendations/stroke)  

 
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Use of smartphone and 3D printed objects will be in home over a 11- week span. 
Five of these weeks the participants will perform a limited number of task trials 
without feedback to act as a probe for performance quality. The other 6 weeks, 
participants will be asked to perform their exercise program 5/7 days and the in 
home exercise program may take up to an hour to complete. 
User Feedback Measures: User Interaction Satisfaction: We will ask participants 
to rate the effectiveness of the information displays in supporting a set of key 
needs. The Questionnaire for User Interaction Satisfaction (QUIS) is a validated 
usability assessment tool applied in numerous studies of interface design (80-82, 
information on online assessment found at 
http://www.lap.umd.edu/QUIS/index.html), including assessment of health 
information interfaces (83-85). This licensed, online questionnaire will be 
supplemented with context specific questions related to the display. Comments 
and Debriefing: Participant will be interviewed to obtain additional feedback on 
their overall experience during the test. A semi-structured interview will be used 
in which broad questions are formulated and the conversation progresses. 
Findings from these components will be used to make iterative improvements as 
necessary to the system to support future research and implementation  
Caregiver Feedback Measures: Caregivers of participants will be given the 
opportunity to provide their feedback on mRehab and the participant’s use of the 
mRehab system. A semi-structured interview will be used to gain feedback on 
how much assistance caregiver’s provided for 1) setting up mRehab, 2) providing 
motivation to use mRehab, 3) assisting the participant in using mRehab and 4) 
suggestions for improving mRehab. 
9.2 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:  
Aim 1: 
The controlled environment will allow us to measure motion accuracy and 
thus calculate gold standard numbers for jerk score, task completion, total 
path length, and other qualitative metrics (i.e., the number of repetitions). 
Video assessments will allow us to review motor behavior and further 
assess mobility. 
Aim 2: 
Clinical Assessments used to determine mobility of the more affected limb: 
Wolf Motor Function Test (WMFT): examines functional abilities. It is a 
valid and reliable outcome measure following stroke  
9-Hole Peg Test: a timed test of manual dexterity which involves 
lifting/placing/removing 9 pegs into/out of holes. It is both valid and 
reliable in measuring arm function after stroke. 

 
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Grip assessment: Grip strength is measured with a hand dynamometer. 
Modified Ashworth Scale: Assesses spasticity 
Probes: Perform the ADLs from the training program without feedback. 
 
Performance will be assessed by examining data collected from the 
smartphone: 
Participants will be asked to complete only two repetitions of the training 
tasks without receiving feedback on three separate days during each 
baseline week and each follow-up week to determine baseline 
performance and in follow-up retention of task learning. 
Performance Measures: We will examine the following measurements of 
movement and task performance for comparison between the baseline and 
training intervention periods: 
Task completion time: Measured from the start to the end of the task. 
Normalized jerk score (NJS)/smoothness: Using the acceleration readings 
from the inertial measurement unit embedded in the smartphone, the 
normalized jerk score can be computed. 
Usability: Participants will evaluate the usability of the system based on ease of 
use and interpretability of the feedback. Usage metrics will be recorded to track 
how often and for how long they use the system at home. Also, a post-survey study 
will be used to collect quantitative participant feedback for UI improvement.  
User Feedback Measures: User Interaction Satisfaction: We will ask participants 
to rate the effectiveness of the information displays in supporting a set of key 
needs. The Questionnaire for User Interaction Satisfaction (QUIS) is a validated 
usability assessment tool applied in numerous studies of interface design, 
including assessment of health information interface. This licensed, online 
questionnaire will be supplemented with context specific questions related to the 
display. Semistructured interviews will also be used. 
Caregiver Feedback Measures: Caregivers will be given the option of 
participating in a  semi-structured interview to assess their feedback on how much 
assistance the caregiver provided for 1) setting up mRehab, 2) providing 
motivation to use mRehab, 3) assisting the participant in using mRehab and 4) 
suggestions for improving mRehab. 
 
 
 
 
9.3 List any instruments or measurement tools used to collect data (e.g. 
questionnaire, interview guide, validated instrument, data collection form).   

 
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Include copies of these documents with your submission. 
Response:  
List of instruments used in study: 
Questionnaires for young adults and adults with stroke 
Mattis Dementia Rating Scale- Licensed manual with scoring software 
http://www4.parinc.com/Products/Product.aspx?ProductID=DRS-2 
Montreal Cognitive Assessment 
Clinical Assessments: 
Wolf Motor Function Test 
9-hole peg test 
Modified Ashworth Scale 
Grip Strength- measured with hand dynamometer; the hand dynamometer 
is an instrument used to measure the strength of the hand and forearm muscles by 
asking the participant to squeeze the dynamometer with as much force as 
possible.  
Berg Balance Scale 
 
The Questionnaire for User Interaction Satisfaction (QUIS)- licensed online 
assessment , http://www.lap.umd.edu/QUIS/index.html 
Semi-structured interview for participants 
Semi-structured interview for caregivers 
A modification will be submitted to upload the QUIS and Mattis Dementia Rating 
Scale after funding is received for the project and the license and the test is 
purchased. 
9.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response: Not applicable 
 
9.5 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:  
9.6  If participants ask about their performance, we could inform them of their 
performance on the clinical assessments. Indicate whether or not study 

 
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results will be shared with subjects or others, and if so, describe how these 
will be shared. 
Response:  
Data from the study will be analyzed and will be presented in professional 
journals and conferences. 
10.0 
Study Timelines 
10.1 Describe the anticipated duration needed to enroll all study subjects. 
Response:  
It is anticipated that all participants will be enrolled within two years of the start 
of the study. 
10.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response:  
Aim 1: Participants will come to Kimball Tower on South Campus three times for 
approximately 1 hour each session. 
Aim 2: Participants with stroke will be asked to come to Kimball Tower a total of 
4 times (2 pre-tests and 2 post-tests) and participate in a 10 week in-home 
technology guided exercise program. Pre and post testing will be done in the two 
weeks pre and post the exercise program. The caregiver feedback measures would 
obtain information from caregivers in one session lasting 5-30 minutes depending 
on the amount of feedback the caregiver provides. We could conduct the 
interview over the phone on or near the last day of the testing session or the 
caregiver can do it in person during the participant’s 3rd or 4th testing sessions.  
10.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
Response:  
It is anticipated that data collection and analyses will be completed in 2-2.5 years. 
11.0 
Setting 
11.1 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.” 

 
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Response: Data collection will be done on the South Campus of UB in Kimball 
Tower. The building is handicap accessible and is open to the public during 
normal working hours. Parking spaces are reserved for participants and in 
addition handicapped parking is available next to Kimball Tower. The lab is 
located on the fifth floor of Kimball Tower. The de-identified data from the in-
home exercise program will be collected through the smartphone. De-identified 
data will be uploaded to Amazon Simple Storage Service (Amazon S3). Security 
measures have been taken so that only members of the research team are able to 
access de-identified data on Amazon S3. If internet is not available to upload the 
data, data will remain stored on the phone.  
 
11.2 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. 
12.0 
Community-Based Participatory Research 
12.1 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. 
12.2 
Describe the composition and involvement of a community advisory 
board. 
Response:  
 
☒ 
N/A:  This study does not have a community advisory board. 

 
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13.0 
Resources and Qualifications 
13.1 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.  
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 PI has completed a PhD program, post-doctoral training and has a 
productive research lab. Key personnel have completed a PhD or 
advanced graduate degrees in their respective fields and are involved in 
ongoing scholarship. All research personnel have completed CITI training. 
Research assistants have been trained in the lab on use of equipment, 
clinical assessments, and pen and paper assessments. Training includes 
reading pertinent literature, hands on training and training with more 
senior research personnel. Research assistants working with participants 
have completed CPR and First Aid training. Research assistants are 
responsible for screening potential participants, obtaining verbal consent, 
collecting data, managing data sets and writing. The PI will regularly 
communicate with research personnel regarding recruitment, data 
collection, data management and writing. 
 
 
Describe other resources available to conduct the research.  
13.2 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: Key personnel with academic appointments will devote .5-.9 academic 
months and up to .75 summer months. Personnel with 12 month appointments 
will devote .3 calendar months. In addition, Graduate (9 month appointment yr 1 
and 12 month appointment yr 2) and undergraduate research assistants (total of 30 
hours per week) will work on the project.   
 
13.3 Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if 
applicable. 

 
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NOTE:  One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Response: If individuals demonstrate they are at higher risk for falls based upon 
the clinical assessments, they will be encouraged to consult with their physician 
and given basic information regarding fall prevention strategies. If a fall were to 
occur during assessments or training, there are not medical resources on site. If 
needed, medical resources would need to be called.  
 
13.4 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: Research personnel working with the participants are trained in 
the use of clinical assessments, equipment used in the study and are 
familiarized with the research protocol. This is done through hands on 
training, reading pertinent literature and working with senior research 
personnel. In addition, all research personnel have completed CITI 
training. 
 
 
14.0 
Other Approvals 
14.1 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:  
Prior to dispersing advertisements through Meals on Wheels, the Program of All-
Inclusive Care for the Elderly (PACE), stroke support groups, senior centers, or 
clinical facilities, permission will be obtained from the organization to do so. 
☒ 
N/A:  This study does not require any other approvals. 
15.0 
Provisions to Protect the Privacy Interests of Subjects 
 
15.1 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.”   

 
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Response:  
Participants will self-select to respond to one of the advertisements for the 
study. They need to choose to contact the researchers to participate in the 
study. The settings for the phone conversation will be in private areas.  
The subjects will be seen in private lab areas for clinical assessment.  
 
15.2 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: Participants will directly provide personal data to research 
personnel. Research personnel do not have access to medical or other 
records for the participant. 
 
 
16.0 
Data Management and Analysis 
16.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Response:  
Aim 1: 
Validation of smartphone with motion monitor system. We will look at 
consistency of motor performance across time. 
Aim 2: 
A strength of the proposed single-subject study design is the internal 
validity gained by using repeated measurement from the same individuals 
and the ability to replicate the effect of the intervention across participants. 
As is typical with single-subject designs, visual inspection will be used as 
the first stage of analysis to determine the general stability of performance 
during the baseline phase and the trend of performance change during the 
training intervention. Statistical analysis to corroborate the visual analysis 
will include time-series analysis to infer changes in trend and level across 
phases.80 The serial dependency in the data for each participant will be 
accounted for using the autoregressive integrated moving average 
(ARIMA).80 If a significant positive trend in overall performance during 
the training intervention is observed, the hypothesis will be accepted. To 
validate the effect of the training program on the performance measures, 
the effect on the standardized assessments will be tested. A repeated 
measures analysis of variance (ANOVA) will be used to assess whether 
there is a difference within each participant for performance on the Wolf 

 
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Motor and 9 hole peg test assessments at the start of baseline, end of 
baseline, start of follow-up, and end of follow-up. Post hoc pairwise 
comparisons will be used to assess the differences ΔB = Bend-Bstart, 
ΔTraining (ΔT) = Fstart-Bend, and ΔF = Fend-Fstart. It is hypothesized 
that ΔB and ΔF will be 0, indicating stable performance during the 
baseline and follow-up, and that ΔT > 0. If these results are consistent 
with the findings from the functional tests, then the results will be 
considered valid. 
16.2 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:  
Aim 1: In a study (N=15 young adults) we will examine the ability of the 
smartphone to accurately identify the above listed components for the 
ADLs listed in Table 1. Each participant will be asked to perform five 
repetitions of each activity in three different testing sessions. We will 
qualify the performance of our activity recognition algorithms using 
accuracy and area under the receiver-operator characteristic (ROC) curve 
(AUC). We will perform an evaluation with random hold out and cross-
validation as well as leave-one-person-out evaluation. Particularly, we will 
compute sensitivity, specificity, and F-measure values. Then we will 
generate a learning curve that plots classification accuracy as a function of 
training set size and will add data collection time until the curve plateaus. 
Our previous research work has shown that it is critical to collect enough 
sensor training data in building robust models. Similarly, we will consider 
recruiting new participants until the curve plateaus. 
 
Aim 2: Sample size estimation was based on the repeated measures 
ANOVA test of within subjects change in standardized assessment scores 
from baseline to follow-up. With α = 0.05, power = 0.8, 4 measurements, 
and a desired effect size (f) = 0.25 to detect, a sample size of 15  
participants is needed. This effect size is consistent with studies on 
functional activity performance and recovery following stroke.68 A total 
of 20 participants will be recruiting to account for a 25% attrition rate. 
 
16.3 Describe any procedures that will be used for quality control of collected 
data. 
Validation of the system in aim 1 acts as a quality control. 
17.0 
Confidentiality 
 

 
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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.   
 
17.1 
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: Data collected from participants will be coded with a participant 
number. Subject identifiers (e.g., name, address, birth date) will be kept separate 
from other data in a locking cabinet in the PI’s South Campus office (Kimball 
Tower 522). Thus the signed consent forms and master list of participants will be 
in a secure location accessible to the PI and co-researchers. Data will be retained 
for a minimum of three years. Digital data such as video tape will be kept on a 
password protected server. If manuscripts related to this work continue to be 
generated at the end of three years the data will be maintained until all 
manuscripts have been published. 
 
17.2 
A.  How long will the data be stored? 
Response:  
Data will be stored a minimum of three years 
 
17.3 
A.  Who will have access to the data? 
Response:  
Research personnel 
17.4 
A.  Who is responsible for receipt or transmission of the data? 
Response:  
Research personnel 
17.5 
A.  How will the data be transported? 
Response: 
Data will be coded and entered into computerized spreadsheets accessible 
on a secure drive. 
 
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study 
specimens.   

 
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☒ 
N/A:  No specimens will be collected or analyzed in this research.   
(Skip to Section 19.0) 
 
17.6 
B.  Where and how will all specimens be stored?  Include information 
about:  physical controls, authorization of access, and labeling of specimens, as 
applicable.   
Response:  
 
17.7 
B.  How long will the specimens be stored? 
Response:  
 
17.8 
B.  Who will have access to the specimens? 
Response:  
 
17.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response:  
 
17.10 B.  How will the specimens be transported? 
Response: 
 
 
18.0 
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. 
 
18.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 
Response:  
Data will be reviewed by the PI on a quarterly basis. If concerns or 
comments from participants arise they will be noted and discussed by 

 
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research members. We want to ensure the participant’s well-being in the 
study and promote a positive experience without compromising the 
integrity of the research. Serious events and problems will be reported by 
the primary investigator to the SBSIRB in a within 24 hours.   
 
18.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 
Response:  
Performance on assessments of movement, and strength will be reviewed. In 
addition, performance on the Upper Limb Training will be reviewed. 
18.3 Describe any safety endpoints. 
Response:  
Participants will safely complete the technology guided upper limb Training. 
18.4 Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
Response: Participants will be monitored during data collection in aim 1. In aim 
2, participants will start the technology guided upper limb Training in the lab with 
direct mentoring and then progress to completing it independently at home. At the 
start of the in-home program, members from the research team will either go to 
the participant’s home to confirm that the system is working correctly or will use 
a platform such as skype to converse with the participant and see the set up. 
Research members will work with participants if they experience technical 
difficulties by going to their house, skype or a phone conversation. They will be 
provided with contact information for the PI and other research personnel in case 
they have concerns or difficulties at home. Participants will also be asked about 
their in home upper limb training experience at their post-intervention testing. 
 
18.5 Describe the frequency of safety data collection. 
Response:  
Quarterly or within 24 hours of a participant raising a concern. 
18.6 Describe who will review the safety data. 
Response:  
The PI 
18.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response:  
Quarterly 
18.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 

 
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Response:  
Participants will be debriefed following training, if they report concerns about the 
in-home training these will be recorded and evaluated by the research personnel. 
If participants call in to report concerns, these will be recorded and considered by 
research personnel. 
18.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response: If participants report concerns that the research team deems could 
cause difficulties for all participants, research will be suspended. 
19.0 
Withdrawal of Subjects 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
19.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Response: If participants fail to complete the testing sessions in Aim 1 in a timely 
manner, they may be withdrawn from the study.  
Participants will be assessed with the Berg Balance Scale. If they do not score 
above a 42, they will only perform exercises in a seated position in Aim2. If 
participants report pain with activities in the program and the program cannot be 
modified to eliminate pain, the participant will be taken out of the study. 
 
19.2 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: Exit interview with research personnel. If balance concerns have 
prompted termination in the training portion of the study, the PI will consult with 
the participant. The participant will need to return the rehabilitation device and fill 
out the paper work for payment of the pre-intervention testing session. 
 
19.3 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:  
Data collected prior to participant’s departure from the study may be used in 
portions of the data analyses. 
20.0 
Risks to Subjects 

 
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20.1 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 Risks to the Subjects 
It is possible for the participant to experience: 
• fatigue   
• loss of balance, possibly resulting in a fall  
• a muscle strain or orthopedic injury 
• breach of confidentiality with your personnel information 
  
 
20.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
Risks to participants are minimized by: 
 screening participants using the inclusion/exclusion criteria 
 providing the participants with rests as they wish between 
assessments 
 tailoring the Upper Limb Training program to the abilities of each 
participant 
 reminding participants that they can terminate their participation at 
any time, without penalty. 
 Coding data used in analyses 
 
20.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response:  
The Upper Limb Training is a new approach to rehabilitation at home.  It is 
possible that participants may have difficulties with this home exercise program. 
To reduce risks, participants who score at or below 42 on the Berg Balance Scale 
must complete all home exercises in a seated position. The Training program will 
also be tailored to each participant’s abilities. 
20.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response:  

 
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The procedures should not cause increased risk to the embryo or fetus. 
20.5 If applicable, describe risks to others who are not subjects. 
Response:  
The procedures should not cause risk to others who are not subjects. 
21.0 
Potential Benefits to Subjects 
21.1 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: It is unlikely that participants in Aim 1 will experience a direct 
physical benefit for their participation in the study. It is possible that participants 
that complete aim 2 may experience some level of benefit in their ability to move 
their arm/hand. The results of the study may influence rehabilitation approaches 
in the future. All participants may derive satisfaction from the potential to help 
others. The risk to benefit ratio is excellent. 
 
22.0 
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.   
22.1 
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: 
Safety precautions will be taken to limit the risks to participants in the 
study to “minimal risk”. The Upper Limb Training may involve activities 
in standing, making it possible that the participant may fall. By assessing 
individuals for fall risk, using a clinical assessment, prior to enrollment 
into aim 2 of the study, we will lower the risk to the participant.  
If a participant feels like they have been injured because of taking part in 
this study.  They should inform the PI and they will be encourage to 
consult with their physician. Treatment options will be explained by your 
physician. Generally, this care will be billed to you, your insurance or 
other third party. The University at Buffalo has no program to pay for 
medical care for research-related injury. 
 
22.2 
Provide a copy of contract language, if any, relevant to compensation for 
research related injury. 

 
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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:  
NA 
23.0 
Economic Burden to Subjects 
23.1 Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
Response: No costs are associated with 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. 
24.0 
Compensation for Participation 
25.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 
Response:  
If you agree to take part in the first part of this research study, we will pay 
you _$30 for your time and effort. The paperwork for the check will be 
completed at the testing session. Processing payment may take 4-6 weeks.  
 
If you have had a stroke and agree to take part in the second part of this 
research study, we will pay you _$25 each for the pre and post 
intervention testing sessions and $200 for completing the 11 week in home 
Upper Limb Training program (5 weeks baseline and 6 weeks training). 
This will be a total of $300. The paperwork for the check will be 
completed at the last testing session. If participants do not complete the 
training program, they will be asked to bring the equipment back to 
Kimball Tower and will complete the paperwork for payment of the pre-
test sessions. Processing payment may take 4-6 weeks. 
☐ 
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. 
25.0 
Consent Process 
25.1 Indicate whether you will be obtaining consent.   

 
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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) 
 
25.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 
Response:  
When potential participants come to South campus for an in lab session, 
they will again be given a description of the study. Any questions potential 
participants may have will be answered to their satisfaction by study 
personnel. Once all questions have been answered, potential participants 
will be asked if they wish to continue in the study.  Their written consent 
is necessary for enrollment into the study. 
 
25.3 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-090)” Sections 5.5 and 5.6. 
Response: Participants will be encouraged to ask questions and will be given the 
time they desire to determine if they would like to participate. If participants feel 
comfortable signing the informed consent, we will then start the assessments. 
 
25.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response:  
At the beginning of each testing session, the participant will be given a summary 
of the activities to be completed that day. Participants will be asked if they want 
to continue.  
25.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-090).” 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 

 
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Response:  
 
☒ 
We have reviewed and will be following “SOP: Informed Consent Process 
for Research (HRP-090).” 
 
Non-English Speaking Subjects  
☒ 
N/A:  This study will not enroll Non-English speaking subjects.   
(Skip to Section 26.8) 
25.6 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:  
 
25.7 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.  Indicate the language that will be used by those 
obtaining consent. 
NOTE:  Guidance is provided on “SOP:  Informed Consent Process for Research 
(HRP-090).” 
Response:  
 
 
Cognitively Impaired Adults 
☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 26.9) 
25.8   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) 

 
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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). 
25.9  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.  
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).”  
25.10 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:  
 
25.11 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:  
 
25.12 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:  

 
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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) 
25.13 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:  
25.14For 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:  
 
25.15 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).”  

 
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25.16Describe 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:  
 
25.17 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:  
 
25.18 When assent of children is obtained, describe how it will be documented. 
Response:  
 
26.0 
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. 
26.1 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:  
 
26.2 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:  
 
27.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 29.0) 

 
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27.1 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 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). 
28.0 
Multi-Site Research (Multisite/Multicenter Only) 
☒ 
N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply. 
 
28.1 If this is a multi-site study where you are the lead investigator, describe the 
processes to ensure communication among sites, such as: 
• 
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. 
• 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with local policy. 
Response:  
 
28.2 Describe the method for communicating to engaged participating sites: 

 
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• 
Problems 
• 
Interim results 
• 
Study closure 
Response:  
 
28.3 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 
Response:  
 
28.4 
If this is a multicenter study for which UB will serve as the IRB of record, 
and subjects will be recruited by methods not under the control of the local site 
(e.g., call centers, national advertisements) describe those methods.  
Response:  
 
29.0 
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. 
29.1 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:  
 
29.2 List the data to be stored or associated with each specimen. 
Response:  
 
29.3 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:  
 

 
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30.0 
Drugs or Devices 
☐ 
N/A:  This study does not involve drugs or devices.  This section does not 
apply. 
30.1 If the research involves drugs or devices, list and describe all drugs and 
devices used in the research, the purpose of their use, and their regulatory 
approval status.  
Response:  
Participants will be using a common smartphone purchased commercially and 3D 
printed objects. These items do not pose undue risk to the participant. 
30.2 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. 
Response: 
The participant will be provided with a smartphone during the study. When 
smartphones are not in use by participants, they will be stored securely in the lab 
by research personnel. 
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: 
30.3 Identify the holder of the IND/IDE/Abbreviated IDE. 
Response:  
NA 
30.4 Explain procedures followed to comply with FDA sponsor requirements 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  
 
31.0 
Humanitarian Use Devices 

 
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☒ 
N/A:  This study does not involve humanitarian use devices.  This does 
not apply. 
31.1 
For Humanitarian Use Device (HUD) uses provide a description of the 
device, a summary of how you propose to use the device, including a description 
of any screening procedures, the HUD procedure, and any patient follow-up 
visits, tests or procedures. 
Response:  
 
31.2 
 For HUD uses provide a description of how the patient will be informed 
of the potential risks and benefits of the HUD and any procedures associated with 
its use. 
Response: