Feasibility and Preliminary Effects of Using a Music-based, Rhythm-modulating Wearable Sensor System in the Community in Persons With Parkinson Disease
Phase: NA
Conditions: Parkinson Disease
Sponsor: MedRhythms, Inc.

 
 
 
 
 
 
Feasibility and Preliminary Effects of using a Music-based, Rhythm-
modulating Wearable Sensor System in the Community in Persons 
With Parkinson Disease 
 
Study Protocol 
 
NCT Number: NCT04891107 
 
Date of Document: April 29, 2023 
 

1 
Version:  November, 2017 
 
 
 
BU Charles River IRB 
Application Form (Full Board and Expedited Review) 
 
SECTION A:  PROTOCOL AND CONTACT INFORMATION 
Protocol Number (To be 
assigned by IRB Office): 
 
Protocol Title:   
Feasibility and preliminary effects of using a music-based, 
rhythm-modulating wearable sensor system in the community in 
persons with Parkinson disease 
Principal Investigator 
(Name, degrees, licenses, 
etc.): 
☐ Mr. 
☐ Ms. 
Terry Ellis PhD, PT 
             Department/School: Department of Physical Therapy & Athletic Training; College of 
Health & Rehabilitation Sciences: Sargent College 
BU Mailing Address: 
635 Commonwealth Ave, Boston, MA 02215 
             Email: 
tellis@bu.edu 
             Telephone: 
617-353-7571 
Additional Contact Person: 
Jenna Zajac PT, DPT, Research Physical Therapist  
              Email: 
zajacj@bu.edu 
              Telephone: 
617-419-0704 
☒ YES 
(REQUIRED) 
I confirm that I qualify to serve as the Principal Investigator of this study 
and am in compliance with the following policies: 
• http://www.bu.edu/researchsupport/compliance/human-subjects/  
 
SECTION B:  FUNDING 
 
Provide information regarding ALL funding sources in this section.  This includes ANY 
EXISTING FUNDING, PENDING FUNDING, OR FUNDING THAT HAS BEEN 
APPLIED FOR TO SUPPORT THIS RESEARCH.   
Please check all that apply: 
 ☒ 
This research is funded 
 
Have you received Just In Time (JIT) Notification?   ☐ Yes           ☐ No 
 
☐ 
Funding has been requested  
Have you received Just In Time (JIT) Notification?   ☐ Yes           ☒ No 
IRB Office use only 
Date submitted________ 
 
FB_____   Exp. ____ 
 

2 
Version:  November, 2017 
 
NOTE:  Once the funding has been awarded, submit an amendment to the IRB 
to add the funding source 
☐ 
Research is not funded 
 
If the research is funded or funding has been requested, it is REQUIRED that you 
complete the box below.  The Sponsor Award # must be included in the box below.  If you 
don’t have an award #, please state that in the box below.  If you have multiple funding 
sources, add additional boxes as necessary. 
 
Sponsor Name 
 
MedRhythms, Inc. 
Title of 
Grant/Proposal 
 
Feasibility and preliminary effects of using a music-based, 
rhythm-modulating wearable sensor system in the community 
in persons with Parkinson disease 
Sponsor Award # 
(REQUIRED)* 
*If Award # is 
pending, put 
pending.  Once 
the funding has 
been awarded, 
submit an 
amendment to 
the IRB to add 
the funding 
source 
 
Pending 
 
 
 
YES 
NO 
 
 
☒ 
☐ 
 
Is Boston University the Prime Awardee of the grant? 
☐ 
☒ 
 
Is Boston University receiving a sub-award? 
Name of Prime Recipient: 
 
*NOTE:  Provide a copy of the grant application, funding proposal, scope of work, or sub-award 
agreement.  The University is required to verify that all funding proposals and grants have been 
reviewed by the IRB before funds are awarded. 
 
If this research study is for your dissertation, provide a copy of your prospectus (if available). 
 
 
 
 

3 
Version:  November, 2017 
SECTION C:  CONFLICT OF INTEREST 
☒ YES 
(REQUIRED) 
I confirm that ALL those responsible for the design, conduct, or reporting 
of the proposed program, including at minimum, all Senior/key personnel 
in the grant application, have completed the financial interest disclosure 
forms, submitted them to the COI office, and completed training as 
dictated at: http://www.bu.edu/researchsupport/compliance/conflicts-of-
interest/,  and as provided under the Boston University Investigator 
Conflicts of Interest Policy for Research.     
 
NOTE:  You must attach a copy of the PI’s COI submission 
confirmation email.  COI submission confirmation emails for all 
other study staff should be maintained at the research site.     
Of the financial interest disclosure forms submitted, did you check “yes” to any of the 
questions on either the FIND1 or NONFIND1 form? 
      ☐ Yes*           ☒  No 
 
 
 
*If  you checked “yes” to any of the questions on either the FIND1 or NONFIND1 form, the 
IRB Director will contact the COI office to obtain the disclosure information. 
 
SECTION D:  TYPE OF REVIEW 
 
For Guidance regarding Type of Review please refer to the following website: 
http://www.bu.edu/researchsupport/compliance/human-subjects/submitting-an-irb-protocol/  
 
I. 
FULL BOARD 
☒  
Please refer to the IRB website for Full Board submission deadlines and meeting dates:  
http://www.bu.edu/researchsupport/compliance/human-subjects/dates-and-timing-of-the-irb-
committee/  
II. 
EXPEDITED  
☐  
In order to qualify for expedited review, the study must be no more than minimal risk* AND 
must fall into one of the categories below.  Check all that apply: 
 
1. ☐ Clinical studies of drugs and medical devices only when an investigational new drug 
application (IND)  or investigational device exemption application (IDE) is not required 
 
2. ☐ Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as 
follows: 
a. From healthy, nonpregnant adults who weigh at least 110 pounds. For these 
subjects, the amounts drawn may not exceed 550 ml in an 8 week period and 
collection may not occur more frequently than 2 times per week; or 

4 
Version:  November, 2017 
b. From other adults and children, considering the age, weight, and health of the 
subjects, the collection procedure, the amount of blood to be collected, and the 
frequency with which it will be collected. For these subjects, the amount drawn 
may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and 
collection may not occur more frequently than 2 times per week. 
 
3. ☐ Prospective collection of biological specimens for research purposes by noninvasive 
means.  Examples include hair and nail clippings, saliva or cheek swabs, sweat, etc. 
 
4. ☐  Collection of data through noninvasive procedures (not involving general anesthesia 
or sedation) routinely employed in clinical practice, excluding procedures involving x-
rays or microwaves. Where medical devices are employed, they must be 
cleared/approved for marketing.  
 
Examples:  
1. Physical sensors that are applied either to the surface of the body or at a distance 
and do not involve input of significant amounts of energy into the subject or an 
invasion of the subject’s privacy  
2. Weighing or testing sensory acuity  
3. Magnetic resonance imaging  
4. Electrocardiography, electroencephalography, thermography, detection of 
naturally occurring radioactivity, electroretinography, ultrasound, diagnostic 
infrared imaging, doppler blood flow, and echocardiography  
5. Moderate exercise, muscular strength testing, body composition assessment, and 
flexibility testing where appropriate given the age, weight, and health of the 
individual 
 
5. ☐ Research involving materials (data, documents, records, or specimens) that have been 
collected, or will be collected solely for nonresearch purposes (such as medical treatment 
or diagnosis)  
 
6. ☐  Collection of data from voice, video, digital, or image recordings made for research 
purposes. 
 
7. ☐ Research on individual or group characteristics or behavior (including, but not limited 
to, research on perception, cognition, motivation, identity, language, communication, 
cultural beliefs or practices, and social behavior) or research employing survey, 
interview, oral history, focus group, program evaluation, human factors evaluation, or 
quality assurance methodologies.  
 
Note:  The IRB will make the final determination on the Type of Review 
*Minimal risk means that the probability and magnitude of harm or discomfort anticipated in 
the research are not greater in and of themselves than those ordinarily encountered in daily life or 
during the performance of routine physical or psychological examinations or tests. 

5 
Version:  November, 2017 
SECTION E:  STUDY STAFF AND HUMAN SUBJECTS TRAINING 
 
List ALL current members of the research team in the table below.  Add more rows as 
necessary. 
STUDENT RESEARCH:   
The Faculty Advisor must be listed as a co-investigator in this section and must complete 
the Human Subjects training requirements.  Faculty Advisors are responsible for reviewing 
the IRB application, agreeing to serve as the Co-PI for this study with the student and are 
responsible for the ethical conduct of this student’s human subjects research.  Faculty 
Advisors must sign this Application prior to it being submitted to the IRB. 
 
BU CHARLES RIVER CAMPUS (CRC) INVESTIGATORS/STUDY STAFF 
Note: Boston University Medical Campus (BUMC) investigators/study staff should be listed in 
the NON-BU INVESTIGATOR/STUDY STAFF section 
Name, Degree, & 
Department/School 
Study Role (e.g. co-
investigator, research 
coordinator, research 
assistant, project 
manager, lab 
manager) 
Human Subjects Training* 
Terry Ellis, PhD, PT 
Department of Physical Therapy and 
Athletic Training, College of Health 
& Rehabilitation Science: Sargent 
College, Boston University  
Principal Investigator 
☒ CITI 
☐ Other**: HIPAA training completed 
09-02-2015 
Most Recent Date Completed:  
07-19-2019 
Louis Awad, PT, DPT, PhD 
Department of Physical Therapy and 
Athletic Training, College of Health 
& Rehabilitation Science: Sargent 
College, Boston University 
Co-Investigator 
☒ CITI 
Most Recent Date Completed:  
01-02-2017 
Lillian Ribeirinha-Braga    
Neuromotor Recovery Laboratory    
Research Assistant   
☒ CITI   
Most Recent Date Completed:  
07-08-2019   
Jenna Zajac, PT, DPT 
Center for Neurorehabilitation 
Boston University  
  
Research Physical 
Therapist   
 
☒ CITI  
☐ Other**:  
Most Recent Date Completed:   
07-26-2019 
Steven Zachariadis 
Student, Boston University  
Research Assistant 
☒ CITI  
☐ Other**:  
Most Recent Date Completed:   
08-07-2020 

6 
Version:  November, 2017 
Aaron Gu 
DPT Student, Boston University 
Research Assistant  
☒ CITI  
☐ Other**:  
Most Recent Date Completed:   
08-07-2020 
 
*For more information regarding the Human Subjects Training Policy, refer to the ‘Training’ 
section of the Policies & Guidance section IRB website: 
http://www.bu.edu/researchsupport/training-how-to/human-subjects-training/.   This site includes 
a Study Personnel Training List.  You can search this list by name to obtain the completion and 
expiration dates of training for investigators and study staff. 
**If the investigator/study staff did not complete CITI, you must submit a copy of his/her 
training certificate. 
NON-BU INVESTIGATORS/STUDY STAFF*  
 
 
☒ N/A 
Note:  BUMC and BMC staff are considered to be non-BU staff and should be listed in this 
section.    Add more rows as necessary.  All the columns in the box below must be 
completed.  In addition, you must complete the box that follows with a description of the 
activities for each staff member.   
 
Name, Degree, & Affiliate 
Institution 
Study Role 
Staff Information 
Will IRB Approval be Obtained 
from Affiliate? 
 
 
1. Will this staff 
interact with subjects? 
☐ Yes          ☐ No 
 
2.Will this staff have 
access to identifiable 
information? 
☐ Yes          ☐ No 
 
3.Is the work that the 
staff will complete 
related to his/her role 
or coursework at 
his/her affiliate 
institution.? 
☐ Yes          ☐ No 
 
☐ Yes:  Provide copy of IRB 
approval letter when available: 
☐ No (provide reason):  ______ 

7 
Version:  November, 2017 
 
 
1. Will this staff 
interact with subjects? 
☐ Yes          ☐ No 
 
2.Will this staff have 
access to identifiable 
information? 
☐ Yes          ☐ No 
 
3.Is the work that the 
staff will complete 
related to his/her role 
or coursework at 
his/her affiliate 
institution.? 
☐ Yes          ☐ No 
 
☐ Yes:  Provide copy of IRB 
approval letter when available: 
☐ No (provide reason):  ______ 
 
*If IRB approval will be obtained from the affiliate site, only list the lead investigator from the 
affiliate on this form. 
The box below must be completed.  Include a summary for each staff listed in the above 
box.  If any of the investigators listed on this form are not affiliated with BU, provide a summary 
of the study activities that he/she will conduct.  If IRB approval is not being obtained at the 
affiliate institution, provide an explanation.  NOTE:  Non-BU staff may be required to 
complete an Individual Investigator Agreement (IIA).  The IRB will notify you if this form 
is required. 
 
 

8 
Version:  November, 2017 
REQUIRED GOOD CLINICAL PRACTICE TRAINING FOR NIH-
FUNDED CLINICAL TRIALS 
 
YES* 
NO 
NIH-FUNDED CLINICAL TRIALS 
☐   
      
☒   
Is your study NIH-Funded AND meet the definition of a clinical trial as defined 
below:   
Clinical Trial:  A research study in which one or more human subjects are 
prospectively assigned to one or more interventions (which may include 
placebo or other control) to evaluate the effects of those intervention on health-
related biomedical or behavioral outcomes.  This definition encompasses phase 
1 trials of FDA-regulated drug and biological products, small feasibility studies 
of FDA-regulated device products, and studies of any intervention not regulated 
by the FDA, e.g. behavioral interventions. 
Of note, this requirement for GCP training applies to both biomedical and 
behavioral clinical trials funded by the NIH. 
 On January 1, 2017, a new policy of the National Institutes of Health (NIH) 
goes into effect that requires all NIH-funded investigators and staff who are 
involved in the conduct, oversight, or management of clinical trials to be trained 
in Good Clinical Practice (GCP). 
The policy applies to all active grants and contracts, no matter what point they 
are in the life cycle of the trial.   
Currently, there is a GCP course available in our CITI training program 
(https://www.citiprogram.org/).  This current course does have a focus on FDA-
regulated research.  Please note that online social-behavioral GCP courses are 
under development and we expect to have a social-behavioral focused GCP 
course available in the near future.   
If this study meets the definition, all staff must complete GCP training. 
For more information on this policy please refer to: 
• NIH definition of a Clinical Trial: 
http://osp.od.nih.gov/sites/default/files/NIH%20Definition%20of%20Cli
nical%20Trial%2010-23-2014-UPDATED_0.pdf 
• Policy on Good Clinical Practice Training for NIH Awardees Involved 
in NIH-funded Clinical Trials:  
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html 
• Frequently Asked Questions:  
http://osp.od.nih.gov/sites/default/files/FAQs_on_NIH_GCP_Policy.pdf 

9 
Version:  November, 2017 
SECTION F:  LOCATION OF THE RESEARCH 
 
YES* 
NO 
 
☐ 
☒ 
Will this research take place at sites/locations other than Boston University? 
Note:  If the research will take place at Boston University, state the location 
(Center for Neurorehabilitation, Sargent College (6th floor, room 610)): 
 
*If YES, please complete the boxes below 
 
NOTE:  You are responsible for obtaining permission/letters of support for research conducted 
off-site.  This may include locations such as schools, workplaces, community organizations, etc.  
You must submit the letters/documentation of support with this application. 
 
Institution Name and 
Address (if known) 
Describe Involvement 
(recruiting, consenting, data 
analysis, etc.) of the site.  If the 
site or the site staff is not 
involved (engaged)1 in research 
procedures, state NONE. 
IRB/Ethics Approval/Site 
Permission Attached?  If 
no2, explain the plan to 
obtain this approval.  If the 
site is not engaged in the 
research, you do not need to 
complete the box. 
 
 
 
 
 
 
1Guidance on Engagement of Institutions in Human Subjects Research: 
http://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-
institutions/index.html 
 
 
2If IRB approval will not be obtained at the site, describe the IRB oversight arrangements here:  
 
 
 
 
YES* 
NO 
 
☐ 
☒ 
N/A 
Is the off-site location requesting that the Boston University IRB review the 
protocol in place of local IRB review? 
*If YES, complete the Single IRB Review Form “Boston University is 
Institution A”: http://www.bu.edu/researchsupport/compliance/human-
subjects/.  
 
 
 
 

10 
Version:  November, 2017 
YES* 
NO 
 
☐  
☐ 
N/A 
Is the BU PI the lead investigator OR is BU the lead site for this research? 
Note:  This box only needs to be completed if the off-site location is 
engaged in the research. 
*If YES, provide the following information in this box:  
• The plan for collection and management of data from all the sites 
• The plan for reporting and evaluating: 
o Unanticipated problems 
o Serious and/or continuing non-compliance 
o Suspensions and terminations of research 
o Interim results 
o Protocol modifications 
• The name of the Principal Investigator from each site  
• If IRB approval will be obtained at the site, confirmation that you have a copy (or will 
obtain a copy) of the IRB approval letters and the IRB-approved protocols from each 
site  
• If IRB approval will be obtained at the site, confirmation that the site IRB has a federal 
wide assurance (FWA)  
 
YES* 
NO 
 
☐ 
☒  Will this research be conducted outside of the United States?* 
 
*If YES, complete the International Research Form at 
http://www.bu.edu/researchsupport/compliance/human-subjects/ 
 
SECTION G:  STUDY SUMMARY 
 
Summarize the study in lay language (do not copy from the grant/scope of work/proposal, 
etc.).  This summary should include the research design, purpose, objectives, research 
question, hypothesis, and any relevant background information.   
 
Note:  Do not include a list of citations in this section.  Please limit this section to no more 
than 300 words. 
Parkinson disease (PD) is a chronic progressive health condition affecting older adults. Of 
particular concern is walking decline, which is a marker of emerging disability. Pathophysiologic 
changes in the basal ganglia result in a high expenditure of cognitive resources for once automatic 
movements, such as walking. Auditory cueing has been shown to compensate for impairments in 
the basal ganglia by harnessing the human capacity for rhythm perception through a mechanism 
called entrainment. Entrainment refers to the activation of motor-related centers of the brain in 
response to an external rhythmic stimulus. Direct sensorimotor connections between the auditory 
and motor system demonstrate the capacity for the auditory system to drive motor movement 
patterns. Music-based auditory cueing has demonstrated immediate and potent effects on walking, 
as reflected clinically by improvements in speed, stride length, and step frequency. Improvements 

11 
Version:  November, 2017 
observed in the quality and thus, quantity, of walking make a music-based device a promising 
rehabilitation adjunct for persons with PD.  
 
Study Objectives: The purpose of this study is to evaluate the effects of  music, tailored to the 
participant’s cadence, on adherence, quality of life, gait speed, functional mobility, and walking 
activity in individuals with Parkinson disease when used in the home and community  
environment. 
 
Primary and Secondary Endpoints: 
Primary Study Endpoints: 
• Observed adherence to therapy schedule (feasibility) 
• Mobility impact as assessed by PDQ-39 mobility dimension 
Secondary Study Endpoints: 
• Change in gait speed at baseline as compared to end of study participation (or earlier if the 
participant withdraws) as determined by the 10MWT 
• Overall quality of life impact as assessed by PDQ-39 
• Improvements in functional mobility as measured by the Five Times Sit to Stand test 
• Change in amount (steps/day) and intensity (moderate intensity minutes; >100 steps/min) 
of walking activity as measured by the StepWatch Activity Monitor (SAM) 
 
 
SECTION H:  RESEARCH METHODS AND ACTIVITIES (Check all that 
apply) 
 
☐  
Collection of audio, video, digital, or image recordings 
☐ 
Biological samples → Complete Biological Samples Form: 
http://www.bu.edu/researchsupport/compliance/human-subjects/ 
Examples:  blood, hair, cheek swab, urine, tears, saliva, etc. 
☐ 
Collection of data that may be sensitive and if disclosed could put subjects at risk for 
legal or social harms. 
Examples:  Illegal behaviors, HIV status, psychiatric illness, information related to 
sexual behaviors, etc. 
☐ 
Coordinating Center/Lead Site 
☐ 
Deception 
☒  
Devices → Complete Devices Form: 
http://www.bu.edu/researchsupport/compliance/human-subjects/ 
 
☐ 
Drugs → Complete Drugs Form: 
http://www.bu.edu/researchsupport/compliance/human-subjects/ 
 
☐ 
Ethnographic: 

12 
Version:  November, 2017 
The study of people in their own environment through the use of methods such as 
participant observation and face-to-face interviewing 
☐ 
Focus Groups 
☐ 
Genetics Testing → Complete Genetics Form: 
http://www.bu.edu/researchsupport/compliance/human-subjects/ 
☐ 
MRI 
☐ 
Placebo 
☐ 
Pregnancy Testing 
☐  
Randomization 
☐ 
Surveys, interviews, questionnaires 
☐ 
Secondary Data Analysis 
☒ 
Other (please describe): Clinical assessments that occur as part of standard clinical 
practice will be administered (e.g., cognition, walking). 
 
SECTION I:  SUBJECT POPULATION 
 
Number of Subjects to be Enrolled: 
 
If you have sub-groups or more than one arm, please 
separate out these enrollment numbers. 
 
Note:  Please account for subjects who may drop out or 
be withdrawn from the study.  Any subject who signs a 
consent form is considered to be enrolled regardless of 
whether they complete any study procedures 
• Up to 20 individuals with 
Parkinson Disease will be 
included in this protocol 
 
 
Check all categories that apply to your target population: 
 
☒ 
Adults 
 
☐ 
Children (< 18 years of age) 
☐ 
Cognitively-Impaired Adults 

13 
Version:  November, 2017 
☐ 
Non-English Speaking 
☐ 
Prisoners 
☐ 
BU Employees 
☐ 
BU Students 
☐ 
Wards of the state 
☐ 
Other (please describe): 
 
If Categories other than ‘Adult’ are checked, describe the additional safeguards that 
have been put in place to protect that subject population.  For Cognitively-Impaired 
Subjects, provide the rationale for including this population in this research study. 
N/A; Persons with PD with significant cognitive impairment will be excluded from the study. 
Persons with PD with any mild cognitive impairments are capable of providing consent.  
 
Eligibility Criteria 
Inclusion Criteria: Based on our experience conducting exercise trials in PD, the following 
criteria have been established to ensure participants can safely engage in a home/community 
walking program. 
 
1. Diagnosis of idiopathic, typical Parkinson disease provided by a physician per participant 
report. 
2. Modified Hoehn and Yahr stages 1-3 per physical exam by a licensed physical therapist. 
3. Able to walk independently without physical assistance or an assistive device. 
4. Willing and able to provide informed consent.  
5. Provide HIPAA Authorization to allow communication with the primary healthcare 
provider for communication (as needed) during the study period. 
 
Exclusion Criteria: Exclusion criteria are the specific criteria which would disqualify an 
individual from participating in the study not simply the opposite of the inclusion criteria. 
 
1. < 18 years of age; 
2. diagnosis of atypical Parkinsonism; 
3. Modified Hoehn & Yahr stages 4-5; 
4. moderately or significantly disturbing freezing episodes during daily walking;  
4.1 moderate freezing episodes = freezing episodes that disrupt continuous walking 
4.2 significant freezing episodes = freezing episodes that prevent continuous walking 
5. cognitive impairment (i.e., MoCA score <24); 
6. unable to walk at a comfortable speed of 0.4 m/s (i.e., 10-meter walk test (10MWT)); 
7. unable to walk independently (i.e., requires physical assistance or assistive device); 

14 
Version:  November, 2017 
8. unable to independently use the music-based device following training; 
9. significant hearing impairment (unable to hear the music on the device); 
10. currently participating in physical therapy; 
11. self-reported cardiac problems that interfere with the ability to safely exercise (e.g., 
congestive heart failure, uncontrolled cardiac arrhythmias, chest pain; resting tachycardia 
(>100 beats/min) or uncontrolled BP (resting systolic BP >160 mmHg or diastolic BP 
>100 mmHg)) as measured by the physical therapist; 
12. orthopedic problems in the lower extremities or spine that may limit walking distance 
(e.g., severe arthritis, spinal stenosis, or significant pain); 
13. any other medical conditions that would preclude successful participation, as determined 
by a physical therapist 
 
If participants meet one or more of the exclusion criteria, they will be informed that they are not 
eligible to participate in this study. Participants will not be informed which categories were not 
met (i.e., cognitive impairment), simply that they did not meet the collective criteria.   
 
SECTION J:  RECRUITMENT 
 
Provide a summary of the recruitment process, including who will recruit, when and 
where recruitment will occur, and how subjects will be identified 
 
Note:  Submit any recruitment materials such as advertisements, brochures, flyers, 
letters/e-mails, scripts, etc.  Please submit these materials as separate documents in 
either Word or PDF format. 
Twenty persons with Parkinson disease will be recruited to participate in this study.  
 
At BU, recruitment will occur primarily through the PD and Movement Disorders Center at the 
School of Medicine/Boston Medical Center and the Center for Neurorehabilitation (CNR) 
serving more than 2000 people with PD. Recruitment will occur in the following ways: 1) 
potential participants from the CNR patient registry are contacted by study personnel; 2) 
potential participants are informed of the study by their neurologist or physical therapist and 
provide their contact information to a member of the research team who initiates contact; 3) 
IRB-approved flyers are distributed to PD support groups throughout MA; 4) IRB-approved 
flyers are distributed to physicians and physical therapists in the community; 5) IRB-approved 
recruitment materials are included in the American Parkinson Disease Information and Referral 
Center newsletter in MA sent out regularly (via US mail or e-mail) to the Parkinson’s 
community (5000-9500 contacts); 6) study information will be posted on Clinical Trials.gov 
and Fox Trial Finder, online services; 7) IRB-approved recruitment materials are posted on the 
CNR website; 9) IRB-approved recruitment materials are posted on the APDA’s Facebook 
page, newsletter and other relevant social media sites (see Appendix IV: Recruitment Flyer; see 
Appendix V: Recruitment Posting Information). 
 
SECTION K:  CONSENT AND ASSENT 
 
NOTE:   Please refer to the consent and assent form templates on the IRB website when creating 
your consent/assent documents.  The templates include the required elements of consent and will 

15 
Version:  November, 2017 
help to ensure that your consent/assent form meets the requirements of the federal regulations 
and the BU CRC IRB.  The consent templates can be located at:  
http://www.bu.edu/researchsupport/compliance/human-subjects/. 
 
Note:  STUDENT RESEARCHERS must: 1) indicate in the consent form/information 
sheet/script that he/she is a student and 2) list the Faculty Advisor as a contact in the 
form/sheet/script. 
 
Provide a summary of the consent process, including who will consent, and when and 
where consent will occur.  The summary should include, as appropriate, any waiting 
period between informing the prospective participant and obtaining consent, that the 
prospective participant or the legally authorized representative has sufficient 
opportunity to consider whether to participate, and steps taken to minimize coercion or 
undue influence. 
 
Note:  Submit copies of all consent forms and scripts.   Please submit these materials as 
separate documents in Word format. 
Potential participants will be screened via phone to determine initial eligibility for the study (see 
Appendix I: Phone Screen). This screen will take approximately ten minutes and will be 
conducted by one of the trained personnel on the research team. The potential participant will 
be asked questions to ascertain whether they meet the study’s initial inclusion/exclusion criteria. 
If the participant meets the study criteria and remains interested in participating, they will be 
scheduled for an in-person screening / baseline assessment visit to confirm eligibility and 
perform baseline clinical outcome measures. Testing will take place at the Center for 
Neurorehabilitation located at 635 Commonwealth Avenue (6th floor), Boston, MA 02215. 
 
At the in-person screening, a trained study personnel (listed in section E) will begin the face-to-
face interview by explaining the study in detail and reviewing the informed consent document 
(see Appendix II: Informed Consent) with each potential study participant. The potential 
participant will be informed that participation in the study is entirely voluntary and will have no 
effect on any present or future medical or rehabilitation care. The potential participant will be 
encouraged to ask questions about the study to ensure complete understanding of all study 
elements. Potential participants will be provided with as much time as they request to review 
the informed consent and ask questions. All questions will be answered thoroughly by the 
trained study personnel. Only when the study participant has provided full written informed 
consent will the trained study personnel proceed to the in-person screening and subsequent study 
procedures.  
 
Indicate the consent and/or assent process and document(s) to be used in this study.  Check 
all that apply 
 
Consent:  Adults (>18 years of age)                                      N/A ☐ 
 
One of the following MUST apply 
☒ 
Consent Form/Information Sheet 
 

16 
Version:  November, 2017 
 
☐ 
Verbal Consent (Script) 
 
Note:  If written consent will not be obtained, complete the ‘Waiver of Written 
Documentation Consent’ box (Box 1) located further down in this section 
☐ 
Consent will not be obtained 
 
Note:  If consent will not be obtained, complete the ‘Waiver or Alteration of 
Consent’ box (Box 2) located further down in this section 
 
 
 
Assent of Children (< 18 years of age)                                      N/A ☒ 
 
One of the following MUST apply 
☐ 
Assent Form OR Parent Consent Form/Information Sheet (older children may sign the 
parent consent form along with their parents as long as the consent form is written at 
the grade level of the subjects) 
 
 
☐ 
Verbal Assent (Script) 
☐ 
Assent will not be obtained 
 
If assent will not be obtained, one of the following conditions must exist:    
 
1. ☐ The capability of some or all of the children is so limited that they cannot 
reasonably be consulted  
 
2. ☐ The children are  too young to provide assent 
 
3. ☐ The intervention or procedure involved in the research holds out the prospect of 
direct benefit to the health or well-being of the children and is available only in the 
context of the research   
 
4. ☐ The research meets the same conditions as those for waiver or alteration of 
informed consent in research involving adults, as specified in the regulations at 45 
CFR 46.116(d)*.   (Complete the ‘Waiver or Alteration of Consent’ box (Box 2) 
located further down in this section) 
 
*45 CFR 46.116(d): 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html 
 
 
Guidance on age requirements for obtaining assent: 

17 
Version:  November, 2017 
• Parental Permission for minors under 6 years of age 
• Verbal assent for minors 6-11 years of age  
• Written assent from minors ages 12-17 (unless verbal consent is approved for the 
parents/adult subjects 
 
Parental Permission                                                                     N/A ☒ 
 
One of the following MUST apply 
☐ 
Parental Consent Form 
 
 
☐ 
Parental Verbal Consent (Script) 
 
Note:  If written consent will not be obtained, complete the ‘Waiver of Written 
Documentation of Consent’ box (Box 1) located further down in this section 
☐ 
Parental permission will not be obtained 
 
If parental permission will not be obtained, one of the following conditions must 
exist: 
 
1. ☐ The research protocol is designed to study conditions in children or a subject 
population for which parental or guardian permission is not a reasonable 
requirement to protect the subjects (for example, neglected or abused children). 
 
2. ☐ The research meets the same conditions as those for waiver or alteration of 
informed consent in research involving adults, as specified in the regulations at 
45 CFR 46.116(d)*.  (Complete the ‘Waiver or Alteration of Consent’ box 
(Box 2) located further down in this section) 
 
 
*45 CFR 46.116(d): 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html 
 
 
Consent:  Cognitively Impaired Adults (>18 years of age)                  N/A ☒ 
 
Describe the process for the consent and/or assent process for enrolling cognitively 
impaired adult subjects including how capacity to consent is determined and if there is 
continual assessment of capacity 
 
Assent will be obtained from: 
☐ All Subjects 
☐ Some Subjects, specify: 
☐ No Subjects 
 

18 
Version:  November, 2017 
☐ 
Consent will be obtained from the subject’s Legally Authorized Representative 
(REQUIRED) 
 
CONSENT OF NON-ENGLISH SPEAKING SUBJECTS                            N/A ☒                    
 
Describe the process for obtaining consent from non-English speaking subjects.  List the 
individual who will serve as the interpreter and his/her qualifications. 
 
NOTE:  A copy of the translated consent along with the Attestation Form for Translation 
of Consent must be submitted.  The Attestation Form can be located at: 
http://www.bu.edu/researchsupport/compliance/human-subjects/. 
 
 
 
 
BOX 1—WAIVER OF WRITTEN DOCUMENTATION OF CONSENT 
 
WAIVER OF WRITTEN DOCUMENTATION OF CONSENT   N/A ☒      
    
Either Criteria 1 or 2 must be met in order to qualify                  
Yes 
No 
 
 
 
 ☐ Criteria 1 
The research is NOT FDA Regulated 
 
☐ 
☐ 
The only record linking the subject and the research would be the consent 
document 
☐ 
☐ 
The principal risk would be potential harm resulting from a breach of 
confidentiality 
☐ 
☐ 
Each subject will be asked whether the subject wants documentation linking 
the subject to the research and the subject’s wishes will govern 
☐ 
☐ 
A written statement/information sheet will be provided to subjects.  If NO, 
provide rationale for not providing this information 
☐ 
☐ 
 
 ☐ Criteria 2 
The research is NOT FDA Regulated 
☐ 
☐ 
The research presents no more than minimal risk of harm to subjects 
☐ 
☐ 
The research involves no procedures for which written consent is normally 
required outside of the research context 
☐ 
☐ 
A written statement/information sheet will be provided to subjects.  If NO, 
provide rationale for not providing this information 
☐ 
☐ 
 
BOX 2—WAIVE OR ALTERATION OF CONSENT 
 

19 
Version:  November, 2017 
WAIVER OR ALTERATION OF CONSENT                    N/A ☒                   
 
All of the criteria below must be met in order to qualify 
Yes 
No 
 
 
The research is NOT FDA Regulated  
☐ 
☐ 
The research involves no more than minimal risk to the subjects 
☐ 
☐ 
The waiver or alteration will not adversely affect the rights and welfare of the 
subjects 
 
☐ 
☐ 
The research could not practicably be carried out without the waiver or 
alteration 
☐ 
☐ 
Whenever appropriate, the subjects will be provided with additional pertinent 
information after participation.  If NO, provide rationale for not providing this 
information: 
☐ 
☐ 
Provide the justification/rationale for why this study meets the above criteria for waiving 
or altering consent (REQUIRED): 
 
 
SECTION L:  STUDY PROCEDURES 
 
In the box below provide a detailed description of the study procedures to be performed 
(preferably in sequential order).  Be sure to specify which procedures are for research 
purposes versus which procedures are part of standard of care, if applicable.    Be sure to 
include the following information: 
 
• Methods of data collection  
• Details regarding research activities/procedures/interventions 
• Number, frequency, duration and types of subject contacts (visits, phone calls, 
internet surveys, mailings, etc.) 
• Time required from each subject 
• Use of equipment (eye-tracker, treadmill, sensors, etc.).  Provide a brief description 
of equipment that will be used in the study.* 
  
*Note:  The IRB may request more information about the equipment (including equipment 
manuals) and/or request that you submit Appendix C: Device Form. 
 
Submit copies of all surveys, interview questions, assessments, screening scripts, etc. that 
will be used during the conduct of this study.  Please submit these materials as separate 
documents in either Word or PDF format. 
 
Note:  If subjects will have standard of care procedures in addition to research procedures, 
clearly state which procedures are standard of care and which are for research purposes 
only. 
Study Design: 
The proposed study is a pilot investigation in which the study evaluations will take place at the 
Center of Neurorehabilitation (CNR) at Sargent College, Boston University. Twenty persons with 

20 
Version:  November, 2017 
Parkinson disease will be enrolled to determine the effects of a community walking program with 
a music-based device on adherence, quality of life, walking speed and walking activity. The 
walking program will be carried out independently by participants in their home/community 
environment. Noninvasive functional assessments commonly administered in clinical practice 
(described below) will be used to measure the variables of interest.  
 
Study Procedures 
 
Preliminary Phone Screen (approximately 10 minutes):  
A phone screen will be conducted to make a preliminary determination if potential participants 
meet the initial inclusion / exclusion criteria prior to scheduling a more in-depth, in-person 
screening assessment. During the phone screen (see Appendix I: Phone Screen), potential 
participants will be asked their age (exclude if <18 years of age), if they are currently 
participating in physical therapy (exclude if yes), and if a medical doctor diagnosed them with 
Parkinson disease (exclude if no). Potential participants will be asked about their ability to walk 
independently without physical assistance or an assistive device (exclude if no) and whether 
they experience freezing episodes during daily walking (exclude if moderately or significantly 
disturbing – see operational definition under exclusion criteria). Lastly, a brief medical history 
from the participant will be reviewed to determine the following:  
• Those with a history of cardiac problems that interfere with the ability to safely exercise 
(e.g., congestive heart failure, uncontrolled cardiac arrhythmias, chest pain) will be 
excluded. 
• Those with orthopedic conditions in the lower extremities or spine that may limit 
walking distance (e.g., severe arthritis, spinal stenosis, significant pain) will be excluded. 
• Those with any other medical conditions that would preclude successful participation, as 
determined by a physical therapist, will be excluded.  
 
Data on the screening form will be entered into REDCap to allow investigators to monitor the 
number of persons screened and pass/failure rate.  
 
Potential participants who are deemed eligible based on the preliminary phone screen will be 
scheduled for an in-person screening and baseline assessment visit at Boston University. 
 
In-Person Screening & Baseline Assessment Visit (approximately 2 hours):  
The in-person screening and baseline assessment visit will take place at the Center for 
Neurorehabilitation at Boston University. All participants will be guided through the informed 
consent process upon arrival (see Appendix II: Informed Consent; see section K). After 
consenting, participants will be asked to sign a HIPAA Authorization to Disclose Protected 
Health Information for Research Purposes (see Appendix III: HIPAA Authorization). This will 
allow our team to communicate directly with the participant’s healthcare provider during the 
study if needed.  
 
In-Person Screening: After consenting, potential participants will be screened in-person to 
determine if they meet all study inclusion/exclusion criteria. The elements included in the 
screening process are part of routine physical therapy evaluation. 
 

21 
Version:  November, 2017 
A physical exam will be conducted to assess cognitive status, Parkinson’s symptoms and 
walking capacity.  
• A diagnosis of Parkinson disease will be confirmed per participant report.  
• The Montreal Cognitive Assessment (MoCA) will be administered by a licensed physical 
therapist (exclude MoCA score <24) (see Appendix VI: Screening Tools). The MoCA is 
a rapid screen of cognitive abilities to detect mild cognitive dysfunction. Participants are 
tested on 16 items that cover multiple cognitive domains. The score ranges from 0-30, 
with higher scores indicating less cognitive impairment.  
• Disease severity will be assessed by a licensed physical therapist using the Modified 
Hoehn & Yahr Scale (only H&Y 1-3 will be included) (see Appendix VI: Screening 
Tools). The Modified H&Y Scale includes additional criteria to rate Parkinson disease 
symptoms on a scale from 1 to 5. Higher scores indicate increased disease progression. 
• The 10-meter walk test (10MWT) will be administered by a licensed physical therapist 
(comfortable walking speed <0.4 m/s excluded based on the average of 2 trials at 
comfortable walking speed) (see Appendix VI: Screening Tools). The 10MWT is an 
assessment of gait speed over a short distance (2 meters ramp up, 6 meters walking, 2 
meters ramp down). The aforementioned distances will be pre-measured for accuracy 
and only the middle 6 meters will be timed. Participants will be asked to walk at a 
comfortable pace for 2 trials and a fast pace for 2 trials. The physical therapist 
conducting the test will be guarding the participant as necessary to optimize safety. 
• Walking capacity will be measured via the six-minute walk test (6MWT) (see Appendix 
VI: Screening Tools). The 6MWT assesses how far a person can walk over a 6-minute 
period. The test will be performed along a pre-measured (30-meter), level, obstacle-free 
hallway. Participants will be instructed to walk as far as possible in 6-minutes. The 
physical therapist conducting the test will be guarding the participant as necessary to 
optimize safety. Physiological measurements (e.g., heart rate, blood pressure) will be 
taken prior to initiation of the walking test to determine whether the participant is safe to 
participate in the walking program. The participant will be excluded based on the 
following: resting heart rate >100 beats/min; resting systolic BP >160 mmHg, resting 
diastolic BP >100 mmHg. The same physiological measurements will be taken upon 
completion of the walking test to assess hemodynamic response to exercise. 
• Based on clinical expertise and judgement, the physical therapist conducting the in-
person screening will determine if a participant requires additional guarding and/or 
assistance during walking activities (i.e., occasional hand contact to maintain balance or 
dynamic stability and/or an assistive device). If guarding is needed, the participant will 
be excluded. 
 
Baseline Assessment: Participants who are deemed eligible through the in-person screen will 
continue on to complete the remainder of the baseline assessment measures, including: 
• Demographic questionnaire consisting of age, gender, education level, living situation, 
employment, ethnicity, race, and PD-specific questions (see Appendix VII: Outcome 
Measures). This form will be completed interview-style by the physical therapist.  
• Medication form pertaining to PD and non-PD medications (see Appendix VII: Outcome 
Measures). Participants will be asked during the phone screen to bring their medication 
list to this first evaluation visit. The physical therapist will transcribe the medications 

22 
Version:  November, 2017 
onto the designated form. Medication lists that contain identifiable information will be 
given back to the participant and not be kept by the research team. 
• Motor & Functional Measures:  
o Motor symptoms will be assessed using the Movement Disorder Society Unified 
Parkinson Disease Rating Scale (MDS-UPDRS)-III (see Appendix VII: Outcome 
Measures). The MDS UPDRS is the most widely used clinical rating scale for 
Parkinson disease. Part III is a motor examination (33 scores summed from 18 
questions) conducted by the rater. Total scores can range from 0 to 141, with 
higher scores indicating worse disease severity.  
o Functional Mobility will be measured via the Five Times Sit to Stand (5xSTS) 
(see Appendix VII: Outcome Measures). The 5xSTS objectively assesses the time 
it takes to complete 5 sit-to-stands and is a method to observe movement 
strategies or compensations. The test will be performed in a standard chair with 
participants instructed to stand up and sit down 5 times as quickly as possible. 
The physical therapist conducting the test will be guarding the participant as 
necessary to optimize safety. 
• Self-report/Interview Measures: 
o Section I and II of the Movement Disorder Society Unified Parkinson Disease 
Rating Scale (MDS-UPDRS) will be utilized to assess non-motor and motor 
signs. Section IA includes 6 items related to non-motor experiences such as 
cognition, mood, and motivation which are assessed by the examiner (see 
Appendix VII: Outcome Measures). Section IB consists of 7 items related to non-
motor aspects of experiences of daily living such as sleep and fatigue which are 
filled out by the participant (with or without the help of a caregiver), but 
independent of the examiner (see Appendix VII: Outcome Measures). Section II 
is a self-administered questionnaire consisting of 13 items related to motor 
aspects of experiences of daily living (see Appendix VII: Outcome Measures).  
o Health-related quality of life will be measured by the Parkinson’s Disease 
Questionnaire – 39 (PDQ-39)(see Appendix VII: Outcome Measures). The PDQ-
39 is a self-report questionnaire that assesses quality of life over the past month 
across 8 different dimensions. Items are scored based on a 5-point ordinal system 
with lower scores reflecting better quality of life.  
• Walking Activity: Walking activity will be measured over a 4-day period prior to 
initiating the intervention and continuously measured for an additional 4 days upon 
intervention initiation (total of 8 days of data). The purpose of this sequence is to be able 
detect changes in walking activity that may occur with initiation of a structured walking 
program. For example, once the walking program is initiated, do participants appear to 
increase their walking activity compared to baseline (before initiating the walking 
program)? Is the increase in walking activity isolated to during the individual sessions, or 
is there an overall increase noted throughout the day? Walking activity will be measured 
using the StepWatch 4 Activity Monitor (SAM; Orthocare Innovations, Mountlake 
Terrace, Washington). The SAM is a self-contained, maintenance-free device that 
combines acceleration, position and timing information to count complete gait cycles 
(strides) of the user; it is the size of a pager, weighs 38g, and will be attached with self-
adhesive straps above the lateral malleolus (where the shin meets the foot) of the 
participants’ less impaired lower extremity. Participants will be instructed to wear the 

23 
Version:  November, 2017 
SAM for 8 consecutive days during all waking hours, expect when bathing, showering, 
or swimming. The physical therapist will fill out the SAM researcher form to 
appropriately document the SAM calibration process for each participant (see Appendix 
VII: Outcome Measures). Participants will be given instructions on how to don/doff the 
device and will be provided with a form to record times the SAM is removed over the 8-
day period (see Appendix VII: Outcome Measures). The SAM requires no maintenance 
by the user besides remembering to keep it on. The physical therapist will provide 
strategies to help the participant remember to put the SAM back on if they do take it off 
at any time (e.g., if the SAM is taken off at night, place it on a nightstand next to the bed 
so it is seen in the morning). Using the manufacturer’s software, the SAM will be 
calibrated by a physical therapist to each participant’s gait pattern based on height, 
typical walking speed, and leg motion. The validity and reliability of the SAM for 
capturing stride counts has been demonstrated in persons with various neurological 
disorders including PD (Shepard 1999, Coleman 1999, Macko 2002, Salarian  2004, 
Gaines 2005, Manns 2009, Speelman 2011). Collected data will be downloaded to a 
computerized tablet, with which manufacturer’s software will convert stride counts to 
step counts and calculate daily step count values. No identifiable information is collected 
by the SAM. Participants will return the SAM to study personnel via a pre-labeled, 
addressed envelope to mail following the 8-day monitoring period. Participants will be 
contacted via phone within 24-48 hours following the evaluation session to ensure that 
they are comfortable with the device and to address any questions or concerns. 
 
Training Procedures / Instruction to Participants: 
• Music-Based Device Training: During the 2 hour evaluation visit, a physical therapist 
will train the participant on how to use the music-based device and independently 
conduct the remote walking program. To ensure that the participant is able to hear the 
music, the physical therapist will have the participant put on the headphones while music 
is played. The participant will then practice donning/doffing, setting up, and using the 
device (i.e., walk for 5 minutes) to demonstrate comprehension and independent use. A 
team member will provide the participant with the necessary equipment (i.e., 
smartphone, shoe sensors, headphones, study diary). The physical therapist will discuss 
the space and location in which the participant plans to conduct the walking program, 
and review space adequacy and safety considerations. A safe environment will be 
considered to be the following: indoor spaces – level surfaces, obstacle-free, no slippery 
surfaces, no unsecure area rugs; outdoor spaces – avoid auto or bike traffic, obstructive 
tree roots, divots in the asphalt and concrete. These environments could include, but are 
not limited to: home, apartment building hallway, neighborhood sidewalks, local track or 
park, office environments, and community/recreation centers. Ideally the space is at least 
50 feet in length that meet the above indoor and outdoor space criteria. This will decrease 
the amount of pivot turns thereby optimizing the amount of continuous walking.   
The purpose of the music-based device is to help participants entrain to a musical beat to 
improve the quality of their walking. The device monitors a participant’s cadence using 
the sensor placed on the shoe. The musical tempo is matched to the baseline walking 
cadence of the participant. As the quality of a participant’s walking improves and the 
participant accurately “entrains” to the tempo of the music, the tempo will adapt and 
increase cadence by 5%. For example, if the participant starts off walking 100 

24 
Version:  November, 2017 
steps/minute, once considered entrained, the tempo will increase to 105 steps/minute. 
This increase is very small and will most likely not be noticed by the participant. If the 
participant is unable to increase their cadence to match this tempo, the tempo is reduced 
back to baseline. The algorithm used to set the tempo is dynamic and adjusts to the 
cadence of the participant. If a participant feels that they cannot keep up with the faster 
cadence, they can continue walking at their comfortable pace. Participants will also be 
instructed to stop the intervention if they feel uncomfortable or anxious at any time. 
Following this training, it is expected that participants will be able to independently set-
up (including donning/doffing the device), perform and conclude a walking session 
independently. Participants will have access to Instructions for Use (IFU) that will detail 
all procedures required for proper operation of the system. However, participants will be 
encouraged to contact the research team if they have any additional questions, issues or 
concerns. Participants will be excluded from the study if unable to demonstrate how to 
use the device independently as determined by the physical therapist. Please note, 
participants will be provided with a pre-established username and password. No 
personally identifiable information will be recorded or stored in the device application. 
 
Remote Walking Program Description (10 hours total over four weeks + concurrent use of SAM 
device over 4 walking days)  
Overview: Following enrollment, participants will wear the SAM for a 4-day period prior to 
initiating the intervention (to collect baseline walking activity). After approximately 4 days, 
participants will initiate the walking program while continuing to wear the SAM for the first 4 
days of the walking program. As the sensor for the music-based device is hooked onto the shoe 
and the SAM is worn on the lower leg (just above the ankle), both can be worn simultaneously on 
the same side of the body without interfering with a participant’s walking and/or increasing the 
risk for trips/falls. Participants will be instructed to complete five home-based walking sessions 
per week (approximately 30-40 minutes in duration) for four weeks. Participants will be able to 
carry out their five (5) sessions a week on any days of the week according to their needs. 
Participant engagement in the walking program will be monitored remotely by the study team at 
the end of each week via a phone call. This phone call will last approximately 5-10 minutes 
(depending on whether the participant has questions/concerns and/or any medical/technical 
issues). During the evaluation visit, the research team will ask you at which time each week you 
would like to have this check-in call. If participants are unable to carry out the walking program 
5-days per week, a study staff member will discuss the barriers to implementation (by phone) and 
suggest ways to optimize adherence to the program (e.g., setting a schedule). A study staff member 
will also inquire about adverse events during the weekly phone call and ensure that the participant 
is comfortable with the walking program. 
 
Description of Walking Sessions: Using the music-based device, participants will conduct the 
walking sessions at their self-selected pace in a home/community environment that limits the 
amount of stops and/or pivot turns in order to optimize continuous walking. For the purposes of 
this study, home/community environment is considered any environment outside a professional 
healthcare facility. This includes but is not limited to the home, apartment building, independent 
living retirement homes, outdoor environments (tracks, parks, sidewalks), office environments 
and community/recreation centers. Participants will be asked to record in a study diary their 
schedule (dates and times) of walking, location, record of any falls they experience and any 

25 
Version:  November, 2017 
comments/issues they experience while using the device (see Appendix VII: Outcome Measures). 
The entire session will take approximately 30-40 minutes, including 5-10 minutes to allow for a 
warm-up and cool-down period. The goal is for 30 minutes of continuous walking with music to 
be completed, however, rest periods are allowed as needed. The participant will be reminded that 
it is ok if they are not able to achieve 30 minutes of walking. Each individual walking session 
should be completed in one bout (i.e., should not be split up throughout the day). Participants will 
be instructed to terminate any walking session in the event of technical or medical issues to allow 
for adequate resolution. Participants will be informed of the potential risk of falls that can occur 
as part of the walking program in the community. Determination of a safe environment (as 
described in the Music-Based Device Training section above) will be discussed with the 
participant to mitigate external risk factors that could lead to a fall. Participants will be instructed 
to reach out to their healthcare provider if experiencing dizziness, chest pain, or other serious 
symptoms and will be asked to notify the study team following the episode. If participants 
experience a fall while using the device, they are advised to seek medical attention and record the 
incident in their study diary. In addition, participants will be asked to contact the research team 
following the event to determine whether it is safe for them to continue.  
 
Participants will be contacted by a member of the study team weekly to see if they have any 
questions or concerns with the walking program. However, participants will be encouraged to 
reach out to the research team at any point if they do not feel comfortable using the device. 
 
Post-Intervention Assessment Visit (approximately 1 hour): 
The post-intervention assessment visit will be scheduled within approximately 7 days of 
completion of the walking program and take place at the Center for Neurorehabilitation at 
Boston University. This visit will entail the same battery of assessments performed at baseline 
including: 10MWT, 6MWT, MDS-UPDRS I/II/III, 5xSTS, and PDQ-39. In addition, post-
intervention self-report questionnaires will be completed regarding the usability of the music-
based device (Usability Scale), perceptions of change in walking abilities (Global Rating of 
Change Scale), and overall experience with the device (Post-training Questions)(Appendix VII: 
Outcome Measures). The music-based device and study diary will be returned to study personnel 
at this visit. The study team then will send back the music-based device to MedRhythms to be 
cleared of the data. Participants will be given the SAM again to wear for 4-days following the 
post-intervention visit. Following the 4-day monitoring period, participants will return the SAM 
to study personnel via mail using a pre-labeled, stamped addressed envelope. Participants who 
withdraw or are withdrawn prior to completing their last walking session may be asked to 
complete closing visit activities, if feasible. 
 
Circumstances under which participants will be withdrawn without their consent: 
• If a change in medical/functional status occurs that makes a participant ineligible for the 
study, the participant will be withdrawn. 
• If a participant is unable to follow verbal instructions to ensure their safety during the 
study, he/she may be withdrawn from the study. 
 

26 
Version:  November, 2017 
SECTION M:  RISKS 
 
Describe any expected risks to subjects.  Consider physical, psychological, social, political, 
legal, economic, or other risks that are related to the study.   
There are no identifiable social, political, legal, or economic risks associated with the study. There 
are some potential physical and psychological risks to participating in this study. The potential 
risks to participants include the following: (a) musculoskeletal injuries and/or cardiopulmonary 
complications, (b) injury or falls during assessments of physical function, (c) falls during the 
walking program in the community, (d) fatigue, (e) loss of confidentiality.  
 
 
 
Describe the plan to minimize risks.  Include in the description the availability of any 
medical or psychological resources.  
The PI and co-investigators have extensive experience with clinical research involving individuals 
with Parkinson disease. Many of the investigators are licensed physical therapists and most study 
personnel and students have training in CPR and first aid. The risks of participating in this trial 
are minimal because the walking program is conducted at low to moderate intensity, which has 
been found to be safe in other studies of people with PD.  In addition, a physical therapist will be 
instructing the participant on the use of the music-based device and be available via phone to 
answer any questions concerning set-up, use, and/or technological difficulties throughout the 
study. Furthermore, as the music-based device is dynamic in nature, the musical tempo will be 
adapted to the participant’s specific needs and walking cadence.  
 
The following procedures will be implemented to minimize risk: 
• Musculoskeletal injuries and cardiopulmonary complications are minimized as persons 
with pre-existing orthopedic and cardiac conditions that may interfere with and/or 
compromise participant safety are excluded from the study. In addition, the musical 
tempo produced by the device is gradually progressed and accommodates to the 
participant’s walking cadence, tailoring individually to each participant. This allows 
each person to acclimate gradually to the increased cadence thereby reducing the risk 
of musculoskeletal and cardiopulmonary complications. During the remote walking 
program, vitals will not be monitored, but vital signs will be examined during walking 
as part of the screening to ensure appropriate hemodynamic responses to walking.  
Participants will be instructed to reach out to their healthcare provider if they are 
experiencing any dizziness, chest pain, or other serious symptoms.  
• Falling during in-person assessments is minimized as licensed physical therapists are 
conducting all assessments and are well-trained in safe guarding procedures and 
implementation of all assessment procedures. During community walking, falls are 
minimized as the physical therapist provides instruction on safe walking in the 
community (e.g., safe location, level surfaces, proper shoes). Prior studies that have 
been done in persons with mild to moderate PD (Modified Hoehn & Yahr 1-3) that 
participated in community walking programs found that increased physical activity 
levels did not result in an increase in falls (Penko et al., 2019; Shen et al., 2015). If 
participants experience a fall while using the device, they are advised to seek medical 
attention and record the incident in their study diary. In addition, participants will be 

27 
Version:  November, 2017 
asked to contact the research team following the event to determine whether it is safe 
for them to continue.  
• Participants with freezing of gait that moderately or significantly impacts daily walking 
are excluded to minimize the risk of falling. 
• Fatigue will be minimized due to the gradual progression of the musical tempo 
delivered by the device based on each individual participant. This increase is minimal 
(5%) and will most likely not be detected by the participant. In addition, participants 
walk to a self-selected pace and are allowed to rest during the approximately 30-40 
minute walking session. Participants will be educated on the potential for the device to 
increase in speed beyond their usual pace. The participant will be instructed to reduce 
their speed or stop the walking session if they feel uncomfortable or anxious. 
• 
Loss of confidentiality is unlikely as data with ID numbers only will be entered, 
password protected, into the REDCap database. All forms completed in-person on 
paper will be de-identified (ID number only) and kept in a locked filing cabinet in a 
locked office. A master list that links participant information with ID number will be 
kept in a password protected file in the REDCap database. Access to the REDCap 
database will be restricted to the PI and selected study staff only. 
 
 
 
 
SECTION N:  BENEFITS 
 
Describe the potential benefits to subjects related to the study.  State if there are no direct 
benefits. 
 
NOTE:  Compensation and/or course credit are not considered benefits. 
This study will provide multiple, structured walking sessions using a music-based device. This 
walking program will provide participants with an opportunity to practice walking while 
entraining to the beat of the music.  Participants may or may not experience improvements in the 
quality and quantity of walking as a result of the program.    
 
 
Describe the potential benefits to society and/or others related to the study 
 
This project will facilitate the development and clinical translation of targeted interventions that 
can improve the quality and quantity of walking in persons with PD through specific action on 
the impairments most likely to be limiting mobility.  In addition, the study will contribute to the 
application of new technology that extends the abilities of clinicians. 
 
 
 
 
SECTION O:  COSTS/PAYMENTS 
 
YES* 
NO 
 

28 
Version:  November, 2017 
☒ 
☐ 
Are there any costs to subjects as a result of participating in this study?  
*If YES, provide a description of the costs: Participants will be responsible for 
transportation costs; however, parking costs will be covered by the study. 
☒ 
☐ 
Will subjects be compensated for participating in the study?  Compensation 
may include cash, checks, gift cards, lotteries, course credit, etc. 
*If YES, provide a description of the compensation:  
$50 amazon gift cards will be given to participants at the in-person 
screening/baseline assessment visit and at the post-intervention visit ($100 
total)  
NOTE:  Payments should be prorated to compensate subjects for time and 
procedures completed 
☐ 
☒ 
Will identifiable information be sent to Central University departments 
(Accounts Payable, Post Award Financial Operations, etc.) for payment 
purposes? 
*If YES, this information must be disclosed in the consent form. 
 
 
SECTION P:  CONFIDENTIALITY OF DATA 
Describe how data will be stored (e.g. paper, electronic database, etc.) 
 
Data Management: Step Activity Monitor (SAM) data is coded (de-identified) and will be 
downloaded to a BU personal protected computer for data reduction and analysis using the 
manufacturer’s software. Other data from outcome measures will be collected on paper versions 
(coded, de-identified) and entered into REDCap ®  - a cross-platform, secure and accessible data 
collection application that allows for multiple concurrent users to enter data directly into pre-
specified fields. The REDCap database will be housed at Boston University. Our team has 
experience using REDCap in other trials.  
 
Each participant will be provided with an ID from the research team at Boston University that will 
be used to begin each walking session with the MedRhythms’ music-based device. The device 
collects walking session data and uploads it to the secured cloud-based drive, with the data 
attached to this ID. A master list of participants connecting them to an ID will be stored on the 
REDCap database housed at Boston University and only select study personnel will have access. 
The MedRhythms company will not have access to this master list linking ID to participant. The 
data collected by the device are not study outcome data, but are device performance data. From 
this performance data, MedRhythms can extract secondary outcomes data for the research team at 
Boston University (e.g., entrainment data). 

29 
Version:  November, 2017 
 
 
Per Boston University (BU) Record Retention Policy, records concerning human subjects must 
be retained for 7 years.  Please refer to the policy at: http://www.bu.edu/policies/finance/record-
retention/.  As the investigator, you must also adhere to all applicable requirements as defined by 
regulatory agencies (e.g. FDA, etc.) or Sponsors. 
YES* 
NO 
 
☒ 
☐ 
Will you collect identifiable information? (e.g. names, social security 
numbers, addresses, telephone numbers, etc.) 
*If YES, complete the box below 
Describe the coding system* that will be used to protect the information including who 
will have access to the code   
*Coding system:  Coding systems are used to: 1) protect the confidentiality of the 
research data and 2) allow the investigator to link subjects to their responses.    Each 
subject is assigned a unique study ID at the beginning of the study.  A separate document 
(key) should be maintained that links the names of the subjects to the study ID numbers. 
To ensure confidentiality of all data collected, each subject will be assigned a unique 
alphanumeric code determined by the PI, Terry Ellis. Only the PI and designated research 
personnel associated with the project will have access to the master-code with the 
corresponding identifiers. The master-code will be housed on a password protected file within 
the REDCap database, requiring a two-factor authentication to login. 
YES* 
NO 
 
☐  
☒  Will you share data with others outside of the study? 
*If YES, complete the box below 
Describe how data will be transferred and how confidentiality will be maintained (e.g. 
identifying information will not be sent outside, etc.) 
 
 
Describe how you will maintain the confidentiality of the data (e.g. locked cabinet, 
password-protected files, encryption, etc.) 
 
Note: Confidentiality refers to the researcher’s agreement with the participant about how 
the subject’s identifiable private information will be handled, managed, and disseminated 
 
For further assistance and/or access to resources regarding information security, please 
refer to the BU Information Security website: http://www.bu.edu/tech/security/  
 

30 
Version:  November, 2017 
Only data that is de-identified will be entered on paper forms. Paper forms will be stored behind 
2 locks. The de-identified data will be entered and stored in the REDCap database housed at 
Boston University. Two-factor authentication is required to login. A master code will contain a 
link to identifiable information. The master code will be housed in a file within the REDCap 
database with access restricted to essential study staff who will login using a 2-factor 
authentication process. The PI will approve any access to the master code. Data collected through 
the MedRhythms music-based device will be uploaded to a secure cloud-based drive owned by 
MedRhythms. A de-identified ID will be given to each participant to begin walking sessions with 
the device. A master list linking the unique ID to the participant will be stored in the REDCap 
database housed at Boston University with only essential study staff having access. The 
MedRhythms company will not have access to this master list. 
 
SECTION Q:  CERTIFICATE OF CONFIDENTIALITY 
Complete this box if the study is UNFUNDED or  FUNDED by any entity (e.g 
department, foundation, NSF, or other federal agencies) other than the NIH 
 
On October 1, 2017 the NIH updated its policy for issuing Certificates of Confidentiality.  
The updated policy is located at:  https://grants.nih.gov/grants/guide/notice-files/NOT-
OD-17-109.html 
 
Additional information regarding the policy can be found on the NIH FAQ’s website at: 
https://humansubjects.nih.gov/coc/faqs.  Note:  Sections C and D describe the process for 
obtaining a Certificate for studies not funded by NIH 
 
 
YES 
NO 
 
☐ 
☒ 
Will you obtain a Certificate of Confidentiality? 
The NIH has updated the required consent form language.  The language is at 
the following website:  https://humansubjects.nih.gov/coc/suggested-consent-
language.  Note:  A consent form with the applicable language must be 
included with this submission. 
 
Certificates of Confidentiality are issued by the National Institutes of Health 
(NIH).   A Certificate of Confidentiality (Certificate) protects the privacy of 
research participants enrolled in biomedical, behavioral, clinical or other 
research. With limited exceptions, researchers may not disclose names or any 
information, documents or biospecimens containing identifiable, sensitive 
information. The Certificate prohibits disclosure in response to legal demands, 
such as a subpoena.  
 

31 
Version:  November, 2017 
 
 
Complete this box if the study is FUNDED by the NIH 
 
On October 1, 2017 the NIH updated its policy for issuing Certificates of Confidentiality.  
The updated policy is located at:  https://grants.nih.gov/grants/guide/notice-files/NOT-
OD-17-109.html 
 
Note:  Under the new policy, the investigator will not need to apply for a Certificate.  All 
eligible research studies that are funded by NIH are automatically issued a certificate 
under the NIH Policy on Certificates of Confidentiality 
 
Additional information regarding the policy can be found on the NIH FAQ’s website at: 
https://humansubjects.nih.gov/coc/faqs 
 
YES 
NO 
 
☐ 
☐ 
N/A 
Does this study qualify for a Certificate of Confidentiality under the NIH 
Policy or Issuing Certificates of Confidentiality? 
To determine if this study (which is conducted or supported by NIH) qualifies 
for a Certificate of Confidentiality, please answer the following question: 
• Is the activity biomedical, behavioral, clinical, or other research? 
☐ YES 
☐ NO 
If the answer to the above question is “NO”, then this study will not be issued 
a Certificate of Confidentiality by the NIH.  If the answer is “YES”, please 
consider the questions below: 
▪ Does the research involve Human Subjects as defined by 45 CFR 46? 
▪ Are you collecting or using biospecimens that are identifiable to an 
individual as part of the research? 
▪ If collecting or using biospecimens as part of the research, is there a 
small risk that some combination of the biospecimen, a request for the 
biospecimen, and other available data sources could be used to deduce 
the identity of an individual? 
▪ Does the research involve the generation of individual level, human 
genomic data? 
If the answer to any one of the four questions above is “YES”, then this NIH 
policy will apply and will be considered to have a Certificate of 
Confidentiality by the NIH. 

32 
Version:  November, 2017 
If this study is covered under this policy, the consent form must include 
language about the protections and exceptions allowed with the Certificate.  
The NIH has updated the required consent form language.  The language is at 
the following website:  https://humansubjects.nih.gov/coc/suggested-consent-
language.  Note:  A consent form with the applicable language must be 
included with this submission.  
Certificates of Confidentiality are issued by the National Institutes of Health 
(NIH).  A Certificate of Confidentiality (Certificate) protects the privacy of 
research participants enrolled in biomedical, behavioral, clinical or other 
research. With limited exceptions, researchers may not disclose names or any 
information, documents or biospecimens containing identifiable, sensitive 
information. The Certificate prohibits disclosure in response to legal demands, 
such as a subpoena 
 
 
SECTION R:  PRIVACY 
 
Describe how you will protect the privacy of subjects.  Include the following information: 
location of data storage, who will have access to study information, and location of study 
visits 
 
Note:  Privacy can be defined in terms of having control over the extent, timing, and 
circumstances of sharing oneself (physically, behaviorally, or intellectually) with others 
Privacy of subjects will be protected by conducting all in-person interactions and assessments in 
a semi-private or private space within the Center for Neurorehabilitation and sixth floor hallway 
of Sargent College, Boston University. While outside these spaces, no personally identifiable 
information will be discussed. All study personnel have completed training and undergo regular 
re-training to ensure their understanding of the steps taken to maintain confidentiality of data 
and privacy of subjects.  
Only the study PI’s and necessary research personnel will have access to identifiable research 
data. The master-code will be housed at site specific secure data storage sites (Sharepoint at 
Boston University) with 2 factor authentication required for access. Access will be limited to 
specific personnel, approved by the PI’s at each site. Only data that is de-identified will be 
entered on paper forms and into the REDCap database. Paper forms with linked name and ID 
will be stored behind 2 locks.   
The PI and all study personnel (listed in section E) will have access to all coded data on paper 
forms and data housed in the REDCap database.   

33 
Version:  November, 2017 
No identifiable or coded data will be shared with non-study personnel including students, 
professional colleagues, outside institutions or study sponsors. No identifiable data will be used 
in scholarly presentations, in future research projects and in publications.   
We will store study information for future research related to Parkinson disease. We will store 
only a limited data set which will include the data collected and dates collected. No identifiable 
information will be used for future research (see Appendix III: HIPAA Authorization).  
 
SECTION S:  MONITORING STUDY DATA 
 
How will data be monitored?: 
 
Note:  The Data and Safety Monitoring Plan should be tailored to the nature, size, and 
complexity of the research protocol, the expected risks of the research, and the type of 
subject population being studied  
 
☒ 
Principal Investigator 
☐ 
Monitor/Monitoring Group 
☐ 
Data and Safety Monitoring Board (DSMB) 
Note:  The DSMB Charter must be submitted with this Application 
For more information regarding a DSMB, please refer to the following website: 
http://www.nidcr.nih.gov/Research/ToolsforResearchers/Toolkit/DSMBGuidelines.htm  
 
Describe the plan for monitoring study data.  This should include a description of how data 
will be collected and analyzed as the project progresses to assure the appropriateness of 
the research, its design, and subject protections. 
Data will be collected and de-identified (using participant ID number only). This de-identified 
data will be processed and analyzed by the PI and research team (Section E). 
 
Research staff will inquire about adverse events during a weekly phone call. Occurrences of 
adverse events will be described and recorded and any medical attention sought will be 
documented. If a deviation in data collection/usage, adverse or unanticipated event involving risks 
to participants or others, or a breach in confidentiality is suspected or found, the study will be 
halted until a resolution is determined in accordance with the IRB. The following definitions will 
be applied to the present study to monitor adverse events: 
 
Adverse Event: Any untoward or unfavorable physical or psychological occurrence in a 
participant, including any abnormal sign (e.g., abnormal physical exam or laboratory finding), 
symptom, or disease temporally associated with participation in the research, whether or not 
considered related to participation in the research. The PI will be notified when any adverse event 
is identified and will report this to the IRB. 

34 
Version:  November, 2017 
Serious Adverse Event: Any adverse event that: 
i. results in death 
ii. is life-threatening (places the participant at immediate risk of death) 
iii. results in hospitalization 
iv. results in a persistent or significant disability/incapacity 
v. results in a congenital anomaly/birth defect 
vi. may jeopardize the participant’s health and may require medical or surgical intervention to 
prevent one of the other outcomes listed in this definition. 
 
Unexpected Adverse Event: Any adverse event occurring in one or more participants, the nature, 
severity, or frequency of which is not consistent with either: 
i. the known or foreseeable risk of adverse events associated with the procedures involved in 
the research that are described in (a) the protocol-related documents, such as the IRB-
approved protocol, any applicable investigator brochure, and the current IRB-approved 
informed consent document, and (b) other relevant sources of information, such as product 
labeling and package inserts or the expected natural progression of any underlying disease, 
disorder, or condition of the subject(s) experiencing the adverse event and the subject’s 
predisposing risk factor profile for the adverse event. 
 
 
SECTION T:  HEALTH INSURANCE PORTABILITY AND 
ACCOUNTABILITY ACT (HIPAA) 
 
YES* 
NO 
 
X 
      Is this research being conducted in a covered entity?  
The following components have been determined to be covered entities on the 
Boston University Charles River Campus: 
• Sargent College Rehabilitation Services 
o Physical Therapy Center at the Ryan Center for Sports 
Medicine and Rehabilitation 
o Sargent Choice Nutrition Center 
• The Danielsen Institute 
• Boston University Health Plan 
 *If YES, contact the IRB office for assistance. 
 
 
SECTION U:  FAMILY EDUCATIONAL RIGHTS AND PRIVACY ACT 
(FERPA): FERPA is the federal law that protects the privacy of student education records.  
Research funded by the Department of Education or research conducted in educational 

35 
Version:  November, 2017 
institutions that receive funds from the Department of Education (for research or other purposes) 
must comply with FERPA. 
 
YES* 
NO 
 
☐ 
☒ 
Does this study involve collection of information from student 
school/university records?  
*If YES, refer to the  following websites for guidance on FERPA: 
• http://www.bu.edu/researchsupport/compliance/human-subjects/ 
• 
http://www.bu.edu/reg/general-information/ferpa/ 
• http://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html 
 
If FERPA applies, you must complete the box below: 
In accordance with FERPA, written consent must be obtained to access student records.  The 
consent must:  
• 
Specify the records that may be disclosed 
• 
State the purpose of the disclosure 
• 
Identify the person or class of parties to whom the disclosure can be made 
 
☐ YES 
(REQUIRED) 
I confirm that I will comply with the FERPA policy that is in place at the 
educational institution where I am conducting my research.  This 
includes, if applicable, the requirements for written agreement when 
requesting a waiver of consent for personally identifiable information.  If 
an agreement is required, this agreement must be submitted to the 
IRB. 
 
SECTION V:  PROTECTION OF PUPIL RIGHTS AMENDMENT (PPRA): 
PPRA is a federal law that affords certain rights to parents of minor students with regard to 
surveys that ask questions of a personal nature.  Research funded by the Department of 
Education or research conducted in educational institutions that receive funds (for research or 
other purposes) from the Department of Education must comply with the PPRA. 
 
YES* 
NO 
 
☐ 
☒ 
Does PPRA apply to this study?  
*If YES, refer to the  following websites for guidance:  
• 
http://www2.ed.gov/policy/gen/guid/fpco/ppra/index.html 
• http://www.bu.edu/researchsupport/compliance/human-subjects/ 

36 
Version:  November, 2017 
If PPRA applies, you must complete the box below: 
In accordance with PPRA, written parental consent must be obtained prior to subjects 
participation in the study.  
 
☐ YES 
(REQUIRED) 
I confirm that I will comply with the PPRA policy that is in place at the 
educational institution where I am conducting my research.   
 
SECTION W:  CLINICAL TRIALS REGISTRATION: 
The Food Drug and Administration Amendments Act (known as FDAAA 801) requires that 
“applicable clinical trials” be registered and have results reported on clinicaltrials.gov. The 
Responsible Party for a clinical trial must register the trial and submit results information.  In 
addition, the International Committee of Medical Journal Editors (ICJME) and the National 
Institutes of Health (NIH) also have requirements for registration.  Please see box below to 
determine if your study requires registration in accordance with either FDAAA 801, ICJME, or 
NIH. 
 
YES 
NO 
FDAAA 801 Requirements 
☐ 
 ☒ 
Does your study meet the definition of an applicable clinical trial and require 
registration AND results submission in accordance with FDAAA 801?  
Applicable Clinical Trials include the following: 
• 
Trials of drugs and biologics: Controlled clinical investigations, other 
than phase 1 clinical investigations, of drugs or biological products 
subject to Food and Drug Administration (FDA) regulation 
• 
Trials of devices (see note): 1) Controlled trials with health outcomes 
of devices subject to FDA regulation, other than small feasibility 
studies, and 2) pediatric postmarket surveillance required by FDA 
The Responsible Party is defined as: 
• 
The sponsor of the clinical trial or  
• 
The principal investigator (PI) of such clinical trial if so designated by 
a sponsor, grantee, contractor, or awardee, so long as the PI is 
responsible for conducting the trial, has access to and control over the 
data from the clinical trial, has the right to publish the results of the 
trial, and has the ability to meet all of FDAAA's requirements for the 
submission of clinical trial information 
Refer to the following website for guidance:  

37 
Version:  November, 2017 
• FDAA 801 Requirements: https://clinicaltrials.gov/ct2/manage-
recs/fdaaa 
Note:  If your study meets the requirement for registration and 
reporting, you must submit the National Clinical Trial (NCT) Identifier # 
to the IRB prior to IRB approval. 
NCT #:__________________ 
 
 
YES 
NO 
ICMJE Requirements 
☒ 
☐ 
Does your study meet the definition of a clinical trial and require registration 
in accordance with ICMJE?  
ICMJE definition of clinical trial:  Any research study that prospectively 
assigns human participants or groups of humans to one or more health-related 
interventions to evaluate the effects on health outcomes. Health-related 
interventions include any intervention used to modify a biomedical or health-
related outcome (for example, drugs, surgical procedures, devices, behavioral 
treatments, dietary interventions, and process-of-care changes). Health 
outcomes include any biomedical or health-related measures obtained in 
patients or participants, including pharmacokinetic measures and adverse 
events. Purely observational studies (those in which the assignment of the 
medical intervention is not at the discretion of the investigator) will not 
require registration. 
Refer to the following websites for guidance:  
• ICMJE Clinical Trials Registration: http://www.icmje.org/about-
icmje/faqs/clinical-trials-registration/ 
Note:  If your study meets the requirement for registration, you must 
submit the National Clinical Trial (NCT) Identifier # to the IRB prior to 
IRB approval. 
NCT #:__pending________________ 
***this is a small feasibility study of a new gait training approach. Moreover, 
outcomes assessed are the transient, single-session effects of this training 
approach.  
YES 
NO 
NIH Requirements 

38 
Version:  November, 2017 
☐ 
☒ 
Does your study meet the definition of an applicable clinical trial and require 
registration AND results submission in accordance with NIH?  
As of January 18, 2017, NIH is requiring that clinical trials be registered at 
ClinicalTrials.gov.  Confirm whether this study meets the registration 
requirements for clinical trial registration in accordance with the definition of 
a clinical trial as defined by NIH.  See definition below. 
Clinical Trial:  A research study in which one or more human subjects are 
prospectively assigned to one or more interventions (which may include 
placebo or other control) to evaluate the effects of those intervention on 
health-related biomedical or behavioral outcomes”.  This definition 
encompasses phase 1 trials of FDA-regulated drug and biological products, 
small feasibility studies of FDA-regulated device products, and studies of any 
intervention not regulated by the FDA, e.g. behavioral interventions. 
Of note, this requirement for registering and results reporting includes clinical 
trials beyond those already required by the FDA.  The requirements are 
expanded to include to Phase I drug studies and NIH-funded clinical trials of 
social-behavioral interventions.   
For more information on this policy please refer to:   
• NIH Policy on the Dissemination of NIH-Funded Clinical Trial 
Information:  https://s3.amazonaws.com/public-
inspection.federalregister.gov/2016-22379.pdf 
• Checklist:  https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf 
• NIH Definition of Clinical Trial:  
http://osp.od.nih.gov/sites/default/files/NIH%20Definition%20of%20
Clinical%20Trial%2010-23-2014-UPDATED_0.pdf 
 
Note:  If your study meets the requirement for registration and 
reporting, you must submit the National Clinical Trial (NCT) Identifier # 
to the IRB prior to IRB approval. 
NCT #:__________________ 
 
 
Certification / Signatures 
 
 
• By submitting this protocol I attest to the fact that all research activities to be implemented 
related to human subjects have been completely and accurately described herein. 
 

39 
Version:  November, 2017 
• I agree to conduct the describe research in an ethical manner.  
 
• I agree to comply with all institutional policies and procedures related to human subjects 
research and will not begin any human subjects research activities until I have obtained full 
approval from the IRB. 
 
• I agree to conduct the research as described in this protocol and not to make any changes 
(except to eliminate immediate harm to subjects) without first obtaining approval for the 
changes from the IRB.  
 
• I agree to immediately report any unanticipated problems involving risks to subjects or 
others, any subject complaints, and any incidents of non-compliance with the requirements of 
this protocol as soon as I become aware of them.  
 
• I agree to comply with any relevant HIPAA and FERPA regulations if applicable.  
 
• I verify that all those responsible for the design, conduct, or reporting of the proposed 
program, including at minimum, all Senior/key personnel in the grant application, have 
completed the financial interest disclosure forms and completed training as dictated at 
http://www.bu.edu/orc/coi/forms/, and returned the forms to   the Office for Research 
Compliance COI Unit.  NOTE: If anyone checked “yes” to any of the questions on either 
the FIND1 or NONFIND1 form, the IRB Director will contact the COI office to obtain 
the disclosure information. 
 
PI printed name:      Terry Ellis, PhD, PT 
 
 
PI Signature: 
 
 
 
 
  
 
Date: 04-05-2021 
 
Submission 
This form can be completed, signed, scanned and submitted to the IRB at irb@bu.edu.   Faxed 
documents and handwritten materials are not accepted.   Be sure to include all relevant 
attachments.   
 
FACULTY Research: 
 
The Department Chair signature is required: This application must be signed by the 
Department Chair for all faculty researchers.  If the PI is the Department Chair then signature by 
the appropriate Dean is required. Department Chair signature is not required for student research.  
By signing this form you are indicating that you have reviewed the application, the 
faculty/staff person listed as PI on this protocol is a member of your department, that 
he/she is qualified to serve as the PI for this study, he/she has the adequate resources, and 
the research utilizes acceptable practice for the discipline. 
 

40 
Version:  November, 2017 
Department Chair (print name):  
 
Gael Orsmond  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
              
Signature: 
 
 
 
 
 
 
  
  
 
Date:  
 
 
4-11-2021 
 
 
  
 
 
STUDENT Research 
 
Student research: Student research must be signed by the faculty advisor AND the designated 
School IRB pre-reviewer (if applicable) PRIOR TO submission to the IRB.  Students should 
check with their School to determine if School IRB pre-review is required.  Students must submit 
a copy of their dissertation with the IRB Application  
 
By signing this form you are indicating that you have reviewed the application, that you 
agree to serve as the Co-PI for this study with the student and that you will be responsible 
for the ethical conduct of this student’s human subjects research.   
 
Faculty Advisor (print name): 
 
 
 
 
 
  
 
 
Signature: 
 
 
 
 
 
 
  
 
 
Date:  
 
 
 
 
  
 
 
 
 
IRB School Reviewer, if applicable (print name): 
 
 
 
 
 
  
 
 
Signature: 
 
 
 
 
 
 
  
 
 
Date: