Amped-PD: Amplifying Physical Activity Through a Novel Digital Music Therapeutic in Parkinson Disease
Phase: NA
Conditions: Parkinson Disease
Sponsor: Boston University Charles River Campus

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Official Title: Amped-PD: Amplifying Physical Activity Through a Novel Digital Music 
Therapeutic in Parkinson Disease   
 
NCT#: NCT05421624 
 
Date: July 12, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Protocol 
 
Study Design: 
The study is a parallel community-based 2-arm randomized controlled trial 
(RCT) in which the study evaluations will take place at the Center of 
Neurorehabilitation (CNR) at Sargent College, Boston University. We will enroll 44 
community-dwelling adults ages 40-80 yrs with idiopathic PD of mild to moderate 
disease severity, who are independent community ambulators. We will exclude 
those with atypical PD, have significant freezing of gait, have history of falls in the 
past 3 months, have a comfortable walking speed <0.4 m/s, and significant cognitive 
or hearing impairments. Eligible participants will be randomly allocated to either 
Figure 1 Study flow. Abbreviations: CoV: Coefficient of Variation; SAM: Step Activity Monitor; 
SRHI: Self-Report of Habit Index 

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Amped-PD (experimental arm) or Active Control (control arm). Assessments will 
include a standard set of motor and non- motor assessments and will be 
administered at Baseline, Post-Assessment (after 6 weeks of training), and Follow-
up (after 2 additional weeks of unstructured training). Figure 1 summarizes the 
study flow for the protocol.  
 
Study Procedures 
 
Primary Screen (approximately 10 minutes): 
A primary screen will be conducted over the phone 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: Primary Screen), potential participants will be asked 
their age (exclude if < 40 years of age), if they are currently participating in physical 
therapy (exclude if yes), if they are currently performing walking exercise of at least 
30 min for > 3x/week (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), their history of falls of > 1 fall over the past 3 months, or a singular 
fall over the past 3 months that is PD-related, with a fall defined as an unexpected 
event that caused a person to unintentionally land on a lower surface (e.g. floor, 
ground), regardless of presence or absence of resultant injury (exclude if yes), 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 based on self-reports from the participant 
will be reviewed to determine the following: 
• Those with known 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 known 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 other medical conditions that would preclude successful 
participation, as determined by a physical therapist on the research team, 
will be excluded. The physical therapist will make this determination based 
on participant self-report and a PTs informed questioning which is part of a 
licensed PTs training. 
It is possible to have self-reports of cardiac, orthopedic, or other medical conditions 
that may need further clarification and clinical assessment due to limited 
information from the participant or unclear description. The physical therapist will 
decide whether an in-person screening will be appropriate. Additionally, 
communication with the participant’s physician may take place to understand their 
health status. A HIPAA authorization from the participant will be obtained prior to 
any communication with the participant’s health provider. 
 
If the participant is deemed eligible based on primary screen, the participant will be 

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asked about scheduling an informed consent. The participant will be given the 
option to receive this virtually or in-person. Virtual consenting may be administered 
right after the primary phone screen if the participant wishes, or may be scheduled 
at a different time. In-person consenting will be held on the same day of the first in-
clinic visit prior to any study procedure. The researcher will coordinate scheduling 
with the participant. 
 
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. 
 
1. First Evaluation Visit: In-Person Screening & Baseline Assessment Visit 
(approximately 2-3 hours): 
The in-person screening and baseline assessment visit will take place at the Center 
for Neurorehabilitation at Boston University. All participants will have completed 
and provided their informed consent prior to Screening and Baseline Assessment 
(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. 
 
1.a In-Person Screening: An in-person Screening will be administered to 
determine if participants meet all study inclusion/exclusion criteria. The elements 
included in the screening process are part of routine physical therapy evaluation. 
A physical exam will be conducted to assess cognitive status, Parkinson’s 
symptoms and walking capacity. 
1. A diagnosis of Parkinson disease will be confirmed per participant report. 
2. The Mini-Mental State Exam (MMSE) will be administered to screen for 
significant cognitive impairment (exclude MMSE score < 24) (see Appendix 
VI: Screening Tools). The MMSE is a brief screening tool that examines 
cognitive impairment. Participants are tested on 11 items that cover multiple 
cognitive domains. The score ranges from 0-30, with higher scores 
indicating less cognitive impairment. 
3. Disease severity will be assessed by a licensed physical therapist using the 
Modified 
4. 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. 
5. Walking capacity assessments instrumented with wearable sensors: 
o The following tests on walking will be instrumented with in-lab 
movement sensors (XSENS, Enschede, the Netherlands), which will 
be worn on both mid-shank (2) and mid-thigh (2) areas, and on mid-

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line low-back area (1), and the sensors of the music-based device 
(MedRhythms, Portland, ME), which will be secured on to the outer 
sides of the shoes (2). The other components of the music-based 
device such as its audio-cue mechanism and headphones will not be 
used during this screening procedure. 
• 
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 3 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. 
• 
The six-minute walk test (6MWT) (see Appendix VI: Screening 
Tools) will be administered by a physical therapist. The 6MWT, a 
measure of long- distance walking capacity, 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) 
and perceived ratings of walking intensity (using Borg’s Rating of 
Perceived Exertion) 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. 
o Walking duration from both 10MWT and 6MWT will be used to generally 
gauge the participant’s walking tolerance. Exclude if the physical 
therapist determines that the participant is unable to walk independently 
for at least 10 minutes. 
o While wearable sensors are used during the 10MWT and 6MWT, sensor 
data will not be used for determination of participant eligibility. Instead, 
sensor data will be used as part of Baseline Assessment and is 
integrated in this screening procedure in the clinical screening to reduce 
the repetition of testing of the same test (10MWT, 6MWT) during the 
Baseline Assessment, once the participant determined to be eligible to 
proceed. 
6. 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 at any point during the evaluation, 

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the participant will be excluded. 
 
1.b 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. 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 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: 
i. 
Dynamic balance will be measured using the Mini Balance Evaluation 
Systems Test (Mini BESTest). This test comprises of 14 items that span 
anticipatory postural adjustments, reactive postural control, sensory 
orientation, and dynamic gait.   
ii. 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 fork 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. 
iii. Quantification of movement will be performed using in-lab movement 
sensors (XSENS, Enschede, the Netherlands) and sensors of the music-
based device (MedRhythms, Portland, ME) (see Appendix VII: Schematic 
of Wearable Sensors). These sensors will be used to measure gait quality 
during performance of the 10MWT and 6MWT as performed in the in-
person screening, and to measure posture as examined in posture-related 
items within the UPDRS III and Mini BESTest. Sample metrics include but 
are not limited to gait velocity, stride length, cadence, and limb velocities, 
and postural sway measures based on velocity, magnitude, smoothness. 
As a clarification, the instrumented 10MWT and 6MWT as performed 
during the initial screen provide the data needed for this Baseline 
Assessment, therefore these tests will not be repeated.  
iv. Functional Mobility will be measured via the Five Times Sit to Stand 
(5xSTS). 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; however, if guarding is 
needed for the 5xSTS, participants will not be allowed to continue with the 

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intervention. 
• Self-report/ Interview Measures: 
i. 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. 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. Section II is a self-administered 
questionnaire consisting of 13 items related to motor aspects of 
experiences of daily living. 
ii. The Self-Report Habit Index (SRHI) will be administered to measure 
exercise-habit strength and automaticity. This self-report index comprises 
of 12 statements with constructs spanning behavior repetition, 
automaticity, and identity, with responses made on 11-point Likert scales 
(0 = strongly disagree; 10 = strongly agree) (see Appendix VII: Outcome 
Measures). 
iii. Self-Efficacy of Walking – Duration (SEW-D) is a 10-item self-report that 
will be administered to determine participants’ beliefs of their physical 
capabilities to successfully complete incremental 5-minute intervals (5 to 
40 minutes) of walking at a moderately fast pace, with responses made 
on 11-point Likert scale (0% = not at all  confident; 100% = highly 
confident). 
iv. Geriatric Depression Scale (GDS) is a brief, self-report involving yes/no 
questions instrument on psychological aspects and social consequences 
of depression in the elderly. The short form of GDS of 15-items will be 
used in this study. 
v. 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: 
o Step Activity Monitor: 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 (roughly the weight of two AA batteries for comparison) 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. Data from the SAM, which includes measurement of daily step 
counts and step intensities, will allow us to examine changes in physical 
activity in response to the intervention. 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 

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1999, Macko 2002, Salarian 2004, Gaines 2005, Manns 2009, 
Speelman 2011). 
o General wear instructions and considerations: Participants will be 
instructed to wear the SAM for 4-11consecutive days depending on the 
assessment timepoint. The SAM will be worn continuously 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. 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 wear 
period. 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). 
o Specific wear schedule for Baseline Assessment: For the Baseline 
Assessment, the SAM will be worn for 4 consecutive days prior to initiating 
the intervention (and will continue to wear it for another 7 days during 
training – please see next section 2. Intervention). 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. Furthermore, participants will be notified that they 
may contact study staff during work hours at any point during the wear 
period if they experience any technical issues with the SAM or have any 
questions. 
o Operation and data download: 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. Collected 
data will be downloaded to a tablet computer, 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. 
1.c Randomization : At the completion of procedures for Baseline Assessment, 
the participant will be randomized to receive either the experimental or control 
arm of the intervention. The experimental arm, called Amped-PD, is a 6-week 
community-based structured walking program that uses a music-adaptive RAS 
followed by 2 weeks of unstructured walking protocol (continue as desired) for a 
total of 8 weeks. The control arm, called Active-Control is a similarly structured 
6-week community-based walking program that does not use RAS, followed by 
2 weeks of unstructured walking protocol (continue as desired) for a total of 8 
weeks of training. Block randomization with balanced allocation between the two 
groups will be implemented. A randomization list will be generated prior to 
enrollment of participants. The researcher will gain knowledge of treatment 
assignment only after procedures in In- person Screen and Baseline 
Assessments have been completed. 
 
1.d Device Training Amped-PD Intervention: 

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Training Procedures / Instruction to Participants: 
Music-Based Device Training (Only for Amped-PD) 
Participants who are randomized to receive Amped-PD intervention will 
undergo training on how to use how to use the music-based device and 
independently conduct the remote walking program. The music-based 
device (MedRhythms, Portland, ME) is specifically designed for gait training 
in people with neuromotor impairments. Participants will be trained to 
independently use the device. A simple setup which takes < 2 min involves 
initiating the smartphone application, wearing the headphones, and 
attaching a movement sensor to the outer side of each shoe below the 
ankle. The smartphone is kept in the user’s pocket throughout the session. 
The music-based device obtains real-time walking information through the 
shoe sensors that communicate wirelessly with the smartphone application 
software. The music-based device delivers music cues that are adjusted 
according to the user’s walking pace as detected by the shoe sensors. 
These music cues serve as the substrate for rhythmic auditory stimulation 
during walking. 
Training with the music-based device will be administered after 
completing the In-person screening and Baseline Assessment procedures. 
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 physical therapist will instruct participants to listen to the music 
at a safe volume so they can still hear sounds in their environment. The 
participant will then practice donning/doffing, adjusting the volume, 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 be able to determine 
safe and independent walking ability during the 5 minutes of walking with 
the device. Five minutes is enough time for the participant to experience an 
increase in music tempo and for the physical therapist to determine if 
guarding is needed during these  transitions. At the end of this training 
period, if the physical therapist determines that the participant will need 
continued assistance from another person to walk and perform transitions 
(i.e. turns, step initiation) while using the music-based device, the participant 
will be withdrawn from the study. Otherwise, the physical therapist will 
proceed and 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 

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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. Leveraging 
the benefits of RAS such as increased stride length, cadence, and speed 
enable walking at faster speeds and higher intensities, thus making it 
advantageous to perform greater amounts of walking at moderate 
intensities – an important health objective set forth by guidelines by public 
health and clinical practice sectors. 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 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 setup (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. 
 
2. 
Intervention: 
 
Amped-PD: Remote Walking Program Description 
(prescribed walking program of 15 hours total over six weeks + concurrent 
use of SAM device 4 days during early training) 
Overview: The remote walking program is a self-directed, structured 
walking program held in home/community settings using the music-based 
device. Participants will be instructed to complete five home/community-
based walking sessions per week (one session/ day, 30 minutes in duration) 
for six weeks. Participants may choose to perform these 5 training sessions 
on any days of the week according to their needs. 
Description of Walking Program: Using the music-based device, 
participants will conduct the walking sessions at their self-selected pace in 

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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. 
Duration of Walking Session: Each individual walking session will be 
completed within a 30- minute timespan (i.e., should not be split up 
throughout the day). Participants are allowed to rest as needed during the 
30-minute training period. The time clock will continue to run down 
continuously once the 30 minutes are started (i.e., if a participant rests for 
5 minutes, this will equate to 25 minutes of walking). Participants will be 
instructed to terminate any walking session in the event of technical or 
medical issues to allow for adequate resolution. 
Walking program diary: 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 comments/issues they experience while using the 
device (see Appendix VII: Outcome Measures). 
Safety Considerations: 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 (if needed) 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. The physical therapist will examine the context of the 
fall. It is possible to discontinue the training program due to but not limited 
to the following reasons: (1) participant self-report of injuries that prevent 
them from participating fully and safely in the program; (2) participant self- 
reports on change in function and mobility after a fall; (3) concerns related 
to the execution of the walking program or proper use of the device, its 
components, and functionality; (4) considerations related to a change in 
participant’s walking function. 
The program may be continued based on discretion of the physical 
therapist if the fall is determined to be ancillary, unrelated to the training 
program or the device, resulted in negligible or insignificant injuries post-
fall, and no change in safety determination. 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. 

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Physical therapy check-in call: During the baseline evaluation visit, the 
research team will ask the participant which time each week is preferred to 
have a check-in call. This phone call will last approximately 5-10 minutes to 
check on participant engagement in the walking program, and to provide 
guidance regarding any questions/concerns and/or any medical/ technical 
issues. 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. 
Step Activity Monitoring: After completing 4 days of wear prior to starting 
training, the participant will continue to wear the SAM for an additional 7 
days upon intervention initiation (total of 11 days continuous wear). During 
training, both the SAM and the shoe sensors of the music-based device 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 return the SAM to study personnel via a pre-labeled, 
addressed envelope to mail following 11 days of continuous monitoring 
period. The researchers will download the data and will store in a secure 
server. 
Interruptions in training: In the event of unavoidable interruptions in 
training, booster sessions may be implemented to promote treatment 
fidelity. For  training interruptions that last up to 2 weeks, the participant will 
continue the program and receive booster sessions at 100% of the time 
missed. For training interruptions of greater than 2 weeks, the training will 
be restarted after a reasonable washout interval, as determined by the 
Principal Investigator (a licensed physical therapist). If training interruption 
resulted in permanent change in eligibility, the participant will be withdrawn 
from the study.     
 
Active-Control Intervention: Remote Walking Program Description 
 (Prescribed walking program of 15 hours total over six weeks + concurrent 
use of SAM device 4 days during early training) 
Overview: The Active-Control Intervention is similarly structured as Amped-
PD Intervention, with the only exception of not using RAS/ music-based 
device. Participants will be instructed to complete five home/community-
based walking sessions per week (one session/ day, 30 minutes in duration) 
for six weeks. 
Description of Walking Sessions: Without using the music-based device, 
participants will conduct the walking sessions at their self-selected pace in 
a home/community environment. All other considerations as outlined above 
apply to this intervention. 
Duration of Walking Session: Each individual walking session will be 
completed within a 30- minute timespan (i.e., should not be split up 
throughout the day. Participants will be asked to use their own wristwatch, 

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timer, or cellphone to monitor the time/ duration of walking session. 
Participants are allowed to rest as needed during the 30-minute training 
period. 
Walking program diary: 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 comments/issues they experience while 
performing the walking program. 
Safety Considerations: Same as above as outlined in Amped-PD. 
Physical therapy check-in call: Same as above as outlined in Amped-PD. 
Step Activity Monitoring: Same as above as outlined in Amped-PD. 
Interruptions in training: In the event of unavoidable interruptions in 
training, booster sessions may be implemented to promote treatment 
fidelity. For  training interruptions that last up to 2 weeks, the participant will 
continue the program and receive booster sessions at 100% of the time 
missed. For training interruptions of greater than 2 weeks, the training will 
be restarted after a reasonable washout interval, as determined by the 
Principal Investigator (a licensed physical therapist). If training interruption 
resulted in permanent change in eligibility, the participant will be withdrawn 
from the study.     
 
3. Second Evaluation Visit: Post-Assessment Visit (approximately 2-3 
hours): 
The post-intervention assessment visit will be scheduled within approximately 
7 days of completion of the structured 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 Assessment including: 
10MWT, 6MWT, Borg’s RPE,  Mini BESTest, MDS-UPDRS I/II/III, 5xSTS, 
PDQ-39, SRHI, GDS. Quantification of movement will be performed using 
wearable sensors to measure balance and walking as examined in the 
aforementioned battery of assessments.   
Further, a usability questionnaire will be administered for those who 
completed Amped-PD. For both Amped-PD and Active-Control groups, 
participants will be asked to bring in their study diary for study personnel to 
review and to make a copy for their data file. This study diary will be returned 
to the participant for continued use if needed during the Follow-up Period. For 
the Amped-PD group, they will have continued access to the music-based 
device during the Follow-up Period. The SAM monitor will be given to the 
participant to wear for 7 days during Follow-Up Training. Participants who 
withdraw or are withdrawn prior to completing their last walking session may 
be asked to complete closing visit activities, if feasible. 
 
4. Follow-Up Walking Program (2 weeks): Extended Remote Walking Program 
Description  for both groups (recommended continuation of routine walking + 
concurrent use of SAM  device 4 days during follow-up training)  
Overview: Participants in both Amped-PD and Active-Control groups will be 
recommended to carry out the walking program independently for another 2 weeks, 

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with walking duration and amount similar to that of the 6-week Remote Walking 
program (i.e. 30 min/ session x 5x/week). This recommendation to continue the 
walking program is similar to the common practice of a home exercise program 
that is recommended after discharge from an episode of physical therapy care. 
The main difference in this Follow-up Training relative to the prior Remote Walking 
Program is that this Follow-up Training is completely self-managed by the 
participants, where participants will naturally make choices on how they will 
continue and adhere with the recommended balance and walking as examined in 
the aforementioned battery of assessments. For both Amped-PD and Active-
Control groups, participants will be asked to bring in their study diary for study 
personnel to review and to make a copy for their data file. For participants in the 
Amped-PD, they will return the music-based device to the research team. 
Step Activity Monitoring: The participant will wear the SAM for 4 days after this 
final assessment visit. Once completed, the participant will return the SAM to study 
personnel via a pre-labeled addressed mailing envelope which will be provided to 
them during the final assessment. The researchers will download the data and will 
store in a secure server.