Low-Interventional Study to Record Gait and Physical Activity Using ActiGraph Devices in Children Ages 3-17.
Conditions: Child, Preschool, Child, Adolescent
Sponsor: Pfizer

X9001263 LOW-INTERVENTIONAL STUDY PROTOCOL
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Title A LOW-INTERVENTIONAL STUDY TO RECORD GAIT AND PHYSICAL 
ACTIVITY USING DEVICE(S) in CHILDREN AGES 3-17. 
Study Intervention Number:
N/A
Study Intervention Name:
N/A
US IND Number:
N/A
[EudraCT/CTIS] Number:
N/A
ClinicalTrials.gov ID:  
N/A
Pediatric Investigational Plan Number
N/A
Protocol Number:
X9001263
Phase:
N/A
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writing, by accepting or reviewing this document, you agree to hold this information in confidence and not 
copy or disclose it to others (except where required by applicable law) or use it for unauthorized purposes.  In 
the event of any actual or suspected breach of this obligation, Pfizer must be promptly notified.
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PFIZER CONFIDENTIAL
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TABLE OF CONTENTS
1. LIST OF ABBREVIATIONS................................................................................................5
2. RESPONSIBLE PARTIES....................................................................................................7
3. AMENDMENTS AND UPDATES.......................................................................................8
4. MILESTONES.....................................................................................................................21
5. SUMMARY.........................................................................................................................22
6. SCHEDULE OF ACTIVITIES............................................................................................25
7. RATIONALE AND BACKGROUND................................................................................33
8. RESEARCH QUESTION AND OBJECTIVES .................................................................34
9. RESEARCH METHODS ....................................................................................................36
9.1. Study Design ...........................................................................................................36
9.1.1. Inclusion Criteria ........................................................................................38
9.1.2. Exclusion Criteria.......................................................................................39
9.1.3. Variables.....................................................................................................39
9.1.3.1. Data Sources..............................................................................40
10. STUDY PROCEDURES ...................................................................................................42
10.1. Recruitment ...........................................................................................................42
10.2. Initial Contact........................................................................................................42
10.3. Prescreening ..........................................................................................................42
10.4. Screening and Enrollment .....................................................................................42
10.5. Visit 1 (Day 1).......................................................................................................43
10.6. At-home Monitoring (Day 1 to Day 15+3 days)...................................................45
10.7. Follow-up Phone Interview (Day 15+3 days).......................................................47
10.8. Lost-to-follow-up ..................................................................................................48
11. ASSESSMENTS................................................................................................................48
11.1. Additional Research ..............................................................................................48
11.2. Assessment of Suicidal Ideation and Behavior.....................................................48
11.3. Biological Samples................................................................................................48
11.4. Imaging Assessments ............................................................................................48
11.5. Rater Qualifications...............................................................................................48
11.6. Medical/Surgical History, Prior/Concomitant Treatments....................................48
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11.7. Body Weight and Height.......................................................................................48
11.8. Handedness Questionnaire ....................................................................................48
11.9. Patient Reported Outcome ....................................................................................49
11.10. Performance of In-lab Tasks ...............................................................................50
11.11. Devices Assessment and Exposure .....................................................................50
12. DATA ANALYSIS/STATISTICAL METHODS.............................................................51
12.1. Study Size..............................................................................................................51
12.2. Data Management .................................................................................................52
12.3. Case Report Forms/Data Collection Tools (DCT)/Electronic Data Record .........52
12.4. Record Retention...................................................................................................53
12.5. Data Analysis ........................................................................................................53
12.5.1. Statistical Analysis....................................................................................53
13. QUALITY CONTROL AND QUALITY ASSURANCE.................................................58
14. LIMITATIONS OF THE RESEARCH METHODS.........................................................58
15. PROTECTION OF HUMAN SUBJECTS ........................................................................59
15.1. Patient Information and Consent...........................................................................59
15.2. Participant Withdrawal..........................................................................................60
15.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ............61
15.4. Ethical Conduct of the Study ................................................................................61
16. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS ......................................................................................................................61
16.1. Single Reference Safety Document.......................................................................61
16.2. Requirements.........................................................................................................62
16.3. Adverse Events (AE).............................................................................................62
16.4. Research-Related Injury........................................................................................62
17. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........63
17.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH 
GCP ...........................................................................................................................63
17.2. Publications by Investigators ................................................................................63
18. REFERENCES ..................................................................................................................65
19. LIST OF TABLES.............................................................................................................68
20. LIST OF FIGURES ...........................................................................................................68
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ANNEX 1. LIST OF STAND ALONE DOCUMENTS .........................................................68
ANNEX 2. LIST OF GAIT METRICS ENDPOINTS............................................................68
ANNEX 3. LIST OF PHYSICAL ACTIVITY METRICS ENDPOINTS..............................70
ANNEX 4. EDINBURGH HANDEDNESS INVENTORY – SHORT FORM .....................72
ANNEX 5. WEARABILITY/COMFORT QUESTIONNAIRE.............................................73
ANNEX 6. ACTIVITY DIARY..............................................................................................74
ANNEX 7. COGNITIVE DEBRIEF OF WEARABILITY/COMFORT 
QUESTIONNAIRE ............................................................................................................74
ANNEX 8. ACTIVITY AND SLEEP DIARY........................................................................75
21. APPENDIX 1: COHORT LISTING AT HOME MONITORING....................................75
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LIST OF ABBREVIATIONS
Abbreviation
Definition
AE
adverse event
APDM
Ambulatory Parkinson’s Disease Monitoring
ASIS
Anterior Superior Iliac Spine
BLE
Bluetooth Long Energy
CRF
case report form
CSR
Clinical Study Report
CTIS
Clinical Trial Information System
DCT
data collection tool
EC
Ethics Committee
EHI
Edinburgh Handedness Inventory
FDA
Food & Drug Administration
FSFV
first subject first visit
GCP
Good Clinical Practice
GPP
Good Pharmacoepidemiology Practices
ICC
Intraclass Correlation Coefficient
ICCnull
Intraclass Correlation Coefficient null
ICH
International Council for Harmonisation of 
Technical Requirements for Pharmaceuticals for 
Human Use
IEC
Independent Ethics Committee
IRB
Institutional Review Board
LAR
legally acceptable representative
LSLV
last subject last visit
MM
Medial Malleoli
MMRM
mixed effect model repeat measurement
MVPA
Moderate-to-Vigorous Physical Activity
PACL
Protocol Administrative Change Letter 
PASS
Post-authorization safety study
PfIRe Lab
Pfizer Innovation Research Laboratory
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Abbreviation
Definition
PRO
Patient reported outcomes
SAP
Statistical Analysis Plan
SoA
schedule of activities
TMF
trial master file
TSO
Total Sleep Opportunity
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RESPONSIBLE PARTIES
Principal Investigator(s) of the Protocol
Name, degree(s)
Job Title
Affiliation
Address
Denise Chou, MD
Director
Digital Sciences and 
Translational Imaging
610 Main Street 
Cambridge, MA
Mar Santamaria, MD
Senior Director
Digital Sciences and 
Translational Imaging
610 Main Street, 
Cambridge, MA
Xuemei Cai, MD
Senior Director
Digital Sciences and 
Translational Imaging
610 Main Street, 
Cambridge, MA
Sana Ghafoor, MD
Director
Digital Sciences and 
Translational Imaging
610 Main Street, 
Cambridge, MA
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PFIZER CONFIDENTIAL
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AMENDMENTS AND UPDATES
This global amendment incorporates all revisions to date, including amendments made at the 
request of country health authorities and IRBs/ECs and any protocol administrative change 
letter (PACL). 
Document 
Version Date
Amendment 1
03-March-2023
Original protocol
30-October-2020
Protocol Amendment Summary of Changes Table
Amendment 1 (03-March-2023)
Overall Rationale for the Amendment: The rationale for the amendment is to add a new 
Cohort (Cohort B) to study a new device (Panoramic Bracelet device) in the same pediatric 
population, add changes in objectives and endpoints required for Panoramic Bracelet device
and update the schedule of activities for Cohort B,  as well as to distinguish the original 
cohort which had ActiGraph Centrepoint Insights Watch [it will be referenced as ActiGraph 
Device throughout the protocol] as the device under investigation to be renamed Cohort A. In 
addition we will evaluate the Panoramic Bracelet device and associated algorithms in the 
quantification of physical activity (eg sleep), scratch, and wear time, as compared to another 
accelerometry device (GENEActiv) during the at-home period
Section # and 
Name
Description of Change
Brief 
Rationale
Substantial or non-
substantial
Study Design
Added new study design 
definition to denote the new 
device under study.
Arm 
Title
Cohort A
Cohort B
Arm 
Type 
(Device 
under 
study)
ActiGraph 
Device
Panoramic 
Bracelet 
Device
Describe 
Arms for 
devices for 
Cohort A and 
B.
Substantial
Section 4 
Added milestones table
Describe 
milestones 
differences
for Cohort A 
and B
Substantial
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Section # and 
Name
Description of Change
Brief 
Rationale
Substantial or non-
substantial
Research 
Questions and 
Objectives
Added Cohort B objectives:
Primary Objectives:

Evaluate the
Panoramic Bracelet 
device and associated 
algorithms in the 
quantification of 
physical activity (eg
sleep), scratch, and 
wear time, as 
compared to another 
accelerometry device 
(GENEActiv) during 
the at-home period.

To evaluate the 
participant’s or 
caregiver’s perception 
of wearability and 
comfort of Panoramic 
Bracelet device during 
the at home monitoring 
period
Secondary Objectives

To assess the 
compliance in wearing 
the Panoramic Bracelet 
device at home.

To compare gait 
quality metrics 
collected using 
Panoramic Bracelet 
devices, APDM 
devices and 
GAITRite® walkway, 
during in-lab sessions.
To denote the 
difference in 
objectives 
between the 
two cohorts.
Substantial
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Section # and 
Name
Description of Change
Brief 
Rationale
Substantial or non-
substantial
Tertiary/Exploratory 
Objectives

To evaluate the 
participant’s or 
caregiver’s perception 
of wearability and 
comfort of Panoramic 
Bracelet devices in-lab 
sessions.

To evaluate the effect 
of floor surface (carpet 
vs tile) on gait metrics 
collected using 
Panoramic Bracelet 
and APDM devices.
Section 6
Added new SoA for Cohort B.   Denote 
changes in 
SoA
Substantial
Section 8
Added Objectives and 
endpoints for Cohort B
Primary Endpoints:

Sleep and scratch 
endpoints, and wear 
time compliance (~
days 8-15)

At-home Panoramic 
Bracelet device 
wearability/comfort 
questionnaire 
responses from at-
home monitoring 
period (this is Day 
7+2, only 1 wrist).
Secondary Endpoints:

Number of hours per 
day wearing the device 
(only Panoramic
Bracelet Days 1-7)
Describe new 
objectives 
and endpoints 
for Cohort B
Substantial
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Section # and 
Name
Description of Change
Brief 
Rationale
Substantial or non-
substantial

Gait metrics defined in 
the Annex 2 (eg, gait 
speed, stride length) 
measured by APDM 
devices, GAITRite®
walkway and 
Panaromic device 
(extracted with GaitPy 
algorithm).
Tertiary/Exploratory 
Endpoints:

In-lab Panoramic 
Bracelet 
wearability/comfort 
questionnaire 
responses from Visit 1 
(Day 1).(wrist and 
lumbar)

Gait metrics defined in 
the Annex 2 (eg, gait 
speed, stride length) 
measured by 
Panoramic Bracelet 
and APDM devices 
across different floor 
surfaces.
Section 9.1.3.1 
Data Sources
Added GENEActiv and 
Panoramic Bracelet as data 
source
Panoramic Bracelet:
The Panoramic Digital Health 
Bracelet is a wearable inertial 
measurement unit “intended 
for use by researchers and 
healthcare professionals for 
high frequency or continuous 
collection of physical data in 
home and professional 
healthcare settings during 
Describe new 
data sources 
from devices 
added for 
Cohort B
Substantial
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Section # and 
Name
Description of Change
Brief 
Rationale
Substantial or non-
substantial
research studies.” It includes a 
3 axis accelerometer and 
gyroscope, as well as 
magnetometer, pressure, and 
temperature sensors, all of 
which can be configured to 
collect data or not. Sampling 
rates can be set from 12-52 Hz 
depending on the sensor. The 
Bracelet has no interface or 
screen for participants to 
interact with. Additionally, 
“beacons” or “tags” can be 
optionally placed in strategic 
locations to monitor when 
participants are near these 
beacons. The beacons interact 
with the Panoramic Bracelet 
via a Bluetooth Low Energy 
(BLE) antenna and can 
provide information as to 
when the Bracelet is in 
proximity with the beacon.
GENEActiv:
The Activinsights GENEActiv 
device is a wearable inertial 
measurement unit “designed 
for public health research and 
clinical trials” The device is a 
circular unit with attachable 
wristbands and has no 
interface or screen for 
participants to interact with. 
The GENEActiv device is 
FDA 510(k) exempt. The 
device can record acceleration 
data between 10-100 Hz and 
depending on configuration 
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Section # and 
Name
Description of Change
Brief 
Rationale
Substantial or non-
substantial
can collect data remotely for 
up to 1 month.
Section 10.6 At-
home 
Monitoring
Added Figure 2
To describe 
wearable 
sensor device 
locations on 
participant at-
home for 
Cohort A and 
B.
Substantial
Section 11.11.
Devices 
Assessment and 
Exposure
Added Cohort B language 
relevant to Panoramic Bracelet 
Device:
Cohort B: APDM opal 
devices will be worn during 
visit 1 only on both wrists, 
both feet, chest, and waist. 
Device under study 
(Panoramic Bracelet) will be 
worn during visit 1 and also 
during the at-home monitoring 
portion between Day 1 and 
Day 15+3 days on the non-
dominant wrist. GENEActiv 
device will be worn on the 
same non-dominant wrist from 
Day 7 until the end of study 
(approximately7 days
consecutively).
Section 12.1.
Study Size
Added Cohort B language:
The proposed sample size is 
appropriate for assessing the 
association of other metrics, 
such as sleep, across devices 
in Cohort B. Using data from 
previous study 
(NCT03898427, healthy 
participants 18 years and 
To provide 
evidence that 
the current 
sample size 
has enough 
power to 
satisfy the 
objectives of 
Cohort B
Substantial
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Section # and 
Name
Description of Change
Brief 
Rationale
Substantial or non-
substantial
older), data from 21 
participants wearing 
ActiGraph and GENEActiv on 
their wrists simultaneously. 
The ICC value of total sleep 
time obtained from ActiGraph 
and GENEActiv devices 
averaged across both arms at 
visit 1 was 0.88. The ICC 
value for null hypothesis was 
computed by randomly 
breaking the participant 
pairings 1000 times and 
computing the 95th percentile 
of the ICC values of these 
randomly assigned pairs 
(ICCnull was 0.36). In order to 
reach ICC value of 0.88 with 
ICCnull value of 0.36 using a 
one-tailed test with alpha =
0.05 and power = 0.8 it is 
estimated that at least 8 
participants will be needed. 
Therefore, we will have 
appropriate power (more than 
95%) to be able to assess 
metrics such as total sleep 
time between devices in 
Cohort B.
It is anticipated that the 
proposed sample size will 
achieve the following goals: 
(1) assess the agreement of 
gait metrics from ActiGraph
and Panoramic Bracelet 
against reference comparators; 
(2) provide data on usability, 
wearability and comfort of 
ActiGraph and Panoramic 
Bracelet for future clinical 
trials, and (3) assess the 
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Section # and 
Name
Description of Change
Brief 
Rationale
Substantial or non-
substantial
agreement of other metrics 
such as related to sleep and 
scratch from Panoramic 
Bracelet against comparators. 
The data obtained in this study 
will enable power calculations 
for future pediatric studies.
Section 12.5.1.
Statistical 
Analysis
Added Cohort B language.
Primary Objectives
1. Evaluate the 
Panoramic Bracelet 
and associated 
algorithms in the 
quantification of 
physical activity (eg 
sleep), scratch, and 
wear time, as 
compared to another 
accelerometry device 
(GENEActiv) during 
the at-home period.
Raw accelerometry data 
collected by Panoramic 
Bracelet and GENEActiv will 
be processed by the SleepPy25
followed by ScratchPy26
algorithms to generate 
endpoints related to sleep and 
nocturnal scratching (eg total 
sleep time, total scratch 
duration, etc) SleepPy is a 
combination of three 
previously published heuristic 
algorithms27,28,29, augmented 
for their integrated use, for 
To 
differentiate 
the analyses
that will be 
performed to 
address the 
study 
objectives for 
Cohort A and 
Cohort B
Substantial
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Section # and 
Name
Description of Change
Brief 
Rationale
Substantial or non-
substantial
detecting a subject’s total 
sleep opportunity (TSO) 
window and computing sleep 
metrics within that window. 
ScratchPy is a machine 
learning based algorithm that 
relies on SleepPy for context 
detection, extracts periods of 
movement from the TSO 
window, and then classifies 
those periods as either restless 
behaviors during sleep or 
scratch. The resulting 
predictions are then 
aggregated into endpoints 
summarizing the subject’s 
scratch behaviors.
During the at home period (~
days 8-15), common endpoints 
related to wear time, sleep, 
and scratching will be 
compared between Panoramic 
Bracelet and GENEActiv 
(reference). Accuracy of the 
sensor-derived metrics will be 
determined by computing the 
mean absolute percent error 
between the comparator and 
reference metrics and assess 
the bias using Bland-Altman 
plots and 95% limits of 
agreement. The agreement 
between metrics will be 
assessed using ICC and its 
95% lower and upper 
confidence limits. 
2. To evaluate the 
participant’s or 
caregiver’s perception 
of wearability and 
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Section # and 
Name
Description of Change
Brief 
Rationale
Substantial or non-
substantial
comfort of Panoramic 
Bracelet during the at 
home monitoring 
period
The wearability/comfort
questionnaire during the at 
home period (Day 7+2) will be 
summarized by frequency and 
percentages.
Secondary Objectives
1. To assess the 
compliance in wearing 
the Panoramic device 
at home.
Wear time of the Panoramic 
Bracelet during the at home 
period (~ days 1-7) will be 
summarized.
2.
To compare gait 
quality metrics 
collected using 
Panoramic devices, 
APDM devices and 
GAITRite® walkway, 
during in-lab sessions.
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Section # and 
Name
Description of Change
Brief 
Rationale
Substantial or non-
substantial
Raw accelerometry data 
collected by Panoramic 
Bracelets will be processed by 
the GaitPy24 algorithm to 
generate gait quality metrics 
(eg, gait speed, stride length 
etc). GaitPyis an open-source 
Python package that 
implements several published 
algorithms in a modular 
framework for extracting 
features of gait from a single 
accelerometer device mounted 
on the lumbar. The package 
has been developed to make it 
easy for researchers to derive 
measures of gait from raw 
accelerometer data. GaitPy
includes 2 key algorithms for 
processing raw accelerometer 
data to derive gait features. 
The first algorithm is used for 
detecting bouts of gait from 
continuous accelerometer data 
collected under free-living 
conditions and the second 
algorithm derives temporal 
and spatial features of gait 
from pre-identified bouts of 
gait. This second GaitPy
algorithm will be used to 
process data and extract gait 
features collected during in-
lab sessions.
During the in-lab walking 
tasks, gait metrics extracted 
from GaitPy will be compared 
to those that are extracted 
from GAITRite® walkway 
and APDM. During the natural 
walk between activities 
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Section # and 
Name
Description of Change
Brief 
Rationale
Substantial or non-
substantial
stations, gait metrics from 
GaitPy will be compared to 
APDM. Accuracy of the 
sensor-derived metrics will be 
determined by computing the 
mean absolute percent error 
between the sensor-derived 
and reference standard metrics 
and assess the bias using 
Bland-Altman plots and 95% 
limits of agreement. The 
agreement between 
sensor-derived and reference 
standard metrics will be 
assessed using ICC and its 
95% lower and upper 
confidence limits. 
Tertiary/Exploratory 
Objectives:
1.
To evaluate the 
participant’s or 
caregiver’s perception 
of wearability and 
comfort of Panoramic 
Bracelet device in-lab 
sessions.
The wearability/comfort 
questionnaire for the in-lab 
session will be summarized by 
frequency and percentages. 
2. To evaluate the effect 
of floor surface (carpet 
vs tile) on gait metrics 
collected using 
Panoramic Bracelet 
and APDM devices.
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Section # and 
Name
Description of Change
Brief 
Rationale
Substantial or non-
substantial
We will quantify differences 
between sensor-derived gait 
quality metrics (from 
Panoramic Bracelet and 
APDM) collected on different 
floor surfaces using paired 
tests (t-test or Wilcoxon 
signed ranks test depending on 
normality of the data).
Appendix1
Cohort Listing
Added Cohort A and Cohort B
on the table in Appendix 1
To describe in 
detail device 
location, 
configuration 
in body and 
home 
monitoring 
period for 
both Cohort 
A and Cohort 
B during 
home 
monitoring.
Substantial
Throughout the 
protocol 
Added Cohort A and Cohort B 
language throughout the 
protocol 
To clarify the 
differences 
between
Cohort A and 
B study 
procedures.
Substantial
Throughout the 
protocol
Corrections of typographical 
errors and administrative edits 
were made. 
Corrections 
of 
typographical 
errors and 
administrative 
edits were 
made.
Non-substantial
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MILESTONES
Cohort A: Device under study = ActiGraph
Milestones
Planned Date
Start of data collection: FSFV
01 April 2021 
End of data collection: LSLV
01 April 2022 
Interim study report
01 March 2023
Cohort B: Device under study = Panoramic Bracelet Device
Milestones
Planned Date
Start of data collection: FSFV
01 May 2023
End of data collection: LSLV
01 November 2023
Final study report
01 October 2024
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SUMMARY
Title: A Low-Interventional Study to Record Gait and Physical Activity Using Devices in 
Children Ages 3-17.
Rationale and background:
The quantitative assessment of physical activity is challenging in both healthy and patient 
populations. The benefit of physical activity in children is well defined: obesity prevention, 
reduction in cardiovascular risk factors, normal growth and development, depression 
prevention, health-related quality of life. Some conditions, such as Duchenne Muscular 
Dystrophy, Atopic Dermatitis, Dermatomyositis, Polymyositis, Friedreich’s Ataxia and 
Achondroplasia, affect the mobility of children and make it difficult for them to perform 
physical activities. Clinical studies have demonstrated the ability of wearable devices to 
detect and quantify physical activity in adults. However, there is a lack of digital studies in 
the pediatric population. This study will assess the feasibility and generate compliance and 
recruitment data to help design future clinical trials in children.
Research question and objectives: In a pediatric qualified population, ages 3 to 17 years 
old, the following are the objectives of this study:
COHORT A:

To compare gait quality metrics collected using the ActiGraph devices, APDM 
devices and GAITRite® walkway, during in-lab sessions.

To assess the feasibility of recruiting pediatric participants to conduct a wearable 
device study.

To assess the ability of pediatric participants to perform a battery of lab-based tasks.

To assess the compliance in wearing the ActiGraph devices at home.

To evaluate the participant’s or caregiver’s perception of wearability and comfort of 
ActiGraph and APDM devices during in-lab sessions.

To evaluate the participant’s or caregiver’s perception of wearability and comfort of 
ActiGraph devices during the at-home monitoring period.

To evaluate the effect of floor surface (carpet vs tile) on gait metrics collected using 
ActiGraph and APDM devices.

To investigate the feasibility of using a daily activity diary to provide context in 
pediatric physical activity data collected by the ActiGraph devices at home in 
pediatric participants.
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
To compare gait speed collected using the SIMI system and GAITRite® walkway, 
during in-lab sessions.
COHORT B:

Evaluate the Panoramic Bracelet device and associated algorithms in the 
quantification of physical activity (eg, sleep), scratch, and wear time, as compared to 
another accelerometry device (GENEActiv) during the at-home period.

To evaluate the participant’s or caregiver’s perception of wearability and comfort of 
Panoramic Bracelet device during the at home monitoring period

To assess the compliance in wearing the Panoramic Bracelet device at home.

To compare gait quality metrics collected using Panoramic Bracelet devices, APDM 
devices and GAITRite® walkway, during in-lab sessions. 

To evaluate the participant’s or caregiver’s perception of wearability and comfort of 
Panoramic Bracelet device in-lab sessions.

To evaluate the effect of floor surface (carpet vs tile) on gait metrics collected using 
Panoramic Bracelet and APDM devices.
Study design: This is a non-randomized, single site, low-interventional study. The in-lab 
sessions will be conducted in the Pfizer Innovation Research Laboratory (PfIRe Lab). There 
will be approximately 13 participants per age group and a total of approximately
39 participants for Cohort A (device under study ActiGraph) and Cohort B (device under 
study is Panoramic Bracelet Device).
Arm Title
Cohort A
Cohort B
Arm Type (Device under study)
ActiGraph Device
Panoramic Bracelet Device
Eligible participants will be assigned to the following age groups:

Group 1: 3 years to 5 years old inclusive

Group 2: 6 years to 11 years old inclusive

Group 3: 12 years to 17 years old inclusive
All participants will come for a single in-lab visit during which they will perform gait and 
activity monitoring procedures. Additionally, the study will include approximately 2 weeks
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at-home monitoring while wearing the devices under study and filling out an activity diary
(Only for Cohort A).
Population: Qualified male or female participants aged 3 to 17 years old inclusive, as 
determined by a medically qualified individual. Eligible pediatric participants will be 
assigned to 1 of 3 age groups.
Variables: No interventional drug. Outcomes will be compliance and recruitment data, gait 
and activity metrics, wearability/comfort data.
Data sources: Data sources will include case report forms (CRFs), patient reported outcomes 
(PRO) from an activity diary (Cohort A only), and activity and sleep diary for Cohort B,
wearability/comfort questionnaires, non-CRF data generated by devices during in-lab visit 
and at-home monitoring period.
Study size: There will be approximately 13 participants per age group and a total of 
approximately 39 participants for Cohort A and 39 participants in Cohort B of this study.
Data analysis: The primary analysis will compare several metrics collected using the devices 
under study for Cohort A and B, APDM devices, GAITRite® walkway, and Panoramic 
Bracelet during in-lab sessions. Secondary analysis will include the feasibility of recruiting 
pediatric participants to conduct a wearable device study, the ability of pediatric participants 
to perform a battery of lab-based tasks and the compliance in wearing devices. The 
participant’s or caregiver’s perception of wearability/comfort of the devices, and the effects 
of floor surface on gait metrics will be evaluated. Data collected from devices worn during 
the at home portion will be analyzed as part of the study objectives.
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SCHEDULE OF ACTIVITIES
Refer to STUDY PROCEDURES and ASSESSMENTS sections of the protocol for detailed information on each procedure and 
assessment required for compliance with the protocol.
The investigator may schedule visits (unplanned visits) in addition to those listed in the schedule of activities table, in order to conduct 
evaluations or assessments required to protect the well-being of the participant.
COHORT A: ACTIGRAPH DEVICE SoA
Procedure/ 
Assessment 
In-Lab
At-home monitoring
Final 
study 
evaluation 
Return of 
Study 
Materials
Screening Visit
1
Day 
1 
Day 
2
Day 
3
Day
4
Day 
5
Day 
6
Day 
7
Day 
8
Day 
9
Day 
10
Day 
11
Day 
12
Day 
13
Day 
14
Day 
15
Day 15 
(+3 days)
> Day 15
Day 1
Day 1
Informed Consent 
and Assent
X
Demography
X
Medical/Surgical 
Historya
X
Prior/Concomitant 
treatmenta
X
Inclusion/Exclusion 
criteria
X
Height, leg 
length,Error! Reference 
source not found. and 
weight
X
Edinburgh 
Handedness 
Inventory (EHI)-
short form
X
Device exposure 
(APDM 
provisioning)c
X
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Procedure/ 
Assessment 
In-Lab
At-home monitoring
Final 
study 
evaluation 
Return of 
Study 
Materials
Screening Visit
1
Day 
1 
Day 
2
Day 
3
Day
4
Day 
5
Day 
6
Day 
7
Day 
8
Day 
9
Day 
10
Day 
11
Day 
12
Day 
13
Day 
14
Day 
15
Day 15 
(+3 days)
> Day 15
Day 1
Day 1
Device exposure 
(In-Lab ActiGraph
provisioning)d
X
Walking on 
GAITRite®
walkway (~20 feet 
x 3) at participant’s 
natural speede
X
Walking on 
GAITRite®
walkway (~20 feet 
x 3) at varied 
speedsf
X
Walking on tile and 
carpet at 
participant’s natural 
speede
X
Capture 
time-activity 
blocks; moving 
naturally between 
activities’ stationsg
X
Device exposure –
(APDM collection)
X
Device exposure –
(In-Lab ActiGraph
collection)
X
Wearability/Comfor
t questionnaire
X
X
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Procedure/ 
Assessment 
In-Lab
At-home monitoring
Final 
study 
evaluation 
Return of 
Study 
Materials
Screening Visit
1
Day 
1 
Day 
2
Day 
3
Day
4
Day 
5
Day 
6
Day 
7
Day 
8
Day 
9
Day 
10
Day 
11
Day 
12
Day 
13
Day 
14
Day 
15
Day 15 
(+3 days)
> Day 15
Day 1
Day 1
Cognitive debrief of 
wearability/comfort 
questionnaire
X
Participant chooses 
paper or electronic 
activity diary
X
Instruct participant 
and parent/LAR on 
use of ActiGraph
X
Device exposure-
(At-Home 
ActiGraph 
provisioning)d
X
At-home 
monitoring with 
ActiGraph devicesd
X
→
→
→
→
→
→
→
→
→
→
→
→
→
→
X
Electronic Activity 
diaryh
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Paper Activity 
diaryh
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Phone interviewi
X
Collect Paper 
Activity diary
X
Device exposure –
(At-Home
ActiGraph
collection)j
X
Device assessmentj
X
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
X
Adverse event 
monitoringk
X
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
X
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Procedure/ 
Assessment 
In-Lab
At-home monitoring
Final 
study 
evaluation 
Return of 
Study 
Materials
Screening Visit
1
Day 
1 
Day 
2
Day 
3
Day
4
Day 
5
Day 
6
Day 
7
Day 
8
Day 
9
Day 
10
Day 
11
Day 
12
Day 
13
Day 
14
Day 
15
Day 15 
(+3 days)
> Day 15
Day 1
Day 1
a.
Medical/Surgical history, prior/concomitant treatment will be recorded by a medically qualified individual.
b.
Leg length is measured by the clinician utilizing a flexible tape measure with the participant in supine position. The leg length will be measured from the 
Anterior Superior Iliac Spine to the Medial Malleoli on the right side. The measurements will be recorded in the CRF.1
c.
APDM Opal sensors placed on left wrist, right wrist, chest, lumbar, left foot, right foot.
d.
ActiGraph placed on non-dominant wrist and lumbar, serial numbers of both devices to be collected on CRF for every participant.
e.
Natural speed is participant’s self-chosen pace.
f.
Varied speeds include participant’s self-chosen slow pace (“Walk slow”) and fast pace (“Walk fast”).
g.
Participant will alternate between activities’ stations. Participants will do ~7 minutes of activities, ~5 minutes of break and ~7 minutes of activities. The task 
stations include 2 sitting activities, 2 standing activities, and 2 walking activities. Order of stations will be determined at random using dice roll.
h.
Participants will complete activity diary (choice between either electronic or paper) at home daily between Day 2 and Day 15.
i.
The study staff will instruct the participants to mail back both ActiGraph devices at the final study evaluation over the phone at the exit interview.
j.
Any event with a device (issues with devices, loss of the devices, etc.), the impact of this event and the action taken with device will be recorded in a device 
assessment CRF. 
k.
Adverse events (AEs) will be queried at the clinic visit and during the exit phone interview using open-ended and nonleading verbal questioning of the 
participant. Any spontaneously reported AEs noted during the home visits will be captured during the exit phone interview.
Abbreviations: →= ongoing/continuous event; APDM = Ambulatory Parkinson’s Disease Monitoring.
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COHORT B: PANORAMIC BRACELET SoA
Procedure/ 
Assessment 
In-Lab
At-home monitoring
Final 
study 
evaluation 
Return of 
Study 
Materials
Screenin
g
Visit 
1
Day 
1 
Day 
2
Day 
3
Day 
4
Day 
5
Day 
6
Visit 
2
Day 
8
Day 
9
Day 
10
Day 
11
Day 
12
Day 
13
Day 
14
Day 
15
Day 15 
(+3 days)
> Day 15
Day 1
Day 1
Day 
7 +2
Informed Consent 
and Assent
X
Demography
X
Medical/Surgical 
Historya
X
Prior/Concomitant 
treatmenta
X
Inclusion/Exclusion 
criteria
X
Height, leg lengthb
and weight
X
Edinburgh 
Handedness 
Inventory (EHI)-
short form
X
Device exposure 
(APDM 
provisioning)c
X
Device exposure (In-
Lab Panoramic 
Bracelet Device
provisioning)d
X
Walking on 
GAITRite®
walkway (~20 feet x 
3) at participant’s 
natural speede
X
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Procedure/ 
Assessment 
In-Lab
At-home monitoring
Final 
study 
evaluation 
Return of 
Study 
Materials
Screenin
g
Visit 
1
Day 
1 
Day 
2
Day 
3
Day 
4
Day 
5
Day 
6
Visit 
2
Day 
8
Day 
9
Day 
10
Day 
11
Day 
12
Day 
13
Day 
14
Day 
15
Day 15 
(+3 days)
> Day 15
Day 1
Day 1
Day 
7 +2
Walking on 
GAITRite®
walkway (~20 feet x 
3) at varied speedsf
X
Walking on tile and 
carpet at participant’s 
natural speede
X
Capture time-activity 
blocks; moving 
naturally between 
activities’ stationsg
X
Wearability/Comfort 
questionnaire for 
Panoramic Bracelet 
Deviceh
X
X
Outside lab free walk
condition (10 min)i
X
Cognitive debrief of 
wearability/comfort 
questionnaire
X
Instruct participant 
and parent/LAR on 
use of Panoramic 
Bracelet Device and 
GENEActiv
X
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Procedure/ 
Assessment 
In-Lab
At-home monitoring
Final 
study 
evaluation 
Return of 
Study 
Materials
Screenin
g
Visit 
1
Day 
1 
Day 
2
Day 
3
Day 
4
Day 
5
Day 
6
Visit 
2
Day 
8
Day 
9
Day 
10
Day 
11
Day 
12
Day 
13
Day 
14
Day 
15
Day 15 
(+3 days)
> Day 15
Day 1
Day 1
Day 
7 +2
At-home monitoring 
with Panoramic 
(non-dominant wrist 
only) Bracelet 
devices
X
→
→
→
→
→
→
→
→
→
→
→
→
→
→
X
Device exposure-
(At-Home 
GENEActiv
provisioning, non-
dominant wrist only)
X
At-home monitoring 
with GENEActiv 
devices
→
→
→
→
→
→
→
→
X
Activity and Sleep 
diary
X
→
→
→
→
→
→
→
→
→
→
→
→
→
X
Exit phone interviewj
X
Device exposure –
(At-Home devices
collection)k
X
Device assessmentk
X
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
X
Adverse event 
monitoringl
X
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
→
X
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Procedure/ 
Assessment 
In-Lab
At-home monitoring
Final 
study 
evaluation 
Return of 
Study 
Materials
Screenin
g
Visit 
1
Day 
1 
Day 
2
Day 
3
Day 
4
Day 
5
Day 
6
Visit 
2
Day 
8
Day 
9
Day 
10
Day 
11
Day 
12
Day 
13
Day 
14
Day 
15
Day 15 
(+3 days)
> Day 15
Day 1
Day 1
Day 
7 +2
a.
Medical/Surgical history, prior/concomitant treatment will be recorded by a medically qualified individual.
b.
Leg length is measured by the clinician utilizing a flexible tape measure with the participant in supine position. The leg length will be measured from the 
Anterior Superior Iliac Spine (ASIS) to the Medial Malleoli (MM) on the right side. The measurements will be recorded in the CRF. 1
c.
APDM Opal sensors placed on left wrist, right wrist, chest, lumbar, above left foot, right foot. 
d.
Panoramic Bracelet device placed on non-dominant wrist and lumbar region, serial numbers of device to be collected on CRF for every participant.
e.
Natural speed is participant’s self-chosen pace.
f.
Varied speeds include participant’s self-chosen slow pace (“Walk slow”) and fast pace (“Walk fast”).
g.
Participant will alternate between activities’ stations. Participants will do ~7 minutes of activities, ~5 minutes of break and ~7 minutes of activities. The task 
stations include 2 sitting activities, 2 standing activities, and 2 walking activities. Order of stations will be determined at random using dice roll.
h.
Phone call visit to complete Comfort and Wearability Questionnaire for Panoramic Bracelet and advise participant to don the GENEActiv
i.
The participant will be asked to perform an approximately 10 minute walk outside of the lab.
j.
The study staff will instruct the participants to mail back both devices at the final study evaluation over the phone at the exit interview.
k.
Any event with a device (issues with devices, loss of the devices, etc.), the impact of this event and the action taken with device will be recorded in a device 
assessment CRF. 
l.
Adverse events (AEs) will be queried at the clinic visit and during the exit phone interview using open-ended and nonleading verbal questioning of the 
participant. Any spontaneously reported AEs noted during the home visits will be captured during the exit phone interview.
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RATIONALE AND BACKGROUND
This is not a post-authorization safety study (PASS) and is not a commitment or requirement 
to any regulatory authority.
Assessing the appropriate levels of physical activity is a challenge in healthcare currently. 
Physical inactivity is linked to 10% of premature mortality and is the fourth leading cause of 
death globally.2 The benefit of physical activity in children is well defined: obesity 
prevention,3,4 reduction of cardiovascular risk factors,5,6 normal growth and development,7,8
depression prevention,9 reduction in risk of chronic diseases, health-related quality of life.10
The American guideline recommends 60 minutes per day of moderate-to-vigorous physical 
activity.11 However, there is a lack of standardized measures of gait and physical activity,
and more accurate measures are needed.
There is a significant growth and interest in wearable accelerometry devices that can measure 
various gait and activity metrics. The ActiGraph device has been investigated in several 
studies involving children age from 2 to 18.12-18 Despite this growing interest, only a few 
studies have focused their objective on assessing the feasibility of implementing these types 
of devices.19,20 Also, little is known about how children and parents accept the devices and 
perceive their usability and comfort.21
The rationale for this study is to compare gait quality metrics collected using the ActiGraph
devices, APDM devices and GAITRite® walkway, during in-lab sessions (in the PfIRe Lab). 
APDM and GAITRite® walkway are used as reference comparators. GAITRite® is a 
pressure-sensitive walkway, which records gait metrics. APDM is a set of 6 devices that 
collect gait metrics. Both devices are used during in-lab assessments, but the deployment of 
these devices at home is impractical and not feasible. Hence the needed validation study of
the ActiGraph device to measure for gait metrics continuously in a home environment. 
In addition to the ActiGraph device studied in Cohort A, Cohort B of the study aims to 
evaluate the feasabilty of the Panoramic Bracelet and associated algorithms such as SleepPy 
and GaitPy compared to the GENEActiv device and to evaluate the comfort and wearability
of the Panoramic Bracelet. The results of this study will enable the use of novel devices in 
future clinical trials measuring scratch and sleep.
This study will generate compliance data and recruitment data to derisk future clinical 
protocols, and potentially enable the use of wearable devices in pediatric research studies.
Device data from this study can be used for sample size estimates in future digital studies 
involving pediatric populations.
The study will include an in-person session at the PfIRe Lab, located on the Pfizer Kendall 
Square campus at 610 Main Street, Cambridge, MA 02139, as well as an approximately 
2 week at-home monitoring period. The PfIRe Lab is a clinical research facility designed to 
evaluate and validate novel technologies for potential use in clinical trials. In the PfIRe Lab, 
a multidisciplinary team of clinicians and researchers utilize state-of-the-art motion capture 
technologies, coupled with environmental and wearable sensors to develop new 
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patient-centric clinical trial endpoints, enabling measures of physical function and activity 
outside of the traditional hospital and clinical settings. To help mitigate risk in vulnerable 
populations, conducting studies to develop the set-up of anticipated laboratory procedures in 
qualified pediatric participants is necessary.
The risks to study participants are minimal and further outlined in sections below. There is no 
direct benefit to study participants.
RESEARCH QUESTION AND OBJECTIVES
Cohort A: This study aims to compare gait quality metrics collected using the ActiGraph
devices, APDM devices and GAITRite® walkway, during in-lab sessions.
The primary, secondary and tertiary/exploratory objectives for this study and their respective 
endpoints are listed below.
COHORT A: ActiGraph Device
Primary Objective(s):
Primary Endpoint(s):

To compare gait quality metrics 
collected using ActiGraph
devices, APDM devices and 
GAITRite® walkway, during in-
lab sessions.

Gait metrics defined in the Annex 2 (eg, gait 
speed, stride length) measured by APDM 
devices, GAITRite® walkway and ActiGraph
devices (extracted with GaitPy algorithm).
Secondary Objective(s):
Secondary Endpoint(s):

To assess the feasibility of 
recruiting pediatric participants to 
conduct a wearable device study.

Total number of participants contacted for the 
study. Recruitment data listed by age group: 
number of participants screened and enrolled 
over time, time to enroll approximately 13 
participants per group.

To assess the ability of pediatric 
participants to perform a battery 
of lab-based tasks.

Number of participants (overall and per age 
group) able to perform each of the 7 tasks and 
task-completion percentage (among total of 
7 tasks) per participant.

To assess the compliance in 
wearing the ActiGraph devices at 
home.

Number of hours per day wearing the device 
and number of days with more than 10 hours 
of wearing time for each participant.

To evaluate the participant’s or 
caregiver’s perception of 
wearability and comfort of 
ActiGraph and APDM devices 
during in-lab sessions.

In-lab ActiGraph/APDM wearability/comfort 
questionnaire responses from Visit 1 (Day 1).
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
To evaluate the participant’s or 
caregiver’s perception of 
wearability and comfort of 
ActiGraph devices during the 
at-home monitoring period.

At-home ActiGraph wearability/comfort 
questionnaire responses from at-home 
monitoring period in the Final Study 
Evaluation (Day 15 + 3 days).

To evaluate the effect of floor 
surface (carpet vs tile) on gait 
metrics collected using ActiGraph
and APDM devices.

Gait metrics defined in the Annex 2 (eg, gait 
speed, stride length) measured by ActiGraph
and APDM devices across different floor 
surfaces.
Tertiary/Exploratory Objective(s):
Tertiary/Exploratory Endpoint(s):

To investigate the feasibility of 
using a daily activity diary to 
provide context in pediatric 
physical activity data collected by 
ActiGraph devices at home in 
pediatric participants.

Daily activity diary responses and metrics 
related to physical activity endpoints from 
ActiGraph (eg, sedentary time as defined in 
Annex 3).

To compare gait speed collected 
using the SIMI system and 
GAITRite® walkway, during 
in-lab sessions.

Gait speed defined in the Annex 2 measured 
by SIMI system and GAITRite® walkway.
COHORT B: Panoramic Bracelet Device
Cohort B of the study aims to evaluate the feasabilty of the Panoramic Bracelet device and 
associated algorithms compared to the GENEActiv device and to evaluate the comfort and 
wearabilty of the Panoramic Bracelet device.
The primary, secondary and tertiary/exploratory objectives for Cohort B of study and their 
respective endpoints are listed below.
Primary Objective(s):
Primary Endpoint(s):

Evaluate the Panoramic Bracelet 
device and associated algorithms in 
the quantification of physical 
activity (eg sleep), scratch, and 
wear time, as compared to another 
accelerometry device (GENEActiv) 
during the at-home period.

Sleep and scratch endpoints, and wear time 
compliance (~ days 8-15)

To evaluate the participant’s or 
caregiver’s perception of 
wearability and comfort of 

At-home Panoramic Bracelet device 
wearability/comfort questionnaire responses 
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Panoramic Bracelet device during 
the at home monitoring period
from at-home monitoring period (this is Day 
7+2, only 1 wrist).
Secondary Objective(s):
Secondary Endpoint(s):

To assess the compliance in 
wearing the Panoramic Bracelet 
device at home.

Number of hours per day wearing the device 
(only Panoramic Bracelet Days 1-7)

To compare gait quality metrics 
collected using Panoramic Bracelet 
devices, APDM devices and 
GAITRite® walkway, during in-lab 
sessions.

Gait metrics defined in the Annex 2 (eg, gait 
speed, stride length) measured by APDM 
devices, GAITRite® walkway and Panaromic
Bracelet devices (extracted with GaitPy 
algorithm).
Tertiary/Exploratory Objective(s):
Tertiary/Exploratory Endpoint(s):

To evaluate the participant’s or 
caregiver’s perception of 
wearability and comfort of 
Panoramic Bracelet device in-lab 
sessions.

In-lab Panoramic Bracelet wearability/comfort 
questionnaire responses from Visit 1 (Day 1)
(wrist and lumbar)

To evaluate the effect of floor 
surface (carpet vs tile) on gait 
metrics collected using Panoramic 
Bracelet and APDM devices.

Gait metrics defined in the Annex 2 (eg, gait 
speed, stride length) measured by Panoramic 
Bracelet and APDM devices across different 
floor surfaces.
RESEARCH METHODS
Study Design
This is a non-randomized, single site, low-interventional study to compare gait and activity
quality metrics collected using wearable devices, APDM devices and GAITRite® walkway, 
during in-lab sessions (in the PfIRe Lab). There will be approximately 39 participants in 
Cohort A and 39 participants in Cohort B divided equally into 3 independent age groups 
based on the schematic detailed below:

Group 1: 3 years to 5 years old inclusive 

Group 2: 6 years to 11 years old inclusive

Group 3: 12 years to 17 years old inclusive
Participant’s assignment to a group will be determined by the age at the time the informed 
consent is signed. Participants will be recruited into age groups in parallel. Recruitment will 
stop in a group when there are at least 13 completers in that group. Participants who drop out 
for reasons other than safety before completion of the study may be replaced.
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The study is composed of:
1. A visit at the PfIRe Lab (Visit 1, Day 1), during which participant eligibility will be 
confirmed, consent and assent will be obtained. Participants will perform in-lab gait and 
activities monitoring procedures (see Table 1 below). During all these activities, participants 
will wear or interact with the following devices:
a.
Wearable devices (ActiGraph for Cohort A), (Panoramic Bracelet device and 
GENEActiv for Cohort B)
b. GAITRite® Electronic Walkway
c.
Ambulatory Parkinson’s Disease Monitoring System (APDM);
d. Camera based SIMI system
GAITRite® walkway, APDM will be used as reference comparators for the in-lab portion of 
the protocol. For Cohort B of the protocol the aim is to use GENEActiv as a comparator 
device to Panoramic Bracelet during the at-home collection period. The in-lab gait and 
activity monitoring will be video recorded from multiple angles with multiple cameras
(camera-basedSIMI system) , this will be used to provide contextual information of each 
portion of the tasks and procedures that may be used by the reviewer when analyzing and 
interpreting the sensor data. As a tertiary/exploratory objective, gait speed recorded by the 
SIMI system against the gait speed collected by GAITRite® walkway may be validated.
Table 1.
In-lab Assessments
Assessments
Objectives
Location
Walking on 
GAITRite® walkway 
(20 feet x 3) at 
participant’s natural 
speed and at various 
speed 

Compare gait metrics collected between 
devices and APDM devices.

Compare gait metrics collected between 
devices and GAITRite® walkway.

Compare gait speed collected between
SIMI system and GAITRite® walkway.
GAITRite®
walkway
Walking on tile and 
carpet at participant’s
natural speed

Compare gait metrics collected between 
devices and APDM devices.
Tile and Carpet
Moving naturally 
between activities’ 
stations

Compare gait metrics between devices 
and APDM devices, collected during the 
walk between the activities’ stations and 
during the sit/stand position at the 
stations.
Walking pathway 
between activities’ 
stations
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Table 1.
In-lab Assessments
Assessments
Objectives
Location
Free 10 minute walk
(Cohort B)

Compare gait metrics between devices 
and APDM devices, collected during the 
walk
10 minute walk 
outside the lab
1. At-home monitoring for approximately 2 weeks (from Day 1 to Day 15 + 3 days) 
during which participants will wear the devices under study. Complete a daily activity 
diary on Day 2 to Day 15 (Only Cohort A). Complete activity and sleep diary for 
Cohort B on Day 2 to day 15.
2. Cohort B Only: At-home monitoring day 7+2 Wearability/comfort questionnaire
(Annex 5) for Panoramic Bracelet device and instruct participant to start wearing the
GENEActiv device from Day 7 to end of study. Daily activity and sleep diary.
(Annex 8)
3. For Cohort A Only: A telephone follow-up interview at the end of the 2 weeks at-
home monitoring period (Day 15 + 3 days) with administration of the 
Wearability/comfort questionnaire (Annex 5). For Cohort B follow up call to remind 
participants to take off devices and mail back. In addition to an end of study phone 
call for Cohort B. 
For a detailed description of the study activities, see Section 6 Schedule of Activities.
Inclusion Criteria
Participants must meet all of the following inclusion criteria to be eligible for inclusion in the 
study:
1. Evidence of a personally signed and dated informed consent document indicating that 
the participant and/or a parent/legally acceptable representative (LAR) has been 
informed of all pertinent aspects of the study. When there are 2 LAR, consent should 
be obtained from both of the child’s LAR if present when the informed consent 
document is signed. When the participant is an emancipated minor with proven 
documentation present for review, consent should be obtained from the participant 
only.
2. Evidence of a personally signed and dated assent, indicating that the participant
understands the nature of all pertinent aspects of the study, and is willing to 
participate in the study activities, if applicable, as consistent with the participant’s age 
and ability to provide assent (verbal assent for children 3 to 5 years old, written assent 
for children 6 to 17 years old).
3. The participant (to degree appropriate for age) and parent/legally acceptable 
representative are able to understand, are willing and able to comply with protocol 
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requirements, scheduled visits, and other study procedures, and are likely to complete 
the study as planned. 
4. Qualified male or female participants aged 3 to 17 years old inclusive. Qualified is 
defined as no significant health problems that would impair the completion of the 
physical activity tasks, does not carry any diagnosis of developmental delay and/or 
significant co-morbid medical conditions as determined by a medically qualified 
individual during medical history review with LAR and participant.
5. Children who are ambulatory.
Exclusion Criteria
Participants meeting any of the following criteria will not be included in the study:
1. Participation in other studies involving digital devices within 1 week and/or treatment 
with an investigational drug (Phases 1-4) within 30 days or 5 half-lives before the 
current study begins and/or during study participation. If the participant was enrolled 
in a trial with both digital devices and investigational drug, whichever time period is 
longest for exclusion (5 half-lives or 1 week) will be used.
2. Participants with implanted medical devices.
3. Minor participants who reach the age of majority during the study, as recognized 
under local law.
4. Participants whose parents/LAR are investigational site staff members directly 
involved in the conduct of the study and their immediate family members, site staff 
members otherwise supervised by the investigator.
5. Participants who self-report any medical condition (including pregnancy) and/or 
medication use, or in the investigator’s opinion, any medical or psychiatric condition, 
and/or use of medications such as but not limited to antipsychotics, hallucinogens, 
amphetamines, barbiturates, etc, that may affect the safety of the participant and may 
interfere with the conduct of the study.
6. Other medical or psychiatric condition that may increase the risk of study 
participation or, in the investigator’s judgment, make the participant inappropriate for 
the study.
7. Participants with known allergies to components as specified by device manufacturer 
if applicable (eg, plastic, stainless steel and silicone).
Variables
The study will enroll pediatric qualified participants at a single center in Cambridge, MA. 
Potential confounding variables including age, gender and race will be assessed at the start of 
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study procedures and be adjusted for as necessary in the statistical analysis, as noted in the 
Statistical Analysis Plan (SAP) and DATA ANALYSIS Section.
The following variables will be measured for each age group:

Gait metrics defined in Annex 2 (eg, gait speed, stride length) measured by APDM 
devices and GAITRite® walkway, device under study, SIMI system and GENEActiv
(for Cohort B only)

Measures of the recruitment: number of participants contacted, screened and enrolled
over time, time to enroll approximately 13 participants per group, mean number of 
participants recruited per month (overall and per group).

Measures of the ability to perform a battery of lab-based tasks: number of participants 
(overall and per age group) able to perform each of the 8 tasks and task-completion 
percentage (among total of 8 tasks) per participant.

Measures of the compliance in wearing device under study at-home: number of hours 
per day wearing the device and number of days (>10 hours per day) wearing the 
device for each participant.

Measures of the perception of wearability/comfort of the device under study and 
APDM (Cohort A only) devices: wearability/comfort questionnaires answers.

Daily activity diary answers. (Only Cohort A)

Daily activity and sleep diary answers Only Cohort B)

Physical activity endpoints from devices under study (eg, sedentary time, sleep as 
defined in Annex 3)

Measures of the effect of floor surface: gait metrics defined in the Annex 2 (eg, gait 
speed, stride length) measured by device under study and APDM devices across 
different floor surfaces.
Data Sources
Data sources will include:

Case report forms.

Patient reported outcomes (PRO) from the activity diary (Only Cohort A) and the 
wearability/comfort questionnaires. Activity and sleep diary for Cohort B.

Non-CRF data generated by devices under study for in-lab visit and at-home 
monitoring, APDM devices, GAITRite® walkway, video from camera-based SIMI
system).
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For every device that is used in the study, all information pertaining to the hardware 
(eg, device name, manufacturer, device version) and software (eg, operating system) being 
worn or monitoring the participants will be recorded and reported.
ActiGraphCentrepoint Insight Watch:
The Bluetooth LE 5 smart CentrePoint Insight Watch features ActiGraph’s 3 axis 
accelerometer and data filtering technology and features a Liquid Crystal Display window 
that displays the date and time, device wireless mode, and battery status. It is a Food and 
Drug Administration cleared Class II device 510(k) Number: K181077. The Intended Use 
Statement for the CentrePoint Insight Watch does not identify a particular medical condition. 
Rather it states: “The ActiGraph CentrePoint Insight Watch is a small worn activity monitor 
designed for documenting physical movement associated with applications in physiological 
monitoring. The device is intended to monitor the activity associated with movement during 
sleep. The Insight Watch can be used to analyze circadian rhythms and assess activity in any 
instance where quantifiable analysis of physical motion is desirable.”
Panoramic Bracelet:
The Panoramic Digital Health Bracelet is a wearable inertial measurement unit “intended for 
use by researchers and healthcare professionals for high frequency or continuous collection 
of physical data in home and professional healthcare settings during research studies.” It 
includes a 3 axis accelerometer and gyroscope, as well as magnetometer, pressure, and 
temperature sensors, all of which can be configured to collect data or not. Sampling rates can 
be set from 12-52 Hz depending on the sensor. The Bracelet has no interface or screen for 
participants to interact with. Additionally, “beacons” or “tags” can be optionally placed in 
strategic locations to monitor when participants are near these beacons. The beacons interact 
with the Panoramic Bracelet via a Bluetooth Low Energy (BLE) antenna and can provide 
information as to when the Bracelet is in proximity with the beacon.
GENEActiv:
The Activinsights GENEActiv device is a wearable inertial measurement unit “designed for 
public health research and clinical trials.” The device is a circular unit with attachable wrist-
bands and has no interface or screen for participants to interact with. The GENEActiv device 
is FDA 510(k) exempt. The device can record acceleration data between 10-100 Hz and 
depending on configuration can collect data remotely for up to 1 month.
GAITRite® Electronic Walkway:
The GAITRite® Electronic Walkway has at its core a grid of pressure sensors (48 sensors by 
480 sensors placed on 0.5 inch /1.27 cm, in the 20 ft version used in this study) and has 
accompanying interface and software to automate measuring temporal (timing) and spatial 
(distance) gait parameters (temporal/spatial). In essence, when the participant walks over the 
walkway, their sequential footprints (and any associated contacts to the walkway, ie, ground) 
activates the sensors and the spatiotemporal patterns of these contacts are recorded and 
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analyzed to generate a multitude of gait parameters. The GAITRite® walkway system is 
widely used as a reference comparator gait measurement device by research and clinical 
community. Also, it has been used previously in pediatric studies.22,23
APDM Mobility Lab Sensor Monitoring:
The APDM, Inc. “Mobility Lab” system is comprised of 6 body-worn sensors, each 
recording accelerometry, angular velocity, and magnetic field orientation (magnetometry). 
Data will be sampled at 128 Hz throughout the performance of each activity described in the
schedule of activities (SoA). Data from each modality are synchronized between sensors with 
± 1 millisecond of error. Sensors will be applied to the sternum, the small of the back 
(lumbar region), both wrists and both feet in accordance with APDM’s operating 
instructions.
Video from Camera-based SIMI system:
Video will be recorded from multiple synchronized cameras at multiple angles (eg, 8 angles).
STUDY PROCEDURES
Recruitment
Recruitment may be done via paper and electronic flyers, internet postings 
(eg, ClinicalTrials.gov), advertising on public transportation and community centers, 
advertisement in general pediatric clinics, and via mailed post cards. Internal recruitment at 
Pfizer sites in Cambridge, MA, may use electronic communications and announcements. No 
children whose parents/LAR are an immediate family member of the study team (or any 
supervised member of the study team) will be a participant of the study.
All advertising methods will be approved by an Institutional Review Board (IRB). The 
communication will include sufficient information including a brief description of the study 
detailing the methodologies used.
Initial Contact
Potential participants’ parent(s)/LAR interested in their child participating in the study will 
be put in contact with a member of the study team who will provide the eligibility criteria 
and pre-screening questionnaire by phone or in person. After receiving the information, the 
participant/respondent can determine if they would like to join the study. If interested, they 
will be scheduled for a visit.
Prescreening
Participants will be prescreened between Day -14 and Day 0.
Screening and Enrollment
Participants will be screened at Day 1. The investigator or a medically qualified individual
designated by the investigator will explain the study to the participant and the participant’s 
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parent(s)/LAR. The investigator must ensure that each participant and participant’s 
parent(s)/LAR is fully informed about the nature and objectives of the trial and possible risks 
associated with participation. If the participant’s parent(s)/LAR desires the participant to 
participate in the study and the participant wishes to participate in the study, an 
IRB-approved informed consent form will be signed and dated by the participant’s
parent(s)/LAR and a verbal or written assent from the participant will be collected (if 
applicable, as consistent with the participant’s age and ability to provide assent), as required 
by the IRB. The informed consent and assent forms must be agreed by Pfizer and the IRB 
and must be in compliance with the International Council for Harmonisation (ICH) Good 
Clinical Practice (GCP), local regulatory requirements, and legal requirements.
The signed documents will be retained at the site, and the investigator or person designated 
by the investigator must document in the source documents that informed consent and assent 
were obtained.
The participant will be assigned a participant identifier after informed consent and assent are 
obtained.
Visit 1 (Day 1)
After informed consent and assent have been obtained, the following assessments will be 
performed during the study visit:
1. Collect participant demography and parent(s)/LAR’s contact information.
2. Obtain medical and surgical history.
3. Review prior and concomitant treatments.
4. Confirm eligibility for the study based on inclusion/exclusion criteria.
5. Record height, leg length, and weight.
6. Handedness questionnaire: Edinburgh Handedness Inventory (EHI)-short form
(Annex 4).
7. Place device under study and APDM devices on participant.
8. Walk on a GAITRite® walkway at participant’s natural speed (3 rounds = ~20 feet
x 3) and at varied speeds while wearing device under study and APDM system.
Natural speed is participant’s self-chosen pace and varied speeds includes 
participant’s self-chosen slow pace (“Walk slow”) for 3 rounds and fast pace (“Walk 
fast”) for 3 rounds.
9. Walk on tile and carpet (3 rounds on each surface) at participant’s natural speed while 
wearing device under study and APDM system.
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10. Move naturally (sit/stand/walk) through a random path created by dice roll in the 
PfIRe Lab (between activities’ stations) while wearing device under study and APDM
system as well as recorded with video/motion capture cameras. Participants will 
perform age-related activities using 6 activity stations for ~20 minutes (defined as 
follows: ~7 minutes of activities, ~5 minutes of break and ~7 minutes of activities). 
The task stations include 2 sitting activities (such as look through a book, 
draw/write), 2 standing activities (such as turn a switch or hang a coat), 2 walking 
activities (such as move blocks/objects, toss a beanbag and pick it up).
11. Free 10 minute walk outside the lab (Cohort B Only)
12. Wearability/Comfort questionnaire (Annex 5) followed by a Cognitive Debrief of the 
questionnaire. 
13. Instruct participant and parent(s)/LAR on use of device under study and activity diary 
(Cohort A only) and activity and sleep diary (Cohort B only) at home.
14. Monitor for AEs.
A medically qualified individual is responsible for reviewing the inclusion/exclusion criteria, 
medical/surgical history, prior/concomitant treatments and for the review of the systems.
For the assessments 8, 9 and 10, every participant will have up to 3 attempts.
The in-lab gait and activity monitoring will be video recorded from multiple angles with 
multiple cameras (camera-based SIMI system). This will be used to provide gait speed and 
contextual information of each portion of the tasks and procedures that may be used by the 
reviewer when analyzing and interpreting the sensor data. Time segments of sensor data from 
each modality will be identified based on these annotations.
The locations of the device under study and the APDM system on the participant’s body are 
defined on Figure 1.
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Figure 1.
Wearable Sensor Device Locations on Participant In-lab Cohort A and B
Legend:

Blue circle – APDM Opal sensors to be worn on each wrist, chest, lumbar, and 
above each shoe.

Orange triangle – Device under study to be worn on nondominant wrist and 
lumbar.
All in-lab assessments will be performed at the PfIRe lab with site personnel and will take 
approximately 2 hours.
Any event with a device, the impact of this event and the action taken with device will be 
recorded in a device assessment CRF during Visit 1.
At-home Monitoring (Day 1 to Day 15+3 days)
The participant will wear device under study (on the non-dominant wrist) for at least 2 weeks
with some flexibility on the end date for scheduling the follow-up phone interview. They will 
be asked to wear the wrist device continuously. For the lumbar device (Cohort A only), they 
will be instructed to put on the device when they get up in the morning and remove when 
they go to sleep at night or nap during the daytime.
For Cohort B the participant will wear the Panoramic Bracelet device for approximately one 
week on the non-dominant wrist and at approximately Day 7 they will start wearing the 
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GENEActiv device on the same wrist until end of study. Both devices (Panoramic Bracelet 
and GENEActiv) will be worn at the same time. The position of the GENEActiv device and 
the Panoramic Bracelet device closeness to the wrist will be balanced per age group. 
Approximately half the participants in each age group will wear the Panoramic Bracelet 
device proximal to the wrist and the GENEactiv device more distal to the wrist and vice 
versa See Figure 2.  A phone interview for the Wearability/Comfort questionnaire will be 
conducted at approximately Day 7.
The at-home monitoring will be performed outside the PfIRe lab without video monitoring or 
direct observation by site personnel.
The participant will complete an activity diary at home daily between Day 2 and Day 15
(Cohort A only).
For Cohort B the participant will complete an activity and sleep diary between Day 2 and 
Day 15
Any event with a device (issues with devices, loss of the devices, etc), the impact of this 
event and the action taken with device will be recorded anytime between Day 1 and 
Day 15+3 days in a device assessment CRF.
Figure 2.
Wearable Sensor Device Locations on Participant At-home
COHORT 
NAME
DEVICE(S) 
[LOCATION OF 
DEVICE on 
body]
DESCRIPTION OF 
DEVICE(S) 
DEVICE(S) XSENSORS 
CONFIGURATION ON 
BODY
HOME 
MONITORING
A
Lumbar and 
non-dominant 
wrist
ActiGraph 
CentrePoint 
Insight Watch
Yes ~15days
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COHORT 
NAME
DEVICE(S) 
[LOCATION OF 
DEVICE on 
body]
DESCRIPTION OF 
DEVICE(S) 
DEVICE(S) XSENSORS 
CONFIGURATION ON 
BODY
HOME 
MONITORING
B
Non-dominant 
wrist
Panoramic 
Wearable 
Bracelet
Yes ~15 days
B
Non-dominant 
wrist
GENEActiv
Watch
Yes ~ Day 7 to 15
Cohort B: The position of the GENEactiv device and the Panoramic Bracelet device 
[closeness to the wrist] will be balanced per age group. Approximately half the participants 
in each age group will wear the Panoramic Bracelet device proximal to the wrist and the 
GENEActiv device more distal to the wrist and vice versa.
Follow-up Phone Interview (Day 15+3 days)
The follow-up visit will be conducted as a phone interview at the end of the 2 week at-home 
monitoring period (Day 15+3 days to allow for flexibility in scheduling) to record any AEs,
any issues with devices and to remind participants to send back the devices. The participant 
will also answer a Wearability/comfort questionnaire (Annex 5) (Cohort A only) during the 
follow-up phone interview. This phone interview will be scheduled during Visit 1. The study 
site staff should make at least 2 attempts to contact the participant’s legal representative by 
phone. All attempts should be documented. The devices will be sent back to Pfizer in a 
prepaid envelope (envelope given to the participant during Visit 1).
Any event with the devices (both reference and under study), the impact of this event, and the 
action taken with device will be recorded in the device assessment CRF.
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Lost-to-follow-up
Lost-to-follow-up is defined by the inability to reach the participant’s parent(s)/LAR after a 
minimum of 2 documented attempts (eg phone calls, e-mails). All attempts should be 
documented.
If a participant is lost-to-follow-up, the investigators will attempt to contact the participant’s 
parent(s)/LAR to ask that the participant return the devices. If the participant’s 
parent(s)/LAR cannot be contacted or refuses to return the devices, a report will be filed in 
the trial master file (TMF)/Clinical Study Report (CSR) to account for the loss of the device.
ASSESSMENTS
Additional Research
Not applicable.
Assessment of Suicidal Ideation and Behavior 
Not applicable.
Biological Samples 
Not applicable.
Imaging Assessments
Not applicable.
Rater Qualifications
Not applicable.
Medical/Surgical History, Prior/Concomitant Treatments
The medical/surgical history, prior/concomitant treatments will be collected by a medically 
qualified individual and recorded in several CRFs.
Body Weight and Height
Body weight (kg), height (cm) and leg length (cm) will be measured at the screening visit
(Day 1) and recorded. All measurements should be taken with the participant wearing only 
light indoor clothing and without shoes.
Handedness Questionnaire
The Edinburgh Handedness Inventory (EHI)-short form (Annex 4) will be asked by a study 
staff member and answered by the participant or participant’s parent(s)/LAR. This 
questionnaire which assesses the handedness propensity of an individual (writing score, 
throwing score, toothbrush score, spoon score, total laterality quotient score) helps inform the 
best location for wrist device placement, and interpret sensor data. For participants 
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scoring -1 to -100, the non-dominant wrist will be considered the right wrist. For participants 
scoring 0 to 100, the non-dominant wrist will be considered the left wrist. 
Patient Reported Outcome
All patient reported outcomes (PRO) are completed by the study participant or the study 
participant’s parent(s)/LAR at home, or in the lab, following a schedule of assessments as per 
the SoA and the Table 2.
Table 2.
Patient Reported Outcome
PRO
Frequency
Location
Number of Questions
Wearability/comfort 
questionnaire 
(Annex 5)
Conducted at Visit 1 
(Day 1).
At the PfIRe Lab
10
Cohort A: Conducted 
at the Final Study 
Evaluation (Day 15+3 
days).
Cohort B: Conducted 
at Day 7+2
At home
Cognitive debrief of 
wearability/comfort 
questionnaire
(Annex 7)
Conducted at Visit 1 
(Day 1).
At the PfIRe Lab
6
Activity diary
(Annex 6) Cohort A
ONLY
Conducted once daily 
during the at-home 
monitoring period 
(Day 2 to Day 15).
At home
2
Activity and Sleep 
diary Cohort B
(Annex 8)
Conducted once daily 
during the at-home 
monitoring period 
(Day 2 to Day 15).
At home
2
All the PROs should be completed by the participant’s parent(s)/LAR if the participant is 
3 years old to 11 years old. If the participant is 12 years old or older, the participant can fill 
the PROs.
The wearability/comfort questionnaire and the cognitive debrief of the wearability/comfort 
questionnaire are electronic questionnaires.
For the activity diary and the wearability/comfort questionnaire, participant or participant’s 
parent(s)/LAR will have the choice between a paper version or an electronic version.
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If the electronic version is chosen, the activity diary will be sent by email starting Day 2 and 
ending Day 15 and there will be a window of several hours to fill it each day.
Performance of In-lab Tasks
The performance of the following assessments in lab will be recorded in a CRF at Visit 1
(Day 1):

To walk on a GAITRite® walkway at participant’s natural speed.

To walk on a GAITRite® walkway at varied speed (slow pace).

To walk on a GAITRite® walkway at varied speed (fast pace).

To walk on tile.

To walk on carpet.

To walk naturally between activities’ stations first time.

To walk naturally between activities’ stations second time.

Free walking condition outside lab for cohort B only.

Each participant will have up to 3 attempts for each task. If the participant attempts 
the task, the performance should be recorded under column titled “Successfully 
perform task?” with options of “Yes”, “No”, or “Not Done”.
Devices Assessment and Exposure
Cohort A: APDM opal devices will be worn during Visit 1 only on both wrists, both feet, 
lumbar, and waist. Device under study (ActiGraph) will be worn during visit 1 and also 
during the at-home monitoring portion between Day 1 and Day 15+3 days on the non-
dominant wrist and waist.
Cohort B: APDM opal devices will be worn during Visit 1 only on both wrists, both feet, 
chest, and waist. Device under study (Panoramic Bracelet) will be worn during visit 1[wrist 
and lumbar] and also during the at-home monitoring portion between Day 1 and Day 15+3 
days on the non-dominant wrist. GENEActiv device will be worn on the same non-dominant 
wrist from Day 7+2 until the end of study [Day 15+2] approximately for 7 days 
consecutively. 
Any event with a device (issues with devices, loss of the devices, etc), the impact of this 
event and the action taken with device will be recorded anytime between Day 1 and 
Day 15+3 days in a device assessment CRF.
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DATA ANALYSIS/STATISTICAL METHODS
Study Size
The proposed sample size for this study is approximately 39 participants in each cohort
(approximately 13 in each age group). To the best of our knowledge, no relevant data has 
been published before to validate accelerometry-measured gait metrics against GAITRite®
walkway or APDM in pediatric population. Using data from X9001198 study (healthy adult 
participants, ages 18-40 and 65-85 years), the Intraclass Correlation Coefficient (ICC)
between gait speed obtained from the sensor data vs gait speed obtained from the reference 
comparator gait mat was 0.72 (when corrected for a systematic bias of 0.17 m/s). The ICC 
value for the null hypothesis is derived by using the median value of the lower bound of ICC 
for all gait metrics (8 spatial and temporal metrics). ICCnull was 0.27, range = [0, 0.66]. In 
order to reach ICC value of 0.72 with ICCnull value of 0.27 using a one-tailed test with alpha
= 0.05 and power = 0.8 it is estimated that at least 17 participants will be needed. Therefore, 
approximately 20 adult participants (anticipating 15% attrition) are required for the 
validation analyses. Here, we double the amount to roughly 40 participants to account for 
potential higher variance in the healthy pediatric participants (ages 3 – 17). Since we have 
3 age groups, each group will equally have 13 participants, which results in a total of 
39 participants. 
The proposed sample size is appropriate for assessing the association of other metrics, such 
as sleep, across devices in Cohort B. Using data from previous study (NCT03898427, healthy 
participants 18 years and older), data from 21 participants wearing ActiGraph and 
GENEActiv on their wrists simultaneously. The ICC value of total sleep time obtained from
ActiGraph and GENEActiv devices averaged across both arms at Visit 1 was 0.88. The ICC 
value for null hypothesis was computed by randomly breaking the participant pairings 1000 
times and computing the 95th percentile of the ICC values of these randomly assigned pairs 
(ICCnull was 0.36). In order to reach ICC value of 0.88 with ICCnull value of 0.36 using a one-
tailed test with alpha = 0.05 and power = 0.8 it is estimated that at least 8 participants (10 
participants to be recruited, anticipating 15% attrition, per age group, total 30 participants) 
will be needed. Therefore, we will have appropriate power (more than 95%) to be able to 
assess metrics per age group such as total sleep time between devices in Cohort B. In Cohort 
B, considering higher variability in pediatric population and to be able to provide consistent
gait comparison analysis across cohorts, we will recruit the same number of participants as in 
Cohort A.
It is anticipated that the proposed sample size will achieve the following goals: (1) assess the 
agreement of gait metrics from ActiGraph and Panoramic Bracelet against reference 
comparators; (2) provide data on usability, wearability and comfort of ActiGraph and 
Panoramic Bracelet for future clinical trials, and (3) assess the agreement of other metrics 
such as related to sleep and scratch from Panoramic Bracelet against comparators. The data 
obtained in this study will enable power calculations for future pediatric studies.
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Data Management 
Gait metrics (eg, gait speed, stride length, etc.) will be extracted from GAITRite® walkway, 
APDM, and the devices under study (using GaitPy algorithm). Physical activity metrics will 
be extracted from the device under study (using devices provided software), for Cohort B
GENEActiv data will be included.
In addition, participant’s medical history, medication history and demographics, height, and 
weight will be collected as potential confounding variables.
Study data are collected, processed and available for timely clinical and scientific review, 
periodic regulatory reporting, and other ad hoc analysis. The study data are protected from 
unauthorized access and change.
Sensitive Personal Information is preserved in the investigator site file for scientific, safety, 
and/or regulatory reasons, to re-identify certain health data.
Case Report Forms/Data Collection Tools (DCT)/Electronic Data Record
As used in this protocol, the term CRF/DCT should be understood to refer to either a paper 
form or an electronic data record or both, depending on the data collection method used in 
this study.
In collaboration with the relevant study staff members, available/applicable standard data 
modules are selected for the CRF/DCTs. If the appropriate data module is not available, at 
the discretion of study data manager and principal investigator, a local standard can be 
created instead.
A CRF/DCT is required and should be completed for each included participant. The 
completed original CRFs/DCTs are the sole property of Pfizer and should not be made 
available in any form to third parties, except for authorized representatives of Pfizer or 
appropriate regulatory authorities, without written permission from Pfizer. The investigator 
shall ensure that the CRFs/DCTs are securely stored at the study site in encrypted electronic 
and/or paper form and will be password protected or secured in a locked room to prevent 
access by unauthorized third parties.
The Investigator has ultimate responsibility for the collection and reporting of all clinical, 
safety, and laboratory data entered on the CRFs/DCTs and any other data collection forms 
(source documents) and ensuring that they are accurate, authentic/original, attributable, 
complete, consistent, legible, timely (contemporaneous), enduring, and available when 
required. The CRFs/DCTs must be signed by the investigator or by an authorized staff 
member to attest that the data contained on the CRFs/DCTs are true. Any corrections to 
entries made in the CRFs/DCTs or source documents must be dated, initialed, and explained 
(if necessary) and should not obscure the original entry.
In some cases, the source documents are the hospital or the physician’s chart. In these cases, 
data collected on the CRFs/DCTs must match those charts.
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In most cases, the CRF/DCT may also serve as the source document. In these cases, a 
document should be available at the investigator site and at Pfizer that clearly identifies those 
data that will be recorded on the CRF/DCT, and for which the CRF/DCT will stand as the 
source document.
Record Retention
To enable evaluations and/or inspections/audits from regulatory authorities or Pfizer, the 
investigator agrees to keep records, including the identity of all participants (sufficient 
information to link records, eg, CRFs/DCTs and hospital records), all original signed 
informed consent/assent documents, copies of all CRFs/DCTs, safety reporting forms, source 
documents, detailed records of treatment disposition, and adequate documentation of relevant 
correspondence (eg, letters, meeting minutes, and telephone call reports). The records should 
be retained by the investigator according to the International Council for Harmonisation 
(ICH) guidelines or according to local regulations, whichever is longer. The investigator 
must ensure that the records continue to be stored securely for so long as they are retained.
If the investigator becomes unable for any reason to continue to retain study records for the 
required period (eg, retirement, relocation), the study records must be transferred to another 
investigator.
Investigator records must be kept for a minimum of 2 years after completion or 
discontinuation of the study or for longer if required by applicable local regulations. 
The investigator must obtain Pfizers written permission before disposing of any records, even 
if retention requirements have been met.
Data Analysis 
Detailed methodology for summary and statistical analyses of data collected in this study will 
be documented in a Statistical Analysis Plan (SAP), which will be dated, filed and 
maintained by the sponsor. The SAP may modify the plans outlined in the protocol; any 
major modifications of primary endpoint definitions or their analyses would be reflected in a 
protocol amendment.
Statistical Analysis
Below are examples of analyses that will be performed to address the study objectives:
COHORT A:
Primary Objectives
1. To compare gait quality metrics collected using ActiGraph devices, APDM devices
and GAITRite® walkway, during in-lab sessions.
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Raw accelerometry data collected by ActiGraph devices will be processed by the GaitPy24
algorithm to generate gait quality metrics (eg, gait speed, stride length etc.). GaitPy is an 
open-source Python package that implements several published algorithms in a modular 
framework for extracting features of gait from a single accelerometer device mounted on the 
lumbar. The package has been developed to make it easy for researchers to derive measures 
of gait from raw accelerometer data. GaitPy includes 2 key algorithms for processing raw 
accelerometer data to derive gait features. The first algorithm is used for detecting bouts of 
gait from continuous accelerometer data collected under free-living conditions and the 
second algorithm derives temporal and spatial features of gait from pre-identified bouts of 
gait. This second GaitPy algorithm will be used to process data and extract gait features 
collected during in-lab sessions.
During the in-lab walking tasks, gait metrics extracted from GaitPy will be compared to 
those that are extracted from GAITRite® walkway and APDM. During the natural walk 
between activities stations, gait metrics from GaitPy will be compared to APDM. Accuracy 
of the sensor-derived metrics will be determined by computing the mean absolute percent 
error between the sensor-derived and reference standard metrics and assess the bias using 
Bland-Altman plots and 95% limits of agreement. The agreement between sensor-derived 
and reference standard metrics will be assessed using ICC and its 95% lower and upper 
confidence limits.
Secondary Objectives
1. To assess the feasibility of recruiting pediatric participants to conduct a wearable 
device study.
Total number of participants contacted will be collected. Recruitment data for number 
of participants screened and enrolled will be summarized (frequency and percentage) 
overall and by age group. Time to enroll approximately 13 participants per group will 
be recorded. Number of participants recruited per month will be summarized overall 
and by age group.
2. To assess the ability of pediatric participants to perform a battery of lab-based tasks.
Number of participants able to perform each of the 7 tasks will be recorded and 
summarized overall and by age group. Task-completion percentage (among total of 
7 tasks) per participant will be calculated and summarized overall and by age groups.
3. To assess the compliance in wearing the ActiGraph devices at home.
Number of hours per day wearing the device and number of days with more than 
10 hours of wearing for each participant will be recorded. Summary statistics will be 
provided for both endpoints for all participants and by age groups. 
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4. To evaluate the participant’s or caregiver’s perception of wearability and comfort of 
ActiGraph and APDM devices during in-lab sessions.
The wearability/comfort questionnaire for the in-lab session will be summarized by 
frequency and percentages. The study will further compare participant reported
wearability and comfort from the exit questionnaire amongst locations (wrist and 
lumbar) using Wilcoxon signed rank test.
5. To evaluate the participant’s or caregiver’s perception of wearability and comfort of 
ActiGraph devices during the at-home monitoring period.
The wearability/comfort questionnaire during the at home period (Day 15+3 days) 
will be summarized by frequency and percentages. This study will compare responses 
from each of questionnaire amongst locations (wrist and lumbar) using Wilcoxon 
signed rank test. 
6. To evaluate the effect of floor surface (carpet vs tile) on gait metrics collected using 
ActiGraph and APDM devices.
This study will quantify differences between sensor-derived gait quality metrics (from 
ActiGraph and APDM) collected on different floor surfaces using paired tests (t-test 
or Wilcoxon signed ranks test depending on normality of the data).
Tertiary/Exploratory objectives
1. To investigate the feasibility of using a daily activity diary to provide context in pediatric 
physical activity data collected by ActiGraph devices at home in pediatric participants.Mixed 
effects model with repeated measurement, ie, MMRM will be utilized to examine the 
association between ActiGraph measured activity metrics and participants’ responses from 
the daily activity diaries across the whole at-home monitoring period.
2. To compare gait speed collected using the SIMI system and GAITRite® walkway, during 
in-lab sessions.
Accuracy of the measurements of gait speed will be determined by computing the mean 
absolute percent error between SIMI system and GAITRite® walkway and assess the 
bias using Bland-Altman plots and 95% limits of agreement. The agreement between SIMI 
system and GAITRite® walkway will be assed using ICC and its lower and upper limits.
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COHORT B:
Primary Objectives
1. Evaluate the Panoramic Bracelet device and associated algorithms in the 
quantification of physical activity (eg sleep), scratch, and wear time, as compared to 
another accelerometry device (GENEActiv) during the at-home period.

Raw accelerometry data collected by Panoramic Bracelet and GENEActiv will be 
processed by the SleepPy25 followed by ScratchPy26 algorithms to generate endpoints related 
to sleep and nocturnal scratching (eg, total sleep time, total scratch duration, etc) SleepPy is a 
combination of three previously published heuristic algorithms27,28,29, augmented for their 
integrated use, for detecting a subject’s total sleep opportunity (TSO) window and computing 
sleep metrics within that window. ScratchPy is a machine learning based algorithm that relies 
on SleepPy for context detection, extracts periods of movement from the TSO window, and 
then classifies those periods as either restless behaviors during sleep or scratch. The resulting 
predictions are then aggregated into endpoints summarizing the subject’s scratch behaviors.
During the at home period (~ days 8-15), common endpoints related to wear time, sleep, and 
scratching will be compared between Panoramic Bracelet and GENEActiv (reference). 
Accuracy of the sensor-derived metrics will be determined by computing the mean absolute 
percent error between the comparator and reference metrics and assess the bias using 
Bland-Altman plots and 95% limits of agreement. The agreement between metrics will be 
assessed using ICC and its 95% lower and upper confidence limits. 
2. To evaluate the participant’s or caregiver’s perception of wearability and comfort of 
Panoramic Bracelet device during the at home monitoring period
The wearability/comfort questionnaire during the at home period (Day 7+2) will be 
summarized by frequency and percentages.
Secondary Objectives
To assess the compliance in wearing the Panoramic Bracelet device at home.
Wear time of the Panoramic Bracelet device during the at home period (~ Days 1-7) will be 
summarized.
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To compare gait quality metrics collected using Panoramic Bracelet devices, APDM 
devices and GAITRite® walkway, during in-lab sessions.
Raw accelerometry data collected by Panoramic Bracelet devices will be processed by the
GaitPy algorithm to generate gait quality metrics (eg, gait speed, stride length etc). GaitPy24
is an open-source Python package that implements several published algorithms in a modular 
framework for extracting features of gait from a single accelerometer device mounted on the 
lumbar. The package has been developed to make it easy for researchers to derive measures 
of gait from raw accelerometer data. GaitPy includes 2 key algorithms for processing raw 
accelerometer data to derive gait features. The first algorithm is used for detecting bouts of 
gait from continuous accelerometer data collected under free-living conditions and the 
second algorithm derives temporal and spatial features of gait from pre-identified bouts of 
gait. This second GaitPy algorithm will be used to process data and extract gait features 
collected during in-lab sessions.
During the in-lab walking tasks, gait metrics extracted from GaitPy will be compared to 
those that are extracted from GAITRite® walkway and APDM. During the natural walk 
between activities stations, gait metrics from GaitPy will be compared to APDM. Accuracy 
of the sensor-derived metrics will be determined by computing the mean absolute percent 
error between the sensor-derived and reference standard metrics and assess the bias using 
Bland-Altman plots and 95% limits of agreement. The agreement between sensor-derived 
and reference standard metrics will be assed using ICC and its 95% lower and upper 
confidence limits. 
Tertiary/Exploratory Objectives:
1.
To evaluate the participant’s or caregiver’s perception of wearability and comfort of 
Panoramic Bracelet device in-lab sessions.
The wearability/comfort questionnaire for the in-lab session will be summarized by 
frequency and percentages. 
2. To evaluate the effect of floor surface (carpet vs tile) on gait metrics collected using 
Panoramic Bracelet and APDM devices.
We will quantify differences between sensor-derived gait quality metrics (from Panoramic 
Bracelet and APDM) collected on different floor surfaces using paired tests (t-test or 
Wilcoxon signed ranks test depending on normality of the data).
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QUALITY CONTROL AND QUALITY ASSURANCE
Pfizer or its agent will conduct periodic monitoring visits during study conduct to ensure that 
the protocol, Good Clinical Practices (GCPs), and/or Good Pharmacoepidemiology Practices 
(GPPs), as relevant, are being followed. The monitors may review source documents to 
confirm that the data recorded on CRFs/DCTs are accurate. The investigator and institution 
will allow Pfizer monitors/auditors or its agents and appropriate regulatory authorities direct 
access to source documents to perform this verification. This verification may also occur 
after study completion.
During study conduct and/or after study completion, the investigator site may be subject to 
review by the Institutional Review Board/Ethics Committee (IRB/EC), and/or to quality 
assurance audits performed by Pfizer, or companies working with or on behalf of Pfizer, 
and/or to inspection by appropriate regulatory authorities.
The investigator(s) will notify Pfizer or its agents immediately of any regulatory inspection 
notification in relation to the study. Furthermore, the investigator will cooperate with Pfizer 
or its agents to prepare the investigator site for the inspection and will allow Pfizer or its 
agent, whenever feasible, to be present during the inspection. The investigator site and 
investigator will promptly resolve any discrepancies that are identified between the study 
data and the participant’s medical records. The investigator will promptly provide copies of 
the inspection findings to Pfizer or its agent. Before response submission to the regulatory 
authorities, the investigator will provide Pfizer or its agents with an opportunity to review 
and comment on responses to any such findings.
It is important that the investigator(s) and their relevant personnel are available during the
monitoring visits and possible audits, or inspections and that sufficient time is devoted to the 
process.
LIMITATIONS OF THE RESEARCH METHODS
There are several limitations to this protocol. The first one is a selection bias given the study 
will take place at a single site in Cambridge, MA. The compensation for the participants can 
also be a recruitment bias. The period of the study (holidays or school year) can impact the 
recruitment as well. During the at-home monitoring period, we need to consider the poor 
compliance of wearing the devices and the improper use of the sensors. Participants will not 
receive feedback from the sensors regarding gait and physical activity. The absence of 
feedback can influence the activity of the participants. The lack of blinding of participants 
and investigators may lead to observer bias.
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PROTECTION OF HUMAN SUBJECTS
Patient Information and Consent
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of patient personal data. Such 
measures will include omitting patient names or other directly identifiable data on any 
sponsor forms, reports, publications, or in any other disclosures, except where required by 
applicable laws.
The personal data will be stored at the study site in encrypted electronic and/or paper form 
and will be password protected or secured in a locked room to ensure that only authorized 
study staff have access. The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster. In the event of a potential personal data breach, the study site shall be responsible 
for determining whether a personal data breach has in fact occurred and, if so, providing 
breach notifications as required by law.
To protect the rights and freedoms of natural persons with regard to the processing of 
personal data, when study data are compiled for transfer to Pfizer and other authorized 
parties, participant names will be removed and will be replaced by a single, specific 
numerical code, based on a numbering system defined by Pfizer. All other identifiable data 
transferred to Pfizer or other authorized parties will be identified by this single, participant-
specific code. The investigator site will maintain a confidential list of participants who 
participated in the study, linking each participant’s numerical code to his or her actual 
identity. In case of data transfer, Pfizer will maintain high standards of confidentiality and 
protection of participant’s personal data consistent with applicable privacy laws.
The informed consent/assent documents and any participant recruitment materials must be in 
compliance with ICH GCP, local regulatory requirements, and legal requirements, including 
applicable privacy laws.
The informed consent/assent documents used during the informed consent process and any 
participant recruitment materials must be reviewed and approved by Pfizer, approved by the 
IRB/EC before use, and available for inspection.
The investigator must ensure that each study participant, or his or her legally acceptable 
representative, or parent(s) or legal guardian if a minor, is fully informed about the nature 
and objectives of the study, the sharing of data relating to the study and possible risks 
associated with participation, including the risks associated with the processing of the 
participant’s personal data. The investigator further must ensure that each study participant,
or his or her legally acceptable representative, or parent(s) or legal guardian if a minor, is 
fully informed about his or her right to access and correct his or her personal data and to 
withdraw consent for the processing of his or her personal data.
Whenever consent is obtained from a participant’s legally acceptable representative/parent(s)
or legal guardian the participant’s assent (affirmative agreement) must subsequently be 
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obtained when the participant has the capacity to provide assent, as determined by the 
IRB/EC. If the investigator determines that a participant’s decisional capacity is so limited 
that he or she cannot reasonably be consulted, then, as permitted by the IRB/EC and 
consistent with local regulatory and legal requirements, the participant’s assent may be 
waived with source documentation of the reason assent was not obtained. If the study 
participant does not provide his or her own consent, the source documents must record why 
the participant did not provide consent (eg, minor), how the investigator determined that the 
person signing the consent was the participant’s legally acceptable representative, the consent 
signer’s relationship to the study participant (eg, parent, spouse), and that the participant’s 
assent was obtained or waived. If assent is obtained verbally, it must be documented in the 
source documents.
The identity of the participant’s legally acceptable representative (LAR) and the 
participant-LAR relationship should be documented in some manner, for example, a parent’s
identification card and insurance card listing the child. Birth records or legal documents are 
not necessarily required unless it is the investigator’s normal practice, or an investigator feels 
a parent-child relationship is questionable. Older siblings and other relatives cannot provide 
consent, even though they may be a child’s primary caregiver, unless they have been 
appointed the child’s LAR.
If the enrollment of emancipated minors is permitted by the study age criteria, the IRB/EC, 
and local law, they must provide documentation of legal status to give consent without the 
permission of a parent or legal guardian.
The investigator, or a person designated by the investigator, will obtain written informed 
consent from each participant (or the participant’s legally acceptable representative, 
parent(s), or legal guardian and the participant’s assent, when applicable,) before any 
study-specific activity is performed (unless a waiver of informed consent has been granted by 
an IRB/EC). The investigator will retain the original of each participant’s signed 
consent/assent document.
The investigator, or a person designated by the investigator, will obtain oral or written assent 
from each participant (oral assent for participant 3 to 5 years old, written assent for 
participants 6 to 17 years old) indicating that the participant understands the nature of all 
pertinent aspects of the study, and is willing to participate in the study activities.
Age- and maturity- appropriate study information must be given to all the participants.
Participant Withdrawal
Participants may withdraw from the study at any time at their own request, or they may be 
withdrawn at any time at the discretion of the investigator or sponsor for safety, behavioral, 
or administrative reasons. In any circumstance, every effort should be made to document 
participant outcome, if applicable. The investigator should inquire about the reason for 
withdrawal and follow-up with the participant regarding any unresolved adverse events.
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If the participant withdraws from the study, and also withdraws consent for disclosure of 
future information, no further evaluations should be performed, and no additional data should 
be collected. The sponsor may retain and continue to use any data collected before such 
withdrawal of consent.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
It is the responsibility of the investigator to have prospective approval of the study protocol, 
protocol amendments, informed consent(/assent) documents, and other relevant documents, 
eg, recruitment advertisements, if applicable, from the IRB/IEC. All correspondence with the 
IRB/IEC should be retained in the investigator file. Copies of IRB/IEC approvals should be 
forwarded to Pfizer.
The only circumstance in which an amendment may be initiated prior to IRB/IEC approval is 
where the change is necessary to eliminate apparent immediate hazards to the participants. In 
that event, the investigator must notify the IRB/IEC and Pfizer in writing immediately after 
the implementation.
Ethical Conduct of the Study
The study will be conducted in accordance with the protocol, legal and regulatory 
requirements, and the general principles set forth in the International Ethical Guidelines for 
Biomedical Research Involving Human Subjects (Council for International Organizations of 
Medical Sciences 2002), ICH Guideline for Good Clinical Practice, and the Declaration of 
Helsinki.
MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS
Single Reference Safety Document
There is no Pfizer product in this study and thus no single reference safety document. 
For ActiGraph devices, the CentrePoint Insight Watch manual v1.0.1 will serve as a safety 
document during the course of the study.
For APDM devices and GAITRite® walkway, the Mobility Lab by APDM user guide 
version 2 and the GAITRite® manual v487 will serve as a safety document during the course 
of the study.
For Panoramic Bracelet device, the study start quick user guide v1.1 will serve as a safety 
document during the course of the study.
For GENEActiv device, the Activinsights GENEActiv instructions for use, will serve as a 
safety document during the course of the study.
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Requirements
This study includes qualifying monitoring procedures required per protocol to collect clinical 
data needed to meet the study objectives, which are not standard-of-care but that do not pose 
more than a minimal risk or burden to the study participant. The qualifying procedures in this 
study are: Gait and activity measures from devices under study, APDM devices and
GAITRite® walkway and, gait speed and video from camera-based SIMI system.
Qualifying Diagnostic or Monitoring 
Procedure(s)
Recording Time Period
Gait measures from GAITRite® walkway
Until 12 hours after the end of the in-lab 
study visit
Gait and activity measures from APDM 
devices
Until 12 hours after the end of the in-lab 
study visit
Video recording and gait speed from SIMI
system
Until 12 hours after the end of the in-lab 
study visit
ActiGraph, Panoramic Bracelet and 
GENEActiv devices
Until the end of the study [End of study call 
on day 15+3]
Adverse Events (AE)
An AE is defined as any untoward medical occurrence and can therefore be any unfavorable 
and unintended sign (including an abnormal laboratory finding), symptom, or disease, 
whether or not related to the participant’s participation in the study.
Any AE that occurs from the time the participant consents to the clinical research 
through and including 12 hours after completion of the qualifying procedure must be 
recorded. The investigator is required to assess whether the AE may be related to the 
participant’s participation in the study. All AEs (ie, serious and non-serious, including those 
attributed to qualifying procedure identified as research-related injury) are collected in the 
clinical study database.
The investigator must pursue and obtain information adequate to determine the outcome of 
the AE and to assess whether it meets the criteria for classification as a research-related 
injury requiring immediate notification to Pfizer as described below.
Research-Related Injury
Should a participant, in the investigator’s opinion, suffer a medically important research-
related injury caused by their participation in the study, the designated Pfizer clinician or 
medical monitor must be notified immediately.
A medically important research-related injury is any untoward medical occurrence that:

Results in death;
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
Is life threatening (immediate risk of death);

Requires inpatient hospitalization or prolongation of existing hospitalization;

Results in persistent or significant disability/incapacity (substantial disruption of the 
ability to conduct normal life functions);

Results in congenital anomaly/birth defect.
Medical and scientific judgment is exercised in determining whether an injury is an 
important medical event. An important medical event may not be immediately life
threatening and/or result in death or hospitalization. However, if it is determined that the 
event may jeopardize the participant or may require intervention to prevent one of the other 
outcomes listed in the definition above, the important medical event should be reported as a 
research-related injury.
An investigator may be requested by the designated Pfizer clinician or medical monitor to 
obtain specific additional follow up information in an expedited fashion. In general, this will 
include a description of the injury in sufficient detail to allow for a complete medical 
assessment of the case and independent determination of possible causality. Information on 
other possible causes of the event, such as concomitant treatments, vaccines, and/or illnesses 
must be provided. In the case of a participant death, a summary of available autopsy findings 
must be submitted as soon as possible to Pfizer or its designated representative.
PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS
Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the investigational 
product, Pfizer should be informed immediately.
In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study participants against any immediate hazard, and 
of any serious breaches of this protocol or of ICH GCP that the investigator becomes aware 
of.
Publications by Investigators
The investigator will provide any publication to Pfizer at least 30 days before it is submitted 
for publication or otherwise disclosed. If any patent action is required to protect intellectual 
property rights, the investigator agrees to delay the disclosure for a period not to exceed an 
additional 60 days.
The investigator will, on request, remove any previously undisclosed confidential 
information before disclosure, except for any study- or Pfizer product-related information 
necessary to the appropriate scientific presentation or understanding of the study results.
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For all publications relating to the study, the institution will comply with recognized ethical 
standards concerning publications and authorship, including Section II “Ethical 
Considerations in the Conduct and Reporting of Research” of the Uniform Requirements for 
Manuscripts Submitted to Biomedical Journals, http://www.icmje.org/index.html#authorship, 
established by the International Committee of Medical Journal Editors.
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REFERENCES
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Winter’s Pediatric Orthopedics. Philadelphia, PA: Lippincott Williams & Wilkins; 
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Kohl HW, Craig CL, Lambert EV, et al: Lancet Physical Activity Series Working 
Group The pandemic of physical inactivity: global action for public health. Lancet. 
380:294-305, 2012.
3.
Reilly JJ, Kelly L, Montgomery C, et al: Physical activity to prevent obesity in young 
children: cluster randomised controlled trial. BMJ. 333:1041, 2006.
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Nyberg G, Sundblom E, Norman Å et al: Effectiveness of a universal parental support 
programme to promote healthy dietary habits and physical activity and to prevent 
overweight and obesity in 6-year-old children: the Healthy School Start Study, a cluster-
randomised controlled trial. PLoS One. 10(2), 2015.
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Janssen I, Leblanc AG: Systematic review of the health benefits of physical activity and 
fitness in school-aged children and youth. Int J Behav Nutr Phys Act. 7:40, 2010.
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Voss C, Harris KC: Physical activity evaluation in children with congenital heart 
disease. Heart. 103(18):1408-1412, 2017.
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Bidzan-Bluma I, Lipowska M: Physical Activity and Cognitive Functioning of 
Children: A Systematic Review. Int J Environ Res Public Health. 15(4), 2018.
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Álvarez-Bueno C, Pesce C, Cavero-Redondo I, et al: The Effect of Physical Activity 
Interventions on Children's Cognition and Metacognition: A Systematic Review and 
Meta-Analysis. J Am Acad Child Adolesc Psychiatry. 56(9):729-738, 2017.
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Korczak DJ, Madigan S, Colasanto M: Children's Physical Activity and Depression: A 
Meta-analysis. Pediatrics. 139(4), 2017.
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Marker AM., Steele RG., Noser AE: Physical activity and health-related quality of life 
in children and adolescents: A systematic review and meta-analysis. Health Psychol. 
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Piercy KL, Troiano RP, Ballard RM et al: The Physical Activity Guidelines for 
Americans. JAMA. 320(19):2020-2028, 2018.
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Costa S, Barber SE, Cameron N, et al: Calibration and validation of the ActiGraph
GT3X+ in 2-3 year olds. J Sci Med Sport. 17(6):617-22, 2014.
13.
Child Heart and Health Study in England (CHASE). Access date: April 01, 2020
http://www.chasestudy.ac.uk/.
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14.
Owen CG, Nightingale CM, Rudnicka AR, et al: Travel to school and physical activity 
levels in 9-10 year-old UK children of different ethnic origin; Child Heart and Health 
Study in England (CHASE). PLoS One. 7:e30932, 2012.
15.
Corder K, van Sluijs EM, Wright A, et al: Is it possible to assess free-living physical 
activity and energy expenditure in young people by self-report? Am.J.Clin.Nutr.
89:862-70, 2009.
16.
Charlotte A. Pratt, Josephine Boyington, Layla Esposito et al: Childhood Obesity 
Prevention and Treatment Research (COPTR): Interventions Addressing Multiple 
Influences in Childhood and Adolescent Obesity. Contemp Clin Trials. 36(2): 406–413, 
2013.
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Identification and Prevention of Dietary- and Lifestyle-induced Health Effects in Infants 
and Children Study (IDEFICS) Access date: April 01, 2020
http://www.ideficsstudy.eu/home.html.
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Buck C, Eiben G, Lauria F et al: Urban Moveability and physical activity in children:
longitudinal results from the IDEFICS and I.Family cohort. Int J Behav Nutr Phys Act. 
16(1):128, 2019.
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Vaughn J, Gollarahalli S, Shaw RJ, et al: Mobile Health Technology for Pediatric 
Symptom Monitoring: A Feasibility Study. Nurs Res. 2020.
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Vaughn J, Summers-Goeckerman E, Shaw RJ et al: A Protocol to Assess Feasibility, 
Acceptability, and Usability of Mobile Technology for Symptom Management in 
Pediatric Transplant Patients. Nurs Res. 68(4):317-323, 2019.
21.
Mackintosh KA, Chappel SE, Salmon J et al: Parental Perspectives of a Wearable 
Activity Tracker for Children Younger Than 13 Years: Acceptability and Usability 
Study. JMIR Mhealth Uhealth. 7(11), 2019.
22.
Hedge N, Zhang T, Uswatte G et al: The Pediatric SmartShoe: Wearable Sensor System 
for Ambulatory Monitoring of Physical Activity and Gait. IEEE Trans Neural Syst 
Rehabil Eng. 26(2):477-486, 2018.
23.
Möhring W, Klupp S, Grob A: Effects of dual tasking and methylphenidate on gait in 
children with attention deficit hyperactivity disorder. Hum Mov Sci. 62:48-57, 2018.
24.
Czech M, Patel S: GaitPy: An Open-Source Python Package for Gait Analysis Using an 
Accelerometer on the Lower Back. Journal of Open Source Software. 4(43)1778, 2019.
25.
Christakis et al., (2019). SleepPy: A python package for sleep analysis from 
accelerometer data. Journal of Open Source Software, 4(44), 1663.
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26.
Mahadevan, N., Christakis, Y., Di, J., Bruno, J., Zhang, Y., Dorsey, E.R., Pigeon, W.R., 
Beck, L.A., Thomas, K., Liu, Y. and Wicker, M., 2021. Development of digital 
measures for nighttime scratch and sleep using wrist-worn wearable devices. NPJ 
Digital Medicine, 4(1), p.42.
27.
van Hees, V.T., Sabia, S., Jones, S.E., Wood, A.R., Anderson, K.N., Kivimäki, M., 
Frayling, T.M., Pack, A.I., Bucan, M., Trenell, M.I. and Mazzotti, D.R., 2018. 
Estimating sleep parameters using an accelerometer without sleep diary. Scientific 
reports, 8(1), p.12975.
28.
Cole, Roger J., Daniel F. Kripke, William Gruen, Daniel J. Mullaney, and J. Christian 
Gillin. "Automatic sleep/wake identification from wrist activity." Sleep 15, no. 5 
(1992): 461-469. 
29.
Bai, Jiawei, Chongzhi Di, Luo Xiao, Kelly R. Evenson, Andrea Z. LaCroix, Ciprian M. 
Crainiceanu, and David M. Buchner. "An activity index for raw accelerometry data and 
its comparison with other activity metrics." PloS one 11, no. 8 (2016): e0160644.
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LIST OF TABLES
Table 1.
In-lab Assessments ...................................................................................37
Table 2.
Patient Reported Outcome........................................................................49
LIST OF FIGURES
Figure 1.
Wearable Sensor Device Locations on Participant In-lab Cohort A 
and B.........................................................................................................45
Figure 2.
Wearable Sensor Device Locations on Participant At-home ...................46
Figure 2.
Wearable Sensor Device Locations on Participant At-home
ANNEX 1. LIST OF STAND ALONE DOCUMENTS
None.
ANNEX 2. LIST OF GAIT METRICS ENDPOINTS
APDM

Cadence (steps/min)

Double support (sec)

Gait cycle duration (sec)

Gait speed (meters/sec)

Initial double support (sec)

Single limb support (sec)

Stance time (sec)

Step duration (sec)

Stride length (meters)

Swing time (sec)

Terminal double support (sec)

Steps
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GAITRite®

Single support time (sec)

Double support time (sec)

Stance time (sec)

Step length (meters)

Step time (sec)

Step velocity (gait speed) (meters/sec)

Stride length (meters)

Stride time (sec)

Swing time (sec)

Steps (steps)

Cadence (steps/min)
GaitPy

Steps (steps)

Stride duration (sec)

Step duration (sec)

Cadence (meters/min)

Initial double support (sec) 

Terminal double support (sec)

Double support (sec)

Single limb support (sec)

Stance time (sec)

Swing time (sec)

Step length (meters) 
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
Stride length (meters)

Gait speed (meters/sec)
SIMI system

Gait speed (meters/sec)
ANNEX 3. LIST OF PHYSICAL ACTIVITY METRICS ENDPOINTS
ActiGraph

Sedentary time (min)

Sedentary percentage (%)

Light time (min)

Light percentage (%)

Life-style time (min)

Life-style percentage (%)

Moderate-to-Vigorous Physical Activity (MVPA) time (min)

MVPA percentage (%)

Total daily activity counts (on each axis, and vector magnitude of 3 axes)

Total daily calories (calories)
Pfizer Wear Algorithm (GENEActiv, Panoramic Bracelet)

Number of available hours (h)

Number of hours of wear (h)

Number of wear hours while awake (h)
Pfizer Sleep Algorithm (SleepPy - GENEActiv, Panoramic Bracelet)

Time in Bed (min)

Percent time asleep (%)

Number of wake bouts (no.)
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
Sleep onset latency (min)

Wake after sleep onset (min)
Pfizer Scratch Algorithm (ScratchPy - GENEActiv, Panoramic Bracelet)

Total scratch duration (min.)

Total scratch episodes (no.)
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ANNEX 4. EDINBURGH HANDEDNESS INVENTORY – SHORT FORM
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ANNEX 5. WEARABILITY/COMFORT QUESTIONNAIRE
Instructions: If the child is 3 years old to 11 years old, the parent or caregiver (legal 
representative) should answer the questions. If the child is 12 years old or older, the child 
can answer the questions.
Below the word device refers to [insert name of device].
Please select the option below to show how much you agree or disagree with each of the 
sentences. Each list of questions is specific to one device and its location, eg, a device on 
your left wrist. The device you are being asked about is listed above.
Select only ONE response.
Strongly 
Disagree
Disagree
Neutral
Agree
Strongly 
Agree
The device is comfortable 
to wear
The device is easy to put on
The device is easy to take 
off
The device is easy to wear
The device changes the way 
I move
The device changes the way 
I behave
I am willing to wear the 
device for 4 to 7 days
I am willing to wear the 
device for more than 7 days
If the device could follow 
my progress during a 
treatment, I would wear it
If the device could follow 
my progress during a 
treatment, I would want my 
doctor to have access to my 
results
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ANNEX 6. ACTIVITY DIARY
ANNEX 7. COGNITIVE DEBRIEF OF WEARABILITY/COMFORT
QUESTIONNAIRE
Instructions: If the child is 3 years old to 11 years old, the parent or caregiver (legal 
representative) should answer the questions. If the child is 12 years old or older, the child 
can answer the questions.
1. Approximately how long did it take you to complete the wearability questionnaire? 
(___minutes).
2. Did you find any of the questions confusing? Yes or No, if Yes, please explain:
3. Did you find any words confusing? Yes or No, if Yes, please list:
4. Do you have suggestions for rewording any questions to make it more clear to you 
what is being asked? Yes or No, if Yes, please explain:
5. Do you have any other feedback on the questionnaire for us? Yes or No, if Yes, 
please explain further:
6. Is there anything else that you think would be important to ask?
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ANNEX 8. ACTIVITY AND SLEEP DIARY
APPENDIX 1: COHORT LISTING AT HOME MONITORING
COHORT 
NAME
DEVICE(S) 
[LOCATION 
OF DEVICE 
ON BODY]
DESCRIPTION 
OF DEVICE(S) 
DEVICE(S) SENSORS 
CONFIGURATION ON 
BODY
HOME 
MONITORING
ENDPOINTS
A
Lumbar and 
non-
dominant
wrist
ActiGraph 
CentrePoint 
Insight Watch0
Yes ~14 days
At-home 
physical 
activity 
related 
endpoints 
(wrist)
At-home gait 
and sit-to-
stand related 
endpoints 
(lumbar)
B
Non-
dominant 
wrist
Panoramic 
Wearable 
Bracelet
Yes ~14 days
At-home 
activity 
related 
endpoints 
090177e19d2ca190\Approved\Approved On: 12-Apr-2023 20:13 (GMT)

X9001263 LOW-INTERVENTIONAL STUDY PROTOCOL
Final Protocol Amendment 1, 10 April 2023
PFIZER CONFIDENTIAL
CT45-GSOP-RF15 2.0 Low-Interventional Study Protocol Template 05-Dec-2019 
Page 76 of 76
COHORT 
NAME
DEVICE(S) 
[LOCATION 
OF DEVICE 
ON BODY]
DESCRIPTION 
OF DEVICE(S) 
DEVICE(S) SENSORS 
CONFIGURATION ON 
BODY
HOME 
MONITORING
ENDPOINTS
B
Non-
dominant 
wrist
GENEActiv 
Watch
Yes ~ Day 7 to 
14
At-home 
activity 
related 
endpoints 
090177e19d2ca190\Approved\Approved On: 12-Apr-2023 20:13 (GMT)

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090177e19d2ca190\Approved\Approved On: 12-Apr-2023 20:13 (GMT)
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