Monitoring Activity And Gait In Children (MAGIC)

Low-Interventional Study to Record Gait and Physical Activity Using ActiGraph Devices in Children Ages 3-17.

COHORT A: To study whether a digital health tool called Actigraph can be used to collect information on gait and physical activity in healthy children aged 3-17. The study will be conducted at the Pfizer Innovation Research Laboratory (PfIRe Lab) in Cambridge MA. In the lab at the first visit, we will ask participants to do activities such as walking on different surfaces as well as to roll a dice and move between different activity stations. Children will wear 2 Actigraph devices, one as a watch and one as a belt. They will then go home and do usual daily activities while answering a brief daily activity diary for approximately 2 weeks. The conclusion of the study will be over the telephone and include questions on the comfort and wearability of the device. The analysis of gait and physical activity as well as adherence and wearability will be looked across three different age groups 3-5, 6-11, and 12-17.

COHORT B: Cohort B of the study aims to evaluate the feasibility 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. . In the lab at the first visit, we will ask participants to do activities such as walking on different surfaces as well as to roll a dice and move between different activity stations. They will then go home and do usual daily activities while wearing both devices in the same wrist at different times stipulated in the protocol, answering a brief daily activity and sleep diary for approximately 2 weeks. Cohort B includes questions on the comfort and wearability of the Panoramic device on Day 7 approximately. The conclusion of the study will be over the telephone.The analysis will be looked across three different age groups 3-5, 6-11, and 12-17

Study Overview

• Status: Completed
• Conditions: Adolescent; Child; Child, Preschool
• Intervention / Treatment: Device: COHORT A: Actigraph; Device: Panoramic Bracelet and GENEActiv

• Study Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02139
      • Pfizer Innovation Research, PfIRe, Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy children and adolescents aged 3-17.

Description

Inclusion Criteria:

• Ambulatory
• 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

Exclusion Criteria:

• 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.
• Participants with implanted medical devices.
• Minor participants who reach the age of majority during the study, as recognized under local law.
• Any 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.
• Participants with known allergies to components as specified by device manufacturer if applicable (eg, plastic, stainless steel and silicone).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ages 3-5; COHORT A and B	Device: COHORT A: Actigraph; The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.; Device: Panoramic Bracelet and GENEActiv; 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. The bracelet has no interface or screen for participants to interact with. GENEActiv: The 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 records acceleration data and can collect data remotely for up to 1 month.
Ages 6-11; COHORT A and B	Device: COHORT A: Actigraph; The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.; Device: Panoramic Bracelet and GENEActiv; 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. The bracelet has no interface or screen for participants to interact with. GENEActiv: The 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 records acceleration data and can collect data remotely for up to 1 month.
Ages 12-17; COHORT A and B	Device: COHORT A: Actigraph; The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.; Device: Panoramic Bracelet and GENEActiv; 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. The bracelet has no interface or screen for participants to interact with. GENEActiv: The 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 records acceleration data and can collect data remotely for up to 1 month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks	Gait speed was the time taken to walk a specified distance. Participants had to walk on GAITRite walkway (20 feet*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks	Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had to walk on GAITRite walkway (20 feet*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks	Single support time referred to the time when only one limb was in contact with the ground. Participants had to walk on GAITRite walkway (20 feet*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometery data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks	Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had to walk on GAITRite walkway (20 feet*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks	Swing time was defined as the time during which the foot was not in contact with the ground. Participants had to walk on GAITRite walkway (20 feet*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks	Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had to walk on GAITRite walkway (20 feet*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).	Up to 20 minutes of Day 1
Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks	Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had a single in-laboratory visit on Day 1 during which they performed gait monitoring procedures. Participants had to walk on GAITRite walkway (20 feet*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks	Cadence referred to the number of steps taken per minute during gait cycle. Participants had to walk on GAITRite walkway (20 feet*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks	Stride duration refers to the duration between successive heel contacts of the same foot. Participants had to walk on GAITRite walkway (20 feet*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities	Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities [activity block 1], approximately 5 minutes of break and approximately 7 minutes of activities [activity block 2]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities	Single support time referred to the time when only one limb was in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities [activity block 1], approximately 5 minutes of break and approximately 7 minutes of activities [activity block 2]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities	Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities [activity block 1], approximately 5 minutes of break and approximately 7 minutes of activities [activity block 2]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities	Swing duration was defined as the time during which the foot was not in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities [activity block 1], approximately 5 minutes of break and approximately 7 minutes of activities [activity block 2]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities	Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities [activity block 1], approximately 5 minutes of break and approximately 7 minutes of activities [activity block 2]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities	Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-lab simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities [activity block 1], approximately 5 minutes of break and approximately 7 minutes of activities [activity block 2]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities	Cadence referred to the number of steps taken per minute during gait cycle. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities [activity block 1], approximately 5 minutes of break and approximately 7 minutes of activities [activity block 2]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities	Gait speed was the time taken to walk a specified distance. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities [activity block 1], approximately 5 minutes of break and approximately 7 minutes of activities [activity block 2]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities	Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities [activity block 1], approximately 5 minutes of break and approximately 7 minutes of activities [activity block 2]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities	Stride duration refers to the duration between successive heel contacts of the same foot. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities [activity block 1], approximately 5 minutes of break and approximately 7 minutes of activities [activity block 2]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).	Up to 20 minutes on Day 1
Cohort B: Total Sleep Time During the At-Home Period	Total sleep time for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's total sleep opportunity (TSO) window and computing sleep metrics within that window.	From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Cohort B: Percentage of Time Asleep During the At-Home Period	The percentage of time asleep for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.	From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Cohort B: Number of Wake Bouts During the At-Home Period	Number of wake bouts for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.	From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Cohort B: Sleep Onset Latency During the At-Home Period	Sleep onset latency which is time to transition from full wakefulness to sleep, for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.	From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Cohort B: Wake After Sleep Onset During the At-Home Period	Wake after sleep onset is time for which participants were awake after having initially fallen asleep, for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.	From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Cohort B: Total Scratch Duration During the At-Home Period	Total scratch duration for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.	From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Cohort B: Total Scratch Episodes During the At-Home Period	Total scratch episodes for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.	From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Cohort B: Number of Available Minutes During the At-Home Period	Available minutes represented any recorded accelerometer data per day per device in minutes. Number of available minutes for GENEActiv and Panoramic Bracelet was derived by the in-house built Sci-kit Digital Health (SKDH) package.	From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Cohort B: Number of Minutes of Wear During the At-Home Period	Number of minutes of wear include the total number of minutes the device is worn including sleep time and awake time. The wear time parameter (number of minutes of wear) for GENEActiv and Panoramic Bracelet was derived by the in-house built SKDH package.	From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Cohort B: Number of Wear Minutes While Awake During the At-Home Period	The wear time parameter (number of wear minutes while awake) for GENEActiv and Panoramic Bracelet was derived by the in-house built SKDH package.	From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7	Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicated more comfort, except for questions 5 ("The device changes the way I move") and 6 ("The device changes the way I behave") , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.	Day 7
Cohort A: Number of Days to Complete Enrollment	Number of days to complete enrollment corresponded to the total number of days it took to enroll all study participants within the age groups of 3-5 years, 6-11 years and 12-17 years.	Up to approximately 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort A: Number of Participants Enrolled Over Time	Number of participants enrolled at specified month intervals in the study is reported in this outcome measure.	Up to approximately 8 months
Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks	Number of participants who were able to perform each of the 7 tasks (i.e., walking at natural, slow and fast speeds, tile and carpet walks, 2 sessions of in-lab simulated activities) is reported in this outcome measure.	Up to 20 minutes on Day 1
Cohort A: Percentage of Tasks Completed (From a Total of 7 Tasks)	Percentage of tasks completed from a total of 7 tasks (i.e., walking at natural, slow and fast speeds, tile and carpet walks, 2 sessions of in-lab simulated activities) is reported in this outcome measure.	Up to 20 minutes on Day 1
Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices		From Day 1 to Day 15 (+ 3 days)
Cohort A: Number of Days With More Than 10 Hours of Wear Time for Lumbar Device		From Day 1 to Day 15 (+ 3 days)
Cohort A: Number of Days With More Than 18 Hours of Wear Time for Wrist Device		From Day 1 to Day 15 (+ 3 days)
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1	Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicate more comfort except for questions 5 ("The device changes the way I move") and 6 ("The device changes the way I behave") , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.	Day 1
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation	Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicate more comfort except for questions 5 ("The device changes the way I move") and 6 ("The device changes the way I behave") , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.	Day 15 (+ 3 days)
Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis	Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.	Up to 20 minutes on Day 1
Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis	Single limb support time referred to the time when only one limb was in contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.	Up to 20 minutes on Day 1
Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis	Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.	Up to 20 minutes on Day 1
Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis	Swing time was defined as the time during which the foot was not in contact with the ground. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.	Up to 20 minutes on Day 1
Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis	Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.	Up to 20 minutes on Day 1
Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis	Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.	Up to 20 minutes on Day 1
Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis	Cadence referred to the number of steps taken per minute during gait cycle. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.	Up to 20 minutes on Day 1
Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis	Gait speed was the time taken to walk a specified distance. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.	Up to 20 minutes on Day 1
Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis	Stride duration refers to the duration between successive heel contacts of the same foot. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.	Up to 20 minutes on Day 1
Cohort B: Number of Hours Per Day Wearing the Panoramic Bracelet Devices at Home		From Day 1 up to Day 7
Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks	Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had to walk on GAITRite walkway (20 feet*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.	Up to 20 minutes on Day 1
Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks	Single support time referred to the time when only one limb was in contact with the ground. Participants had to walk on GAITRite walkway (20 feet*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.	Up to 20 minutes on Day 1
Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks	Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had to walk on GAITRite walkway (20 feet*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.	Up to 20 minutes on Day 1
Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks	Swing time was defined as the time during which the foot was not in contact with the ground. Participants had to walk on GAITRite walkway (20 feet*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.	Up to 20 minutes on Day 1
Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks	Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had to walk on GAITRite walkway (20 feet*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.	Up to 20 minutes on Day 1
Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks	Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had to walk on GAITRite walkway (20 feet*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.	Up to 20 minutes on Day 1
Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks	Cadence referred to the number of steps taken per minute during gait cycle. Participants had to walk on GAITRite walkway (20 feet*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.	Up to 20 minutes on Day 1
Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task	Gait speed was the time taken to walk a specified distance. Participants had to walk on GAITRite walkway (20 feet*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.	Up to 20 minutes on Day 1
Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks	Stride duration refers to the duration between successive heel contacts of the same foot. Participants had to walk on GAITRite walkway (20 feet*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.	Up to 20 minutes on Day 1

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• Di J, Tuttle PG, Adamowicz L, Lin W, Zhang H, Psaltos D, Selig J, Bai J, Karahanoglu FI, Sheriff P, Seelam V, Williams B, Ghafoor S, Demanuele C, Santamaria M, Cai X. Monitoring Activity and Gait in Children (MAGIC) using digital health technologies. Pediatr Res. 2024 Aug;96(3):750-758. doi: 10.1038/s41390-024-03147-x. Epub 2024 Mar 21.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): October 28, 2024
• Study Completion (Actual): October 28, 2024

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Gait; Sleep; Activity; Actigraphy; COHORT A :; COHORT B:
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: X9001263; MAGIC (Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes