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OpenTrials
Completed

NCT Number: NCT04823650

Monitoring Activity And Gait In Children

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

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Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Innovation Research, PfIRe, Lab

Cambridge, Massachusetts, 02139, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

COHORT A: Actigraph

Device

The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.

Panoramic Bracelet and GENEActiv

Device

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.

Primary outcomes

  1. Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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).

  2. Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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).

  3. Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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).

  4. Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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).

  5. Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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).

  6. Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes of Day 1

    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).

  7. Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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).

  8. Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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).

  9. Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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).

  10. Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities

    Time frame: Up to 20 minutes on Day 1

    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).

  11. Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities

    Time frame: Up to 20 minutes on Day 1

    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).

  12. Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities

    Time frame: Up to 20 minutes on Day 1

    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).

  13. Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities

    Time frame: Up to 20 minutes on Day 1

    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).

  14. Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities

    Time frame: Up to 20 minutes on Day 1

    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).

  15. Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities

    Time frame: Up to 20 minutes on Day 1

    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).

  16. Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities

    Time frame: Up to 20 minutes on Day 1

    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).

  17. Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities

    Time frame: Up to 20 minutes on Day 1

    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).

  18. Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities

    Time frame: Up to 20 minutes on Day 1

    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).

  19. Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities

    Time frame: Up to 20 minutes on Day 1

    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).

  20. Cohort B: Total Sleep Time During the At-Home Period

    Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv

    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.

  21. Cohort B: Percentage of Time Asleep During the At-Home Period

    Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv

    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.

  22. Cohort B: Number of Wake Bouts During the At-Home Period

    Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv

    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.

  23. Cohort B: Sleep Onset Latency During the At-Home Period

    Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv

    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.

  24. Cohort B: Wake After Sleep Onset During the At-Home Period

    Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv

    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.

  25. Cohort B: Total Scratch Duration During the At-Home Period

    Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv

    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.

  26. Cohort B: Total Scratch Episodes During the At-Home Period

    Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv

    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.

  27. Cohort B: Number of Available Minutes During the At-Home Period

    Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv

    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.

  28. Cohort B: Number of Minutes of Wear During the At-Home Period

    Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv

    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.

  29. Cohort B: Number of Wear Minutes While Awake During the At-Home Period

    Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv

    The wear time parameter (number of wear minutes while awake) for GENEActiv and Panoramic Bracelet was derived by the in-house built SKDH package.

  30. Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7

    Time frame: 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.

  31. Cohort A: Number of Days to Complete Enrollment

    Time frame: Up to approximately 8 months

    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.

Secondary outcomes

  1. Cohort A: Number of Participants Enrolled Over Time

    Time frame: Up to approximately 8 months

    Number of participants enrolled at specified month intervals in the study is reported in this outcome measure.

  2. Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks

    Time frame: Up to 20 minutes on Day 1

    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.

  3. Cohort A: Percentage of Tasks Completed (From a Total of 7 Tasks)

    Time frame: Up to 20 minutes on Day 1

    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.

  4. Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices

    Time frame: From Day 1 to Day 15 (+ 3 days)

  5. Cohort A: Number of Days With More Than 10 Hours of Wear Time for Lumbar Device

    Time frame: From Day 1 to Day 15 (+ 3 days)

  6. Cohort A: Number of Days With More Than 18 Hours of Wear Time for Wrist Device

    Time frame: From Day 1 to Day 15 (+ 3 days)

  7. 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

    Time frame: 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.

  8. Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation

    Time frame: Day 15 (+ 3 days)

    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.

  9. Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis

    Time frame: Up to 20 minutes on Day 1

    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.

  10. Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis

    Time frame: Up to 20 minutes on Day 1

    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.

  11. Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis

    Time frame: Up to 20 minutes on Day 1

    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.

  12. Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis

    Time frame: Up to 20 minutes on Day 1

    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.

  13. Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis

    Time frame: Up to 20 minutes on Day 1

    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.

  14. Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis

    Time frame: Up to 20 minutes on Day 1

    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.

  15. Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis

    Time frame: Up to 20 minutes on Day 1

    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.

  16. Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis

    Time frame: Up to 20 minutes on Day 1

    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.

  17. Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis

    Time frame: Up to 20 minutes on Day 1

    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.

  18. Cohort B: Number of Hours Per Day Wearing the Panoramic Bracelet Devices at Home

    Time frame: From Day 1 up to Day 7

  19. Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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.

  20. Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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.

  21. Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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.

  22. Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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.

  23. Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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.

  24. Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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.

  25. Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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.

  26. Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task

    Time frame: Up to 20 minutes on Day 1

    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.

  27. Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks

    Time frame: Up to 20 minutes on Day 1

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: MAGIC

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2021
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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