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 Type
OBSERVATIONAL
Enrollment
87
The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.
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.
Pfizer Innovation Research, PfIRe, Lab
Cambridge, Massachusetts, United States
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 8 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 20 minutes on Day 1
Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices
Time frame: From Day 1 to Day 15 (+ 3 days)
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)
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)
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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 20 minutes on Day 1
Cohort B: Number of Hours Per Day Wearing the Panoramic Bracelet Devices at Home
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 20 minutes on Day 1