Low-Interventional Study to Record Gait and Physical Activity Using ActiGraph Devices in Children Ages 3-17.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
时间窗: 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).
Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
时间窗: 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).
Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
时间窗: 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).
Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
时间窗: 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).
Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
时间窗: 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).
Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
时间窗: 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).
Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
时间窗: 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).
Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
时间窗: 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).
Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
时间窗: 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).
Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
时间窗: 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).
Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
时间窗: 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).
Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
时间窗: 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).
Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
时间窗: 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).
Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
时间窗: 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).
Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
时间窗: 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).
Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
时间窗: 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).
Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
时间窗: 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).
Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities
时间窗: 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).
Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
时间窗: 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).
Cohort B: Total Sleep Time During the At-Home Period
时间窗: 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.
Cohort B: Percentage of Time Asleep During the At-Home Period
时间窗: 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.
Cohort B: Number of Wake Bouts During the At-Home Period
时间窗: 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.
Cohort B: Sleep Onset Latency During the At-Home Period
时间窗: 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.
Cohort B: Wake After Sleep Onset During the At-Home Period
时间窗: 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.
Cohort B: Total Scratch Duration During the At-Home Period
时间窗: 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.
Cohort B: Total Scratch Episodes During the At-Home Period
时间窗: 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.
Cohort B: Number of Available Minutes During the At-Home Period
时间窗: 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.
Cohort B: Number of Minutes of Wear During the At-Home Period
时间窗: 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.
Cohort B: Number of Wear Minutes While Awake During the At-Home Period
时间窗: 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.
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
时间窗: 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.
Cohort A: Number of Days to Complete Enrollment
时间窗: 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.
次要结局
- Cohort A: Number of Participants Enrolled Over Time(Up to approximately 8 months)
- Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks(Up to 20 minutes on Day 1)
- Cohort A: Percentage of Tasks Completed (From a Total of 7 Tasks)(Up to 20 minutes on Day 1)
- Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices(From Day 1 to Day 15 (+ 3 days))
- Cohort A: Number of Days With More Than 10 Hours of Wear Time for Lumbar Device(From Day 1 to Day 15 (+ 3 days))
- Cohort A: Number of Days With More Than 18 Hours of Wear Time for Wrist Device(From Day 1 to Day 15 (+ 3 days))
- Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1(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(Day 15 (+ 3 days))
- Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis(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(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(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(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(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(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(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(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(Up to 20 minutes on Day 1)
- Cohort B: Number of Hours Per Day Wearing the Panoramic Bracelet Devices at Home(From Day 1 up to Day 7)
- Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks(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(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(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(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(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(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(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(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(Up to 20 minutes on Day 1)