Monitoring Activity And Gait In Children

Study Overview
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Brief Summary
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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

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

Conditions
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Child, Preschool, Child, Adolescent

Intervention / Treatment
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* Device: COHORT A: Actigraph
* Device: Panoramic Bracelet and GENEActiv


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ages 3-5<br>COHORT A and B | Device: COHORT A: Actigraph<br>* The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.<br>Device: Panoramic Bracelet and GENEActiv<br>* 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.<br>|
| Ages 6-11<br>COHORT A and B | Device: COHORT A: Actigraph<br>* The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.<br>Device: Panoramic Bracelet and GENEActiv<br>* 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.<br>|
| Ages 12-17<br>COHORT A and B | Device: COHORT A: Actigraph<br>* The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.<br>Device: Panoramic Bracelet and GENEActiv<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COHORT A:Gait metrics collected using ActiGraph devices | To compare gait quality metrics collected using ActiGraph devices, APDM devices and GAITRite® walkway, during in-lab sessions. Accuracy of the sensor-derived metrics will be determined by computing the mean absolute percent error between the sensor-derived and reference standard metrics and assess the bias using Bland Altman plots and 95% limits of agreement. The agreement between sensor derived and reference standard metrics will be assessed using ICC and its 95% lower and upper confidence limits. | Maximum of 3 hours undertaking a semi-structured movement protocol | 
| COHORT B: Evaluate wearability of Panoramic Bracelet device in the lab setting and at home | Participants or their parent/guardian will be asked to rate their assessment of how comfortable the devices were both at the end of the in lab session and after the at home monitoring period. The same questionnaire will be administered twice. The participant or the parent/guardian are requested to choose a statement on a five-point Likert Scale. The statements are: Strongly disagree Disagree Neutral Agree Strongly agree Participants or their parent/guardians will select the most appropriate statement which they felt reflected how comfortable they found the devices to put on, wear, and take off | Approximately 7 days | 
| COHORT B: Wear time compliance of Panoramic Bracelet such as number of hours of wear (hours) | Number of hours per day wearing the device and number of days with more than 10 hours of wearing for each participant will be recorded. | Approximately 7 days | 
| COHORT B: Sleep metrics time in bed (minutes) | Evaluate the Panoramic Bracelet device and associated algorithm in the quantification of sleep with SleepPy algorithm and comparator device (GENEActiv) during the at-home period. | Approximately 7 days | 
| COHORT B:Percent time asleep (%) | Evaluate the Panoramic Bracelet device and associated algorithm in the quantification of sleep with SleepPy algorithm and comparator device (GENEActiv) during the at-home period. | Approximately 7 days | 
| COHORT B: Sleep metrics : Number of wake bouts (number of episodes)) | Evaluate the Panoramic Bracelet device and associated algorithm in the quantification of sleep with SleepPy algorithm and comparator device (GENEActiv) during the at-home period. | Approximately 7 days | 
| COHORT B: Sleep onset latency (minutes) | Evaluate the Panoramic Bracelet device and associated algorithm in the quantification of sleep with SleepPy algorithm and comparator device (GENEActiv) during the at-home period. | Approximately 7 days | 
| COHORT B: Wake after sleep onset (minutes) | Evaluate the Panoramic Bracelet device and associated algorithm in the quantification of sleep with SleepPy algorithm and comparator device (GENEActiv) during the at-home period. | Approximately 7 days | 
| COHORT B: Scratch metrics such as Total scratch duration (minutes) | Evaluate the Panoramic Bracelet device and associated algorithms in the quantification of scratch with ScratchPy and comparator device (GENEActiv) during the at-home period. | Approximately 7 days | 
| COHORT B: Scratch metrics such as Total scratch episodes (numbers) | Evaluate the Panoramic Bracelet device and associated algorithms in the quantification of scratch with ScratchPy and comparator device (GENEActiv) during the at-home period. | Approximately 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COHORT A: Wear compliance of ActiGraph devices at home | Number of hours per day wearing the device and number of days with more than 10 hours of wearing for each participant will be recorded. | Up to 18 days | 
| COHORT A: Evaluate wearability of device in the lab setting and at home | Participants or their parent/guardian will be asked to rate their assessment of how comfortable the devices were both at the end of the in lab session and after the at home monitoring period. The same questionnaire will be administered twice. The participant or the parent/guardian are requested to choose a statement on a five-point Likert Scale. The statements are: Strongly disagree Disagree Neutral Agree Strongly agree Participants or their parent/guardians will select the most appropriate statement which they felt reflected how comfortable they found the devices to put on, wear, and take off. | Up to 18 days | 
| COHORT A: To assess the ability of pediatric participants to perform a battery of lab-based tasks | Number of participants (overall and per age group) able to perform each of the 7 tasks and task-completion percentage (among total of 7 tasks) per participant. | Maximum of 3 hours undertaking a semi-structured movement protocol | 
| COHORT A: To evaluate the effect of floor surface on gait metrics | Gait metrics measured by devices across different floor surfaces. | Maximum of 3 hours undertaking a semi-structured movement protocol | 
| COHORT A: To assess the feasibility of recruiting pediatric participants to conduct a wearable device study | Recruitment data listed by age group: number of participants contacted, screened and enrolled over time, time to enroll approximately 13 participants per group. | 52 weeks | 
| COHORT B: Number of hours per day wearing the device Panoramic Bracelet | To assess the compliance in wearing the Panoramic Bracelet device at home. | Approximately 7 days | 
| COHORT B: Gait metrics measured by APDM devices, GAITRite® walkway and Panaromic Bracelet devices (extracted with GaitPy algorithm). | To compare gait quality metrics collected using Panoramic Bracelet devices, APDM devices and GAITRite® walkway, during in-lab sessions. | Maximum of 3 hours undertaking a semi-structured movement protocol | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COHORT A :, Gait, Activity, Actigraphy, COHORT B:, Sleep