- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04823650
Monitoring Activity And Gait In Children (MAGIC)
Low-Interventional Study to Record Gait and Physical Activity Using ActiGraph Devices in Children Ages 3-17.
COHORT A: To study whether a digital health tool called Actigraph can be used to collect information on gait and physical activity in healthy children aged 3-17. The study will be conducted at the Pfizer Innovation Research Laboratory (PfIRe Lab) in Cambridge MA. In the lab at the first visit, we will ask participants to do activities such as walking on different surfaces as well as to roll a dice and move between different activity stations. Children will wear 2 Actigraph devices, one as a watch and one as a belt. They will then go home and do usual daily activities while answering a brief daily activity diary for approximately 2 weeks. The conclusion of the study will be over the telephone and include questions on the comfort and wearability of the device. The analysis of gait and physical activity as well as adherence and wearability will be looked across three different age groups 3-5, 6-11, and 12-17.
COHORT B: Cohort B of the study aims to evaluate the feasibility of the Panoramic Bracelet and associated algorithms such as SleepPy and GaitPy compared to the GENEActiv device and to evaluate the comfort and wearability of the Panoramic Bracelet. The results of this study will enable the use of novel devices in future clinical trials measuring scratch and sleep. . In the lab at the first visit, we will ask participants to do activities such as walking on different surfaces as well as to roll a dice and move between different activity stations. They will then go home and do usual daily activities while wearing both devices in the same wrist at different times stipulated in the protocol, answering a brief daily activity and sleep diary for approximately 2 weeks. Cohort B includes questions on the comfort and wearability of the Panoramic device on Day 7 approximately. The conclusion of the study will be over the telephone.The analysis will be looked across three different age groups 3-5, 6-11, and 12-17
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Pfizer CT.gov Call Center
- Phone Number: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Locations
-
-
Massachusetts
-
Cambridge, Massachusetts, United States, 02139
- Recruiting
- Pfizer Innovation Research, PfIRe, Lab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Ambulatory
- No significant health problems that would impair the completion of the physical activity tasks, does not carry any diagnosis of developmental delay and/or significant co-morbid medical conditions as determined by a medically qualified individual during medical history review
Exclusion Criteria:
- Participation in other studies involving digital devices within 1 week and/or treatment with an investigational drug (Phases 1-4) within 30 days or 5 half-lives before the current study begins and/or during study participation.
- Participants with implanted medical devices.
- Minor participants who reach the age of majority during the study, as recognized under local law.
- Any medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Participants with known allergies to components as specified by device manufacturer if applicable (eg, plastic, stainless steel and silicone).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ages 3-5
COHORT A and B
|
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. |
Ages 6-11
COHORT A and B
|
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. |
Ages 12-17
COHORT A and B
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COHORT A:Gait metrics collected using ActiGraph devices
Time Frame: Maximum of 3 hours undertaking a semi-structured movement protocol
|
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
Time Frame: Approximately 7 days
|
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)
Time Frame: Approximately 7 days
|
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)
Time Frame: Approximately 7 days
|
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 (%)
Time Frame: Approximately 7 days
|
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))
Time Frame: Approximately 7 days
|
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)
Time Frame: Approximately 7 days
|
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)
Time Frame: Approximately 7 days
|
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)
Time Frame: Approximately 7 days
|
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)
Time Frame: Approximately 7 days
|
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
Time Frame: Up to 18 days
|
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
Time Frame: Up to 18 days
|
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
Time Frame: Maximum of 3 hours undertaking a semi-structured movement protocol
|
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
Time Frame: Maximum of 3 hours undertaking a semi-structured movement protocol
|
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
Time Frame: 52 weeks
|
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
Time Frame: Approximately 7 days
|
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).
Time Frame: Maximum of 3 hours undertaking a semi-structured movement protocol
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- X9001263
- MAGIC (Other Identifier: Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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