Monitoring Activity And Gait In Children

Recruiting

• Conditions: Child, Preschool; Adolescent; Child
• Interventions: Device: Panoramic Bracelet and GENEActiv

• Registration Number: NCT04823650
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-04-01
• Study Start: 2021-08-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-03-18
• Study Completion: 2025-03-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 39

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

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ages 6-11	Panoramic Bracelet and GENEActiv	COHORT A and B
Ages 12-17	Panoramic Bracelet and GENEActiv	COHORT A and B
Ages 3-5	Panoramic Bracelet and GENEActiv	COHORT A and B

Primary Outcome Measures

Name	Time	Method
COHORT B: Sleep metrics time in bed (minutes)	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.
COHORT B: Wear time compliance of Panoramic Bracelet such as number of hours of wear (hours)	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.
COHORT B:Percent time asleep (%)	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.
COHORT B: Sleep metrics : Number of wake bouts (number of episodes))	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.
COHORT B: Sleep onset latency (minutes)	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.
COHORT B: Evaluate wearability of Panoramic Bracelet device in the lab setting and at home	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
COHORT B: Scratch metrics such as Total scratch duration (minutes)	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.
COHORT A:Gait metrics collected using ActiGraph devices	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.
COHORT B: Scratch metrics such as Total scratch episodes (numbers)	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.
COHORT B: Wake after sleep onset (minutes)	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.

Secondary Outcome Measures

Name	Time	Method
COHORT B: Gait metrics measured by APDM devices, GAITRite® walkway and Panaromic Bracelet devices (extracted with GaitPy algorithm).	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.
COHORT A: To assess the ability of pediatric participants to perform a battery of lab-based tasks	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.
COHORT A: Wear compliance of ActiGraph devices at home	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.
COHORT A: Evaluate wearability of device in the lab setting and at home	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.
COHORT A: To assess the feasibility of recruiting pediatric participants to conduct a wearable device study	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.
COHORT B: Number of hours per day wearing the device Panoramic Bracelet	Approximately 7 days	To assess the compliance in wearing the Panoramic Bracelet device at home.
COHORT A: To evaluate the effect of floor surface on gait metrics	Maximum of 3 hours undertaking a semi-structured movement protocol	Gait metrics measured by devices across different floor surfaces.

Trial Locations

Locations (1)

Pfizer Innovation Research, PfIRe, Lab; 🇺🇸 Cambridge, Massachusetts, United States