Clinical trial NCT04823650: Monitoring Activity And Gait In Children
Official title: Low-Interventional Study to Record Gait and Physical Activity Using ActiGraph Devices in Children Ages 3-17.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child, Preschool
Child
Adolescent
Keywords: COHORT A :
Gait
Activity
Actigraphy
COHORT B:
Sleep
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 87
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children and adolescents aged 3-17.

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


Eligibility criteria: 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).

Primary outcomes:
measure: COHORT A:Gait metrics collected using ActiGraph devices
timeFrame: Maximum of 3 hours undertaking a semi-structured movement protocol
measure: COHORT B: Evaluate wearability of Panoramic Bracelet device in the lab setting and at home
timeFrame: Approximately 7 days
measure: COHORT B: Wear time compliance of Panoramic Bracelet such as number of hours of wear (hours)
timeFrame: Approximately 7 days
measure: COHORT B: Sleep metrics time in bed (minutes)
timeFrame: Approximately 7 days
measure: COHORT B:Percent time asleep (%)
timeFrame: Approximately 7 days
measure: COHORT B: Sleep metrics : Number of wake bouts (number of episodes))
timeFrame: Approximately 7 days
measure: COHORT B: Sleep onset latency (minutes)
timeFrame: Approximately 7 days
measure: COHORT B: Wake after sleep onset (minutes)
timeFrame: Approximately 7 days
measure: COHORT B: Scratch metrics such as Total scratch duration (minutes)
timeFrame: Approximately 7 days
measure: COHORT B: Scratch metrics such as Total scratch episodes (numbers)
timeFrame: Approximately 7 days
Secondary outcomes:
measure: COHORT A: Wear compliance of ActiGraph devices at home
timeFrame: Up to 18 days
measure: COHORT A: Evaluate wearability of device in the lab setting and at home
timeFrame: Up to 18 days
measure: COHORT A: To assess the ability of pediatric participants to perform a battery of lab-based tasks
timeFrame: Maximum of 3 hours undertaking a semi-structured movement protocol
measure: COHORT A: To evaluate the effect of floor surface on gait metrics
timeFrame: Maximum of 3 hours undertaking a semi-structured movement protocol
measure: COHORT A: To assess the feasibility of recruiting pediatric participants to conduct a wearable device study
timeFrame: 52 weeks
measure: COHORT B: Number of hours per day wearing the device Panoramic Bracelet
timeFrame: Approximately 7 days
measure: COHORT B: Gait metrics measured by APDM devices, GAITRite® walkway and Panaromic Bracelet devices (extracted with GaitPy algorithm).
timeFrame: Maximum of 3 hours undertaking a semi-structured movement protocol
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Pfizer Innovation Research, PfIRe, Lab
state: Massachusetts
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: