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NCT04823650 · ClinicalTrials.gov registry record
Monitoring Activity And Gait In Children
A clinical trial, sponsored by Pfizer.
- Completed
- Registry status
- 87
- Enrollment target
NCT04823650: Completed study, sponsored by Pfizer.
NCT04823650 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 87 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04823650 has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 87 participants
- Enrollment target
Study 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
Primary Outcome
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
Interventions
- DEVICE COHORT A: Actigraph
- DEVICE Panoramic Bracelet and GENEActiv
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2021-08-23 |
| Est. Completion | 2024-10-28 |
What the finished NCT04823650 record still lists
NCT04823650 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 87 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which COHORT A: Actigraph is the first listed.
NCT04823650 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04823650 about?
NCT04823650 is a clinical study titled "Monitoring Activity And Gait In Children". 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 wi...
What is the current status of trial NCT04823650?
This trial is currently completed. The enrollment target is 87 participants. The study started on 2021-08-23. Estimated completion is 2024-10-28.
What interventions are being tested in trial NCT04823650?
The interventions under investigation include: COHORT A: Actigraph (DEVICE), Panoramic Bracelet and GENEActiv (DEVICE).
Who is sponsoring clinical trial NCT04823650?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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