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Monitoring Activity And Gait In Children (MAGIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04823650
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : October 25, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Child, Preschool Child Adolescent Device: Actigraph

Study Design
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Study Type : Observational
Estimated Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Low-Interventional Study to Record Gait and Physical Activity Using ActiGraph Devices in Children Ages 3-17.
Actual Study Start Date : August 23, 2021
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
Ages 3-5 Device: Actigraph
The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.
Ages 6-11 Device: Actigraph
The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.
Ages 12-17 Device: Actigraph
The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy children and adolescents aged 3-17.
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04823650


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, Massachusetts
Pfizer Innovation Research, PfIRe, Lab Recruiting
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Principal Investigator: Xuemei Cai, MD Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04823650    
Other Study ID Numbers: X9001263
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Pfizer:
Gait
Activity
Actigraphy