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Sensors Prediction Study

Sponsor
University of Miami (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04541992
Collaborator
Geneva Foundation (Other), Uniformed Services University of the Health Sciences (U.S. Fed), Womack Army Medical Center (U.S. Fed)
8,300
Enrollment
1
Location
16
Anticipated Duration (Months)
519.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test whether measures of balance and agility can help predict if a Service Member may be at risk for an injury to their legs before beginning their school and training.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    8300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Body-Worn Sensors for Risk of Injury Prediction During Military Training
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Airborne Group

    Participants in this group will be tested for balance and agility within a 20 minute time frame.

    Outcome Measures

    Primary Outcome Measures

    1. Region of Limb Stability [Day 1]

      Region of Limb Stability (ROLS) measured in cm^2 using a body-worn sensor.

    2. Transitional Angular Displacement of Segments [Day 1]

      Transitional Angular Displacement of Segments (TADS) measured in degrees per second using a body-worn sensor.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Between the ages of 18-55

    2. Active duty Service Members in the 82nd Airborne Division (ABN DIV)

    3. Fluent in English speak and reading

    Exclusion Criteria:

    1. Service members under the age of 18 or over the age of 55 will be excluded

    2. Told by a doctor that they should not exercise.

    3. Orthopedic injury/surgery of the lower limb or back within the last year and that limits study compliance

    4. Regular use of medications that may alter balance, coordination or agility

    5. Unwilling to comply with the study protocol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Womack Army Medical Center Fort Bragg North Carolina United States 28310

    Sponsors and Collaborators

    • University of Miami
    • Geneva Foundation
    • Uniformed Services University of the Health Sciences
    • Womack Army Medical Center

    Investigators

    • Principal Investigator: Robert Gailey, PhD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Gailey, Professor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT04541992
    Other Study ID Numbers:
    • 20190910
    • HU00011920011
    First Posted:
    Sep 9, 2020
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Robert Gailey, Professor, University of Miami
    hip injury
    knee injury
    ankle injury
    Additional relevant MeSH terms:
    Wounds and Injuries

    Study Results

    No Results Posted as of Jul 21, 2022