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Sensors Prediction Study

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ClinicalTrials.gov Identifier: NCT04541992
Recruitment Status : Not yet recruiting
First Posted : September 9, 2020
Last Update Posted : February 23, 2022
Sponsor:
Collaborators:
Geneva Foundation
Uniformed Services University of the Health Sciences
Womack Army Medical Center
Information provided by (Responsible Party):
Robert Gailey, University of Miami

Study Description
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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
Injury Leg

Study Design
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Study Type : Observational
Estimated Enrollment : 8300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Body-Worn Sensors for Risk of Injury Prediction During Military Training
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022
Groups and Cohorts
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Group/Cohort
Airborne Group
Participants in this group will be tested for balance and agility within a 20 minute time frame.


Outcome Measures
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Primary Outcome Measures :
  1. Region of Limb Stability [ Time Frame: Day 1 ]
    Region of Limb Stability (ROLS) measured in cm^2 using a body-worn sensor.

  2. Transitional Angular Displacement of Segments [ Time Frame: Day 1 ]
    Transitional Angular Displacement of Segments (TADS) measured in degrees per second using a body-worn sensor.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy service member participants stationed at Fort Bragg, North Carolina.
Criteria

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
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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): NCT04541992


Contacts
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Contact: Natasha Crowther 305-284-2351 ncrowther@miami.edu

Locations
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United States, North Carolina
Womack Army Medical Center
Fort Bragg, North Carolina, United States, 28310
Contact: Lauren Gornoski    305-284-2351    lgornoski@genevausa.org   
Principal Investigator: Robert Gailey, PhD         
Sponsors and Collaborators
University of Miami
Geneva Foundation
Uniformed Services University of the Health Sciences
Womack Army Medical Center
Investigators
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Principal Investigator: Robert Gailey, PhD University of Miami
More Information
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Responsible Party: Robert Gailey, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04541992    
Other Study ID Numbers: 20190910
HU00011920011 ( Other Grant/Funding Number: Geneva Foundation )
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: February 23, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of Miami:
hip injury
knee injury
ankle injury
Additional relevant MeSH terms:
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Wounds and Injuries