Sensors Prediction Study

Body-Worn Sensors for Risk of Injury Prediction During Military Training

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.

Study Overview

• Status: Recruiting
• Conditions: Injury Leg

• Study Type: Observational
• Enrollment (Estimated): 8300

Contacts and Locations

• Study Contact: Name: Natasha Crowther; Phone Number: 305-284-2351; Email: ncrowther@miami.edu

Study Locations

• United States
  • North Carolina
    • Fort Bragg, North Carolina, United States, 28310
      • Recruiting
      • Womack Army Medical Center
      • Contact: Lauren Gornoski; Phone Number: 305-284-2351; Email: lgornoski@genevausa.org
      • Principal Investigator: Robert Gailey, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy service member participants stationed at Fort Bragg, North Carolina.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Airborne Group; Participants in this group will be tested for balance and agility within a 20 minute time frame.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Region of Limb Stability	Region of Limb Stability (ROLS) measured in cm^2 using a body-worn sensor.	Day 1
Transitional Angular Displacement of Segments	Transitional Angular Displacement of Segments (TADS) measured in degrees per second using a body-worn sensor.	Day 1

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Uniformed Services University of the Health Sciences; The Geneva Foundation; Womack Army Medical Center
• Investigators: Principal Investigator: Robert Gailey, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: ankle injury; knee injury; hip injury
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 20190910; HU00011920011 (Other Grant/Funding Number: Geneva Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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