Sensors Prediction Study

Injury Leg Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04541992
• Other study ID #: 20190910
• Secondary ID: HU00011920011
• Status: Recruiting
• Start date: September 12, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University of Miami
• Contact: Natasha Crowther
• Phone: 305-284-2351
• Email: ncrowther[@]miami.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Injury Leg
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Womack Army Medical Center	Fort Bragg	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
University of Miami	The Geneva Foundation, Uniformed Services University of the Health Sciences, Womack Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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