NCT04541992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,891

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

October 8, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 29, 2026

Completed
Last Updated

April 29, 2026

Status Verified

September 1, 2025

Enrollment Period

4.7 years

First QC Date

September 1, 2020

Results QC Date

August 22, 2025

Last Update Submit

April 24, 2026

Conditions

Keywords

hip injuryknee injuryankle injury

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Airborne Group

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

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Between the ages of 18-55
  • Active duty Service Members in the 82nd Airborne Division (ABN DIV)
  • Fluent in English speak and reading

You may not qualify if:

  • Service members under the age of 18 or over the age of 55 will be excluded
  • Told by a doctor that they should not exercise.
  • Orthopedic injury/surgery of the lower limb or back within the last year and that limits study compliance
  • Regular use of medications that may alter balance, coordination or agility
  • Unwilling to comply with the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

Location

MeSH Terms

Conditions

Leg InjuriesHip InjuriesKnee InjuriesAnkle Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

Title
Robert Gailey
Organization
University of Miami Miller School of Medicine

Study Officials

  • Robert Gailey, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 9, 2020

Study Start

October 8, 2020

Primary Completion

June 30, 2025

Study Completion

August 15, 2025

Last Updated

April 29, 2026

Results First Posted

April 29, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations