Injury LegNCT04541992
Sensors Prediction Study
An observational study of Injury Leg, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury Leg
- How many people
- 1,891 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2020to 15 Aug 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy service member participants stationed at Fort Bragg, North Carolina.
Who may be able to join
- Between the ages of 18-55
- Active duty Service Members in the 82nd Airborne Division (ABN DIV)
- Fluent in English speak and reading
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Womack Army Medical Center
Fort Bragg, North Carolina, 28310
About this study
Official title: 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.
- Conditions
- Injury Leg
- Keywords
- hip injury, knee injury, ankle injury
- Medical subject headings
- Leg Injuries, Hip Injuries, Knee Injuries, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Airborne Group | Participants in this group will be tested for balance and agility within a 20 minute time frame. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Region of Limb Stability
Region of Limb Stability (ROLS) measured in cm^2 using a body-worn sensor.
Measured: Day 1
Transitional Angular Displacement of Segments
Transitional Angular Displacement of Segments (TADS) measured in degrees per second using a body-worn sensor.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start8 Oct 2020
- Primary completion30 Jun 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Injury LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,891 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- The Geneva Foundation, Uniformed Services University of the Health Sciences, Womack Army Medical Center
- Responsible party
- Principal investigator, Robert Gailey, University of Miami
- Investigators
- Robert Gailey, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541992
- Sponsor's protocol ID
- 20190910
- Other IDs
- HU00011920011
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2020
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body-Worn Sensors for Risk of Injury Prediction During Military Training
- ClinicalTrials.gov ID
- NCT04541992
- Acronym / sponsor ID
- 20190910
- Conditions
- Injury Leg
- Keywords
- hip injury, knee injury, ankle injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,891 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- The Geneva Foundation, Uniformed Services University of the Health Sciences, Womack Army Medical Center
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Posted 29 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Airborne Group | – | –Participants in this group will be tested for balance and agility within a 20 minute time frame. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy service member participants stationed at Fort Bragg, North Carolina.
Key inclusion criteria (3 listed)
- Between the ages of 18-55
- Active duty Service Members in the 82nd Airborne Division (ABN DIV)
- Fluent in English speak and reading
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Region of Limb Stability
Time frame: Day 1
Region of Limb Stability (ROLS) measured in cm^2 using a body-worn sensor.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Gailey, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Injury Leg, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Region of Limb Stability (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.