Agreement Between Clinician and Instrumented Laxity Assessment

August 12, 2023 updated by: University of Nebraska
Ankle injuries are the most common acute injury to the active population. It is important to ensure best practices and techniques used in clinics for evaluation are validated and consistent. This study will compare diagnostic outcomes of a clinician and of a diagnostic arthrometer when testing acute ankle injuries.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Ankle injuries, specifically lateral ankle sprains, are the most common acute injury to the active population (Hootman, Dick, & Agel, 2007). It is important to insure the use of best practice and ensure that the techniques being utilized in clinics for evaluation are validated and consistent within the techniques. Manual testing and instrumented testing have not yet been tested within the same cohort.

The purpose of this study is to compare the diagnostic outcomes of a clinician and of a diagnostic arthrometer when testing acute ankle injuries. Participants will be recruited at University of Nebraska at Omahas (UNO) Injury Prevention and Care Clinic and Athletic Training Room in Sapp Fieldhouse. Participants with be members of the UNO Wellness Center or UNO athlete, aged 19-80 years old. During a standard evaluation the participant will have a clinician test manual ligamentous laxity and a blinded clinician testing laxity using an arthrometer. Participation will not alter the normal treatment or care for participants. The author hypothesizes that the diagnostic accuracy for all performed test will be good to excellent when assessed for laxity and moderate to good when assessed for pain.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Recreationally active, health adults.

Description

Inclusion Criteria:

  • Membership to University of Nebraska at Omahas Wellness Center: a student taking on campus classes or a paying community member. Acute injury occurred within one week of evaluation.

Exclusion Criteria:

  • Any condition that is contraindicated for manual test (i.e. fracture).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ankle Injury
Person who injures their ankle
Diagnostic test: Ligmaster Arthrometer Assessment
Perform an anterior drawer, inversion stress test and eversion stress test on the participant with an ankle arthrometer (LigMaster Version 1.26, Sport Tech, Inc, Charlottesville, Virginia).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of inversion stress test, eversion stress test and anterior drawer
Time Frame: within 48 hours post-injury
Assess the diagnostic accuracy of the inversion stress test, eversion stress test and anterior drawer using an arthrometer.
within 48 hours post-injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Adam Rosen, PhD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2017

Primary Completion (Actual)

November 28, 2017

Study Completion (Actual)

November 28, 2017

Study Registration Dates

First Submitted

October 9, 2017

First Submitted That Met QC Criteria

October 9, 2017

First Posted (Actual)

October 13, 2017

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 12, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0526-17-EP

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

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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