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NCT03309098 Clinical Trial

Agreement Between Clinician and Instrumented Laxity Assessment

Ankle Sprains Clinical Trial

Official title:
Agreement Between Clinician and Instrumented Laxity Assessment

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03309098
Other study ID # 0526-17-EP
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date November 2017
Est. completion date November 28, 2017

Study information
Verified date August 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 28, 2017
Est. primary completion date November 28, 2017
Accepts healthy volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Nebraska

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