Agreement Between Clinician and Instrumented Laxity Assessment

NCT ID: NCT03309098

Last Updated: 2024-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-28

Study Completion Date

2017-11-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ankle Sprains Ankle Injuries and Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ankle Injury

Person who injures their ankle

Ligmaster Arthrometer Assessment

Intervention Type DIAGNOSTIC_TEST

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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Rosen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Other Identifiers

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0526-17-EP

Identifier Type: -

Identifier Source: org_study_id

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