Ankle SprainsNCT03309098
Agreement Between Clinician and Instrumented Laxity Assessment
An observational study of Ankle Sprains and Ankle Injuries and Disorders, run by University of Nebraska.
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. Read more about this study
- Who is it for?
- Ages 19 to 50 years
- Conditions the study is for
- Ankle Sprains, Ankle Injuries and Disorders
- What is being tested?
- Ligmaster Arthrometer Assessment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2017to 28 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 50 years
- All sexes
- Adult
Study population: Recreationally active, health adults.
Who may be able to join
- 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.
Who cannot join
- Any condition that is contraindicated for manual test (i.e. fracture).
About this study
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.
Read the 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.
- Conditions
- Ankle Sprains, Ankle Injuries and Disorders
- Being tested
- Ligmaster Arthrometer Assessment
- Medical subject headings
- Ankle Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligmaster Arthrometer AssessmentDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| Ankle Injury | Person who injures their ankle Receives: Diagnostic Test: Ligmaster Arthrometer Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 48 hours post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start28 Nov 2017
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
Why it stopped: IRB's initial review of this study was not completed and study was withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Rosen, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309098
- Sponsor's protocol ID
- 0526-17-EP
- Status last verified
- Aug 2024
- First submitted
- 9 Oct 2017
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement Between Clinician and Instrumented Laxity Assessment
- ClinicalTrials.gov ID
- NCT03309098
- Acronym / sponsor ID
- 0526-17-EP
- Conditions
- Ankle Sprains, Ankle Injuries and Disorders
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: IRB's initial review of this study was not completed and study was withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 13 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankle Injury | – | Diagnostic Test: Ligmaster Arthrometer AssessmentPerson who injures their ankle |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Recreationally active, health adults.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Any condition that is contraindicated for manual test (i.e. fracture).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ligmaster Arthrometer AssessmentPerform 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). | Diagnostic test | Ankle Injury |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
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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.
Adam Rosen, PhD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Sprains and Ankle Injuries and Disorders, run by University of Nebraska.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Diagnostic accuracy of inversion stress test, eversion stress test and anterior drawer (time frame: within 48 hours post-injury). 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 3 Sep 2024.