Validation of a Portable Ankle Arthrometer

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07163897
Status
Not Yet Recruiting

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Conditions

  • Ankle Sprain
  • Chronic Ankle Instability, CAI
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Cobra Ankle Arthrometer — DEVICE
    This is a prototype portable ankle arthrometer designed to measure the laxity of the ankle joint.

Study Details

The purpose of this study is to assess the validity and reliability of a prototype portable ankle arthrometer in various populations. There are two aims to this study. Aim 1 will look to determine the reliability and validity of a prototype portable ankle arthrometer on young adults with no history of ankle sprain, copers, and young adults with chronic ankle instability. It is hypothesized that the prototype portable ankle arthrometer will be a valid and reliable tool to assess joint laxity across the three different populations. Aim 2 will look to determine the validity of a prototype portable ankle arthrometer in young adults with an acute ankle sprain across multiple timepoints in their first month post injury. It is hypothesized that the prototype portable ankle arthrometer will be a valid tool to assess joint laxity at three different timepoints for the same individual.

Key Dates

Start date
Oct 1, 2025
Status verified
Sep 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
62 participants (estimated)

Arms

  • Arm: Healthy
    Individuals that have never sprained their ankle.
  • Arm: Copers
    Individuals that have sprained their ankle one time, with no residual problems.
  • Arm: CAI
    Individuals that have been diagnosed with chronic ankle instability.
  • Arm: Acute Sprain
    Individuals that have sprained their ankle in the last 96 hours.

Primary Outcome Measure

Ankle laxity [ Time Frame: Aim 1: From Day 1 to the end of study after Day 2 (One week after Day 1). Aim 2: From Day 1 to the end of study after Day 3 (Four weeks after Day 1). ]

Locations (1)

FacilityCityStateZIPSite coordinators
UVA Department of Student Health and WellnessCharlottesvilleVirginia22903
Jay Hertel, Ph.D.
[email protected]
434-243-8673
George Sikoryak, M.S.
[email protected]
2012842344
Jay Hertel, Ph.D. (PRINCIPAL_INVESTIGATOR)

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By research site
UVA Department of Student Health and Wellness· Charlottesville, VA

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