Validation of a Portable Ankle Arthrometer

NCT07163897 | Not Yet Recruiting

• 1 other identifier: 302715
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Ankle Instability, CAI; Ankle Sprain; Healthy

Keywords

Arthrometer; Ankle; Validity; Reliability

Outcome Measures

Primary Outcomes (1)

• Ankle laxity

  Measured with both the ankle arthrometer and ultrasound imaging. Both will report units of displacement.

  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).

Study Arms (4)

Healthy

Individuals that have never sprained their ankle.

Device: Cobra Ankle Arthrometer

Copers

Individuals that have sprained their ankle one time, with no residual problems.

Device: Cobra Ankle Arthrometer

CAI

Individuals that have been diagnosed with chronic ankle instability.

Device: Cobra Ankle Arthrometer

Acute Sprain

Individuals that have sprained their ankle in the last 96 hours.

Device: Cobra Ankle Arthrometer

Interventions

Cobra Ankle Arthrometer DEVICE

This is a prototype portable ankle arthrometer designed to measure the laxity of the ankle joint.

Acute Sprain; CAI; Copers; Healthy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample.

You may qualify if:

• Young adults between the ages of 18 and 40.
• Willingness and ability to comply with scheduled visits and study procedures.
• Fit one of the three groups: 1. Healthy - no history of ankle sprain, 2. Copers - one previous ankle sprain with no residual problems, 3. Chronic Ankle Instability.
• Ability to sign consent.
• Aim 2:
• Young adults between the ages of 18 and 40.
• Willingness and ability to comply with scheduled visits and study procedures.
• Acute ankle sprain within the last 48-96 hours.
• Ability to sign consent.
• Aim 1:

You may not qualify if:

• Previous history of ankle fracture.
• Diagnosis of Ehlers-Danlos Syndrome
• Aim 2:
• Previous history of ankle fracture.
• Diagnosis of Ehlers-Danlos Syndrome.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

UVA Department of Student Health and Wellness

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joe H. Gieck Professor of Sports Medicine; Chair of the Department of Kinesiology; Licensed Athletic Trainer

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)