Chronic Ankle Instability, CAINCT07163897
Validation of a Portable Ankle Arthrometer
An observational study of Chronic Ankle Instability, CAI and Ankle Sprain, run by University of Virginia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability, CAI, Ankle Sprain, Healthy
- What is being tested?
- Cobra Ankle Arthrometer
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample.
Who may be able to join
- 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.
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- 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:
Who cannot join
- Previous history of ankle fracture.
- Diagnosis of Ehlers-Danlos Syndrome
- Aim 2:
- Previous history of ankle fracture.
- Diagnosis of Ehlers-Danlos Syndrome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UVA Department of Student Health and Wellness
Charlottesville, Virginia, 22903
Jay Hertel, Ph.D., 434-243-8673, jhertel@virginia.edu
George Sikoryak, M.S., 2012842344, jxf5vn@virginia.edu
About this study
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.
Read the detailed description
Aim 1: Participants will report to the Exercise and Sport Injury laboratory to provide informed consent before any study procedures take place. Following consent, there will be an approximate 1 hour data collection period. There will be 2 different days of data collection, with informed consent being provided only at the first session.
Demographics \& Health History: Participants will answer several surveys including a medical history questionnaire, physical activity readiness questionnaire (ParQ), international physical activity questionnaire (IPAQ - short form), identification of functional ankle instability (IdFAI), and a foot and ankle ability measure (FAAM). Measures of age, height, weight, sex, and race or ethnicity will be recorded by practitioners prior to testing. Information gathered will be used to ensure all participants fit the study inclusion criteria.
Instrumentation will include a prototype portable ankle arthrometer created by Luna Labs to measure joint laxity and a GE Healthcare Ultrasound Machine to also measure joint laxity.
Participants will first undergo a series of physical examination tests performed by a Licensed Athletic Trainer. Participants will remain seated on the exam table, and the study team member will perform the "Anterior Drawer Test of the Ankle" and the "Talar Tilt Test" to assess the stability of the participants ankle ligaments.
Following the physical exam tests, participants will remain seated on the exam table and will be outfitted with the ankle arthrometer. Once the arthrometer is fitted, participants will have their foot placed in various positions, and the arthrometer will record measures.
Following the ankle arthrometer, participants will remain seated on the exam table and the ultrasound imaging unit will be used to assess joint laxity in the same positions that were used for the ankle arthrometer.
Following the completion of ultrasound images, participants will be dismissed. Participants will then report back a week later for visit 2. Visit 2 consist of the physical exam tests, ankle arthrometer, and ultrasound imaging again.
Following visit 2, participation in the study will be complete.
Aim 2: Participants will report to the Exercise and Sport Injury laboratory to provide informed consent before any study procedures take place. Following consent, there will be an approximate 1 hour data collection period. There will be 3 different days of data collection, with informed consent being provided only at the first session.
Demographics \& Health History: Participants will answer several surveys including a medical history questionnaire, physical activity readiness questionnaire (ParQ), international physical activity questionnaire (IPAQ - short form), and a foot and ankle ability measure (FAAM). Measures of age, height, weight, sex, and race or ethnicity will be recorded by practitioners prior to testing. Information gathered will be used to ensure all participants fit the study inclusion criteria.
Instrumentation will include a prototype portable ankle arthrometer created by Luna Labs to measure joint laxity and a GE Healthcare Ultrasound Machine to also measure joint laxity.
Participants will first undergo a series of physical examination tests performed by a Licensed Athletic Trainer. Participants will remain seated on the exam table, and the study team member will perform the "Anterior Drawer Test of the Ankle" and the "Talar Tilt Test" to assess the stability of the participants ankle ligaments.
Following the physical exam tests, participants will remain seated on the exam table and will be outfitted with the ankle arthrometer. Once the arthrometer is fitted, participants will have their foot placed in various positions, and the arthrometer will record measures.
Following the ankle arthrometer, participants will remain seated on the exam table and the ultrasound imaging unit will be used to assess joint laxity in the same positions that were used for the ankle arthrometer.
Following the completion of ultrasound images, participants will be dismissed. Participants will then report back 2 weeks later for visit 2. Visit 2 consist of completion of the FAAM, physical exam tests, ankle arthrometer, and ultrasound imaging again. Visit 3 will consist of the same study procedure, however the timepoint will be 4 weeks after visit 1.
Following visit 3, participation in the study will be complete.
- Conditions
- Chronic Ankle Instability, CAI, Ankle Sprain, Healthy
- Being tested
- Cobra Ankle Arthrometer
- Keywords
- Arthrometer, Ankle, Validity, Reliability
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cobra Ankle ArthrometerDevice
This is a prototype portable ankle arthrometer designed to measure the laxity of the ankle joint.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Individuals that have never sprained their ankle. Receives: Device: Cobra Ankle Arthrometer | |
| Copers | Individuals that have sprained their ankle one time, with no residual problems. Receives: Device: Cobra Ankle Arthrometer | |
| CAI | Individuals that have been diagnosed with chronic ankle instability. Receives: Device: Cobra Ankle Arthrometer | |
| Acute Sprain | Individuals that have sprained their ankle in the last 96 hours. Receives: Device: Cobra Ankle Arthrometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle laxity
Measured with both the ankle arthrometer and ultrasound imaging. Both will report units of displacement.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle Instability, CAIStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Hertel, PhD, ATC, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163897
- Sponsor's protocol ID
- 302715
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Portable Ankle Arthrometer
- ClinicalTrials.gov ID
- NCT07163897
- Acronym / sponsor ID
- 302715
- Conditions
- Chronic Ankle Instability, CAI, Ankle Sprain, Healthy
- Keywords
- Arthrometer, Ankle, Validity, Reliability
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 9 Sep 2025 (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.
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.
Detailed description
Aim 1: Participants will report to the Exercise and Sport Injury laboratory to provide informed consent before any study procedures take place. Following consent, there will be an approximate 1 hour data collection period. There will be 2 different days of data collection, with informed consent being provided only at the first session.
Demographics \& Health History: Participants will answer several surveys including a medical history questionnaire, physical activity readiness questionnaire (ParQ), international physical activity questionnaire (IPAQ - short form), identification of functional ankle instability (IdFAI), and a foot and ankle ability measure (FAAM). Measures of age, height, weight, sex, and race or ethnicity will be recorded by practitioners prior to testing. Information gathered will be used to ensure all participants fit the study inclusion criteria.
Instrumentation will include a prototype portable ankle arthrometer created by Luna Labs to measure joint laxity and a GE Healthcare Ultrasound Machine to also measure joint laxity.
Participants will first undergo a series of physical examination tests performed by a Licensed Athletic Trainer. Participants will remain seated on the exam table, and the study team member will perform the "Anterior Drawer Test of the Ankle" and the "Talar Tilt Test" to assess the stability of the participants ankle ligaments.
Following the physical exam tests, participants will remain seated on the exam table and will be outfitted with the ankle arthrometer. Once the arthrometer is fitted, participants will have their foot placed in various positions, and the arthrometer will record measures.
Following the ankle arthrometer, participants will remain seated on the exam table and the ultrasound imaging unit will be used to assess joint laxity in the same positions that were used for the ankle arthrometer.
Following the completion of ultrasound images, participants will be dismissed. Participants will then report back a week later for visit 2. Visit 2 consist of the physical exam tests, ankle arthrometer, and ultrasound imaging again.
Following visit 2, participation in the study will be complete.
Aim 2: Participants will report to the Exercise and Sport Injury laboratory to provide informed consent before any study procedures take place. Following consent, there will be an approximate 1 hour data collection period. There will be 3 different days of data collection, with informed consent being provided only at the first session.
Demographics \& Health History: Participants will answer several surveys including a medical history questionnaire, physical activity readiness questionnaire (ParQ), international physical activity questionnaire (IPAQ - short form), and a foot and ankle ability measure (FAAM). Measures of age, height, weight, sex, and race or ethnicity will be recorded by practitioners prior to testing. Information gathered will be used to ensure all participants fit the study inclusion criteria.
Instrumentation will include a prototype portable ankle arthrometer created by Luna Labs to measure joint laxity and a GE Healthcare Ultrasound Machine to also measure joint laxity.
Participants will first undergo a series of physical examination tests performed by a Licensed Athletic Trainer. Participants will remain seated on the exam table, and the study team member will perform the "Anterior Drawer Test of the Ankle" and the "Talar Tilt Test" to assess the stability of the participants ankle ligaments.
Following the physical exam tests, participants will remain seated on the exam table and will be outfitted with the ankle arthrometer. Once the arthrometer is fitted, participants will have their foot placed in various positions, and the arthrometer will record measures.
Following the ankle arthrometer, participants will remain seated on the exam table and the ultrasound imaging unit will be used to assess joint laxity in the same positions that were used for the ankle arthrometer.
Following the completion of ultrasound images, participants will be dismissed. Participants will then report back 2 weeks later for visit 2. Visit 2 consist of completion of the FAAM, physical exam tests, ankle arthrometer, and ultrasound imaging again. Visit 3 will consist of the same study procedure, however the timepoint will be 4 weeks after visit 1.
Following visit 3, participation in the study will be complete.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Device: Cobra Ankle ArthrometerIndividuals that have never sprained their ankle. |
| Copers | – | Device: Cobra Ankle ArthrometerIndividuals that have sprained their ankle one time, with no residual problems. |
| CAI | – | Device: Cobra Ankle ArthrometerIndividuals that have been diagnosed with chronic ankle instability. |
| Acute Sprain | – | Device: Cobra Ankle ArthrometerIndividuals that have sprained their ankle in the last 96 hours. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample.
Key inclusion criteria (10 listed)
- 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.
- Young adults between the ages of 18 and 40.
Key exclusion criteria (5 listed)
- Previous history of ankle fracture.
- Diagnosis of Ehlers-Danlos Syndrome
- Previous history of ankle fracture.
- Diagnosis of Ehlers-Danlos Syndrome.
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 |
|---|---|---|
| Cobra Ankle ArthrometerThis is a prototype portable ankle arthrometer designed to measure the laxity of the ankle joint. | Device | Acute Sprain, CAI, Copers, Healthy |
Primary outcome
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).
Measured with both the ankle arthrometer and ultrasound imaging. Both will report units of displacement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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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.
UVA Department of Student Health and Wellness
Charlottesville, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Ankle Instability, CAI and Ankle Sprain, run by University of Virginia at 1 site in United States.
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 10 inclusion and 5 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: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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).). 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 9 Sep 2025.