Validation of a Portable Ankle Arthrometer

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects Of Rehabilitation Incorporating Gait Training On Clinical Measures Associated With Chronic Ankle Instability

NCT02533037

Chronic Ankle Instability

COMPLETED PHASE2/PHASE3

Progressing Ankle Brace Restriction on Walking and Running Gait Characteristics in Healthy Individuals

NCT03641066

Ankle Sprains

COMPLETED NA

Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability

NCT06829667

Lateral Ankle Instability

ENROLLING_BY_INVITATION

The Influence of Stability Boots on Gait Pattern in Healthy Adults

NCT03038815

Rehabilitation After Ankle Injuries

COMPLETED NA

Chronic Ankle Instability Diagnostic Tests Determining Underlying Deficits

NCT03818438

Ankle Dislocation Chronic Ankle Instability

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Ankle Instability, CAI Ankle Sprain Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

* 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:

Exclusion Criteria

* Previous history of ankle fracture.
* Diagnosis of Ehlers-Danlos Syndrome

Aim 2:

* Previous history of ankle fracture.
* Diagnosis of Ehlers-Danlos Syndrome.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes