Chronic Instability of Ankle JointNCT07579793
Differences in Ankle Sprain Risk Factors, Anterior Talofibular Ligament, Calcaneofibular Ligament and Lower Leg Muscles' Size Among Athletes With and Without Ankle Sprain Injury History: A Retrospective Study
An observational study of Chronic Instability of Ankle Joint and Dynamic Balance, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to comprehensively explore the relationship between changes in muscle architecture and connective tissue structure in athletes with ankle sprains and the intrinsic biomechanical risk factors observed in these individuals. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Instability of Ankle Joint, Dynamic Balance, Muscle Size
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 15 May 2025
- How long will I take part?
- 6 Months
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study is a retrospective, cross-sectional investigation conducted to evaluate the relationship between intrinsic risk factors, including muscle and ligament sizes, dynamic balance, postural stability, proprioception and ankle instability in athletes diagnosed with chronic ankle instability (CAI). Participants will be equally recruited into the group with athletes who have a lateral ankle sprain history (LAS Group) and the Control group, with consideration for gender stratification (groups will have the same number of males and females).
Who may be able to join
- At least 5 years of active participation in any sport.
- Age between 18 and 35.
- A history of at least two clinically diagnosed LAS episodes with inflammatory symptoms like pain and swelling.
- The last sprain occurred at least 3 months before the study start, and the participant has fully returned to their sport.
- No previous surgeries affecting
Who cannot join
- Any history of ankle fracture.
- Surgery or systemic disease impacting sensorimotor function in the lower limb.
- Neurological disorders.
- Recent (within a month) acute injury to the lower extremity.
- Visual or vestibular issues that impair balance or coordination.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to comprehensively explore the relationship between changes in muscle architecture and connective tissue structure in athletes with ankle sprains and the intrinsic biomechanical risk factors observed in these individuals. The main goal of the research is to compare the risk factors associated with ankle sprains, characteristics of lower extremity muscle architecture, and structural features of the anterior talofibular ligament (ATFL) between athletes with and without a history of ankle sprains. Additionally, the study seeks to identify intrinsic factors that may lead to lateral ankle sprains and to investigate the link between these factors and structural changes related to chronic ankle instability. Overall, the study aims to contribute scientifically to the early detection of sprain risk in athletes and the development of personalised preventative intervention strategies.
The hypotheses of the study are as follows:
Read more
Hypothesis 1: In athletes with a history of ankle sprains, the strength of the muscles surrounding the ankle differs from that of their uninjured ankles and ankles of the athletes without a history of sprains.
Hypothesis 2: Athletes with a history of ankle sprains have a different level of proprioception (position sense) compared to athletes without a history of sprains.
Hypothesis 3: Athletes with a history of ankle sprains have different muscle and ligament sizes compared to their uninjured legs and the legs of athletes without a history of sprains.
Hypothesis 4: Dynamic balance differs between athletes with a history of ankle sprains and those without a history of ankle sprains.
Read the detailed description
Ankle instability exhibits a significant propensity to evolve into a chronic condition. Chronic ankle instability (CAI), defined by enduring residual symptoms following a sprain, recurrent sprains, and perceived instability, occurs in approximately 10% to 40% of cases. According to research conducted by Van Rijn and colleagues, between 5% and 33% of patients continued to experience pain one year subsequent to an ankle sprain, and one-third of the participants reported at least one re-sprain three years thereafter (4, 6).
Research indicates that a minimum of 73% of individuals who have sustained an ankle sprain exhibit persistent symptoms, including pain, a sensation of instability, proprioceptive disturbances, and impairments in neuromuscular control (7, 8). This condition presents a significant risk of both re-injury and the development of CAI. A history of multiple sprains and recurrent feelings of instability are identified as CAI, and the ongoing nature of this condition increases joint damage and the likelihood of osteoarthritis (9). The treatment and prevention of these injuries are costly and hinder athletes' return to training and competition (10).
Numerous intrinsic risk factors have been identified in the literature concerning the incidence and recurrence of lateral ankle sprains. These risk factors include a previous sprain history, gender, height, body weight, anatomical foot posture, alignment abnormalities (e.g., pes cavus, genu varum), joint laxity, joint range of motion, muscle strength, proprioception, reaction time, and postural control (11). Current studies show that, although there are differences in performance levels between genders, there is no significant difference in exposure to injury risk (12, 13). Conversely, it is stated that a direct relationship exists between height, body weight, ankle laxity, muscle strength, and postural control and lateral sprains (7). When assessed in terms of muscle strength, weakness in the ankle and hip muscles is an important risk factor for the development of LAS. Research shows that athletes with more than 15% strength asymmetry, especially during the pre-season, face a higher risk of sprain compared to those without such asymmetry. Postural balance disorders are also regarded as a significant intrinsic risk factor in the development of LAS. In conclusion, ankle sprains are common injuries among athletes and can lead to significant functional impairments. Identifying intrinsic risk factors for these injuries and implementing targeted preventive strategies through individual assessments are essential for both injury prevention and reducing the development of OAS. A review of current literature shows that there are limited studies that thoroughly examine changes in the architecture and functional performance of the muscles around the ankle in athletes who have experienced recurrent ankle sprains. This study aims to comprehensively explore the relationship between changes in muscle architecture and connective tissue structure in athletes with ankle sprains and the intrinsic biomechanical risk factors observed in these individuals.
- Keywords
- chronic ankle instability, risk factors, dynamic balance, muscle size, ligament size
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | The control group will include athletes who have no history of ankle injuries. | |
| Ankle Instability Group | The group will consist of athletes diagnosed with chronic ankle instability (CAI). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle and Ligament Size Assessment
Muscle and ATFL thickness will be measured using an HS60 ultrasound system (Samsung Medicine, Gangwon-do, Korea) with a 5-13 MHz linear probe. Muscle cross-sectional area (MCA) of the ankle muscles will be assessed under two conditions: resting and maximal voluntary contraction (MVC), using B-mode ultrasound. All measurements will be taken by a physical therapist experienced in musculoskeletal ultrasound. Participants will lie on a medical bed with legs fully extended, the ankle in a neutral position, and muscles relaxed during imaging.
Measured: 1 hour
Dynamic Balance Assessment
The Y balance test, a short and practical variation of the star balance test, will be used to assess dynamic stability. Athletes will perform the Y balance test according to the test procedures defined by Plisky et al. Three white bands, each 125 cm in length, will be affixed to the ground to form a Y shape, with the small angle at 90° and the two larger angles at 135°, and centimeter-scale markings will be added to the bands by hand.Participants will be positioned at the center of the apparatus with the second phalanges of the extremity being tested in the coronal plane and the metatarsophalangeal joints in the sagittal plane, both aligned with the midline. Participants will be asked to stand with their hands at the level of the iliac crest, adjacent to their bodies, and with the foot to be measured on the ground, to reach out with the other foot in the anterior, posteromedial, and posterolateral directions, once in each direction, and to lightly touch the final point they can reach.
Measured: 15 minute
Proprioception Assessment
An ankle joint position sense test will be administered to assess deficiencies in ankle proprioception. An electronic goniometer will be used to assess ankle joint position sense. The reliability of this test among recreational athletes with ankle instability has been reported as ICC = 0.94-0.98 [45]. Athletes will be seated with their knees flexed at 90°, and their eyes will be closed to eliminate visual cues. The ankle subtalar joint (STJN) will be held in a neutral position, and the goniometer will be set to zero. The ankle will be passively moved through 10° dorsiflexion, 10° eversion, 15° plantar flexion, or 15° inversion, and then returned to the neutral position [46]. Participants will then be asked to actively perform these movements as closely as possible to the previous movements. Three repeated measurements will be taken for each test angle, and deviations from the target angle will be recorded.
Measured: 15 minute
Postural Stability Assessment
Athletes' postural stability and center of pressure (CoP) assessments will be performed using the Prokin force platform (Prokin PK 252). The Prokin PK 252 is a proprioceptive system used for static and dynamic balance assessment and training. In this study, the "Static and Dynamic Stability Assessment Program" will be used to provide detailed and accurate data on participants' static standing posture through the stabilometry platform and sensors placed on the body [47]. During the test, participants' standing position will be determined with their feet shoulder-width apart, and their foot positions will be aligned at equal distances from the origin point, using the lines on the platform's x and y axes as references.First, a single-leg static stability test will be performed. This test will be administered in two sub-tests: with eyes open and with eyes closed.
Measured: 20 minute
Muscle Strength Assessment
Isometric muscle strength measurements of the tibialis anterior, peroneus longus and brevis, gastrocnemius, and gluteus medius muscle groups will be performed using a MicroFET digital handheld dynamometer. Measurements will be conducted with participants positioned supine, side-lying, and prone on an examination table [34]. For each muscle group, participants will be asked to perform three maximal voluntary contractions lasting 5 seconds each, with a 1-minute rest between contractions. All measurements will be conducted by the same examiner, and all three recorded values will be used for data analysis.
Measured: 15 minute
Secondary outcomes (2)
Foot and Ankle Ability Measure (FAAM)
Athletes' physical functions will be assessed using the Turkish version of the Foot and Ankle Ability Measure (FAAM). FAAM is a self-report measurement tool developed to assess the physical functions of individuals with musculoskeletal problems related to the foot and ankle. The FAAM consists of a total of 29 items, including a 21-item Activities of Daily Living (ADL) subscale and an 8-item Sports subscale. The Sports subscale provides a sports-specific subclass to assess the ability to perform sports-related activities. Each question is scored using a 5-point Likert scale ranging from 0 (unable to perform) to 4 (able to perform without difficulty). The maximum score for the ADL subscale is 84, while the maximum score for the Sports subscale is 32. Total scores are calculated as percentage scores ranging from 0% to 100%, with a higher score indicating a higher level of function [48].
Measured: 15 minute
Cumberland Ankle Instability Tool (CAIT)
Cumberland Ankle Instability Tool Developed in 2006, the Cumberland Ankle Instability Tool 17 (CAIT) was the first to provide a numerical value measuring the level of ankle instability based on individuals' perceptions [41]. The CAIT scale, designed to assess functional ankle instability levels, consists of 9 questions; the maximum total score is 30 and the minimum is 0. A lower total score indicates more severe functional ankle instability. Test-retest reliability was found to be excellent at 0.96. The CAIT is the first tool to validly and reliably assess functional ankle instability. In the study, the cutoff score was set at 27.5, with a sensitivity of 82.9% and a specificity of 74.7%. Finally, the CAIT score has the potential to predict the risk of re-sprain in individuals with functional ankle instability. Individuals with a sprained ankle and a low CAIT score have a higher likelihood of re-sprain, while those with a high CAIT score have a lower likelihood of re-sprain [42].
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start15 May 2025
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Instability of Ankle JointStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilüfer Kılıç Cerbezer, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579793
- Sponsor's protocol ID
- MedipolU
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Ankle Sprain Risk Factors, Anterior Talofibular Ligament, Calcaneofibular Ligament and Lower Leg Muscles' Size Among Athletes With and Without Ankle Sprain Injury History: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07579793
- Acronym / sponsor ID
- MedipolU
- Keywords
- chronic ankle instability, risk factors, dynamic balance, muscle size, ligament size
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 12 May 2026 (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.
This study aims to comprehensively explore the relationship between changes in muscle architecture and connective tissue structure in athletes with ankle sprains and the intrinsic biomechanical risk factors observed in these individuals. The main goal of the research is to compare the risk factors associated with ankle sprains, characteristics of lower extremity muscle architecture, and structural features of the anterior talofibular ligament (ATFL) between athletes with and without a history of ankle sprains. Additionally, the study seeks to identify intrinsic factors that may lead to lateral ankle sprains and to investigate the link between these factors and structural changes related to chronic ankle instability. Overall, the study aims to contribute scientifically to the early detection of sprain risk in athletes and the development of personalised preventative intervention strategies.
The hypotheses of the study are as follows:
Hypothesis 1: In athletes with a history of ankle sprains, the strength of the muscles surrounding the ankle differs from that of their uninjured ankles and ankles of the athletes without a history of sprains.
Hypothesis 2: Athletes with a history of ankle sprains have a different level of proprioception (position sense) compared to athletes without a history of sprains.
Hypothesis 3: Athletes with a history of ankle sprains have different muscle and ligament sizes compared to their uninjured legs and the legs of athletes without a history of sprains.
Hypothesis 4: Dynamic balance differs between athletes with a history of ankle sprains and those without a history of ankle sprains.
Detailed description
Ankle instability exhibits a significant propensity to evolve into a chronic condition. Chronic ankle instability (CAI), defined by enduring residual symptoms following a sprain, recurrent sprains, and perceived instability, occurs in approximately 10% to 40% of cases. According to research conducted by Van Rijn and colleagues, between 5% and 33% of patients continued to experience pain one year subsequent to an ankle sprain, and one-third of the participants reported at least one re-sprain three years thereafter (4, 6).
Research indicates that a minimum of 73% of individuals who have sustained an ankle sprain exhibit persistent symptoms, including pain, a sensation of instability, proprioceptive disturbances, and impairments in neuromuscular control (7, 8). This condition presents a significant risk of both re-injury and the development of CAI. A history of multiple sprains and recurrent feelings of instability are identified as CAI, and the ongoing nature of this condition increases joint damage and the likelihood of osteoarthritis (9). The treatment and prevention of these injuries are costly and hinder athletes' return to training and competition (10).
Numerous intrinsic risk factors have been identified in the literature concerning the incidence and recurrence of lateral ankle sprains. These risk factors include a previous sprain history, gender, height, body weight, anatomical foot posture, alignment abnormalities (e.g., pes cavus, genu varum), joint laxity, joint range of motion, muscle strength, proprioception, reaction time, and postural control (11). Current studies show that, although there are differences in performance levels between genders, there is no significant difference in exposure to injury risk (12, 13). Conversely, it is stated that a direct relationship exists between height, body weight, ankle laxity, muscle strength, and postural control and lateral sprains (7). When assessed in terms of muscle strength, weakness in the ankle and hip muscles is an important risk factor for the development of LAS. Research shows that athletes with more than 15% strength asymmetry, especially during the pre-season, face a higher risk of sprain compared to those without such asymmetry. Postural balance disorders are also regarded as a significant intrinsic risk factor in the development of LAS. In conclusion, ankle sprains are common injuries among athletes and can lead to significant functional impairments. Identifying intrinsic risk factors for these injuries and implementing targeted preventive strategies through individual assessments are essential for both injury prevention and reducing the development of OAS. A review of current literature shows that there are limited studies that thoroughly examine changes in the architecture and functional performance of the muscles around the ankle in athletes who have experienced recurrent ankle sprains. This study aims to comprehensively explore the relationship between changes in muscle architecture and connective tissue structure in athletes with ankle sprains and the intrinsic biomechanical risk factors observed in these individuals.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –The control group will include athletes who have no history of ankle injuries. |
| Ankle Instability Group | – | –The group will consist of athletes diagnosed with chronic ankle instability (CAI). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study is a retrospective, cross-sectional investigation conducted to evaluate the relationship between intrinsic risk factors, including muscle and ligament sizes, dynamic balance, postural stability, proprioception and ankle instability in athletes diagnosed with chronic ankle instability (CAI). Participants will be equally recruited into the group with athletes who have a lateral ankle sprain history (LAS Group) and the Control group, with consideration for gender stratification (groups will have the same number of males and females).
Key inclusion criteria (5 listed)
- At least 5 years of active participation in any sport.
- Age between 18 and 35.
- A history of at least two clinically diagnosed LAS episodes with inflammatory symptoms like pain and swelling.
- The last sprain occurred at least 3 months before the study start, and the participant has fully returned to their sport.
- No previous surgeries affecting
Key exclusion criteria (5 listed)
- Any history of ankle fracture.
- Surgery or systemic disease impacting sensorimotor function in the lower limb.
- Neurological disorders.
- Recent (within a month) acute injury to the lower extremity.
- Visual or vestibular issues that impair balance or coordination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle and Ligament Size Assessment
Time frame: 1 hour
Muscle and ATFL thickness will be measured using an HS60 ultrasound system (Samsung Medicine, Gangwon-do, Korea) with a 5-13 MHz linear probe. Muscle cross-sectional area (MCA) of the ankle muscles will be assessed under two conditions: resting and maximal voluntary contraction (MVC), using B-mode ultrasound. All measurements will be taken by a physical therapist experienced in musculoskeletal ultrasound. Participants will lie on a medical bed with legs fully extended, the ankle in a neutral position, and muscles relaxed during imaging.
Dynamic Balance Assessment
Time frame: 15 minute
The Y balance test, a short and practical variation of the star balance test, will be used to assess dynamic stability. Athletes will perform the Y balance test according to the test procedures defined by Plisky et al. Three white bands, each 125 cm in length, will be affixed to the ground to form a Y shape, with the small angle at 90° and the two larger angles at 135°, and centimeter-scale markings will be added to the bands by hand.Participants will be positioned at the center of the apparatus with the second phalanges of the extremity being tested in the coronal plane and the metatarsophalangeal joints in the sagittal plane, both aligned with the midline. Participants will be asked to stand with their hands at the level of the iliac crest, adjacent to their bodies, and with the foot to be measured on the ground, to reach out with the other foot in the anterior, posteromedial, and posterolateral directions, once in each direction, and to lightly touch the final point they can reach.
Proprioception Assessment
Time frame: 15 minute
An ankle joint position sense test will be administered to assess deficiencies in ankle proprioception. An electronic goniometer will be used to assess ankle joint position sense. The reliability of this test among recreational athletes with ankle instability has been reported as ICC = 0.94-0.98 [45]. Athletes will be seated with their knees flexed at 90°, and their eyes will be closed to eliminate visual cues. The ankle subtalar joint (STJN) will be held in a neutral position, and the goniometer will be set to zero. The ankle will be passively moved through 10° dorsiflexion, 10° eversion, 15° plantar flexion, or 15° inversion, and then returned to the neutral position [46]. Participants will then be asked to actively perform these movements as closely as possible to the previous movements. Three repeated measurements will be taken for each test angle, and deviations from the target angle will be recorded.
Postural Stability Assessment
Time frame: 20 minute
Athletes' postural stability and center of pressure (CoP) assessments will be performed using the Prokin force platform (Prokin PK 252). The Prokin PK 252 is a proprioceptive system used for static and dynamic balance assessment and training. In this study, the "Static and Dynamic Stability Assessment Program" will be used to provide detailed and accurate data on participants' static standing posture through the stabilometry platform and sensors placed on the body [47]. During the test, participants' standing position will be determined with their feet shoulder-width apart, and their foot positions will be aligned at equal distances from the origin point, using the lines on the platform's x and y axes as references.First, a single-leg static stability test will be performed. This test will be administered in two sub-tests: with eyes open and with eyes closed.
Muscle Strength Assessment
Time frame: 15 minute
Isometric muscle strength measurements of the tibialis anterior, peroneus longus and brevis, gastrocnemius, and gluteus medius muscle groups will be performed using a MicroFET digital handheld dynamometer. Measurements will be conducted with participants positioned supine, side-lying, and prone on an examination table [34]. For each muscle group, participants will be asked to perform three maximal voluntary contractions lasting 5 seconds each, with a 1-minute rest between contractions. All measurements will be conducted by the same examiner, and all three recorded values will be used for data analysis.
2 secondary outcomes
Foot and Ankle Ability Measure (FAAM)
Time frame: 15 minute
Cumberland Ankle Instability Tool (CAIT)
Time frame: 10 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Instability of Ankle Joint and Dynamic Balance, run by Yeditepe University at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 12 May 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle and Ligament Size Assessment (time frame: 1 hour). The study lists 5 primary outcomes in all. 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 12 May 2026.