NCT07579793

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

Same day

First QC Date

May 5, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

chronic ankle instabilityrisk factorsdynamic balancemuscle sizeligament size

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    15 minute

Secondary Outcomes (2)

  • Foot and Ankle Ability Measure (FAAM)

    15 minute

  • Cumberland Ankle Instability Tool (CAIT)

    10 minute

Study Arms (2)

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).

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 12, 2026

Study Start

May 15, 2025

Primary Completion

May 15, 2025

Study Completion

May 15, 2025

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations