NCT07421492

Brief Summary

This study will investigate static and dynamic postural control characteristics in male amateur football players with chronic ankle instability (CAI) compared with football players without ankle instability. Participants will undergo standardized biomechanical assessments using a force-platform-based postural analysis system to quantify postural sway under eyes-open and eyes-closed conditions and to evaluate direction-specific limits of stability performance. In addition to conventional between-group comparisons, objective balance and stabilization variables will be used to develop supervised machine-learning classification models. These models will examine whether athletes demonstrating CAI-like functional patterns can be identified based solely on biomechanical performance data, independent of self-reported instability questionnaires. The results are expected to enhance understanding of neuromuscular control deficits associated with chronic ankle instability and to support the development of objective, performance-based assessment approaches for football players. The aim of this study is to determine the differences in static and dynamic postural control between amateur football players with and without chronic ankle instability and to evaluate whether multidimensional biomechanical balance parameters can be used to objectively characterize CAI-related functional profiles using machine-learning-based analysis.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

February 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

27 days

First QC Date

February 12, 2026

Last Update Submit

February 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Limits of Stability Total Score (%) During Force-Platform Dynamic Postural Control Assessment at Baseline

    Dynamic postural control will be evaluated using the limited stabilization (limits of stability) test performed on a force-platform-based postural analysis system. The total limits of stability score (%) reflects the participant's ability to voluntarily control the center of pressure within stability boundaries, with lower values indicating impaired neuromuscular ankle stabilization.

    Baseline (single laboratory assessment session)

Secondary Outcomes (1)

  • Postural Sway Area (mm²) During Static Balance Assessment With Eyes Open and Eyes Closed at Baseline

    Baseline (single laboratory assessment session)

Interventions

Participants will undergo a non-invasive dynamic balance assessment using a force-platform-based postural analysis system. While standing on the platform, they will intentionally shift their center of pressure toward visual targets in multiple directions to evaluate voluntary postural control within stability limits. The test records total stability performance and directional control (%), test duration (s), and trunk deviation (°), reflecting proprioception and ankle stabilization capacity.

Participants will perform a static postural stability test on a force-platform while standing quietly in an upright position under eyes-open and eyes-closed conditions. The system will measure postural sway area (mm²) to quantify the ability to maintain balance with and without visual input. This assessment evaluates sensory integration and proprioceptive control associated with ankle stability.

The Cumberland Ankle Instability Tool is a validated self-reported questionnaire consisting of 9 items used to assess perceived ankle instability during daily and sport-related activities. It evaluates symptoms such as episodes of giving-way, pain, and functional control of the ankle, with total scores ranging from 0 to 30 (lower scores indicate greater instability). The CAIT is used as a screening questionnaire to classify participants according to the presence or absence of chronic ankle instability.

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male amateur football players competing in a regional league, including athletes with and without chronic ankle instability.

You may qualify if:

  • Male amateur football players with at least 2 years of competitive participation and ≥5 years of regular sports activity
  • Weekly football training volume of at least 3 hours
  • For the CAI group: history of ≥1 significant lateral ankle sprain occurring ≥12 months before testing that caused pain, swelling, and temporary interruption of sports participation
  • Presence of ≥2 episodes of giving-way or perceived ankle instability within the previous 6 months
  • CAIT score ≤24 for classification as chronic ankle instability
  • For the control group: no history of ankle sprain or perceived ankle instability and CAIT score ≥25
  • Participants free from ankle pain and acute inflammation at the time of assessment

You may not qualify if:

  • History of lower-extremity fracture or surgical intervention
  • Musculoskeletal injury of the knee, hip, or spine within the last 3 months
  • Diagnosed vestibular disorder or systemic balance impairment unrelated to the ankle
  • Active ankle pain or acute inflammatory symptoms at the time of testing
  • Any cardiovascular or systemic disease limiting safe participation in testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iğdır University

Iğdır, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

February 1, 2026

Primary Completion

February 28, 2026

Study Completion

March 15, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations