Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:05 AM
Study NCT ID:
NCT07421492
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postural Control in Amateur Footballers With Chronic Ankle Instability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Limits of Stability Total Score (%) During Force-Platform Dynamic Postural Control Assessment at Baseline', 'timeFrame': 'Baseline (single laboratory assessment session)', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Postural Sway Area (mm²) During Static Balance Assessment With Eyes Open and Eyes Closed at Baseline', 'timeFrame': 'Baseline (single laboratory assessment session)'}]}, 'conditionsModule': {'conditions': ['Chronic Ankle Instability, CAI']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male amateur football players competing in a regional league, including athletes with and without chronic ankle instability.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male amateur football players with at least 2 years of competitive participation and ≥5 years of regular sports activity\n* Weekly football training volume of at least 3 hours\n* 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\n* Presence of ≥2 episodes of giving-way or perceived ankle instability within the previous 6 months\n* CAIT score ≤24 for classification as chronic ankle instability\n* For the control group: no history of ankle sprain or perceived ankle instability and CAIT score ≥25\n* Participants free from ankle pain and acute inflammation at the time of assessment\n\nExclusion Criteria:\n\n* History of lower-extremity fracture or surgical intervention\n* Musculoskeletal injury of the knee, hip, or spine within the last 3 months\n* Diagnosed vestibular disorder or systemic balance impairment unrelated to the ankle\n* Active ankle pain or acute inflammatory symptoms at the time of testing\n* Any cardiovascular or systemic disease limiting safe participation in testing'}, 'identificationModule': {'nctId': 'NCT07421492', 'briefTitle': 'Postural Control in Amateur Footballers With Chronic Ankle Instability', 'organization': {'class': 'OTHER', 'fullName': 'Igdir University'}, 'officialTitle': 'Static and Dynamic Postural Control in Amateur Footballers With Chronic Ankle Instability: A Machine-Learning-Based Injury Risk Profiling Approach', 'orgStudyIdInfo': {'id': '02.01.2026 - 2026/1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dynamic stabilization with Tecnobody D-Wall', 'type': 'OTHER', 'description': '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.'}, {'name': 'Static Balance Test with Tecnobody D-Wall', 'type': 'OTHER', 'description': '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.'}, {'name': 'Cumberland Ankle Instability Tool', 'type': 'OTHER', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Iğdır', 'country': 'Turkey (Türkiye)', 'facility': 'Iğdır University', 'geoPoint': {'lat': 39.92371, 'lon': 44.045}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Igdir University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof.', 'investigatorFullName': 'Erkan Güven', 'investigatorAffiliation': 'Igdir University'}}}}