Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-02 @ 6:08 AM
Study NCT ID:
NCT06927557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-15
First Post:
2025-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Applicability of the Cumberland Ankle Instability Tool in Basketball Athletes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2025-03-18', 'studyFirstSubmitQcDate': '2025-04-14', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumberland Ankle Instability Tool', 'timeFrame': 'Baseline and after one week', 'description': 'The CAIT, a 9-item scale, was developed by Hiller et al., in 2006 to assess ankle instability. It encompasses aspects such as ankle pain, instability during activities of daily living, foot adaptation during physical movements, and the perception of spatial awareness in the foot (Hiller et al., 2006). The questionnaire is designed to capture the feeling of instability across various activities, including running, walking, jumping, and descending stairs. Scores on the scale range from 0 to 30, with higher scores indicating greater ankle stability and 0 representing the worst possible score indicating severe instability.'}], 'secondaryOutcomes': [{'measure': 'Foot and Ankle Ability Measure (FAAM)', 'timeFrame': 'Baseline', 'description': "The Foot and Ankle Ability Measure (FAAM) is a self-reported questionnaire designed to assess functional limitations in individuals with foot and ankle disorders. It evaluates a patient's ability to perform daily and sports-related activities.\n\nStructure of FAAM:\n\nFAAM consists of two subscales:\n\nActivities of Daily Living (ADL) Subscale - Includes 21 items assessing functional abilities in everyday activities.\n\nSports Subscale - Includes 8 items evaluating performance in sports-related movements.\n\nEach item is scored using a 5-point Likert scale, ranging from 4 (No difficulty) to 0 (Unable to do it).\n\nScoring:\n\nEach subscale score is calculated as a percentage of the total possible score. Higher scores indicate better foot and ankle function, while lower scores suggest greater disability."}, {'measure': 'The Identification of Functional Ankle Instability (IdFAI)', 'timeFrame': 'Baseline', 'description': 'The Identification of Functional Ankle Instability (IdFAI) is a self-reported questionnaire designed to assess the presence and severity of functional ankle instability (FAI) in individuals with a history of ankle sprains or instability.\n\nStructure of IdFAI:\n\nThe questionnaire consists of 10 items that evaluate:\n\nHistory of ankle sprains Perceived ankle instability Functional limitations during daily and sports activities Each item is scored on a weighted scale, with higher scores indicating a greater degree of functional ankle instability.\n\nScoring:\n\nThe total IdFAI score ranges from 0 to 37. Scores ≥ 11 indicate the presence of functional ankle instability. Higher scores suggest greater severity of instability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ankle instability', 'validity study', 'reliability study'], 'conditions': ['Ankle Injuries', 'Ankle Sprains']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to evaluate the applicability, validity, and reliability of the Cumberland Ankle Instability Tool (CAIT) in basketball athletes. Given that a significant proportion of injuries in basketball occur in the ankle, our study holds importance for instability assessments conducted in this population. If the Cumberland Ankle Instability Tool is found to be applicable in basketball athletes, it may be utilized in future research.', 'detailedDescription': 'The aim of our study is to evaluate the applicability, validity, and reliability of the Cumberland Ankle Instability Tool (CAIT) in basketball athletes. Since most injuries in basketball occur in the ankle, our study is significant for assessing instability in this population. If the Cumberland Ankle Instability Tool is found to be applicable in basketball athletes, it may be utilized in future research.\n\nHypotheses:\n\nH₀ (Null Hypothesis): The Cumberland Ankle Instability Tool is not applicable, valid, or reliable in basketball athletes.\n\nH₁ (Alternative Hypothesis): The Cumberland Ankle Instability Tool is applicable, valid, and reliable in basketball athletes.\n\nThe demographic information of the athletes, including height, age, weight, and years of sports experience, will be recorded. The Cumberland Ankle Instability Tool (CAIT) will be created using Google Forms and distributed to the athletes online.\n\nTo assess the reliability of the questionnaire, it will be administered twice to the athletes within a 3 to 7-day interval. The following reliability parameters will be calculated:\n\nInternal consistency, Test-retest reliability, Standard error of measurement (SEM), Minimal detectable change (MDC). For validity assessment, the relationship between the Cumberland Ankle Instability Tool (CAIT) and the Foot and Ankle Ability Measure (FAAM) as well as the Identification of Functional Ankle Instability (IdFAI) will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Basketball athletes with a history of ankle sprain, at least one year of basketball experience, and who participate in basketball training at least once per week.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 16 and 45\n* History of ankle sprain\n* Participation in basketball training at least once per week\n\nExclusion Criteria:\n\n* Participation in basketball training at least once per week'}, 'identificationModule': {'nctId': 'NCT06927557', 'acronym': 'The CAIT', 'briefTitle': 'The Applicability of the Cumberland Ankle Instability Tool in Basketball Athletes.', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Applicability of the Cumberland Ankle Instability Tool in Basketball Athletes: Validity and Reliability Study', 'orgStudyIdInfo': {'id': 'SUBU 3'}, 'secondaryIdInfos': [{'id': '13.03.2025- 54/20', 'type': 'OTHER', 'domain': 'Sakarya University of Applied Sciences'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Birgül Dıngırdan', 'role': 'CONTACT', 'email': 'birguldingirdan@gmail.com', 'phone': '05444694932'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sakarya University of Applied Sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assisstant', 'investigatorFullName': 'Birgül Dıngırdan', 'investigatorAffiliation': 'Hacettepe University'}}}}