Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT04064502
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2019-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chronıc Ankle Instabılıty And Assocıated Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 273}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-20', 'studyFirstSubmitDate': '2019-07-24', 'studyFirstSubmitQcDate': '2019-08-20', 'lastUpdatePostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'chronic ankle instability', 'timeFrame': '6 months', 'description': 'Cumberland Ankle Instability Tool\n\n(CAIT) is a 9-item questionnaire generating a score from 0 to 30 for each ankle, in which 0 is the worst possible score, meaning severe instability, and 30 is the best possible score, meaning stability. The CAIT is considered a reliable instrument to distinguish between stable and unstable ankles, meanwhile, measuring the severity of functional ankle instability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Ankle Instability', 'Cumberland Ankle Instability Tool', 'Pain'], 'conditions': ['Chronic Ankle Instability']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the prevalence of chronic ankle instability using the Cumberland Ankle Instability Tool (CAIT) and investigate the independent associated factors. The data was collected from adult volunteers by questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot.', 'detailedDescription': 'Chronic ankle instability (CAI) is a common condition encountered with persistent symptoms of giving way, pain, and weakness and recurrent risk, which may lead to functional insufficiency. The purpose of this study was to evaluate the prevalence of chronic ankle instability using the Cumberland Ankle Instability Tool (CAIT) and investigate the independent associated factors.\n\nThe data was collected from adult volunteers by questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot. 273 adult volunteers participated in the study, through face to face or online. Subjects are classified as having CAI with a CAIT score ≤27.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '34 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The cross-sectional study group consisted of 273 adult volunteers, ranging from 18-78 years old, who were recruited via social media to maximize outreach and insure a diverse target group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being volunteer\n* volunteers above 18 years old\n\nExclusion Criteria:\n\n* history of acute ankle sprain\n* acute ankle fracture\n* receiving/having received physiotherapy and rehabilitation programs for foot and ankle problems\n* within the last 6 months,history of foot, ankle, and/or knee surgery\n* neuromuscular disorders\n* disorders affecting balance\n* diabetes mellitus complications'}, 'identificationModule': {'nctId': 'NCT04064502', 'briefTitle': 'Chronıc Ankle Instabılıty And Assocıated Factors', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University'}, 'officialTitle': 'Chronıc Ankle Instabılıty And Assocıated Factors', 'orgStudyIdInfo': {'id': 'YeditepeYUPTR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'volunteers', 'description': '273 adult volunteers ranging from 18-78 years old', 'interventionNames': ['Diagnostic Test: CHRONIC ANKLE INSTABILITY AND ASSOCIATED FACTORS:']}], 'interventions': [{'name': 'CHRONIC ANKLE INSTABILITY AND ASSOCIATED FACTORS:', 'type': 'DIAGNOSTIC_TEST', 'description': 'Questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot.', 'armGroupLabels': ['volunteers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Uğur Şaylı', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Uğur Şaylı, MD, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Yeditepe University Hospital'}, {'name': 'Şule Demirbaş, Asst.Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'editepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation'}, {'name': 'Feryal Subaşı, PT, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Yeditepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation'}, {'name': 'Ebru Akbuğa, MSc, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yeditepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation'}, {'name': 'Elif Tuğçe Çil, MSc, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yeditepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeditepe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yeditepe University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}