Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT04816058
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2021-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Turkish Version of the Ankle Instability Instrument
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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-23', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ankle Instability Instrument', 'timeFrame': '2 weeks', 'description': 'The Ankle Instability Instrument includes 9 questions that can be answered with yes or no. The first version was developed with 21 questions and later modified into 9 questions. The Ankle Instability Instrument determines the development of functional ankle instability in individuals with an ankle injury. The International Ankle Consortium reported that answering yes to 5 of 9 questions will confirm the presence of functional ankle instability. There are French and Iran versions of the Ankle Instability Instrument.'}, {'measure': 'Cumberland Ankle Instability Tool', 'timeFrame': '1 day', 'description': 'The ankle instability levels of the participants included in the study will be determined by the Cumberland Ankle Instability Tool. The Cumberland Ankle Instability Tool is a self-assessment scale that determines the presence of functional or chronic ankle instability and the severity of the instability. This scale consists of 9 items and the total score varies between 0 and 30. Lower scores indicate more severe instability.'}], 'secondaryOutcomes': [{'measure': 'Short Form 12', 'timeFrame': '1 day', 'description': 'Short Form 12 is a valid and reliable scale for determining the level of quality of life. This scale consists of 12 items and can be scored as 8 subscales. These subscales are; physical function, restricted roles due to physical problems, pain, general health, energy / vitality, social functions and mental health with restricted roles due to mental problems. All items are evaluated with a 5-point Likert-type scale, and higher scores indicate better quality of life while lower scores indicate poor quality of life. This scale is used to evaluate the quality of life of healthy individuals with any pathology. Short Form 12 can be scored between 0-100 for each domain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankle Injuries']}, 'descriptionModule': {'briefSummary': 'This study aimed to translate the Ankle Instability Instrument into Turkish language, to perform a cultural adaptation study and to evaluate its validity and reliability in the Turkish population. Ankle Instability Instrument was developed to determine the ankle instability level of individuals with a history of ankle injury. Assessment of ankle instability is particularly useful in determining the complaints and functional levels of individuals with a history of functional or chronic ankle instability. It is anticipated that introducing this scale to our language will contribute to other studies in this field.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a history of ankle injury and healthy population.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of ankle injury or sprain at least one time\n* Aged between 18 to 40 years\n\nExclusion Criteria:\n\n* Neurological or orthopedic disorders that may affect ankle instability.\n\nInclusion criteria for healthy population are; no history of ankle injury or sprain before and. aged between 18 to 40 years'}, 'identificationModule': {'nctId': 'NCT04816058', 'briefTitle': 'Turkish Version of the Ankle Instability Instrument', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'Reliability and Validity of the Turkish Version of the Ankle Instability Instrument', 'orgStudyIdInfo': {'id': 'ATADEK-2021-05/09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ankle Instability Group', 'description': 'Patients with a history of ankle instability or injury.', 'interventionNames': ['Behavioral: Determining the level of ankle instability']}, {'label': 'Healthy Group', 'description': 'Participants without a history of ankle injury', 'interventionNames': ['Behavioral: Determining the level of ankle instability']}], 'interventions': [{'name': 'Determining the level of ankle instability', 'type': 'BEHAVIORAL', 'description': 'Ankle instability', 'armGroupLabels': ['Ankle Instability Group', 'Healthy Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Acıbadem University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Özgül Öztürk', 'investigatorAffiliation': 'Acibadem University'}}}}