Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-02 @ 2:18 AM
Study NCT ID:
NCT04660357
Status:
UNKNOWN
Last Update Posted:
2020-12-09
First Post:
2020-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteoarthritis, Balance, and Fear of Falling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008137', 'term': 'Longitudinal Studies'}], 'ancestors': [{'id': 'D015331', 'term': 'Cohort Studies'}, {'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-08', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2020-12-08', 'lastUpdatePostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC, The Activities-specific Balance Confidence Scale, Falls Efficacy Scale, The functional autonomy measurement system, Community Integration Questionnaire, Berg Balance Scale', 'timeFrame': '1 year', 'description': 'The WOMAC index is a disease-specific, self-administered questionnaire developed to study patients with hip or knee OA. It consists of 24 questions, grouped into 3 subscales.Higher scores indicate more or worse symptoms, maximal limitations, and poor health.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': "Osteoarthritis (OA) is a progressive and irreversible degenerative joint disease characterized by marginal bone hypertrophy, erosion, and subchondral sclerosis in the articular cartilage.It has been determined that being of advanced age and joint involvement due to osteoarthritis are a risk factor for addiction in activities and this increases the individual's self-care ability and dependency in daily living activities.Older individuals with knee osteoarthritis may be at risk of falling.This study was planned to examine the relationship between activity-specific balance confidence and fear of falling, autonomy and social participation in individuals with knee osteoarthritis over 65 years of age.", 'detailedDescription': "Osteoarthritis (OA) is a progressive and irreversible degenerative joint disease characterized by marginal bone hypertrophy, erosion, and subchondral sclerosis in the articular cartilage.It has been determined that being of advanced age and joint involvement due to osteoarthritis are a risk factor for addiction in activities and this increases the individual's self-care ability and dependency in daily living activities.Older individuals with knee osteoarthritis may be at risk of falling.Considering the relationship between the concepts of osteoarthritis and old age with the common concepts of daily life activity problems, falling, loss of autonomy and affecting social participation; this study was planned to examine the relationship between activity-specific balance confidence and fear of falling, autonomy and social participation in individuals with knee osteoarthritis over 65 years of age."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* 65 years old\n* Diagnosed with knee osteoarthritis according to ACR diagnostic criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 years old\n* Diagnosed with knee osteoarthritis according to ACR diagnostic criteria\n\nExclusion Criteria:\n\nNot having enough cooperation'}, 'identificationModule': {'nctId': 'NCT04660357', 'acronym': 'OA', 'briefTitle': 'Osteoarthritis, Balance, and Fear of Falling', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Do Activity-Specific Balance Confidence and Fear of Fall Affect Autonomy and Social Participation in Individuals With Knee Osteoarthritis Above 65 Years Old?', 'orgStudyIdInfo': {'id': '2020/281'}}, 'armsInterventionsModule': {'interventions': [{'name': 'survey study', 'type': 'OTHER', 'description': 'survey study'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edirne', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Özgü İnal', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}], 'overallOfficials': [{'name': 'Özgü İnal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trakya University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Özgü İnal', 'investigatorAffiliation': 'Hacettepe University'}}}}