Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 2:00 PM
Study NCT ID:
NCT06993532
Status:
COMPLETED
Last Update Posted:
2025-05-29
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity, and Reliability of the Turkish Version of the Trapeziometacarpal Arthrosis Symptoms and Disability Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015203', 'term': 'Reproducibility of Results'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}, {'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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trapeziometacarpal Arthrosis Symptoms and Disability Questionnaire', 'timeFrame': '7 days', 'description': 'The TASD was developed by Becker et al. to evaluate symptom intensity, disability severity, and treatment effectiveness in individuals with TMC arthrosis'}], 'secondaryOutcomes': [{'measure': 'Thumb Disability Examination Questionnaire', 'timeFrame': '7 days', 'description': 'The TDX consists of 20 items organized into three subcategories, evaluating limitations in ADLs, pain severity, and patient satisfaction with thumb function'}, {'measure': 'Power Grip Strength and Pinch Strength', 'timeFrame': '7 days', 'description': 'Power grip strength (PGS) and pinch strength (PS) were measured using the Jamar® Hydraulic Hand Dynamometer and Jamar® Hydraulic Pinch Gauge, respectively.'}, {'measure': 'Visual Analogue Scale', 'timeFrame': '7 days', 'description': 'Pain intensity was assessed by asking the patient to rate their current pain on a 10 cm scale (0, no pain, 10, intolerable pain)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trapeziometacarpal arthrosis, cross-cultural adaptation, Turkish version, reliability, validity'], 'conditions': ['Trapeziometacarpal Arthrosis']}, 'referencesModule': {'references': [{'pmid': '27390563', 'type': 'BACKGROUND', 'citation': 'Becker SJ, Teunis T, Ring D, Vranceanu AM. The Trapeziometacarpal Arthrosis Symptoms and Disability Questionnaire: Development and Preliminary Validation. Hand (N Y). 2016 Jun;11(2):197-205. doi: 10.1177/1558944715627239. Epub 2016 Feb 3.'}, {'type': 'BACKGROUND', 'citation': 'Karademir F, Ayhan Kuru Ç, Yakut Y (2022) Cross-Cultural Adaptation, Reliability and Validity of the Turkish Version of the Thumb Disability Examination (TDX) Questionnaire . IFSSH, IFSHT, FESSH Combined Congress (pp.548). London, Canada.'}, {'pmid': '34627390', 'type': 'BACKGROUND', 'citation': 'de Souza Almeida VA, Fernandes CH, Meireles LM, Faloppa F, Ejnisman B, Cohen M. Translation and cross-cultural adaptation of "Trapeziometacarpal Arthrosis Symptoms and Disability-TASD" into Brazilian Portuguese. Adv Rheumatol. 2021 Oct 9;61(1):61. doi: 10.1186/s42358-021-00218-z.'}]}, 'descriptionModule': {'briefSummary': 'To our knowledge, a Turkish version of the TASD questionnaire, frequently used for assessing TMC arthrosis worldwide, does not currently exist. Therefore, proper translation and cross-cultural adaptation of the tool are necessary for non-English speaking patients. This study aimed to develop the Turkish version of the TASD questionnaire, and to demonstrate its reliability and validity for use in patients with TMC arthrosis.', 'detailedDescription': 'The original TASD was translated into Turkish independently by a physiotherapist with expertise in hand research and proficiency in English, a healthcare professional, and English teacher with no healthcare background. Demographic data were collected, followed by administration of the TASD questionnaire, the Thumb Disability Examination (TDX) questionnaire, the Visual Analogue Scale (VAS) for pain assessment, and hand grip and pinch strength measurements using the Jamar® Hydraulic Hand Dynamometer and Jamar Hydraulic Pinch Gauge to assess thumb function and muscle strength. The questionnaires were administered twice, with a 7-day interval, during which no medical or rehabilitation intervention was provided that could alter the clinical condition of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosis of Trapeziometacarpal arthrosis with individuals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older,\n* Diagnosis of Trapeziometacarpal arthrosis\n\nExclusion Criteria:\n\n* Surgery on the thumb and/or hand/wrist,\n* Acute trauma to the thumb,\n* Cognitive problems'}, 'identificationModule': {'nctId': 'NCT06993532', 'briefTitle': 'Validity, and Reliability of the Turkish Version of the Trapeziometacarpal Arthrosis Symptoms and Disability Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'University of Gaziantep'}, 'officialTitle': 'Cross-Cultural Adaptation, Validity, and Reliability of the Turkish Version of the Trapeziometacarpal Arthrosis Symptoms and Disability Questionnaire', 'orgStudyIdInfo': {'id': '2023/346'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trapeziometacarpal arthrosis group', 'description': 'Patients aged 18 years or older, with a diagnosis of TMC arthrosis were included in the study.', 'interventionNames': ['Other: Validity and Reliability']}], 'interventions': [{'name': 'Validity and Reliability', 'type': 'OTHER', 'description': 'The TASD questionnaire, the Thumb Disability Examination (TDX) questionnaire, the Visual Analogue Scale (VAS) for pain, as well as hand grip and pinch strength measurements using the Jamar® Hydraulic Hand Dynamometer and Jamar Hydraulic Pinch Gauge Dynamometer were employed to assess thumb function and muscle strength. The questionnaires were administered twice, with a 7-day interval, during which no medical or rehabilitation intervention was made that could alter the clinical condition of the patients.', 'armGroupLabels': ['Trapeziometacarpal arthrosis group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gaziantep University', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'a decision has not been made yet.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Gaziantep', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof.', 'investigatorFullName': 'Halil Ibrahim ERGEN', 'investigatorAffiliation': 'University of Gaziantep'}}}}