Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-03 @ 11:40 PM
Study NCT ID:
NCT05970692
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2023-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2023-07-24', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atroshi-Lyrén 6-item symptoms scale', 'timeFrame': '1 week', 'description': 'The A-L scale consists of 6 items that inquire about severity and frequency of night and daytime numbness and tingling and pain. For each patient the item responses are scored from 1 (best) to5 (worst) and then averaged for the 6 items to yield a total score (only 1 missing item response is allowed)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carpal Tunnel Syndrome', 'Pain'], 'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'This study aims to develop Turkish version of the Atroshi-Lyrén 6-item symptoms scale (A-L scale) and to perform validity and reliability evaluations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'CTS patients aged between 18-65 years old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18-65 years old,\n* Had symptoms of numbness, tingling, weakness and pain in the hands for at least 1 month,\n* Assessed through provocation tests and physical examination to match the median nerve distribution.\n\nExclusion Criteria:\n\n* Not willing to participate in the study,\n* Clinical or electrophysiological signs of proximal nerve compression,\n* Diabetes or other metabolic disease,\n* Rheumatoid arthritis or other general inflammatory diseases.'}, 'identificationModule': {'nctId': 'NCT05970692', 'briefTitle': 'Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale', 'orgStudyIdInfo': {'id': 'BEU-KTS-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Controls', 'description': 'Healthy individuals aged between 18-65 years old'}, {'label': 'CTS Group', 'description': 'CTS patients aged between 18-65 years old'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13000', 'city': 'Bitlis', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Tülay Çevik Saldıran, PhD', 'role': 'CONTACT', 'email': 'tcsaldiran@beu.edu.tr', 'phone': '+90 (434) 222 83 32'}], 'facility': 'Bitlis Eren University', 'geoPoint': {'lat': 38.40115, 'lon': 42.10784}}], 'centralContacts': [{'name': 'Tülay Çevik Saldıran, PhD', 'role': 'CONTACT', 'email': 'tcsaldiran@beu.edu.tr', 'phone': '+90 (434) 222 83 32'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ilke KARA', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bitlis Eren University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Co-Principal Investigator', 'investigatorFullName': 'Ilke KARA', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}