Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-29 @ 7:07 PM
Study NCT ID:
NCT05916456
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-27
First Post:
2023-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hand10 Questionnaire in Individuals With Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-24', 'studyFirstSubmitDate': '2023-06-07', 'studyFirstSubmitQcDate': '2023-06-14', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The validity and reliability of the Hand10 questionnaire to individuals with carpal tunnel scan included', 'timeFrame': '3 month', 'description': 'Patients diagnosed with Carpal tunnel by the doctor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carpal tunnel syndrome', 'DASH questionnaire', 'Boston carpal tunnel syndrome questionnaire', 'HAND10 questionnaire', 'validity and reliability'], 'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'Hand10 questionnaire, Boston Carpal Tunnel Syndrome Questionnaire and Arm Shoulder Questionnaire for patients with carpal tunnel syndrome and Hand Deficiencies Questionnaire (DASH) will be applied one week apart to investigate the validity of the questionnaire.\n\nTest-retest reliability and internal consistency will be determined using Intraclass Correlation Coefficient analysis and Cronbach alpha, respectively. The validity of Hand10 in individuals with CST will be determined using the Pearson Correlation Coefficient analysis, the Arm, Shoulder, and Hand Disability Questionnaire and the Boston Carpal Tunnel Syndrome Questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Our study will be conducted with individuals between the ages of 18-70 who have been diagnosed with CTS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who volunteer for treatment\n* 18-70 years old patients\n* With patients diagnosed with CTS\n\nExclusion Criteria:\n\n-Patients who have had surgery on the wrist area'}, 'identificationModule': {'nctId': 'NCT05916456', 'briefTitle': 'Hand10 Questionnaire in Individuals With Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Hasan Kalyoncu University'}, 'officialTitle': 'Investigation of the Validity and Reliability of the Hand10 Questionnaire in Individuals With Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': "HasanKU''"}}, 'armsInterventionsModule': {'interventions': [{'name': 'The Hand10 Questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': "The Hand10 Questionnaire is a questionnaire consisting of 10 short questions used in the evaluation of upper extremity diseases. These questions are easy to understand and illustrated questions. Unlike other questionnaires, thanks to these features, it can be used in adults as well as in the elderly and children. Tore et al. In their study, the internal consistency of Hand10 was evaluated with Cronbach's alpha value according to statistical results and found it to be 0.919. According to these results, it has been determined that Hand10 is a reliable and valid assessment tool for patients with upper extremity disorders in the Turkish population."}, {'name': 'DASH Questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'DASH Questionnaire is one of the widely used questionnaires consisting of 30 items. There are five options for each answer. While getting answers ranging from 1 to 5; 1 means no symptoms and 5 means very severe symptoms. The total DASH score ranges from 0 to 100; 0 means no injury and 100 means serious injury. Contrary to the Hand10 questionnaire, DASH was not suitable for assessing upper extremity disorders in patients over 65 years of age.'}, {'name': 'Boston carpal tunnel syndrome questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'Boston carpal tunnel syndrome questionnaire (BKTSA) will be used to evaluate the functionality level and symptom severity of the patients. In this questionnaire, which consists of 2 parts: symptom severity and functional capacity, the average score for each part will be calculated by dividing the total score obtained by the number of questions. An increased score indicates decreased functional capacity and increased symptom severity.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaziantep', 'state': 'Sahinbey', 'country': 'Turkey (Türkiye)', 'facility': 'Hasan Kalyoncu Universty', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasan Kalyoncu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc', 'investigatorFullName': 'Neslihan Torun', 'investigatorAffiliation': 'Hasan Kalyoncu University'}}}}