Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-04-06 @ 7:19 AM
Study NCT ID:
NCT07107620
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2025-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual Task Performance and Type II Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-06-28', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '10 meter walk test', 'timeFrame': 'one day', 'description': 'The dual task cost was calculated to measure dual task performance by applying the 10-meter walking test as single and dual tasks.\n\nThis cost will be calculated as follows:\n\n(Dual task performance-single task performance)/ single task performance x100'}, {'measure': 'time up go test', 'timeFrame': 'one day', 'description': 'The dual task cost was calculated to measure dual task performance by applying the time up go test as single and dual tasks. This cost will be calculated as follows: (Dual task performance-single task performance)/ single task performance x100'}], 'secondaryOutcomes': [{'measure': 'Stroop test', 'timeFrame': 'one day', 'description': 'There are 5 sections in this test. Section 1 includes reading black text, section 2 includes reading colored words related to color names, section 3 includes saying the color of shapes, section 4 includes saying the color of words that are not color names, and section 5 includes saying the color of colored words that are color names. Individuals are asked to read from left to right as fast as possible. The time taken is recorded in seconds.'}, {'measure': 'Dual task survey', 'timeFrame': 'one day', 'description': "It is a test that questions the difficulties experienced by individuals during dual-task activities in daily life activities. The survey consists of 10 questions. The short duration of the survey is an advantage. The survey, which consists of 5 answers, is scored between 0 and 4. A score of ''4'' indicates that difficulties are experienced very often, ''0'' indicates that there is no difficulty."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type II Diabetes Mellitus', 'Dual-task', 'Cognition'], 'conditions': ['Type II Diabetes Mellitus', 'Dual Task Cost']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the dual task performances of individuals with and without type 2 diabetes. Thus, it will be concluded whether having type 2 diabetes affects dual task performance.', 'detailedDescription': 'In our daily lives, we often have to juggle many tasks simultaneously. Performing two tasks simultaneously is called dual-tasking. The ability to perform two tasks simultaneously is called dual-tasking performance. Dual-tasking performance can decrease in individuals with diabetes due to complications of diabetes. This study compared the dual-tasking performance of individuals with type 2 diabetes and healthy individuals using dual-tasking tests categorized as easy, medium, and difficult.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals who have had diabetes for at least 1 year and are over 50 years of age and their matched healthy controls constitute the study sample.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Having been diagnosed with Type II DM (for the Type II diabetes group)\n* Being 50 years old or older\n* Being a native Turkish speaker\n\nExclusion Criteria:\n\n* Not being able to read and write,\n\n * Having communication problems,\n * Having a score below 24 points on the Standardized Mini-Mental Test,\n * Having one of the neurological diseases that will affect the study such as Parkinson's, stroke, etc.,\n * Having upper and/or lower extremity surgery in the last year or having a surgical history that will affect walking,\n * Having retinopathy, foot ulcers, and severe sensory impairment"}, 'identificationModule': {'nctId': 'NCT07107620', 'briefTitle': 'Dual Task Performance and Type II Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': 'Investigation of Dual Task Performance of Individuals With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'KSÜKADİRERTÜRK1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'type II diabetes mellitus group', 'description': 'Dual task tests were applied to the group with type 2 diabetes mellitus', 'interventionNames': ['Diagnostic Test: one task', 'Diagnostic Test: dual task']}, {'label': 'Healthy group', 'description': 'Dual task tests were administered to the healthy group', 'interventionNames': ['Diagnostic Test: one task', 'Diagnostic Test: dual task']}], 'interventions': [{'name': 'one task', 'type': 'DIAGNOSTIC_TEST', 'description': 'Single task tests consist of measuring walking times with normal walking (easy), walking with a 50% reduction in the base of support measured between the medial malleoli (medium difficulty) and tandem walking (difficult) tasks while applying the 10 meter walk test and time up go tests.', 'armGroupLabels': ['Healthy group', 'type II diabetes mellitus group']}, {'name': 'dual task', 'type': 'DIAGNOSTIC_TEST', 'description': 'Dual task consists of single task plus tests of carrying glasses of water or counting backwards from a given number.', 'armGroupLabels': ['Healthy group', 'type II diabetes mellitus group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University hospital', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'overallOfficials': [{'name': 'Suat EREL, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pamukkale University Faculty of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kahramanmaras Sutcu Imam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Abdulkadir Ertürk', 'investigatorAffiliation': 'Kahramanmaras Sutcu Imam University'}}}}