Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
Study NCT ID:
NCT05201768
Status:
COMPLETED
Last Update Posted:
2024-12-03
First Post:
2021-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determination of Walking, Balance, Fall Risk and Kinesiophobia in Individulas with Alzheimer's Dementation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-29', 'studyFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2022-01-09', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age', 'timeFrame': '5 month', 'description': 'between the ages of 50 and 80'}, {'measure': 'Body Mass Index', 'timeFrame': '5 month', 'description': 'BMI was recorded in kg/m\\^2'}], 'secondaryOutcomes': [{'measure': 'The Tinetti Gait and Balance Test (TGBT)', 'timeFrame': '5 month', 'description': 'TGBT consists of balance and gait subheadings. For balance, there are 13 items, and 9 items for gait. Items are scored as 0 (abnormal), 1 (adaptive) and 2 (normal) for balance, 0 (abnormal), 1 (normal) for gait. The maximum balance score of the patient is 26 and the maximum gait score is 9. Total score (balance + walking) is 35 points.'}, {'measure': 'Mini Mental State Test', 'timeFrame': '5 month', 'description': 'It was used to determine the cognitive state before the training. The Mini-Mental State Test was first published by Folstein et al. It consists of eleven items under 5 main headings: orientation, record memory, attention and calculation, recall and language, and the total score is evaluated over 30 points.'}, {'measure': 'Tampa Scale', 'timeFrame': '5 month', 'description': '17 questions is a scale. The scale is used in work-related activities, injury/re-injury and fear-avoidance contains the parameters.'}, {'measure': 'The Time Up Go Test', 'timeFrame': '5 month', 'description': 'The timed "Up \\& Go" measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm), walk a distance of 3 meters, turn, walk back to the chair, and sit down again.'}, {'measure': 'The Gait Speed Measurement Test (GSMT)', 'timeFrame': '5 month', 'description': 'For GSMT, individuals were asked to walk at a speed they wanted on a flat surface of 14 m. Signs were placed on the 2nd and 12th meters of the test area to minimize the speed changes between walking start and walking finish, and to make a more objective measurement. The walking time at this 10-meter distance was measured with the stopwatch and the results were recorded in sec and the walking speed was determined.'}, {'measure': 'Fall Risk Self-Assessment Scale', 'timeFrame': '5 month', 'description': 'It consists of 13 items assessing the risk of falling in the elderly. The answers are yes (1 point) and no (0 points), and individuals who get 4 points or more from the scoring are classified as having a high risk of falling.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '40134734', 'type': 'DERIVED', 'citation': "Doganci O, Sertel M. Determination of balance, fall risk, and kinesiophobia in individuals with Alzheimer's Dementia. Front Psychol. 2025 Mar 11;16:1535440. doi: 10.3389/fpsyg.2025.1535440. eCollection 2025."}]}, 'descriptionModule': {'briefSummary': "THE OBJECTIVE OF THE RESEARCHERS IS TO DETERMINE WALKING, BALANCE, FALL RISK AND KINESIOPHOBIA IN INDIVIDUALS WITH ALZHEIMER'S DEMENTATION.", 'detailedDescription': "The gait, balance, fall risks and kinesiophobia of individuals with Alzheimer's Dementia will be evaluated and compared with healthy individuals."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '36 individual', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* INDEPENDENT walker diagnosed with Alzheimer's Dementia\n\nExclusion Criteria:\n\n* Having a disability to do physical activity Those who have had an operation in the last 6 months"}, 'identificationModule': {'nctId': 'NCT05201768', 'briefTitle': "Determination of Walking, Balance, Fall Risk and Kinesiophobia in Individulas with Alzheimer's Dementation", 'organization': {'class': 'OTHER', 'fullName': 'Kırıkkale University'}, 'officialTitle': "Determination of Walking, Balance, Fall Risk and Kinesiophobia in Individulas with Alzheimer's Dementation", 'orgStudyIdInfo': {'id': 'kku-oguzhandoganci1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'INDIVIDUALS WITH ALZHEIMER', 'description': 'balance and gait will be evaluated survey questions will be asked', 'interventionNames': ['Other: balance tests,questionnaire']}, {'label': 'HEALTHY INDIVIDUALS', 'description': 'balance and gait will be evaluated survey questions will be asked', 'interventionNames': ['Other: balance tests,questionnaire']}], 'interventions': [{'name': 'balance tests,questionnaire', 'type': 'OTHER', 'description': 'Individuals will be tested and recorded.', 'armGroupLabels': ['HEALTHY INDIVIDUALS', 'INDIVIDUALS WITH ALZHEIMER']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kırıkkale', 'country': 'Turkey (Türkiye)', 'facility': 'Kırıkkale University', 'geoPoint': {'lat': 39.84528, 'lon': 33.50639}}], 'overallOfficials': [{'name': 'Oğuzhan Doğancı', 'role': 'STUDY_CHAIR', 'affiliation': 'Kırıkkale University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '1.03.2022-1.07.2022', 'ipdSharing': 'YES', 'description': 'test results of individuals, information such as height and weight will be published.', 'accessCriteria': 'open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kırıkkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Oguzhan Dogancı', 'investigatorAffiliation': 'Kırıkkale University'}}}}