Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT05595902
Status:
UNKNOWN
Last Update Posted:
2023-03-02
First Post:
2022-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Normative Value for Navicular Drop Test in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 445}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2022-10-24', 'studyFirstSubmitQcDate': '2022-10-24', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Navicular Drop Test', 'timeFrame': '10 minutes', 'description': 'The navicular height and the amount of navicular drop will be made separately for each foot. The navicular prominence is found by palpation and marked with a marker pen when the individual is in a sitting position with the hips and knees flexed to 90 degrees and the subtalar joint in neutral position (the subtalar joint is palpated and the talus is in a neutral position). The height of the navicular protrusion from the ground is measured with a rigid ruler. Then, while the person stands on both feet equally, the height of the navicular protrusion from the ground is also measured with a ruler. The difference between the two measurements is noted as the amount of "navicular drop" (NDT).'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': '1 minute', 'description': 'Age'}, {'measure': 'Gender', 'timeFrame': '1 minute', 'description': 'Gender'}, {'measure': 'Body-Mass index', 'timeFrame': '3 minutes', 'description': 'weight/ (height)2'}, {'measure': 'Foot Posture Index', 'timeFrame': '15 minutes', 'description': 'FPI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the normative values of navicular height and navicular drop in individuals over 65 years of age. The secondary aim is to investigate the effects of age, gender, and body mass index on these normative values.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy older adults', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being 65 years or older\n* Having a body mass index between 18.5 and 29.0 kg/m2\n\nExclusion Criteria:\n\n* Having chronic diseases that affect the foot structure and connective tissue (such as diabetes mellitus, rheumatoid arthritis, gout, etc.).\n* Have had foot or ankle surgery in the last 6 months\n* Having orthopedic or neurological deformities (related to stroke, Parkinson's, multiple sclerosis, spinal cord injury, etc.) that will affect the foot structure and mobility.\n* Dependence on standing and ambulation (except independence gained through the use of assistive devices)"}, 'identificationModule': {'nctId': 'NCT05595902', 'briefTitle': 'Normative Value for Navicular Drop Test in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medeniyet University'}, 'officialTitle': 'Determination of Normative Values of Navicular Height and Navicular Drop Amount in Geriatric Individuals and Investigation of the Effect of Age, Gender and Body Mass Index on Normative Values', 'orgStudyIdInfo': {'id': 'IstanbulMU81'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Young older adults', 'description': '≥65-\\<75 years of age'}, {'label': 'Older adults', 'description': '≥75-\\<90 years of age'}, {'label': '≥90 years old'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medeniyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD., Asisst. Prof.', 'investigatorFullName': 'Nilufer Kablan', 'investigatorAffiliation': 'Istanbul Medeniyet University'}}}}