Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT06433167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Gait Pattern in Idiopathic Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-26', 'studyFirstSubmitDate': '2024-05-18', 'studyFirstSubmitQcDate': '2024-05-26', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pedobarography', 'timeFrame': 'Day 1', 'description': 'This assessment uses a specialized device called a pedobarograph, which consists of pressure sensors embedded in a platform. When a person stands or walks on the pedobarograph, the sensors record the pressure exerted by different parts of the foot. The resulting data is then used to create detailed pressure maps and graphs that highlight areas of high and low pressure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': "Scoliosis is a condition characterized by an abnormal curvature of the spine, which can affect an individual's gait. Scoliosis can alter body balance and weight distribution. Pedobarographic analysis identifies imbalances and abnormal pressure points by measuring the distribution of pressure applied to the sole of the foot. This examination helps detect abnormalities in the gait mechanics of individuals with scoliosis. Gait analysis can identify long-term foot and leg problems caused by scoliosis at an early stage, allowing for early interventions to prevent more serious issues.\n\nThe aim of this study is to analyze gait in individuals with idiopathic scoliosis and compare it with that of healthy individuals. The study will include 30 scoliosis patients who visited the Department of Orthopedics and Traumatology at Gazi University Hospital and were diagnosed with idiopathic scoliosis by a specialist physician. The gait patterns of the patients will be evaluated using pedobarography. Information about the type and degree of scoliosis will be obtained from hospital records. The results of this study may provide an objective and detailed evaluation of gait and pressure distribution disorders in individuals with scoliosis and may contribute to more effective treatment plans."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include 30 scoliosis patients who visited the Department of Orthopedics and Traumatology at Gazi University Hospital and were diagnosed with idiopathic scoliosis by a specialist physician and 30 healty control without scoliosis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of idiopathic scoliosis by an orthopedist\n* The Cobb angle measured on the standard scoliosis radiograph should fall within the range of 10°-45°.\n\nExclusion Criteria:\n\n* Presence of any orthopedic or neurological disease affecting trunk and extremity mobility, excluding scoliosis.\n* History of previous spine or orthopedic surgery.'}, 'identificationModule': {'nctId': 'NCT06433167', 'briefTitle': 'Investigation of Gait Pattern in Idiopathic Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Investigation of Gait Pattern in Idiopathic Scoliosis', 'orgStudyIdInfo': {'id': 'Iayas9'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Idiopathic Scoliosis', 'description': 'The patient group for this research comprises patients diagnosed with idiopathic scoliosis, a condition characterized by abnormal lateral curvature of the spine of unknown cause.', 'interventionNames': ['Other: Pedobarographic analysis']}, {'label': 'Healthy control', 'description': 'Healthy control group is healthy individuals without any diagnosed disease.', 'interventionNames': ['Other: Pedobarographic analysis']}], 'interventions': [{'name': 'Pedobarographic analysis', 'type': 'OTHER', 'description': 'During the pedobarographic analysis, the patient takes steps on the platform at a regular walking speed, with arms relaxed at the sides, following a natural gait. In static analysis, measurements are taken while the patient remains stationary on the platform with arms in a relaxed position beside the body. Five measurements are separately recorded for both feet during the phases of stepping, heel strike, and toe lift. These measurements capture the highest pressures on the back of the foot, the middle part of the foot, and the inner, middle, and lateral sides of the front of the foot, including the toes. The pressure, force, and pressure-time integral corresponding to each area are then used to determine how and for how long these areas are exposed to pressure.', 'armGroupLabels': ['Healthy control', 'Idiopathic Scoliosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06500', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Ulunay Kanatlı, Proff', 'role': 'CONTACT', 'email': 'ukanatlı@gazi.edu.tr', 'phone': '(0312) 216 26 01'}, {'name': 'İnci H Ayas, Msc', 'role': 'CONTACT', 'email': 'inciayass@gmail.com', 'phone': '(0312) 216 26 01'}], 'overallOfficials': [{'name': 'İnci H Ayas, Msc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gazi University'}, {'name': 'Furkan Aral, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gazi University'}, {'name': 'Burak Oklaz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gazi University'}, {'name': 'Ulunay Kanatlı, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research asistant', 'investigatorFullName': 'İnci Hazal Ayas', 'investigatorAffiliation': 'Gazi University'}}}}