Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-02-28 @ 8:19 AM
Study NCT ID:
NCT06475794
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Q Angle in Osteoporosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2024-06-24', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Q angle assessment', 'timeFrame': '1 minute', 'description': 'Q angle will be evaluated with goniometer.'}], 'secondaryOutcomes': [{'measure': 'Pain assessment', 'timeFrame': '1 minute', 'description': 'Pain assessment will be done with the Visual Analog Scale (VAS). This measurement is performed with a chart in which no pain is written on one end and very severe pain is written on the other end.'}, {'measure': 'Muscle strength assessment', 'timeFrame': '2 minutes', 'description': 'Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Muscle strength is graded on a scale of 0 to 5 according to muscle tone and ability to resist the force of gravity.'}, {'measure': 'Foot posture assessment', 'timeFrame': '1 minute', 'description': 'Foot posture will be evaluated with the Foot Posture Index (FPI). API is an easy-to-apply, valid and reliable method that provides information about the degree of pronation and supination of the foot with a single numerical result and evaluates the foot in a multidimensional and comprehensive manner.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Osteopenia', 'Q angle'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'Osteoporosis (OP) is a bone disease characterized by reduced bone density and deterioration of bone tissue, leading to an increased risk of fractures. There are no studies evaluating Q angle in patients with OP and Osteopenia (OPN) in the literature. Therefore, the aim of this study was to examine the Q angle in patients diagnosed with OP and OPN and to compare it with patients diagnosed with OA. The study will be carried out by measuring the Q angle measurement with a goniometer. Pain assessment will be done with Visual Analog Scale (VAS). Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Foot posture will be assessed with the Foot Posture Index (FPI).', 'detailedDescription': 'Osteoporosis (OP) is a bone disease characterized by reduced bone density and deterioration of bone tissue, leading to an increased risk of fractures. According to Calis et al; it was found that patients with hip fracture had a significantly higher Q angle compared to patients without hip fracture. According to You et al; contraction of the quadriceps muscles corrects the Q angle, therefore sports that use high amounts of quadriceps (strength) training are associated with lower Q angles due to the pulling effect of the quadriceps muscle. There are no studies evaluating Q angle in patients with OP and Osteopenia (OPN) in the literature. Therefore, the aim of this study was to examine the Q angle in patients diagnosed with OP and OPN and to compare it with patients diagnosed with OA. The study will be carried out by measuring the Q angle measurement with a goniometer. Pain assessment will be done with Visual Analog Scale (VAS). Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Foot posture will be assessed with the Foot Posture Index (FPI).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are willing to participate in the study, being between the ages of 40-65 will be included in the study. Patients who have patellofemoral abnormalities during examination, acute traumatic patellofemoral dislocations, surgical revision around the knee, history of any previous lower extremity surgery and serious trauma will be excluded from the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be willing to participate in the study.\n* Being between the ages of 40-65.\n* Being a woman.\n\nExclusion Criteria:\n\n* Patellofemoral abnormalities during examination.\n* Acute traumatic patellofemoral dislocations\n* Surgical revision around the knee\n* History of any previous lower extremity surgery\n* Serious trauma'}, 'identificationModule': {'nctId': 'NCT06475794', 'briefTitle': 'Investigation of Q Angle in Osteoporosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Firat University'}, 'officialTitle': 'Investigation of Q Angle and Related Factors in Osteoporosis Patients', 'orgStudyIdInfo': {'id': '2024/07-33'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with osteoporosis group', 'description': 'Osteoporosis patients will be evaluated in terms of pain, foot posture, Q angle and lower limbs muscle strength.', 'interventionNames': ['Other: Patients with osteoporosis group']}, {'label': 'Patients with osteoarthritis group', 'description': 'Osteoarthritis patients will be evaluated in terms of pain, foot posture, Q angle and lower limbs muscle strength.', 'interventionNames': ['Other: Patients with osteoarthritis group']}], 'interventions': [{'name': 'Patients with osteoporosis group', 'type': 'OTHER', 'description': 'Pain, Q angle, muscle strength and foot posture will be evaluated.', 'armGroupLabels': ['Patients with osteoporosis group']}, {'name': 'Patients with osteoarthritis group', 'type': 'OTHER', 'description': 'Osteoarthritis patients will be evaluated in terms of pain, foot posture, Q angle and lower limbs muscle strength.', 'armGroupLabels': ['Patients with osteoarthritis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23100', 'city': 'Elâzığ', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Songul Baglan Yentur', 'role': 'CONTACT', 'email': 'songulbaglan23@hotmail.com', 'phone': '04242370000'}, {'name': 'Songul Baglan Yentur', 'role': 'CONTACT', 'email': 'songulbaglan23@hotmail.com'}], 'facility': 'Songul Baglan Yentur', 'geoPoint': {'lat': 38.67431, 'lon': 39.22321}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Firat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Physiotherapy and Rehabilitation Department', 'investigatorFullName': 'Songül Bağlan Yentür', 'investigatorAffiliation': 'Firat University'}}}}