Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:54 AM
Study NCT ID:
NCT07433894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scoliosis and Functional Outcomes in Children With Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}, {'id': 'D001171', 'term': 'Arthritis, Juvenile'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Scoliosis in Children With Juvenile Idiopathic Arthritis', 'timeFrame': 'At baseline (single study visit)', 'description': 'Proportion of participants with scoliosis, defined as a Cobb angle ≥10° measured on standing spinal radiographs.'}], 'secondaryOutcomes': [{'measure': 'Scoliosis Severity (Cobb Angle)', 'timeFrame': 'At baseline (single study visit)', 'description': 'Cobb angle (degrees) measured on standing spinal radiographs. Scoliosis defined as Cobb angle ≥10°.'}, {'measure': 'Health-Related Quality of Life (PedsQL)', 'timeFrame': 'At baseline (single study visit)', 'description': 'Health-related quality of life assessed using the Pediatric Quality of Life Inventory (PedsQL) total score (and physical and psychosocial subscale scores, if available). Scores are transformed to a 0-100 scale (range: 0-100), with higher scores indicating better health-related quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Juvenile Idiopathic Arthritis', 'Scoliosis', 'Functional Outcomes', 'Postural Alignment', 'Pediatric Rheumatology'], 'conditions': ['Scoliosis']}, 'descriptionModule': {'briefSummary': 'Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease that may affect musculoskeletal development and posture in children. Spinal involvement, including scoliosis, is not routinely evaluated in clinical practice despite its potential impact on functional status and quality of life.\n\nThis cross-sectional study aims to assess the presence of scoliosis in children with JIA and to investigate its association with functional status, postural alignment, and disease activity. Clinical and functional parameters will be analyzed to better understand the impact of spinal deformities in this population.', 'detailedDescription': 'Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease that may negatively affect musculoskeletal development, posture, and overall physical function in children. Although peripheral joint involvement is well characterized, axial and postural abnormalities, including scoliosis, are not routinely assessed during follow-up despite their potential clinical significance.\n\nThis cross-sectional study aims to evaluate the presence of scoliosis in children with JIA and to investigate its relationship with disease activity, functional status, pain, and postural alignment. Comprehensive clinical assessments, including physical examination, disease activity scores, and functional evaluation tools, will be performed. Where applicable, postural analysis and imaging findings will also be considered.\n\nBy identifying the frequency and clinical impact of scoliosis in JIA, this study seeks to improve awareness of spinal involvement and to provide a basis for early recognition and multidisciplinary management strategies, including targeted physiotherapy interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of children and adolescents aged 8-18 years diagnosed with juvenile idiopathic arthritis (JIA) according to ILAR criteria and followed up at a tertiary pediatric rheumatology center. Participants will be recruited consecutively during routine outpatient visits. The aim of the study is to evaluate the prevalence and severity of scoliosis, as defined by Cobb angle measurements on physical examination and, if necessary, standing spinal radiographs, and to examine its relationship with clinical and functional parameters. Both patients with and without scoliosis will be included in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age between 8 and 18 years at the time of enrollment\n* Diagnosis of juvenile idiopathic arthritis (JIA) according to ILAR criteria\n* Written informed consent obtained from parent/legal guardian and assent from the child/adolescent, when appropriate\n\nExclusion Criteria\n\n* Known scoliosis due to non-JIA causes (e.g., congenital vertebral anomalies, neuromuscular disorders, or syndromic scoliosis)\n* History of prior spinal surgery or current brace treatment for scoliosis\n* History of significant spinal trauma or spinal infection/tumor affecting spinal alignment\n* Presence of coexisting chronic conditions that significantly affect posture, gait, or functional testing (e.g., severe neurologic impairment) and may confound assessments\n* Inability to undergo required assessments (e.g., inability to stand for radiographs or complete functional measures)'}, 'identificationModule': {'nctId': 'NCT07433894', 'briefTitle': 'Scoliosis and Functional Outcomes in Children With Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Comprehensive Evaluation of Scoliosis and Its Association With Functional Status, Postural Alignment, and Disease Activity in Children With Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': 'Jia-scoliosis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'JIA Patients With Scoliosis', 'description': 'Children diagnosed with juvenile idiopathic arthritis (JIA) who have scoliosis, defined by a Cobb angle of ≥10 degrees on standing spinal radiographs. Clinical characteristics, disease activity parameters, and functional assessments including postural and plantar pressure analyses will be evaluated. No intervention will be applied; this group will be observationally assessed.'}, {'label': 'JIA Patients Without Scoliosis', 'description': 'Children diagnosed with juvenile idiopathic arthritis (JIA) without evidence of scoliosis (Cobb angle \\<10 degrees). Participants will undergo the same clinical, laboratory (if applicable), and functional assessments as the scoliosis group. This is an observational group with no intervention.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bengisu Menentoğlu', 'role': 'CONTACT', 'email': 'bengisusanisoglu@gmail.com', 'phone': '+905359523337'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The decision to share individual participant data (IPD) has not yet been finalized. Data sharing may be considered upon reasonable request after publication, subject to institutional policies, ethical approvals, and data protection regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bengisu Menentoğlu', 'investigatorAffiliation': 'Istanbul University'}}}}