Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT06356350
Status:
COMPLETED
Last Update Posted:
2024-11-15
First Post:
2024-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Programs on Gait in Children JIA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal 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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Loading', 'timeFrame': 'immediately after intervention', 'description': 'It will be obtained using the FreeMed baropodometry platform (the FreeStep v. 1.0. 3 88 software, Sensor Medica, Guidonia Montecelio, Roma, Italy). The unit of the outcome is per cent.'}, {'measure': 'Center of mass displacement', 'timeFrame': 'immediately after intervention', 'description': 'It will be obtained using the FreeMed baropodometry platform (the FreeStep v. 1.0. 3 88 software, Sensor Medica, Guidonia Montecelio, Roma, Italy). The unit of the outcome is milimeter.'}, {'measure': 'Walking speed', 'timeFrame': 'immediately after intervention', 'description': 'It will be obtained using the FreeMed baropodometry platform (the FreeStep v. 1.0. 3 88 software, Sensor Medica, Guidonia Montecelio, Roma, Italy). The unit of the outcome ia meter/second.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['juvenile idiopathic arthritis', 'gait', 'exercise', 'physiotherapy'], 'conditions': ['Juvenile Idiopathic Arthritis', 'Gait, Frontal']}, 'referencesModule': {'references': [{'pmid': '27927641', 'type': 'BACKGROUND', 'citation': 'Ombrello MJ, Arthur VL, Remmers EF, Hinks A, Tachmazidou I, Grom AA, Foell D, Martini A, Gattorno M, Ozen S, Prahalad S, Zeft AS, Bohnsack JF, Ilowite NT, Mellins ED, Russo R, Len C, Hilario MO, Oliveira S, Yeung RS, Rosenberg AM, Wedderburn LR, Anton J, Haas JP, Rosen-Wolff A, Minden K, Tenbrock K, Demirkaya E, Cobb J, Baskin E, Signa S, Shuldiner E, Duerr RH, Achkar JP, Kamboh MI, Kaufman KM, Kottyan LC, Pinto D, Scherer SW, Alarcon-Riquelme ME, Docampo E, Estivill X, Gul A; British Society of Pediatric and Adolescent Rheumatology (BSPAR) Study Group, Inception Cohort of Newly Diagnosed Patients with Juvenile Idiopathic Arthritis (ICON-JIA) Study Group, Childhood Arthritis Prospective Study (CAPS) Group, Randomized Placebo Phase Study of Rilonacept in sJIA (RAPPORT) Investigators, Sparks-Childhood Arthritis Response to Medication Study (CHARMS) Group, Biologically Based Outcome Predictors in JIA (BBOP) Group; Langefeld CD, Thompson S, Zeggini E, Kastner DL, Woo P, Thomson W. Genetic architecture distinguishes systemic juvenile idiopathic arthritis from other forms of juvenile idiopathic arthritis: clinical and therapeutic implications. Ann Rheum Dis. 2017 May;76(5):906-913. doi: 10.1136/annrheumdis-2016-210324. Epub 2016 Dec 7.'}, {'pmid': '29150344', 'type': 'BACKGROUND', 'citation': 'Tokuda K, Anan M, Takahashi M, Sawada T, Tanimoto K, Kito N, Shinkoda K. Biomechanical mechanism of lateral trunk lean gait for knee osteoarthritis patients. J Biomech. 2018 Jan 3;66:10-17. doi: 10.1016/j.jbiomech.2017.10.016. Epub 2017 Nov 4.'}, {'pmid': '19411394', 'type': 'BACKGROUND', 'citation': 'Ringold S, Wallace CA, Rivara FP. Health-related quality of life, physical function, fatigue, and disease activity in children with established polyarticular juvenile idiopathic arthritis. J Rheumatol. 2009 Jun;36(6):1330-6. doi: 10.3899/jrheum.081028. Epub 2009 May 1.'}, {'type': 'BACKGROUND', 'citation': 'KISA, E. P., & OTMAN, A. S. (2020). Skolyoz odaklı egzersizler-yedi büyük okulun kapsamlı incelemesi. Süleyman Demirel Üniversitesi Sağlık Bilimleri Dergisi, 11(2), 255-259.'}, {'pmid': '34190074', 'type': 'BACKGROUND', 'citation': 'Horng J, Liu XC, Thometz J, Tassone C, Duey-Holtz A. Evaluation of plantar pressures and center of pressure trajectories in Adolescent Idiopathic Scoliosis. Stud Health Technol Inform. 2021 Jun 28;280:131-135. doi: 10.3233/SHTI210451.'}, {'pmid': '31009471', 'type': 'BACKGROUND', 'citation': 'Gao CC, Chern JS, Chang CJ, Lai PL, Lung CW. Center of pressure progression patterns during level walking in adolescents with idiopathic scoliosis. PLoS One. 2019 Apr 22;14(4):e0212161. doi: 10.1371/journal.pone.0212161. eCollection 2019.'}, {'pmid': '33999943', 'type': 'BACKGROUND', 'citation': 'Zhu F, Hong Q, Guo X, Wang D, Chen J, Zhu Q, Zhang C, Chen W, Zhang M. A comparison of foot posture and walking performance in patients with mild, moderate, and severe adolescent idiopathic scoliosis. PLoS One. 2021 May 17;16(5):e0251592. doi: 10.1371/journal.pone.0251592. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk. These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA. All these situations can lead to postural imbalance and asymmetrical loading pattern, which we often encounter in children with JIA. Current studies describing various exercise methods effective on postural alignment. However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children JIA.', 'detailedDescription': 'Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk. These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA. These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA. All these situations can lead to postural imbalance and asymmetrical loading pattern, which we often encounter in children with JIA. Current studies describing various exercise methods effective on postural alignment. However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children JIA. Therefore, this study aimed to investigate the effects of two different exercise programs (core based exercise program against neuromuscular training) on gait parameters in children JIA.\n\nIn this study, the participants will be evaluated and then they will be divided into two groups randomly. The first group will be administered as a core based exercise program group and the second one will be undergone as a neuromuscular training group. After the interventions, they will be re-evaluted by the physiotherapist and the outcomes will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a diagnosis of oligoarticular JIA\n* Being between the age of 8 and 16\n* Having included knee joint.\n\nExclusion Criteria:\n\n* Having an additional neurological or orthopedic diagnosis other than JIA Affecting treatment results,\n* Having had any surgery on the spine or the extremity joints\n* Being at a level that will not understand the questions asked.'}, 'identificationModule': {'nctId': 'NCT06356350', 'briefTitle': 'Exercise Programs on Gait in Children JIA', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Effects of Exercise Programs on Gait in Children With Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': 'IUC_jia_gait'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Core based exercise group', 'description': 'This group will be undergone core based exercises program', 'interventionNames': ['Other: Core based exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neuromuscular exercises group', 'description': 'This group will be undergone conventional neuromuscular exercises program', 'interventionNames': ['Other: Conventional neuromuscular exercises']}], 'interventions': [{'name': 'Conventional neuromuscular exercises', 'type': 'OTHER', 'description': 'Conventional neuromuscular exercises represent a contemporary physiotherapeutic approach. These exercises aim to improve neuromuscular control, strength, and endurance in various muscles surrounding the included joint, contributing to the correction and maintenance of proper posture.', 'armGroupLabels': ['Neuromuscular exercises group']}, {'name': 'Core based exercises', 'type': 'OTHER', 'description': 'Core based exercises increase overall mobility, relieve pain, improve posture, and support spinal alignment. Especially important for children who are still growing is to slow or stop the progression of deformities because of the asymmetrical loading pattern.', 'armGroupLabels': ['Core based exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Gokce Leblebici', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}