Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-08 @ 1:54 AM
Study NCT ID:
NCT04203394
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2019-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Controlled Schroth Exercise and Home Exercise Programs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Root Mean Square(RMS)', 'timeFrame': '12 weeks', 'description': 'Body right and left asymmetry will be examined.'}, {'measure': '3D Motion analysis', 'timeFrame': '12 weeks', 'description': '3D motion analysis with 4 cameras, symmetry of certain points will be evaluated during motion.'}, {'measure': 'Postural Trunk Asymmetry Index (POTSI)', 'timeFrame': '12 weeks', 'description': 'It is a method that allows an individual with AIS to evaluate body shape and asymmetry.'}, {'measure': 'Walter Reed Visuel Assesment Scale', 'timeFrame': '12 weeks', 'description': 'Walter Reed Visuel Assesment Scale (WRVAS) each aspect is shown with five levels of increasing severity of the seven type of deformity that are scored from minimum (1) to maximum (5). How individuals perceive their own cosmetic deformities and the effectiveness of treatment in improving cosmetic deformity can be evaluated'}, {'measure': 'Scoliosis Research Society-22', 'timeFrame': '12 weeks', 'description': 'Scoliosis Research Society (SRS-22) is a simple and practical questionnaire specific to individuals with scoliosis. The questionnaire included pain, self-image, function / activity, mental health and treatment satisfaction. There are 22 questionnaire questions, scoring from 1 to 5. The minimum score is the worst score (22).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schroth exercise, conservative treatment, scoliosis'], 'conditions': ['Scoliosis Idiopathic', 'Scoliosis; Adolescence']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://link.springer.com/content/pdf/10.1007/s00586-021-06769-5.pdf', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effects of Schroth 3D exercise method on home symmetry, trunk topography, scapula symmetry, pelvic symmetry, health related quality of life and cosmetic deformity perception in adolescents with idiopathic scoliosis', 'detailedDescription': 'Cobb angle measurement, which is accepted as the gold standard in patients with scoliosis, is a radiological measurement. However, in continuous follow-up, the search for other methods to obtain objective data that will provide a short term evaluation on the patient in determining the efficacy of conservative treatment continues.\n\nIn our study, individuals who meet the criteria will be evaluated at the beginning and end of the study. Sociodemographic features and scoliosis characteristics (Cobb angle, degree of bone maturation according to Risser, apex, vertebra rotation angle) will be recorded. Posterior Trunk Asymmetry Index (POTSI) will be used to determine body asymmetry, and topographic measurements will be performed with Artec Eva 3D Scanner and motion analysis will be performed with Biomechanical Motion Analysis Sistem (Model is BTS Smart DX100) . Individuals will evaluate their cosmetic deformities with the Walter Reed Visual Evaluation Scale. Scoliosis Research Society-22 will be used to measure quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with scoliosis diagnosed and followed up by the attending physician\n* 10-16 age group,\n* Patients who voluntarily agreed to participate in the study\n* Living in Antalya/TURKEY\n\nExclusion Criteria:\n\n* Mental retardation, congenital scoliosis or spinal deformity, spinal surgery, neuromuscular disease, rheumatologic disease, tumor, cardiovascular or pulmonary disease, vertigo attack or balance problem, neurological disease\n* İndividual who does not sign the consent form'}, 'identificationModule': {'nctId': 'NCT04203394', 'briefTitle': 'Comparison of the Effects of Controlled Schroth Exercise and Home Exercise Programs', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Mediterranean University'}, 'officialTitle': 'Comparison of the Effects of Controlled Schroth Exercise and Home Programs on Body Symmetry, Deformity Perception and Quality of Life in Adolescent Idiopathic Scoliosis', 'orgStudyIdInfo': {'id': '02.04.2018 2018/57-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Schroth Exercise Group', 'description': '12 week , Exercises 1 hour, 2 times for a week with physiotherapist 20 minutes home exercise', 'interventionNames': ['Other: Schroth Exercise Group']}, {'type': 'EXPERIMENTAL', 'label': 'Home Exercise Group', 'description': 'Home exercise 20 min at home Once, one hour to determine the Schroth program + teaching home exercises 20 minutes home exercise', 'interventionNames': ['Other: Home Exercise Group']}], 'interventions': [{'name': 'Schroth Exercise Group', 'type': 'OTHER', 'description': '12 week , Exercises 1 hour, 2 times for a week with physiotherapist 20 minutes home exercise', 'armGroupLabels': ['Schroth Exercise Group']}, {'name': 'Home Exercise Group', 'type': 'OTHER', 'description': 'Home exercise 20 min at home Once, one hour to determine the Schroth program + teaching home exercises 20 minutes home exercise', 'armGroupLabels': ['Home Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07100', 'city': 'Antalya', 'state': 'Konyaalti', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz University Physical Therapy and Rehabilitation', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'KADRIYE TOMBAK', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AKDENIZ UNIVERSITY PHYSICAL THERAPY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Mediterranean University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Akdeniz University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}