Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT03497520
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2018-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Asymmetric Spinal Stabilization Exercise on Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2018-03-29', 'studyFirstSubmitQcDate': '2018-04-12', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cobb angle', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'measure lateral curve of vertebra on spine x-ray AP view'}, {'measure': 'Apical vertebral rotation', 'timeFrame': 'through study completion, an average of 1 year', 'description': "angle of trunk rotation in Adam's test"}, {'measure': 'surface electromyography', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'surface muscle contraction of bilateral spinal muscle on T7, T12, L3'}], 'secondaryOutcomes': [{'measure': 'Scoliosis Research Society-22(SRS-22) quastionnaire', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'five different factors (pain, self-image/appearance, function/activity, mental health, and satisfaction with management, 5 = best; 1 = worst)the minimum and maximum score range is from 5 to 25'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surface EMG', 'cobb angle', 'exercise', 'Spinal Curvatures'], 'conditions': ['Scoliosis Idiopathic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of asymmetric spinal stabilization exercise on scoliosis', 'detailedDescription': "* Design: Prospective study\n* Setting: hospital rehabilitation department\n* Intervention: Participants are educated asymmetric spinal stabilization exercise along scoliosis curve patterns, including the location of apex and the direction of convexity. After performing asymmetric spinal stabilization exercise, participants are compared the main outcome measures.\n* Main outcome measures: Cobb angle, Apical vertebral rotation in Adam's test, surface EMG, Scoliosis Research Society-22(SRS-22) quastionnaire"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* who have idiopathic scoliosis, showing at Cobb's angle over 10 degrees on X-ray\n\nExclusion Criteria:\n\n* Patients who underwent spinal surgery\n* Patients with spinal scoliosis due to cerebral palsy, muscle paralysis, polio, congenital spinal abnormalities\n* Patients observed with Cobb's angle less than 10 degrees, over 40 degrees\n* Patients complaining of acute low back pain"}, 'identificationModule': {'nctId': 'NCT03497520', 'briefTitle': 'The Effect of Asymmetric Spinal Stabilization Exercise on Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Asymmetric Spinal Stabilization Exercise on Scoliosis', 'orgStudyIdInfo': {'id': 'B-1701/377-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'scoliosis patients', 'description': 'scoliosis patients who have cobb angle over 10 degree perform asymmetric spinal stabilization exercise', 'interventionNames': ['Behavioral: asymmetric spinal stabilization exercise']}], 'interventions': [{'name': 'asymmetric spinal stabilization exercise', 'type': 'BEHAVIORAL', 'description': "The patients were educated to strengthening weakness side of spinal muscle, as asymmetric spinal stabilization exercise(ASSE)\n\n* before teach ASSE, the investigators will evaluate Cobb angle, Apical vertebral rotation in Adam's test, surface EMG, Scoliosis Research Society-22(SRS-22) quastionnaire for evaluation of scoliosis severity\n* after perform ASSE, the investigators will evaluate Cobb angle, Apical vertebral rotation in Adam's test, surface EMG, Scoliosis Research Society-22(SRS-22) quastionnaire for evaluation of scoliosis severity", 'armGroupLabels': ['scoliosis patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Jusuk Ryu, M.D. PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Ju Seok Ryu', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}