Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-28 @ 2:23 AM
Study NCT ID:
NCT04568759
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-16
First Post:
2020-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2020-09-23', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cobb angle of at least 5 degrees', 'timeFrame': '6, 12 and 24 months', 'description': 'Angle measured on radiograph for scoliosis progression'}], 'secondaryOutcomes': [{'measure': 'Back pain on the Numerical Pain Rating Scale', 'timeFrame': '6, 12 and 24 months', 'description': 'Intensity of back pain on the Numerical Pain Rating Scale (0-10, where 0 indicates no pain et 10 the worst imaginable pain)'}, {'measure': 'Italian Spine Youth Quality of Life questionnaire', 'timeFrame': '6, 12 and 24 months', 'description': 'Quality of life: score is between 0 and 100, where 100 represents a higher quality of life'}, {'measure': 'Trunk imbalance', 'timeFrame': '6 and 12 months', 'description': 'The right/left horizontal deviation between the plumb line placed at C7 and S1 calculated in mm'}, {'measure': 'Diaphragm excursion', 'timeFrame': '6 and 12 months', 'description': 'Diaphragm excursion using ultrasound imaging in mm'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adolescent idiopathic scoliosis', 'Global postural re-education', 'back pain', 'quality of life', 'trunk imbalance', 'inter muscular coherence', 'respiratory function', 'functional performance'], 'conditions': ['Adolescent Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to verify the effect of the global postural reeducation (GPR) intervention used in physiotherapy on scoliosis progression (scoliosis angle), back pain, quality of life, respiratory function, trunk posture and trunk muscle functioning and walking endurance. To do so, we will recruit 144 participants at three scoliosis specialized Centers. Participants will be randomly allocated to the standard of care (SC) group (observation or brace plus home video of exercises for 12 months) or to the GPR group (SC plus individual sessions once a week for 6 months and individual sessions alternating with telerehabilitation sessions once per two weeks between 6 and 12 months). At initial, 6, 12- and 24-months evaluation, participants will have x-ray, complete self-report questionnaires to document back pain and quality of life. Thereafter, measurement of trunk posture, electromyography activity of the back muscles, excursion of the diaphragm muscle using echography and respiratory function as well as distance covered using the 6-minute walk test for walking endurance will be done. We believe that GPR intervention may prevent scoliosis progression and improve physical health and quality of life in adolescence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 10 and 16 years old,\n* Cobb angle between 15º and 45º,\n* Risser sign ≤3 (skeletal growth incomplete),\n* with a risk of progression index \\> 1.3,\n* having recent x-rays (4-6 weeks),\n* ability to travel weekly to attend GPR intervention\n\nExclusion Criteria:\n\n* patients with diagnosis other than AIS,\n* patients who are planned for surgery,\n* have had surgery,\n* worn a brace for at least three months prior to GPR intervention'}, 'identificationModule': {'nctId': 'NCT04568759', 'acronym': 'RCT-RPG', 'briefTitle': 'Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent', 'organization': {'class': 'OTHER', 'fullName': "St. Justine's Hospital"}, 'officialTitle': 'Randomized Controlled Trial to Evaluate the Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent', 'orgStudyIdInfo': {'id': '2021-3065_RCT-RPG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care group', 'description': 'Observation or brace plus conventional physiotherapy exercises on video', 'interventionNames': ['Other: Global postural re-education']}, {'type': 'EXPERIMENTAL', 'label': 'GPR group', 'description': 'GPR interventions added to standard care (observation or brace)', 'interventionNames': ['Other: Global postural re-education']}], 'interventions': [{'name': 'Global postural re-education', 'type': 'OTHER', 'description': 'GPR consists of active treatment posture and sensorimotor control exercises to regain back muscle symmetry and correct posture in daily activities', 'armGroupLabels': ['GPR group', 'Standard care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1M 2S8', 'city': 'Québec', 'country': 'Canada', 'facility': 'Centre interdisciplinaire de recherche en réadaptation et intégration sociale/Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Carole Fortin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Sainte-Justine/Université de Montréal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Justine's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Laval University', 'class': 'OTHER'}, {'name': 'Shriners Hospitals for Children', 'class': 'OTHER'}, {'name': 'Université de Montréal', 'class': 'OTHER'}, {'name': 'CHU de Québec', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Carole Fortin', 'investigatorAffiliation': "St. Justine's Hospital"}}}}