Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-28 @ 8:41 AM
Study NCT ID:
NCT07040150
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Novel Semi-Rigid Brace for Adolescent Idiopathic Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-06-25', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wearing time', 'timeFrame': '180 days from registration'}], 'secondaryOutcomes': [{'measure': 'Initial correction rate', 'timeFrame': 'Immediately after registration'}, {'measure': 'Correction rate after 180 days or more', 'timeFrame': '180 days or more from registration'}, {'measure': 'Treatment success rate', 'timeFrame': '2 years or more from registration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adolescent Idiopathic Scoliosis (AIS)']}, 'referencesModule': {'references': [{'pmid': '16166897', 'type': 'BACKGROUND', 'citation': "Richards BS, Bernstein RM, D'Amato CR, Thompson GH. Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2068-75; discussion 2076-7. doi: 10.1097/01.brs.0000178819.90239.d0."}, {'pmid': '3913566', 'type': 'BACKGROUND', 'citation': 'Struhl K, Chen W, Hill DE, Hope IA, Oettinger MA. Constitutive and coordinately regulated transcription of yeast genes: promoter elements, positive and negative regulatory sites, and DNA binding proteins. Cold Spring Harb Symp Quant Biol. 1985;50:489-503. doi: 10.1101/sqb.1985.050.01.061. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: Spinal bracing remains the gold standard for conservative management of adolescent idiopathic scoliosis (AIS). However, poor adherence often limits treatment efficacy. The development of a brace that enhances compliance while maintaining sufficient corrective force is crucial. This study aimed to develop and evaluate the effectiveness of a novel semi-rigid brace for AIS based on wearing time and correction rate.\n\nMaterials and Methods: The investigators enrolled patients who met the following Scoliosis Research Society (SRS) criteria for brace treatment: (1) confirmed AIS diagnosis, (2) Risser sign ≤ 2, (3) Cobb angle between 25° and 40°, (4) age ≥ 10 years, and (5) single-curve pattern. Wearing time was objectively measured over 180 days using embedded temperature sensors. Correction rates were assessed at initiation and after 180 days or more.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Conducted at seven medical institutions in Japan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed AIS\n* Risser sign ≤ 2\n* Cobb angle between 25° and 40°\n* age ≥ 10 years\n* single-curve pattern (thoracic or thoracolumbar/ lumbar)\n* premenarchial or less than one year post-menarche.\n\nExclusion Criteria:\n\n* Patients who do not meet the SRS criteria for orthosis suitability\n* Patients with a history of spinal surgery'}, 'identificationModule': {'nctId': 'NCT07040150', 'briefTitle': 'Evaluation of a Novel Semi-Rigid Brace for Adolescent Idiopathic Scoliosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nippon Sigmax co., ltd.'}, 'officialTitle': 'Development and Short-Term Evaluation of a Novel Semi-Rigid Brace for Adolescent Idiopathic Scoliosis: Results From a Multicenter Prospective Observational Study of the First 60 Patients', 'orgStudyIdInfo': {'id': 'AMEC brace study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Spinal bracing', 'type': 'DEVICE', 'description': 'The semi-rigid spinal brace was developed to enhance patient compliance while maintaining effective curve correction. Patients were instructed to wear the brace for 18-20 h daily.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '969-3492', 'city': 'Aizu-Wakamatsu', 'state': 'Fukushima', 'country': 'Japan', 'facility': 'Aizu Medical Center at Fukushima Medical University', 'geoPoint': {'lat': 37.49142, 'lon': 139.94546}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigators will not be sharing individual participant data (IPD) due to privacy concerns.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nippon Sigmax co., ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}