Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-01 @ 3:45 PM
Study NCT ID:
NCT06643104
Status:
RECRUITING
Last Update Posted:
2024-10-16
First Post:
2024-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Imaging Assessment of Scoliosis: Back Height Difference vs. Trunk Rotation Angle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-13', 'studyFirstSubmitDate': '2024-10-13', 'studyFirstSubmitQcDate': '2024-10-13', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Back height difference', 'timeFrame': 'Day 1 of Admission and Day 5 of Admission', 'description': 'Using depth cameras to acquire back data, point cloud processing algorithms analyze the information. The height difference between the highest point on the convex side and the corresponding point on the concave side is measured, with three repetitions taken to calculate the average value.'}], 'secondaryOutcomes': [{'measure': 'Angle of trunk rotation', 'timeFrame': 'Day 1 of Admission and Day 5 of Admission', 'description': "A scoliometer is used to measure the patient's angle of trunk rotation (ATR). Measurements are repeated three times, and the average value is taken."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adolescent Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': 'This study focuses on adolescents with idiopathic scoliosis, employing 3D imaging technology with depth cameras to measure back height difference (BHD) and angle of trunk rotation (ATR) before and after conventional treatments such as massage, exercise therapy, and bracing. Statistical analyses are conducted to verify the correlation between BHD and ATR and to assess the sensitivity of BHD in evaluating short-term treatment effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study focuses on adolescents aged 10-18 diagnosed with adolescent idiopathic scoliosis, defined by a Cobb angle of ≥10°.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(1) Adolescents aged 10-18 years, diagnosed with adolescent idiopathic scoliosis (AIS) with a Cobb angle ≥10°; (2) No history of spinal surgery or other corrective treatments; (3) Able to undergo short-term inpatient treatment (5 days) and comply with study procedures.\n\nExclusion Criteria:\n\n(1) Patients with congenital, neuromuscular, or other secondary scoliosis; (2) Presence of major comorbidities affecting spinal structure or muscle tone (e.g., spinal cord injury, muscular dystrophy); (3) Patients unable to complete standardized assessment procedures.'}, 'identificationModule': {'nctId': 'NCT06643104', 'briefTitle': '3D Imaging Assessment of Scoliosis: Back Height Difference vs. Trunk Rotation Angle', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhejiang Chinese Medical University'}, 'officialTitle': 'Assessment of Adolescent Idiopathic Scoliosis Based on 3D Imaging With Depth Cameras: A Comparative Study of Back Height Difference and Angle of Trunk Rotation', 'orgStudyIdInfo': {'id': '2024-KL-215-01-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BHD', 'interventionNames': ['Procedure: Tuina']}], 'interventions': [{'name': 'Tuina', 'type': 'PROCEDURE', 'otherNames': ['Tuina, sports gymnastics'], 'description': 'X-ray mapping guides three days of tailored exercises, including 3D therapy, breathing techniques, and spinal manipulation.', 'armGroupLabels': ['BHD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Honggen Du', 'role': 'CONTACT'}], 'facility': 'the First Affiliated Hospital of Zhejiang Chinese Medical University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Honggen Du', 'role': 'CONTACT', 'email': '1165374551@qq.com', 'phone': '13958088996'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhejiang Chinese Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}