Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
Study NCT ID:
NCT06717568
Status:
RECRUITING
Last Update Posted:
2024-12-05
First Post:
2024-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3D Depth Camera-Based Assessment of Adolescent Idiopathic ScoliosisUsing a Depth Camera
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-30', 'studyFirstSubmitDate': '2024-11-30', 'studyFirstSubmitQcDate': '2024-11-30', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Back height difference', 'timeFrame': 'Day 1 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', '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']}, 'referencesModule': {'references': [{'pmid': '40689983', 'type': 'DERIVED', 'citation': 'Chen S, Liu C, Mou J, Liang J, Sun Y, Chen X, Yu B, Li J, Zhu H, Pan Y, Du H. Radiation-free 3D assessment of back height differences via three-dimensional depth sensing in adolescent idiopathic scoliosis: prospective, single-center, observational study. Eur Spine J. 2025 Jul 21. doi: 10.1007/s00586-025-09154-8. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Adolescent Idiopathic Scoliosis (AIS) is a common spinal deformity affecting adolescent health, and early diagnosis and accurate assessment are crucial for preventing disease progression. Traditional assessment indicators, such as the trunk rotation angle (ATR) and Cobb angle, rely on clinical examinations and X-ray imaging, which have certain limitations, including radiation exposure and insufficient sensitivity. The Back Height Difference (BHD), as a quantitative measure of the back surface morphology, may reflect the degree of trunk deformity caused by scoliosis.\n\nThe use of the Kinect v2 depth camera to capture three-dimensional point cloud data of the back provides a high-precision, radiation-free assessment method.'}, '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': 'NCT06717568', 'briefTitle': '3D Depth Camera-Based Assessment of Adolescent Idiopathic ScoliosisUsing a Depth Camera', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhejiang Chinese Medical University'}, 'officialTitle': 'Assessment of Adolescent Idiopathic Scoliosis Based on 3D Imaging Technology Using a Depth Camera', 'orgStudyIdInfo': {'id': '2024-KL-215-01-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'participant', 'description': 'BHD Measurement: Each participant undergoes two measurements by two different assessors, with a 5-minute interval between each measurement. The average value is taken.\n\nATR Measurement: The trunk rotation angle (ATR) is measured using a Scoliometer. Two assessors each perform two measurements, with a 5-minute interval between each, and the average value is taken.\n\nCobb Angle Measurement: Two experienced spinal specialists independently measure the Cobb angle, with each performing two measurements. The average value is taken. If their measurements differ by 5° or more, a third senior physician is required to perform a review.', 'interventionNames': ['Diagnostic Test: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'DIAGNOSTIC_TEST', 'description': 'This is a diagnostic test with no intervention.', 'armGroupLabels': ['participant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Honggen Du', 'role': 'CONTACT', 'email': '506776186@qq.com', 'phone': '13958088996'}], 'facility': 'the First Affiliated Hospital of Zhejiang Chinese Medical University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Honggen Du', 'role': 'CONTACT', 'email': '506776186@qq.com', 'phone': '13958088996'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhejiang Chinese Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}