3D Depth Camera-Based Assessment of Adolescent Idiopathic ScoliosisUsing a Depth Camera

NCT06717568 | Recruiting DMC

• 1 other identifier: 2024-KL-215-01-3
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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. The 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.

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• Back height difference

  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.

  Day 1 of Admission

Secondary Outcomes (1)

• Angle of trunk rotation

  Day 1 of Admission

Study Arms (1)

participant

BHD Measurement: Each participant undergoes two measurements by two different assessors, with a 5-minute interval between each measurement. The average value is taken. ATR 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. Cobb 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.

Diagnostic Test: no intervention

Interventions

no intervention DIAGNOSTIC_TEST

This is a diagnostic test with no intervention.

participant

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study focuses on adolescents aged 10-18 diagnosed with adolescent idiopathic scoliosis, defined by a Cobb angle of ≥10°.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40689983 DERIVED

Central Study Contacts

Honggen Du

CONTACT

13958088996; 506776186@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: December 5, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)