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

Assessment of Adolescent Idiopathic Scoliosis Based on 3D Imaging Technology Using a Depth Camera

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.

Study Overview

• Status: Recruiting
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Diagnostic test: no intervention

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Honggen Du; Phone Number: 13958088996; Email: 506776186@qq.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The First Affiliated Hospital of Zhejiang Chinese Medical University
      • Contact: Honggen Du; Phone Number: 13958088996; Email: 506776186@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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°.

Description

Inclusion Criteria:

(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.

Exclusion Criteria:

(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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; This is a diagnostic test with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angle of trunk rotation	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.	Day 1 of Admission

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 30, 2024
• First Submitted That Met QC Criteria: November 30, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: November 30, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 2024-KL-215-01-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No