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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04969588
Other study ID # 202002212A3
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date July 31, 2024

Study information

Verified date August 2021
Source Chang Gung Memorial Hospital
Contact Li-Wen Lee, MD, PhD
Phone +886 5 3621 000
Email m4572@cgmh.org.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This perspective observational study will recruited 240 participants for investigating the feasibility of using Microsoft Azure Kinect developer kit as a method for body indices and body composition. Reference methods will be dual energy X-ray absorptiometry and bioelectrical impedance analysis.


Description:

The purpose of this research is to validate the precision and accuracy of Microsoft Azure Kinect Developer Kit in the application of body anthropometric index and body composition measures. This study assumes that depth camera along with skeletal tracking package can estimate the 3D joint position and skeletal length. A dual energy X-ray absorptiometry scanner, a medical device with a daily background dose of radiation will be used as the gold standard. This study aims to investigate the correlation and agreement of using Kinect in estimating skeletal length and body composition in human.A total of 240 participants including children and adults will be recruited for measurements in a 3-year period.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers
Gender All
Age group 6 Years to 65 Years
Eligibility Inclusion Criteria: - Healthy children and adult - Age 6-65 years Exclusion Criteria: - Chronic illness or chronic medication use (> 3 months) - Pregnant - Metal implant(s) or splint(s) - Pacemaker implantation - Limb defect(s) or injury

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Microsoft Azure Kinect Developer Kit
3D images and 3D joint coordinates are obtained.
Bioelectrical impedance analyzer
Fat mass, fat-free mass and percentage body fat in total body and body segments are estimated.
Dual Energy X-ray Absorptiometry
Skeletal length and body composition are estimated.

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Chiayi City

Sponsors (2)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assess association and agreement in body indices and body composition between Kinect and standard methods. Correlation and agreement between depth camera results are compared to the results of dual energy X-ray absorptiometry and bioelectrical impedance analysis. 36 months
Primary Develop and validate Kinect equations to predict body indices and body composition. Prediction equations for body indices and body composition are created using dual energy X-ray absorptiometry and bioelectrical impedance analysis as reference tools. 36 months
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