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Background:  Congenital talipes equinovarus (CTEV) or clubfoot is a common pediatric congenital foot deformity that occurs 1 in 1,000 live births. Clubfoot is characterized by four types of foot deformities: hindfoot equinus; midfoot cavus; forefoot adductus; and hindfoot varus. A structured assessment method for clubfoot is essential for quantifying the initial severity of clubfoot deformity and recording the progress of clubfoot intervention.   Aim:  This study aims to develop a three-dimensional (3D) assessment method to evaluate the initial severity of the clubfoot and monitor the structural changes of the clubfoot after each casting intervention. In addition, this study explores the relationship between the thermophysiological changes in the clubfoot at each stage of the casting intervention and in the normal foot.   Methods:  In this study, a total of 10 clubfoot children who are <2 years old will be recruited. Also, the data of the unaffected feet of a total of 10 children with unilateral clubfoot will be obtained as a reference for normal feet. A Kinect 3D scanner will be used to collect the 3D images of the clubfoot and normal foot, and an Infrared thermography camera (IRT camera) will be used to collect the thermal images of the clubfoot. Three-dimensional scanning and IR imaging will be performed on the foot once a week before casting. In total, 6–8 scanning sessions will be performed for each child participant. The following parameters will be calculated as outcome measures to predict, monitor, and quantify the severity of the clubfoot: Angles cross section parameters, such as length, width, and the radial distance; distance between selected anatomical landmarks, and skin temperature of the clubfoot and normal foot. The skin temperature will be collected on selected areas (forefoot, mid foot, and hindfoot) to find out the relationship between the thermophysiological changes in the clubfoot at each stage of the casting treatment and in the normal foot.   Ethics:  The study has been reviewed and approved on 17 August 2016 by the Sydney Children's Hospitals Network Human Research Ethics Committee (SCHN HREC), Sydney, Australia. The Human Research Ethics Committee (HREC) registration number for this study is: HREC/16/SCHN/163.

Developing a Three-Dimensional (3D) Assessment Method for Clubfoot—A Study Protocol