Clinical Trial

Assessment of Trunk Aesthetics: Development of a New Tool

Study acronym: TRACE2
Active, Not Recruiting
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Record status
This record was last updated October 3, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
Summary
Scoliosis is a three-dimensional deformity of the spine and the trunk. TRACE (Trunk Aesthetic Clinical Evaluation) is an aesthetics assessment tool for patients with scoliosis. It has been validated with Rasch analysis is easily usable in daily clinical practice. Despite this tool being more sensitive in detecting changes in aesthetics during treatment compared to other existing ones, its reliability is still low, probably due to the small number of elements that make up the rating scale. This study aims to develop a new version of the TRACE tool by adding new items. The development of TRACE2 in a Rasch environment will ensure greater sensitivity and specificity of the scale assessment.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-06-12.
Trial Details
NCT Number NCT05912140
Lead Sponsor Istituto Scientifico Italiano Colonna Vertebrale
Conditions Adolescent Idiopathic Scoliosis
Enrollment 600 participants
Start Date 2023-06-06
Primary Completion 2025-06 (estimated)
Study Completion 2025-09 (estimated)
Updated on ClinicalTrials.gov 2024-10-03