Assessment of Trunk Aesthetics: Development of a New Tool (TRACE2)

Istituto Scientifico Italiano Colonna Vertebrale

Status: Active, not recruiting

Conditions: Adolescent Idiopathic Scoliosis

Treatments: Other: TRACE 2

Study type: Observational

Funder types: Other

Identifiers

NCT05912140

TRACE2

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of scoliosis
• age between 10 and 17 years old
• scoliosis >10° Cobb
• humps > 5° ATR

Exclusion criteria

• History of spinal surgery
• positive neurological assessment

Trial design

600 participants in 1 patient group

Trunk Aesthetic Clinical Evaluation

Treatment:

Other: TRACE 2