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Assessment of Trunk Aesthetics: Development of a New Tool

Active, not recruiting
Conditions
Adolescent Idiopathic Scoliosis
Interventions
Other: TRACE 2
Registration Number
NCT05912140
Lead Sponsor
Istituto Scientifico Italiano Colonna Vertebrale
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
600
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Trunk Aesthetic Clinical EvaluationTRACE 2-
Primary Outcome Measures
NameTimeMethod
TRACE2through study completion, an average of 1 year

New version of the TRACE tool for the assessment of trunk aesthetics in patients with scoliosis

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

ISICO

🇮🇹

Milan, Mi, Italy

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