Assessment of Trunk Aesthetics: Development of a New Tool (TRACE2)
TRACE2: Development of a New Tool for the Evaluation of the Trunk Aesthetics in Patients with Scoliosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Mi
-
Milan, Mi, Italy, 20141
- ISICO
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Trunk Aesthetic Clinical Evaluation
|
The first version of TRACE2 will be retrospectively verified through its application by experts on 150 photos of scoliosis patients who agreed to use the material produced for clinical use for retrospective research. Both intra-operator and inter-operator repeatability will be evaluated and a first Rasch analysis will be performed. The new version of TRACE2 (TRACE2.2) obtained following the retrospective validation on the photos will be verified prospectively through its application by the experts on 150 patients in specialist medical examination. Both intra-operator and inter-operator repeatability will be evaluated and further Rasch analysis will follow. On the basis of the results obtained from the analysis, the new TRACE2 scale (TRACE2.3) will then be applied to a further 150 patients, its intra- and inter-operator repeatability will be calculated and a final Rasch analysis will be performed to arrive at the final version of the scale (TRACE2.4). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TRACE2
Time Frame: through study completion, an average of 1 year
|
New version of the TRACE tool for the assessment of trunk aesthetics in patients with scoliosis
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stefano Negrini, MD, Phd, Istituto Scientifico Italiano Colonna Vertebrale
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRACE2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.