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NCT05598021
Self-correction Evaluation in Scoliosis Patients
Conditions: Scoliosis; Juvenile, Scoliosis; Adolescence
Sex: All
Ages: 10 Years – N/A
Enrollment: 185
Sponsor: Istituto Scientifico Italiano Colonna Vertebrale
Location: Italy
Summary
To date, there is no objective assessment method for the quality of the self-correction performed by patients with scoliosis.The study consists of two parts, both retrospective, and distinct on the basis of the tools used to assess self-correction.Part 1: Retrospective assessment of the radiographic variations between spontaneous position and self-correction in subjects suffering from juvenile and adolescent idiopathic scoliosis.
Both measurements were performed in a single session.Part 2: Retrospective assessment of the variations between spontaneous and self-correcting position in subjects with juvenile and adolescent idiopathic scoliosis using objective parameters deriving from non-invasive 3D ultrasound instrumentation (Scolioscan, Telefeld, Hong Kong).
Eligibility Criteria
Inclusion Criteria for both parts:Diagnosis of juvenile or adolescent idiopathic scoliosis;Age >= 10 years;Single and double curves with amplitude >= 15 ° Cobb;Performing exercises according to SEAS for at least 6 monthsOnly for part 1 (radiographic)Availability of radiographic investigation in upright position and in self-correction Only for part 2 (ultrasound)Availability of ultrasound assessment in upright position and in self-correctionComplete radiograph of the spine in anteroposterior projection performed in the 45 days preceding or following the medical examination.Risser between 0 and 2.Exclusion Criteria:For both parts:Patients with more than 2 scoliotic curvesPatients with secondary scoliosisPatients suffering from learning disabilities or clinical conditions impairing neuromotor controlPatients lacking the necessary measures to evaluate the outcome.Part 2 only (ultrasound)● Patients undergoing brace treatment
Source: ClinicalTrials.gov (NCT05598021). StuddyBuddy aggregates publicly available trial information.