Validation of Clinical Assessment of Spinal Stiffness
- Conditions
- Adolescent Idiopathic ScoliosisHyperkyphosis
- Registration Number
- NCT05924581
- Lead Sponsor
- Istituto Scientifico Italiano Colonna Vertebrale
- Brief Summary
This study aims to validate and verify the reliability of the clinical measures used in the daily routine by doctors and therapists that allow assessing the spinal stiffness in all spatial planes. The secondary objective is the verification of the diagnostic accuracy of the most reliable tests in identifying the subjects at risk of failure, using as a radiographic standard the examinations performed by the patients during the treatment (data retrieved retrospectively) using as a control group those patients who did not obtain a correction of the spine curvature.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
- Scoliosis > 10°Cobb or Hyperkyophosis >50° Cobb
- Age between 10 and 17 years old
- Risser between 0 and 5
- History of spinal surgery
- Presence of back pain
- Diagnosis of congenital scoliosis or scoliosis secondary to neurological or muscular diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Reliability through study completion, an average of 6 months Test-retest reliability of the three stiffness assessment tests. Inter class correlation will be calculated
Repeatability through study completion, an average of 6 months Inter-Rater and Intra-Rater Repeatability of the three stiffness assessment tests
Diagnostic accuracy through study completion, an average of 6 months diagnostic sensitivity and specificity of each test
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ISICO
🇮🇹Milan, Mi, Italy
ISICO🇮🇹Milan, Mi, ItalyStefano Negrini, MDContact0039 02 84161700stefano.negrini@isico.it