Validation of Clinical Assessment of Spinal Stiffness

Study Overview
=================
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.

Official Title
-----------------
Validation of Clinical Assessment of Spinal Stiffness in Hyperkyphosis and Scoliosis During Growth

Conditions
-----------------
Hyperkyphosis, Adolescent Idiopathic Scoliosis

Intervention / Treatment
-----------------
* Other: Clinical assessment of spinal stiffness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scoliosis > 10°Cobb or Hyperkyophosis >50° Cobb Age between 10 and 17 years old Risser between 0 and 5 Exclusion Criteria: History of spinal surgery Presence of back pain Diagnosis of congenital scoliosis or scoliosis secondary to neurological or muscular diseases

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical assessment of spinal stiffness<br>Patients' back flexibility will be assessed during the medical examination or physiotherapy session through one of the following non-invasive tests: Thoracic Stiffness Test (TST) Scoliosis stiffness test (SST) Kyphosis Stiffness Test (KST) Each test will be carried out at the beginning of the visit and repeated at the end 2 times by different operators, or once by the same operator to verify that the measurements taken at different times are reliable and that the measurements taken by two different operators are reliable. | Other: Clinical assessment of spinal stiffness<br>* The clinical stiffness tests will be applied twice to the same patient by the same operator to verify intra-operator variability and twice by two operators at the same time to verify inter-operator variability. The verification of diagnostic accuracy with respect to the radiographic reference standard will be carried out retrospectively by using the data already available and systematically collected in electronic format during medical visits and physiotherapy sessions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability | Test-retest reliability of the three stiffness assessment tests. Inter class correlation will be calculated | through study completion, an average of 6 months | 
| Repeatability | Inter-Rater and Intra-Rater Repeatability of the three stiffness assessment tests | through study completion, an average of 6 months | 
| Diagnostic accuracy | diagnostic sensitivity and specificity of each test | through study completion, an average of 6 months |