An interventional study of Clinical assessment of spinal stiffness in Hyperkyphosis and Adolescent Idiopathic Scoliosis, sponsored by Istituto Scientifico Italiano Colonna Vertebrale. Recruiting at 1 site in Italy. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Istituto Scientifico Italiano Colonna Vertebrale · Not applicable, Interventional, and Diagnostic
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.
132 studies on the registry are indexed under Kyphosis; 31 are open to participants now.
This study's planned enrollment of 25 is below the median of 44 across 82 interventional studies indexed under Kyphosis.
Browse Kyphosis studies →Istituto Scientifico Italiano Colonna Vertebrale is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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
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.
Reliability
Test-retest reliability of the three stiffness assessment tests. Inter class correlation will be calculated
Time frame: through study completion, an average of 6 months
Repeatability
Inter-Rater and Intra-Rater Repeatability of the three stiffness assessment tests
Time frame: through study completion, an average of 6 months
Diagnostic accuracy
diagnostic sensitivity and specificity of each test
Time frame: through study completion, an average of 6 months
Plan to share: Yes — Anonymised data will be deposited in an online repository
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Dec 2024, 18 months after the start.
Of 56 non-industry interventional studies with no phase under Kyphosis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 30. This study's planned 18 months is above that.
Counting every sponsor, half of 58 studies reached it within 9 months; a quarter within 4 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
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Istituto Scientifico Italiano Colonna Vertebrale