NCT05924581

Validation of Clinical Assessment of Spinal Stiffness

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Istituto Scientifico Italiano Colonna Vertebrale · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperkyphosis
• Adolescent Idiopathic Scoliosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-06
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-06-29
• Last updated: 2024-05-10

Locations

1 site across 1 country: Italy