Validation of Clinical Assessment of Spinal Stiffness

Not Applicable

Recruiting

• Conditions: Adolescent Idiopathic Scoliosis; Hyperkyphosis
• Interventions: Other: Clinical assessment of spinal stiffness

• 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

Study Timeline

• Study Start: 2023-06-06
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-06-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical assessment of spinal stiffness	Clinical assessment of spinal stiffness	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.

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

Trial Locations

Locations (1)

ISICO; 🇮🇹 Milan, Mi, Italy