Validation of Clinical Assessment of Spinal Stiffness

NCT05924581 | Recruiting

• 1 other identifier: ClinTest-HKS
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperkyphosis; Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Clinical assessment of spinal stiffness

EXPERIMENTAL

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

Interventions

Clinical assessment of spinal stiffness OTHER

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.

Clinical assessment of spinal stiffness

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Scoliosis \> 10°Cobb or Hyperkyophosis \>50° Cobb
• Age between 10 and 17 years old
• Risser between 0 and 5

You may not qualify if:

• History of spinal surgery
• Presence of back pain
• Diagnosis of congenital scoliosis or scoliosis secondary to neurological or muscular diseases

Sponsors & Collaborators

• Istituto Scientifico Italiano Colonna Vertebrale: lead

Study Sites (1)

ISICO

Milan, Mi, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Stefano Negrini, MD, PhD

CONTACT

+3902 8416 1700; stefano.negrini@isico.it

Alessandra Negrini

CONTACT

+3902 8416 1700; alessandra.negrini@isico.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 29, 2023
• Study Start: June 6, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)