Validation of Clinical Assessment of Spinal Stiffness

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05924581
• Other study ID #: ClinTest-HKS
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Istituto Scientifico Italiano Colonna Vertebrale
• Contact: Stefano Negrini, MD, PhD
• Phone: +3902 8416 1700
• Email: stefano.negrini[@]isico.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Hyperkyphosis
• Kyphosis
• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
Italy	ISICO	Milan	Mi

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Italiano Colonna Vertebrale

Country where clinical trial is conducted

Italy, 

Outcome

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