Validation of Clinical Assessment of Spinal Stiffness

Sponsor

Istituto Scientifico Italiano Colonna Vertebrale (Other)

Overall Status

Recruiting

CT.gov ID

NCT05924581

Collaborator

(none)

Enrollment

Location

Arm

8.8

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperkyphosis Adolescent Idiopathic Scoliosis	Other: Clinical assessment of spinal stiffness	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 6, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ISICO	Milan	Mi	Italy	20141

Sponsors and Collaborators

Istituto Scientifico Italiano Colonna Vertebrale

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Scientifico Italiano Colonna Vertebrale

ClinicalTrials.gov Identifier:

NCT05924581

Other Study ID Numbers:

ClinTest-HKS

First Posted:

Jun 29, 2023

Last Update Posted:

Jun 29, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Scoliosis

Kyphosis

Study Results

No Results Posted as of Jun 29, 2023