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Validation of Clinical Assessment of Spinal Stiffness

I

Istituto Scientifico Italiano Colonna Vertebrale

Status

Enrolling

Conditions

Hyperkyphosis
Adolescent Idiopathic Scoliosis

Treatments

Other: Clinical assessment of spinal stiffness

Study type

Interventional

Funder types

Other

Identifiers

NCT05924581
ClinTest-HKS

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

10 to 17 years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Clinical assessment of spinal stiffness
Experimental group
Description:
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.
Treatment:
Other: Clinical assessment of spinal stiffness

Trial contacts and locations

1

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Central trial contact

Alessandra Negrini; Stefano Negrini, MD, PhD

Data sourced from clinicaltrials.gov

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