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Validation of Clinical Assessment of Spinal Stiffness

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05924581
Enrollment
25
Registered
2023-06-29
Start date
2023-06-06
Completion date
2024-12-31
Last updated
2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Idiopathic Scoliosis, Hyperkyphosis

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.

Interventions

OTHERClinical 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.

Sponsors

Istituto Scientifico Italiano Colonna Vertebrale
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reliabilitythrough study completion, an average of 6 monthsTest-retest reliability of the three stiffness assessment tests. Inter class correlation will be calculated
Repeatabilitythrough study completion, an average of 6 monthsInter-Rater and Intra-Rater Repeatability of the three stiffness assessment tests
Diagnostic accuracythrough study completion, an average of 6 monthsdiagnostic sensitivity and specificity of each test

Countries

Italy

Contacts

Primary ContactStefano Negrini, MD, PhD
stefano.negrini@isico.it+3902 8416 1700
Backup ContactAlessandra Negrini
alessandra.negrini@isico.it+3902 8416 1700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026