Validation of Clinical Assessment of Spinal Stiffness

NCT ID: NCT05924581

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperkyphosis Adolescent Idiopathic Scoliosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Clinical assessment of spinal stiffness

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Scientifico Italiano Colonna Vertebrale

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ISICO

Milan, Mi, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Stefano Negrini, MD, PhD

Role: CONTACT

+3902 8416 1700

Alessandra Negrini

Role: CONTACT

+3902 8416 1700

Facility Contacts

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Stefano Negrini, MD

Role: primary

0039 02 84161700

Other Identifiers

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ClinTest-HKS

Identifier Type: -

Identifier Source: org_study_id

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