Back to resultsValidation of Clinical Assessment of Spinal Stiffness
Primary Purpose
Hyperkyphosis, Adolescent Idiopathic Scoliosis
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Clinical assessment of spinal stiffness
Sponsored by
About this trial
This is an interventional diagnostic trial for Hyperkyphosis
Eligibility Criteria
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
Sites / Locations
- ISICORecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Clinical assessment of spinal stiffness
Arm 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.
Outcomes
Primary Outcome Measures
Reliability
Test-retest reliability of the three stiffness assessment tests. Inter class correlation will be calculated
Repeatability
Inter-Rater and Intra-Rater Repeatability of the three stiffness assessment tests
Diagnostic accuracy
diagnostic sensitivity and specificity of each test
Secondary Outcome Measures
Full Information
NCT ID
NCT05924581
First Posted
June 15, 2023
Last Updated
June 26, 2023
Sponsor
Istituto Scientifico Italiano Colonna Vertebrale
1. Study Identification
Unique Protocol Identification Number
NCT05924581
Brief Title
Validation of Clinical Assessment of Spinal Stiffness
Official Title
Validation of Clinical Assessment of Spinal Stiffness in Hyperkyphosis and Scoliosis During Growth
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Scientifico Italiano Colonna Vertebrale
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkyphosis, Adolescent Idiopathic Scoliosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clinical assessment of spinal stiffness
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Clinical assessment of spinal stiffness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reliability
Description
Test-retest reliability of the three stiffness assessment tests. Inter class correlation will be calculated
Time Frame
through study completion, an average of 6 months
Title
Repeatability
Description
Inter-Rater and Intra-Rater Repeatability of the three stiffness assessment tests
Time Frame
through study completion, an average of 6 months
Title
Diagnostic accuracy
Description
diagnostic sensitivity and specificity of each test
Time Frame
through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Negrini, MD, PhD
Phone
+3902 8416 1700
Email
stefano.negrini@isico.it
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandra Negrini
Phone
+3902 8416 1700
Email
alessandra.negrini@isico.it
Facility Information:
Facility Name
ISICO
City
Milan
State/Province
Mi
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Negrini, MD
Phone
0039 02 84161700
Email
stefano.negrini@isico.it
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised data will be deposited in an online repository
Learn more about this trial
Validation of Clinical Assessment of Spinal Stiffness
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