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Validation of Clinical Assessment of Spinal Stiffness

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ClinicalTrials.gov Identifier: NCT05924581
Recruitment Status : Recruiting
First Posted : June 29, 2023
Last Update Posted : May 10, 2024
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Italiano Colonna Vertebrale

Tracking Information
First Submitted Date  ICMJE June 15, 2023
First Posted Date  ICMJE June 29, 2023
Last Update Posted Date May 10, 2024
Actual Study Start Date  ICMJE June 6, 2023
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2023)
  • Reliability [ Time Frame: through study completion, an average of 6 months ]
    Test-retest reliability of the three stiffness assessment tests. Inter class correlation will be calculated
  • Repeatability [ Time Frame: through study completion, an average of 6 months ]
    Inter-Rater and Intra-Rater Repeatability of the three stiffness assessment tests
  • Diagnostic accuracy [ Time Frame: through study completion, an average of 6 months ]
    diagnostic sensitivity and specificity of each test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of Clinical Assessment of Spinal Stiffness
Official Title  ICMJE Validation of Clinical Assessment of Spinal Stiffness in Hyperkyphosis and Scoliosis During Growth
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Hyperkyphosis
  • Adolescent Idiopathic Scoliosis
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Other: Clinical assessment of spinal stiffness
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2023)		 25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stefano Negrini, MD, PhD +3902 8416 1700 stefano.negrini@isico.it
Contact: Alessandra Negrini +3902 8416 1700 alessandra.negrini@isico.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05924581
Other Study ID Numbers  ICMJE ClinTest-HKS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymised data will be deposited in an online repository
Current Responsible Party Istituto Scientifico Italiano Colonna Vertebrale
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Istituto Scientifico Italiano Colonna Vertebrale
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Istituto Scientifico Italiano Colonna Vertebrale
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP