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
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Condition or disease | Intervention/treatment | Phase |
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Hyperkyphosis Adolescent Idiopathic Scoliosis | Other: Clinical assessment of spinal stiffness | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Validation of Clinical Assessment of Spinal Stiffness in Hyperkyphosis and Scoliosis During Growth |
Actual Study Start Date : | June 6, 2023 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
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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:
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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. |
- 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
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Ages Eligible for Study: | 10 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05924581
Contact: Stefano Negrini, MD, PhD | +3902 8416 1700 | stefano.negrini@isico.it | |
Contact: Alessandra Negrini | +3902 8416 1700 | alessandra.negrini@isico.it |
Italy | |
ISICO | Recruiting |
Milan, Mi, Italy, 20141 | |
Contact: Stefano Negrini, MD 0039 02 84161700 stefano.negrini@isico.it |
Responsible Party: | Istituto Scientifico Italiano Colonna Vertebrale |
ClinicalTrials.gov Identifier: | NCT05924581 |
Other Study ID Numbers: |
ClinTest-HKS |
First Posted: | June 29, 2023 Key Record Dates |
Last Update Posted: | May 10, 2024 |
Last Verified: | May 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymised data will be deposited in an online repository |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Scoliosis Kyphosis Spinal Curvatures |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |