HyperkyphosisNCT05924581
Validation of Clinical Assessment of Spinal Stiffness
A study testing Clinical assessment of spinal stiffness in people with Hyperkyphosis and Adolescent Idiopathic Scoliosis, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Hyperkyphosis, Adolescent Idiopathic Scoliosis
- What is being tested?
- Clinical assessment of spinal stiffness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jun 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Scoliosis > 10°Cobb or Hyperkyophosis >50° Cobb
- Age between 10 and 17 years old
- Risser between 0 and 5
Who cannot join
- History of spinal surgery
- Presence of back pain
- Diagnosis of congenital scoliosis or scoliosis secondary to neurological or muscular diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ISICO
Milan, Mi, 20141
Stefano Negrini, MD, 0039 02 84161700, stefano.negrini@isico.it
About this study
Official title: Validation of Clinical Assessment of Spinal Stiffness in Hyperkyphosis and Scoliosis During Growth
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.
- Conditions
- Hyperkyphosis, Adolescent Idiopathic Scoliosis
- Being tested
- Clinical assessment of spinal stiffness
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessment of spinal stiffnessOther
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 group | Role | What they receive |
|---|---|---|
| Clinical assessment of spinal stiffness | Experimental | 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. Receives: Other: Clinical assessment of spinal stiffness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability
Test-retest reliability of the three stiffness assessment tests. Inter class correlation will be calculated
Measured: through study completion, an average of 6 months
Repeatability
Inter-Rater and Intra-Rater Repeatability of the three stiffness assessment tests
Measured: through study completion, an average of 6 months
Diagnostic accuracy
diagnostic sensitivity and specificity of each test
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start6 Jun 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkyphosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Scientifico Italiano Colonna Vertebrale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924581
- Sponsor's protocol ID
- ClinTest-HKS
- Status last verified
- May 2024
- First submitted
- 15 Jun 2023
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be deposited in an online repository
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Clinical Assessment of Spinal Stiffness in Hyperkyphosis and Scoliosis During Growth
- ClinicalTrials.gov ID
- NCT05924581
- Acronym / sponsor ID
- ClinTest-HKS
- Conditions
- Hyperkyphosis, Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Istituto Scientifico Italiano Colonna VertebraleUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical assessment of spinal stiffness | Experimental | Other: Clinical assessment of spinal stiffnessPatients' 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Scoliosis > 10°Cobb or Hyperkyophosis >50° Cobb
- Age between 10 and 17 years old
- Risser between 0 and 5
Key exclusion criteria (3 listed)
- History of spinal surgery
- Presence of back pain
- Diagnosis of congenital scoliosis or scoliosis secondary to neurological or muscular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical assessment of spinal stiffnessThe 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. | Other | Clinical assessment of spinal stiffness |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: Yes. Anonymised data will be deposited in an online repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical assessment of spinal stiffness in people with Hyperkyphosis and Adolescent Idiopathic Scoliosis, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Negrini, MD, PhD (+3902 8416 1700, stefano.negrini@isico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability (time frame: through study completion, an average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.