Self-correction Evaluation in Scoliosis Patients (NCT05598021) | Clinical Trial Compass
UnknownNot Applicable
Self-correction Evaluation in Scoliosis Patients
Italy185 participantsStarted 2022-12-05
Plain-language summary
To date, there is no objective assessment method for the quality of the self-correction performed by patients with scoliosis.
The study consists of two parts, both retrospective, and distinct on the basis of the tools used to assess self-correction.
Part 1: Retrospective assessment of the radiographic variations between spontaneous position and self-correction in subjects suffering from juvenile and adolescent idiopathic scoliosis. Both measurements were performed in a single session.
Part 2: Retrospective assessment of the variations between spontaneous and self-correcting position in subjects with juvenile and adolescent idiopathic scoliosis using objective parameters deriving from non-invasive 3D ultrasound instrumentation (Scolioscan, Telefeld, Hong Kong).
Who can participate
Age range
10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for both parts:
* Diagnosis of juvenile or adolescent idiopathic scoliosis;
* Age \>= 10 years;
* Single and double curves with amplitude \>= 15 ° Cobb;
* Performing exercises according to SEAS for at least 6 months
Only for part 1 (radiographic)
* Availability of radiographic investigation in upright position and in self-correction Only for part 2 (ultrasound)
* Availability of ultrasound assessment in upright position and in self-correction
* Complete radiograph of the spine in anteroposterior projection performed in the 45 days preceding or following the medical examination.
* Risser between 0 and 2.
Exclusion Criteria:
For both parts:
* Patients with more than 2 scoliotic curves
* Patients with secondary scoliosis
* Patients suffering from learning disabilities or clinical conditions impairing neuromotor control
* Patients lacking the necessary measures to evaluate the outcome.
Part 2 only (ultrasound)
● Patients undergoing brace treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Self-correction measure
Timeframe: through study completion, an average of 6 months
Trial details
NCT IDNCT05598021
SponsorIstituto Scientifico Italiano Colonna Vertebrale