Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT02862392
Eligibility Criteria:
Inclusion Criteria:
* Female aged from 11 to 14 years
* Patient with AIS, associated with a frontal deviation of spine measured by the radiographic frontal angle of Cobb between 15° and 20°, and a spinal rotation attested by the presence of a gibbosity minimum 5° with Bunnell scoliometer.
* Risser test \< 2 (evaluation of the spine bone maturity)
* Patient having front and side views radiographies from spine (huge prints) of less than three months (children have a radiographic check-up from total spine every 6 months on average, no additional print is requested)
* Capable of receiving clear informations
* Giving a written consent for their participation via a consent signed by both parents of the patient (or legal tutor)
* Covered by a healthcare insurance
Exclusion Criteria:
* Patient with secondary scoliosis
* AIS with principal cervico-thoracic curve, according to the Scoliosis Research Society (SRS) classification (this patient category only represents 1% of SIA)
* Primary left thoracic topographic AIS, according to the SRS classification (this category of scoliosis is rare and frequently has a secondary origin: neurologic, polymalformative)
* AIS treated by corrective corset
* Length inequality between inferior members more than 20 mm during clinical examination
* Patient with clinical neurological signs
* Pathological ligamentous laxity
* Known vestibular disease
* BMI \> 30
* Refusal to sign an informed consent
* Impossibility to receive clear information
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
11 Years
Maximum Age:
14 Years
Study:
NCT02862392
Study Brief:
Protocol Section:
NCT02862392