Identifying Predictive Factors for Adolescent Idiopathic Scoliosis Progression
Predictive Progressive Factors of Adolescent Idiopathic Scoliosis
This study is trying to find out what factors might predict how scoliosis gets worse in girls aged 11 to 14 by looking at their balance and posture.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 11 Years to 14 Years |
| Sex | Female |
| Sponsor | Lille Catholic University Academic / other |
| Locations | 7 sites (Berck, Nord Pas-de-Calais and 6 other locations) |
| Trial ID | NCT02862392 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify predictive factors for the progression of adolescent idiopathic scoliosis (AIS) by analyzing postural control through posturographic signal analysis on computerized force plates. The study will involve clinical and radiographic examinations to assess the severity of scoliosis in female adolescents aged 11 to 14 years. By understanding the relationship between postural control and scoliosis progression, clinicians can tailor therapeutic approaches, such as kinesitherapy and orthopedic treatments, to improve patient outcomes. The method is non-invasive, quick, and can be integrated into routine care at the time of diagnosis.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 11 to 14 years diagnosed with adolescent idiopathic scoliosis and specific radiographic criteria.
Not a fit: Patients with secondary scoliosis or those with specific types of AIS that do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment strategies for adolescents with scoliosis, potentially preventing severe progression of the condition.
How similar studies have performed: Previous studies have indicated that analyzing postural control can provide insights into AIS progression, suggesting that this approach may yield valuable predictive factors.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berck, Nord Pas-de-Calais and 6 other locations
- Fondation Hopale — Berck, Nord Pas-de-Calais, France (Recruiting)
- Centre de MPR pour enfants de Bois Larris — Lamorlaye, Nord Pas-de-Calais, France (Terminated)
- CHRU de Lille — Lille, Nord Pas-de-Calais, France (Withdrawn)
- Lille Catholic Hospital — Lille, Nord Pas-de-Calais, France (Withdrawn)
- CH Victor Provo — Roubaix, Nord Pas-de-Calais, France (Withdrawn)
- SSR pédiatrique Marc Sautelet — Villeneuve d'Ascq, Nord Pas-de-Calais, France (Recruiting)
- CHU d'Amiens — Amiens, Picardie, France (Terminated)
Study contacts
- Principal investigator: Catanzariti Jean-François, MD — Lille Catholic University
- Study coordinator: Amélie Lansiaux, PhD, MD
- Email: Lansiaux.Amelie@ghicl.net
- Phone: +33 3 20 22 57 41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.