Predictive Progressive Factors of Adolescent Idiopathic Scoliosis

NCT02862392 | Completed

• 1 other identifier: RC-P0047
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 4

Brief Summary

The hypothesis of this study is that progressive AIS is characterized by a disorder of orthostatic postural control. The analysis and the treatment of posturographic signal on computerized integrate force plates, coupled to clinical and radiographic examinations, could highlight predictive and reliable factors at the moment of diagnosis. Thus, it could help the clinician in his therapeutic approach, based on the postural control improvement (individualized prescription in kinesitherapy, better adaptation to orthopedic treatments by corset). This method is non-invasive, without side effects, fast and achievable in routine care at the moment of the diagnosis of AIS.

Conditions

Scoliosis

Keywords

Scoliosis; Adolescent; Idiopathic scoliosis; Predictive factors

Outcome Measures

Primary Outcomes (1)

• Measure of the evolution of AIS by Recurrence quantification analysis (RQA)

  This parameter allows a posturographic recording of the patient in order to predict the evolution of the disease

  Change from baseline at 24 months

Secondary Outcomes (14)

• Questionnaire to determine presence or absence of family background

  Change from baseline at 24 months

• Questionnaire to determine presence or absence of concomitant illnesses

  Change from baseline at 24 months

• Questionnaire to determine presence or absence of clinical tests of equilibration

  Change from baseline at 24 months

• Questionnaire to determine presence or absence of susceptibility to sensorial conflicts

  Change from baseline at 24 months

• Questionnaire to determine presence or absence of visio-manual laterality

  Change from baseline at 24 months

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Female subjects from 11 to 14 years with AIS

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead
• Ecole des hautes études d'ingénieur (HEI): collaborator

Study Sites (4)

Fondation Hopale

Berck, Hauts-de-France, 62600, France

Location

Centre de MPR pour enfants de Bois Larris

Lamorlaye, Hauts-de-France, 60260, France

Location

SSR pédiatrique Marc Sautelet

Villeneuve-d'Ascq, Hauts-de-France, 59650, France

Location

CHU d'Amiens

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Catanzariti Jean-François, MD

  Lille Catholic University

  PRINCIPAL INVESTIGATOR

• Olivier Agnani

  Lille Catholic University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 11, 2016
• Study Start: March 15, 2017
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)