Clinical trial NCT02862392: Predictive Progressive Factors of Adolescent Idiopathic Scoliosis
Official title: Predictive Progressive Factors of Adolescent Idiopathic Scoliosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scoliosis
Keywords: Scoliosis
Adolescent
Idiopathic scoliosis
Predictive factors
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Ecole des hautes études d'ingénieur (HEI)
First posted: 2016-08-11
Enrollment: 140
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female subjects from 11 to 14 years with AIS

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.

Detailed description: Adolescent idiopathic scoliosis (AIS) is a tridimensional spine deformation affecting 2% of subjects between 10 and 16 years-old being predominant among girls. It is a severe, progressive and multifactorial disease, and a genetic origin is currently admitted.

AIS is progressive (in 3 out of 10 cases) when the scoliosis radiographic frontal angle (Cobb angle) strictly increases by 5° between the diagnosis date and the end of growth. This progression can be severe requiring heavy treatments (corset, surgery) and it can generate adverse effects (spine pain, cardio-respiratory and functional consequences on walking). The lack of reliable criteria to predict the evolution of AIS is a real problem for the therapeutic decision and it can impact the socio-economic cost of the disease.

Several studies show orthostatic postural control anomalies in AIS. The orthostatic postural control is elaborated from the central integration of different sensorial signals (visual, somesthesic and vestibular).

Posturography, on computerized integrate force plates, allows to quantify sensorial components of orthostatic postural control. This technique can confirm the disorders of orthostatic postural control in AIS, but the parameters used can not evaluate with precision the progressive potential.

The posturographic signal analysis could lead to the implementation of therapeutic strategies adapted to progressive risk. Moreover, this method could prevent the progression in major scoliosis, limit the use of radiography, the application of a constraining corset (worn 23 hours a day) and the possibility of heavy surgery (extent arthrodesis).

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.

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

Primary outcomes:
measure: Measure of the evolution of AIS by Recurrence quantification analysis (RQA)
timeFrame: Change from baseline at 24 months
Secondary outcomes:
measure: Questionnaire to determine presence or absence of family background
timeFrame: Change from baseline at 24 months
measure: Questionnaire to determine presence or absence of concomitant illnesses
timeFrame: Change from baseline at 24 months
measure: Questionnaire to determine presence or absence of clinical tests of equilibration
timeFrame: Change from baseline at 24 months
measure: Questionnaire to determine presence or absence of susceptibility to sensorial conflicts
timeFrame: Change from baseline at 24 months
measure: Questionnaire to determine presence or absence of visio-manual laterality
timeFrame: Change from baseline at 24 months
measure: Questionnaire to determine type of scoliosis
timeFrame: Change from baseline at 24 months
measure: Questionnaire to determine presence or absence of deformed body perception
timeFrame: Change from baseline at 24 months
measure: Questionnaire to determine date of first periods
timeFrame: Change from baseline at 24 months
measure: Quantification of body mass index
timeFrame: Change from baseline at 24 months
measure: Questionnaire to determine presence or absence of socio-demographic variables
timeFrame: at baseline
measure: Fukuda stepping test in order to evaluate the vestibular sensory input
timeFrame: Change from baseline at 24 months
measure: Pearson correlation coefficient to determine the correlation between posturographic and radiographic parameters
timeFrame: Change from baseline at 24 months
measure: Score of the motion Sickness Susceptibility Questionnaire
timeFrame: Change from baseline at 24 months
measure: Trunk Appearance Perception Scale
timeFrame: Change from baseline at 24 months
Other outcomes:
Locations:
city: Berck
country: France
facility: Fondation Hopale
state: Nord Pas-de-Calais
city: Lamorlaye
country: France
facility: Centre de MPR pour enfants de Bois Larris
state: Nord Pas-de-Calais
city: Lille
country: France
facility: CHRU de Lille
state: Nord Pas-de-Calais
city: Lille
country: France
facility: Lille Catholic Hospital
state: Nord Pas-de-Calais
city: Roubaix
country: France
facility: CH Victor Provo
state: Nord Pas-de-Calais
city: Villeneuve d'Ascq
country: France
facility: SSR pédiatrique Marc Sautelet
state: Nord Pas-de-Calais
city: Amiens
country: France
facility: CHU d'Amiens
state: Picardie
Study officials:
affiliation: Lille Catholic University
name: Catanzariti Jean-François, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lille Catholic University
name: Olivier Agnani
role: STUDY_CHAIR
References: