Predictive Progressive Factors of Adolescent Idiopathic Scoliosis (SCOLEVOL)

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.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis

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.

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: Marine Deseur; Phone Number: +33 3 20 22 57 01; Email: Deseur.Marine@ghicl.net

Study Locations

• France
  • Nord Pas-de-Calais
    • Berck, Nord Pas-de-Calais, France, 62600
      • Recruiting
      • Fondation Hopale
      • Contact: Xavier Malliopoulos, MD
    • Lamorlaye, Nord Pas-de-Calais, France, 60260
      • Terminated
      • Centre de MPR pour enfants de Bois Larris
    • Lille, Nord Pas-de-Calais, France, 59000
      • Withdrawn
      • CHRU de Lille
    • Lille, Nord Pas-de-Calais, France, 59000
      • Withdrawn
      • Lille Catholic Hospital
    • Roubaix, Nord Pas-de-Calais, France, 59100
      • Withdrawn
      • CH Victor PROVO
    • Villeneuve d'Ascq, Nord Pas-de-Calais, France, 59650
      • Recruiting
      • SSR Pédiatrique Marc Sautelet
      • Contact: Jean-François CATANZARITI, MD
  • Picardie
    • Amiens, Picardie, France, 80054
      • Terminated
      • CHU d'AMIENS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female subjects from 11 to 14 years with AIS

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire to determine presence or absence of family background	For statistical analysis categorical variables may be assigned with numeric indices	Change from baseline at 24 months
Questionnaire to determine presence or absence of concomitant illnesses	For statistical analysis categorical variables may be assigned with numeric indices	Change from baseline at 24 months
Questionnaire to determine presence or absence of clinical tests of equilibration	For statistical analysis categorical variables may be assigned with numeric indices	Change from baseline at 24 months
Questionnaire to determine presence or absence of susceptibility to sensorial conflicts	For statistical analysis categorical variables may be assigned with numeric indices	Change from baseline at 24 months
Questionnaire to determine presence or absence of visio-manual laterality	For statistical analysis categorical variables may be assigned with numeric indices	Change from baseline at 24 months
Questionnaire to determine type of scoliosis	For statistical analysis categorical variables may be assigned with numeric indices	Change from baseline at 24 months
Questionnaire to determine presence or absence of deformed body perception	For statistical analysis categorical variables may be assigned with numeric indices	Change from baseline at 24 months
Questionnaire to determine date of first periods	Questionnaire to determine date of first periods	Change from baseline at 24 months
Quantification of body mass index	Quantification of body mass index	Change from baseline at 24 months
Questionnaire to determine presence or absence of socio-demographic variables	For statistical analysis categorical variables may be assigned with numeric indices	at baseline
Fukuda stepping test in order to evaluate the vestibular sensory input	The purpose of the Fukuda Stepping Test (FST) is to measure asymmetrical vestibulospinal reflex tone resulting from labyrinthine dysfunction	Change from baseline at 24 months
Pearson correlation coefficient to determine the correlation between posturographic and radiographic parameters	Pearson correlation coefficient to determine the correlation between posturographic and radiographic parameters	Change from baseline at 24 months
Score of the motion Sickness Susceptibility Questionnaire	Score of the motion Sickness Susceptibility Questionnaire	Change from baseline at 24 months
Trunk Appearance Perception Scale	Evaluation of self appearance or image	Change from baseline at 24 months

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Collaborators: Ecole des hautes études d'ingénieur (HEI)
• Investigators: Principal Investigator: Catanzariti Jean-François, MD, Lille Catholic University; Study Chair: Olivier Agnani, Lille Catholic University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2017
• Primary Completion (ANTICIPATED): June 15, 2025
• Study Completion (ANTICIPATED): June 15, 2025

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (ESTIMATE): August 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Adolescent; Scoliosis; Idiopathic scoliosis; Predictive factors
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: RC-P0047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO