Clinical Trial: Predictive Progressive Factors of Adolescent Idiopathic Scoliosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Predictive Progressive Factors of Adolescent Idiopathic Scoliosis

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 Summary:

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 cha
Sponsor: Lille Catholic University

Current Primary Outcome: Measure of the evolution of AIS by Recurrence quantification analysis (RQA) [ Time Frame: Change from baseline at 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome:

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

Information By: Lille Catholic University

Dates:
Date Received: August 1, 2016
Date Started: September 2016
Date Completion: September 2020
Last Updated: April 10, 2017
Last Verified: April 2017