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Completed

NCT Number: NCT02862392

Predictive Progressive Factors of Adolescent Idiopathic Scoliosis

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.

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Key information

Age range

11 year–14 year

Sex eligibility

Female

Study type

Observational

Primary location

Fondation Hopale, Berck, Hauts-de-France, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Change from baseline at 24 months

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Questionnaire to determine date of first periods

    Time frame: Change from baseline at 24 months

    Questionnaire to determine date of first periods

  9. Quantification of body mass index

    Time frame: Change from baseline at 24 months

    Quantification of body mass index

  10. 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

  11. 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

  12. Pearson correlation coefficient to determine the correlation between posturographic and radiographic parameters

    Time frame: Change from baseline at 24 months

    Pearson correlation coefficient to determine the correlation between posturographic and radiographic parameters

  13. Score of the motion Sickness Susceptibility Questionnaire

    Time frame: Change from baseline at 24 months

    Score of the motion Sickness Susceptibility Questionnaire

  14. Trunk Appearance Perception Scale

    Time frame: Change from baseline at 24 months

    Evaluation of self appearance or image

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Collaborators

  • Ecole des hautes études d'ingénieur (HEI)

Registry information

Acronym: SCOLEVOL

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Aug 11, 2016
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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