Skip to content

Predictive Progressive Factors of Adolescent Idiopathic Scoliosis

Predictive Progressive Factors of Adolescent Idiopathic Scoliosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02862392
Acronym
SCOLEVOL
Enrollment
95
Registered
2016-08-11
Start date
2017-03-15
Completion date
2024-12-04
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Keywords

Scoliosis, Adolescent, Idiopathic scoliosis, Predictive factors

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.

Interventions

None listed

Sponsors

Ecole des hautes études d'ingénieur (HEI)
CollaboratorUNKNOWN
Lille Catholic University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
11 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of the evolution of AIS by Recurrence quantification analysis (RQA)Change from baseline at 24 monthsThis parameter allows a posturographic recording of the patient in order to predict the evolution of the disease

Secondary

MeasureTime frameDescription
Questionnaire to determine presence or absence of concomitant illnessesChange from baseline at 24 monthsFor statistical analysis categorical variables may be assigned with numeric indices
Questionnaire to determine presence or absence of clinical tests of equilibrationChange from baseline at 24 monthsFor statistical analysis categorical variables may be assigned with numeric indices
Questionnaire to determine presence or absence of susceptibility to sensorial conflictsChange from baseline at 24 monthsFor statistical analysis categorical variables may be assigned with numeric indices
Questionnaire to determine presence or absence of visio-manual lateralityChange from baseline at 24 monthsFor statistical analysis categorical variables may be assigned with numeric indices
Questionnaire to determine type of scoliosisChange from baseline at 24 monthsFor statistical analysis categorical variables may be assigned with numeric indices
Questionnaire to determine presence or absence of deformed body perceptionChange from baseline at 24 monthsFor statistical analysis categorical variables may be assigned with numeric indices
Questionnaire to determine presence or absence of family backgroundChange from baseline at 24 monthsFor statistical analysis categorical variables may be assigned with numeric indices
Quantification of body mass indexChange from baseline at 24 monthsQuantification of body mass index
Questionnaire to determine presence or absence of socio-demographic variablesat baselineFor statistical analysis categorical variables may be assigned with numeric indices
Fukuda stepping test in order to evaluate the vestibular sensory inputChange from baseline at 24 monthsThe 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 parametersChange from baseline at 24 monthsPearson correlation coefficient to determine the correlation between posturographic and radiographic parameters
Score of the motion Sickness Susceptibility QuestionnaireChange from baseline at 24 monthsScore of the motion Sickness Susceptibility Questionnaire
Trunk Appearance Perception ScaleChange from baseline at 24 monthsEvaluation of self appearance or image
Questionnaire to determine date of first periodsChange from baseline at 24 monthsQuestionnaire to determine date of first periods

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026