ScoliosisSCOLEVOLNCT02862392
Predictive Progressive Factors of Adolescent Idiopathic Scoliosis
An observational study of Scoliosis, run by Lille Catholic University at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 14 years, women only
- Conditions the study is for
- Scoliosis
- How many people
- 95 participants
- Where
- 4 sitesFrance
- Study dates
- 15 Mar 2017to 4 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- Women only
- No healthy volunteers
- Child
Study population: Female subjects from 11 to 14 years with AIS
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Pathological ligamentous laxity
- Known vestibular disease
- BMI > 30
- Refusal to sign an informed consent
- Impossibility to receive clear information
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU d'Amiens
Amiens, Picardie, 80054
Fondation Hopale
Berck, Hauts-de-France, 62600
Centre de MPR pour enfants de Bois Larris
Lamorlaye, Hauts-de-France, 60260
SSR pédiatrique Marc Sautelet
Villeneuve-d'Ascq, Hauts-de-France, 59650
About this study
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.
Read the 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.
- Conditions
- Scoliosis
- Keywords
- Scoliosis, Adolescent, Idiopathic scoliosis, Predictive factors
- Medical subject headings
- Scoliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline at 24 months
Secondary outcomes (14)
Questionnaire to determine presence or absence of family background
For statistical analysis categorical variables may be assigned with numeric indices
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline at 24 months
Questionnaire to determine type of scoliosis
For statistical analysis categorical variables may be assigned with numeric indices
Measured: 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
Measured: Change from baseline at 24 months
Questionnaire to determine date of first periods
Questionnaire to determine date of first periods
Measured: Change from baseline at 24 months
Quantification of body mass index
Quantification of body mass index
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline at 24 months
Score of the motion Sickness Susceptibility Questionnaire
Score of the motion Sickness Susceptibility Questionnaire
Measured: Change from baseline at 24 months
Trunk Appearance Perception Scale
Evaluation of self appearance or image
Measured: Change from baseline at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start15 Mar 2017
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole des hautes études d'ingénieur (HEI)
- Responsible party
- Sponsor
- Investigators
- Catanzariti Jean-François, MD, Principal investigator, Lille Catholic UniversityOlivier Agnani, Study chair, Lille Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862392
- Sponsor's protocol ID
- RC-P0047
- Acronym
- SCOLEVOL
- Status last verified
- Sep 2025
- First submitted
- 1 Aug 2016
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Progressive Factors of Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT02862392
- Acronym / sponsor ID
- SCOLEVOL / RC-P0047
- Conditions
- Scoliosis
- Keywords
- Scoliosis, Adolescent, Idiopathic scoliosis, Predictive factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Ecole des hautes études d'ingénieur (HEI)
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 14 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Female subjects from 11 to 14 years with AIS
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
14 secondary outcomes
Questionnaire to determine presence or absence of family background
Time frame: Change from baseline at 24 months
Questionnaire to determine presence or absence of concomitant illnesses
Time frame: Change from baseline at 24 months
Questionnaire to determine presence or absence of clinical tests of equilibration
Time frame: Change from baseline at 24 months
Questionnaire to determine presence or absence of susceptibility to sensorial conflicts
Time frame: Change from baseline at 24 months
Questionnaire to determine presence or absence of visio-manual laterality
Time frame: Change from baseline at 24 months
Questionnaire to determine type of scoliosis
Time frame: Change from baseline at 24 months
Questionnaire to determine presence or absence of deformed body perception
Time frame: Change from baseline at 24 months
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
Fukuda stepping test in order to evaluate the vestibular sensory input
Time frame: Change from baseline at 24 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Scoliosis
Active, not recruiting
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catanzariti Jean-François, MD principal investigator
Lille Catholic University
Olivier Agnani study chair
Lille Catholic University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by Lille Catholic University at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the evolution of AIS by Recurrence quantification analysis (RQA) (time frame: Change from baseline at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.