The Idiopathic Scoliosis and Its Treatment (Orthopaedic and Surgery): Effect of the Severity, the Orthosis and the Arthrodesis on the Gait (scoliosis)
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|ClinicalTrials.gov Identifier: NCT00842218|
Recruitment Status : Unknown
Verified February 2009 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was: Recruiting
First Posted : February 12, 2009
Last Update Posted : February 12, 2009
|Condition or disease|
Introduction X-ray studies and three-dimensional analysis in standing showed that this Adolescent Idiopathic Scoliosis was characterised by stiffness of the affected vertebral levels [3, 7, 10] with decreased segmental mobilities. The impact of this stiffness was studied during functional activity such as walking to quantify the functional dynamic consequences. During gait, thoracic AIS provided an asymmetrical trunk rotation with a lack of rotation on the convex side  and an excessive paravertebral muscular bilateral activity . These studies included only moderate scoliosis. There were no studies approaching the effects of the severity of the scoliosis curves on gait parameters.
We hypothesize first that, the spinal deformations in AIS, producing a stiffness of the trunk, pelvic and hip motions, will deteriorate the gait by reducing the segmental mobilities, increasing the mechanical work and the energy cost and second that the severity of the frontal curves will be more damaging on this parameters. To this end, we hope to gain valuable insight as to the functional effects of the scoliosis aggravation from a more dynamic perspective.
Material Fifty-four female adolescents will be included in the study. This sample consists in two groups: healthy girls and girls with adolescent idiopathic scoliosis (divided in 3 subgroups according to the Cobb angle range) .
A standard full spine XRay assessment will be performed to measure the Cobb angle curve, the frontal body balance, the apical vertebral rotation .
Gait will be assessed by a three-dimensional analysis, including synchronous kinematic , electromyographic (EMG) , mechanic [5, 6, 15] and energetic measurements [1, 2, 12].
The sessions begins with a rest period, in which the subjects stand barefoot on the motor driven treadmill for the static calibration of kinematic and energetic variables. Thereafter, the subjects will be asked to walk at a constant speed of 4 km h-1 for a few minutes until a steady state will be reached and maintained for at least two minutes. Then, energetic variables will be computed for two minutes. Other variables will simultaneously be recorded for twenty seconds and averaged for ten successive strides. The mean of each value will be used for statistical analysis. Scoliosis patients will be assessed at T0 i.e. before any treatment and at T1 i.e. one year after the starting of the orthosis wearing (scoliosis subgroup 2) or the surgery (scoliosis subgroup 3)
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Effect of the Severity and the Treatment (Orthosis Versus Surgery)of the Idiopathic Scoliosis on the Locomotor Mechanism of the Gait.|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||April 2009|
|Estimated Study Completion Date :||September 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842218
|Contact: Philippe Mahaudens, Mr||003227645375||Philippe.Mahaudens@uclouvain.be|
|Contact: Detrembleur Christine, PhD||003227645375||Christine.Detrembleur@uclouvain.be|
|Université Catholique de Louvain - Cliniques universitaires Saint-Luc||Recruiting|
|Brussels, Belgium, 1200|
|Contact: Xavier Banse, MD PhD 003227645375 Xavier.Banse@uclouvain.be|
|Principal Investigator:||Mahaudens Philippe, Mr||Université Catholique de Louvain|