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The Idiopathic Scoliosis and Its Treatment (Orthopaedic and Surgery): Effect of the Severity, the Orthosis and the Arthrodesis on the Gait (scoliosis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
The purposes of this study were as follows: 1) to compare locomotion parameters (kinematic, EMG, mechanical work and energy cost changes during walking in able-bodied subjects and AIS patients,2) to evaluate the effects of the frontal curve's severity of the AIS and 3) the effects of the treatment (orthosis or surgery)on these gait parameters.

Condition or disease

Detailed Description:

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 [8] and an excessive paravertebral muscular bilateral activity [11]. 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) [9].

A standard full spine XRay assessment will be performed to measure the Cobb angle curve, the frontal body balance, the apical vertebral rotation [13].

Gait will be assessed by a three-dimensional analysis, including synchronous kinematic [4], electromyographic (EMG) [14], 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)

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects girls were recruited in the town and adolescent idiopathic scoliosis attended our outpatient clinic

Inclusion Criteria:

  • healthy subjects : no scoliosis diagnosed
  • Scoliosis subjects : scoliosis diagnosed by X-Ray assessment

Exclusion Criteria:

  • Patients with leg length discrepancies higher than 1 cm, any locomotor disorders, low back pain, neurological abnormalities observed on clinical examination or with any previous treatment for their scoliosis

Information from the National Library of Medicine

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 identifier (NCT number): NCT00842218

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Contact: Philippe Mahaudens, Mr 003227645375
Contact: Detrembleur Christine, PhD 003227645375

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Université Catholique de Louvain - Cliniques universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Xavier Banse, MD PhD    003227645375   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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Principal Investigator: Mahaudens Philippe, Mr Université Catholique de Louvain

Davis RB OS, Tyburski D, Gage JR (1991) A gait analysis data collection and reduction technique. Hum Mov Sci 10:575-587
McArdle W, Katch F, Katch V (1996) Exercise physiology: Energy, Nutrition, and Human Performance. Baltimore

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Responsible Party: Banse Xavier MD, PhD, Orthopaedic Research Laboratory , Université catholique de Louvain, Brussels, Belgium Identifier: NCT00842218    
Other Study ID Numbers: READ-Mahaudens-01
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: February 2009
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Additional relevant MeSH terms:
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Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases