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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00842218
First received: February 10, 2009
Last updated: February 11, 2009
Last verified: February 2009
  Purpose

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
Scoliosis

Study Type: Observational
Study Design: 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.

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Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Estimated Enrollment: 50
Study Start Date: January 2009
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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)

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders 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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842218

Contacts
Contact: Philippe Mahaudens, Mr 003227645375 Philippe.Mahaudens@uclouvain.be
Contact: Detrembleur Christine, PhD 003227645375 Christine.Detrembleur@uclouvain.be

Locations
Belgium
Université Catholique de Louvain - Cliniques universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Xavier Banse, MD PhD    003227645375    Xavier.Banse@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Mahaudens Philippe, Mr Université Catholique de Louvain
  More Information

Publications:
Davis RB OS, Tyburski D, Gage JR (1991) A gait analysis data collection and reduction technique. Hum Mov Sci 10:575-587

Responsible Party: Banse Xavier MD, PhD, Orthopaedic Research Laboratory , Université catholique de Louvain, Brussels, Belgium
ClinicalTrials.gov Identifier: NCT00842218     History of Changes
Other Study ID Numbers: READ-Mahaudens-01
Study First Received: February 10, 2009
Last Updated: February 11, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Gait
scoliosis
energy
mechanics

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 18, 2014