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

NCT ID: NCT00842218

Last Updated: 2009-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Orthopaedic Research Laboratory , Université catholique de Louvain, Brussels, Belgium

Principal Investigators

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Mahaudens Philippe, Mr

Role: PRINCIPAL_INVESTIGATOR

Université Catholique de Louvain

Locations

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Université Catholique de Louvain - Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Philippe Mahaudens, Mr

Role: CONTACT

003227645375

Detrembleur Christine, PhD

Role: CONTACT

003227645375

Facility Contacts

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Xavier Banse, MD PhD

Role: primary

003227645375

References

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Cavagna GA, Franzetti P, Fuchimoto T. The mechanics of walking in children. J Physiol. 1983 Oct;343:323-39. doi: 10.1113/jphysiol.1983.sp014895.

Reference Type BACKGROUND
PMID: 6644619 (View on PubMed)

Cavagna GA, Kaneko M. Mechanical work and efficiency in level walking and running. J Physiol. 1977 Jun;268(2):467--81. doi: 10.1113/jphysiol.1977.sp011866.

Reference Type BACKGROUND
PMID: 874922 (View on PubMed)

Danielsson AJ, Romberg K, Nachemson AL. Spinal range of motion, muscle endurance, and back pain and function at least 20 years after fusion or brace treatment for adolescent idiopathic scoliosis: a case-control study. Spine (Phila Pa 1976). 2006 Feb 1;31(3):275-83. doi: 10.1097/01.brs.0000197652.52890.71.

Reference Type BACKGROUND
PMID: 16449899 (View on PubMed)

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

Reference Type BACKGROUND

Detrembleur C, van den Hecke A, Dierick F. Motion of the body centre of gravity as a summary indicator of the mechanics of human pathological gait. Gait Posture. 2000 Dec;12(3):243-50. doi: 10.1016/s0966-6362(00)00081-3.

Reference Type BACKGROUND
PMID: 11154935 (View on PubMed)

Detrembleur C, Vanmarsenille JM, De Cuyper F, Dierick F. Relationship between energy cost, gait speed, vertical displacement of centre of body mass and efficiency of pendulum-like mechanism in unilateral amputee gait. Gait Posture. 2005 Apr;21(3):333-40. doi: 10.1016/j.gaitpost.2004.04.005.

Reference Type BACKGROUND
PMID: 15760750 (View on PubMed)

Karski T. Biomechanical factors in the etiology of idiopathic scoliosis: two etiopathological groups of spinal deformities. Ortop Traumatol Rehabil. 2004 Nov-Dec;6(6):800-8.

Reference Type BACKGROUND
PMID: 17618198 (View on PubMed)

Kramers-de Quervain IA, Muller R, Stacoff A, Grob D, Stussi E. Gait analysis in patients with idiopathic scoliosis. Eur Spine J. 2004 Aug;13(5):449-56. doi: 10.1007/s00586-003-0588-x. Epub 2004 Apr 3.

Reference Type BACKGROUND
PMID: 15064994 (View on PubMed)

Lenke LG, Betz RR, Harms J, Bridwell KH, Clements DH, Lowe TG, Blanke K. Adolescent idiopathic scoliosis: a new classification to determine extent of spinal arthrodesis. J Bone Joint Surg Am. 2001 Aug;83(8):1169-81.

Reference Type BACKGROUND
PMID: 11507125 (View on PubMed)

Leong JC, Lu WW, Luk KD, Karlberg EM. Kinematics of the chest cage and spine during breathing in healthy individuals and in patients with adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 1999 Jul 1;24(13):1310-5. doi: 10.1097/00007632-199907010-00007.

Reference Type BACKGROUND
PMID: 10404572 (View on PubMed)

Mahaudens P, Thonnard JL, Detrembleur C. Influence of structural pelvic disorders during standing and walking in adolescents with idiopathic scoliosis. Spine J. 2005 Jul-Aug;5(4):427-33. doi: 10.1016/j.spinee.2004.11.014.

Reference Type BACKGROUND
PMID: 15996612 (View on PubMed)

McArdle W, Katch F, Katch V (1996) Exercise physiology: Energy, Nutrition, and Human Performance. Baltimore

Reference Type BACKGROUND

Roche AF, Eyman SL, Davila GH. Skeletal age prediction. J Pediatr. 1971 Jun;78(6):997-1003. doi: 10.1016/s0022-3476(71)80430-4. No abstract available.

Reference Type BACKGROUND
PMID: 4325224 (View on PubMed)

Van Boxtel GJ, Geraats LH, Van den Berg-Lenssen MM, Brunia CH. Detection of EMG onset in ERP research. Psychophysiology. 1993 Jul;30(4):405-12. doi: 10.1111/j.1469-8986.1993.tb02062.x.

Reference Type BACKGROUND
PMID: 8327626 (View on PubMed)

Willems PA, Cavagna GA, Heglund NC. External, internal and total work in human locomotion. J Exp Biol. 1995 Feb;198(Pt 2):379-93. doi: 10.1242/jeb.198.2.379.

Reference Type BACKGROUND
PMID: 7699313 (View on PubMed)

Other Identifiers

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READ-Mahaudens-01

Identifier Type: -

Identifier Source: org_study_id

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