ScoliosisscoliosisNCT00842218
The Idiopathic Scoliosis and Its Treatment (Orthopaedic and Surgery): Effect of the Severity, the Orthosis and the Arthrodesis on the Gait
An observational study of Scoliosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2009to Sep 2009
- 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 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy subjects girls were recruited in the town and adolescent idiopathic scoliosis attended our outpatient clinic
Who may be able to join
- healthy subjects : no scoliosis diagnosed
- Scoliosis subjects : scoliosis diagnosed by X-Ray assessment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Université Catholique de Louvain - Cliniques universitaires Saint-Luc
Brussels, 1200
Xavier Banse, MD PhD, 003227645375, Xavier.Banse@uclouvain.be
About this study
Official title: Effect of the Severity and the Treatment (Orthosis Versus Surgery)of the Idiopathic Scoliosis on the Locomotor Mechanism of the Gait.
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.
Read the 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)
- Conditions
- Scoliosis
- Keywords
- Gait, scoliosis, energy, mechanics
- Medical subject headings
- Scoliosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Mahaudens Philippe, Mr, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842218
- Sponsor's protocol ID
- READ-Mahaudens-01
- Acronym
- scoliosis
- Status last verified
- Feb 2009
- First submitted
- 10 Feb 2009
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 6644619Cavagna 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.
PubMed 874922Danielsson 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.
PubMed 16449899Davis RB OS, Tyburski D, Gage JR (1991) A gait analysis data collection and reduction technique. Hum Mov Sci 10:575-587
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.
PubMed 11154935Detrembleur 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.
PubMed 15760750Karski 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.
PubMed 17618198Kramers-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.
PubMed 15064994Lenke 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.
PubMed 11507125Leong 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.
PubMed 10404572Mahaudens 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.
PubMed 15996612McArdle W, Katch F, Katch V (1996) Exercise physiology: Energy, Nutrition, and Human Performance. Baltimore
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.
PubMed 4325224Van 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.
PubMed 8327626Willems 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.
PubMed 7699313
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Severity and the Treatment (Orthosis Versus Surgery)of the Idiopathic Scoliosis on the Locomotor Mechanism of the Gait.
- ClinicalTrials.gov ID
- NCT00842218
- Acronym / sponsor ID
- scoliosis / READ-Mahaudens-01
- Conditions
- Scoliosis
- Keywords
- Gait, scoliosis, energy, mechanics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 12 Feb 2009 (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 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
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy subjects girls were recruited in the town and adolescent idiopathic scoliosis attended our outpatient clinic
Key inclusion criteria (2 listed)
- healthy subjects : no scoliosis diagnosed
- Scoliosis subjects : scoliosis diagnosed by X-Ray assessment
Key exclusion criteria (1 listed)
- 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
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2009.
- Background: PubMed 6644619Cavagna GA, Franzetti P, Fuchimoto T. The mechanics of walking in children. J Physiol. 1983 Oct;343:323-39. doi: 10.1113/jphysiol.1983.sp014895.
- Background: PubMed 874922Cavagna 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.
- Background: PubMed 16449899Danielsson 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.
- BackgroundDavis RB OS, Tyburski D, Gage JR (1991) A gait analysis data collection and reduction technique. Hum Mov Sci 10:575-587
- Background: PubMed 11154935Detrembleur 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.
- Background: PubMed 15760750Detrembleur 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.
- Background: PubMed 17618198Karski 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.
- Background: PubMed 15064994Kramers-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.
- Background: PubMed 11507125Lenke 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.
- Background: PubMed 10404572Leong 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.
- Background: PubMed 15996612Mahaudens 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.
- BackgroundMcArdle W, Katch F, Katch V (1996) Exercise physiology: Energy, Nutrition, and Human Performance. Baltimore
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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.
Mahaudens Philippe, Mr principal investigator
Université Catholique de Louvain
1 site 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 Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Mahaudens, Mr (003227645375, Philippe.Mahaudens@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00842218, which also lists 15 linked publications.
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 12 Feb 2009.