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van CCT (UK)

van CCT (UK)

Aspects of bracing in adolescent idiopathic scoliosis

- candidate number22186
- NTR NumberNTR5214
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mei-2015
- Secondary IDsABR 53296 form 
- Public TitleAspects of bracing in adolescent idiopathic scoliosis
- Scientific TitleThe Maastricht brace in the treatment of Adolescent Idiopathic Scoliosis
- hypothesisThe Maastricht brace is a new develwoped thoracolumbar brace that improves wearability and quality of life, while maintaining efficiency and function
- Healt Condition(s) or Problem(s) studiedAdolescent idiopathic scoliosis (AIS)
- Inclusion criteria1. AIS
2. Indication for conservative treatment
3. Age above 12 years old
4. Eligible for follow up
5. Ability to read and write in the Dutch language
6. Patient who are physically and mentally willing and able to comply with the functional evaluation
- Exclusion criteria1. Prior surgery to the spine
2. Morbid obesity (BMI>35)
3. Any musculoskeletal or neurological (congenital) disorder
4. Patients who are unwilling to cooperate with the study protocol and follow-up schedule.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2015
- planned closingdate1-jan-2020
- Target number of participants20
- InterventionsNone applicable Use of Maastricht brace in adolescent idiopathic scoliosis, as is custom in the MUMC+. Tests of pulmonairy function and motion analysis in brace are additional, hoewever not invasive or noted as interventions.
- Primary outcomeThe main objective of the study is to quantify the effect of conservative treatment of AIS with the use of the new developed Maastricht brace (ABR 09-02-029) by determining the deformation of cobb’s angle over time, using longitudinal radiological assessment with use of anteroposterior and lateral full spine radiographs.
- Secondary outcomeSecondary Objectives:
• Compliance in brace treatment for AIS Using an incorporated thermo sensor in the brace to objectify actual brace wearing by the patients.
• Pulmonary function in thoracolumbar brace Brace wear should result in changes in pulmonary function, predictable in nature. Pulmonary function at end point of brace wear comparable to healthy subject. (compared to non-brace wear)
• Pressure measurements in brace Is the brace able to apply the requested amount of force
• Motion analysis in brace (VICON)
Is the brace allowing the patient to demonstrate a normal walking pattern compared to healthy subjects
- TimepointsOutpatient clinic visits every three months. Start bracing is considered enrollment (T=0), every three months outpatient clinic controls (T= 1,2,3,...,e) and last visit at stop bracing when skeletal maturity is reached (T=e)
- Trial web site
- status[default]
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- PublicationsSchrander et al. Scoliosis 2014, 9(Suppl 1):O34
- Brief summaryRationale: Our rationale for the study is multi-layered. Brace treatment is only effective if the patient is compliant. An optimally constructed brace is not effective if only worn for two hours a week. To increase compliance the Maastricht brace is optimally constructed to increase wearability and therefore more comfort, while obtaining the same pressure and therefore effect as the current golden standard, the Boston brace. There are several aspect of bracing which are only partly known or scarcely described in current literature. Pulmonary function in brace, and pressure in bracing or the relation between effect of bracing, pulmonary function and optimal pressure within the brace is scarcely described. Motion analysis in patients with AIS with or without brace is only investigated in small groups using older techniques. With this study we would like to develop an optimal treatment plan for AIS with use of the Maastricht brace, and more insight in the pathophysiology of AIS and the effects (or effectiveness) of bracing. Objective: The main objective of the study is to quantify the effect of conservative treatment of AIS with bracing (Maastricht brace or Boston brace) by determining the deformation of cobb’s angle over time, using longitudinal radiological assessment. Secondary objectives are compliance of bracing using thermal sensors (Orthotimer), pulmonary function development in brace, motion analysis of gait impairment (VICON) in a thoracolumbar brace.
- Main changes (audit trail)
- RECORD9-mei-2015 - 5-jan-2016

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