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A comparison between two bracing methods in idiopatic scoliosis: the Boston and a new developped brace.


- candidate number5181
- NTR NumberNTR1635
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jan-2009
- Secondary IDs 
- Public TitleA comparison between two bracing methods in idiopatic scoliosis: the Boston and a new developped brace.
- Scientific TitleA comparison between two bracing methods in idiopatic scoliosis: the Boston and a new developped brace.
- ACRONYMN/A
- hypothesisThe new developed brace gives better correction by higher body brace interface pressures than the gold standard Boston brace.
- Healt Condition(s) or Problem(s) studiedScoliosis
- Inclusion criteria1. Patients with idiopathic scoliosis, who are treated with a scoliosis brace;
2. Male and female patients;
3. Cobbs angle between 20o-40o at start of treatment;
4. Patients who read and understand the METC approved patient information;
5. Patients who are willing to participate and have written permission from their parents / guardians.
- Exclusion criteria1. Patients requiring surgical treatment (Cobbs angle >40o and progression);
2. Patients with other back problems;
3. Patients with spine operations in the past;
4. Patients with neurological signs;
5. Patients willing, but without parental / guardian permission;
6. Patients without a working knowledge of Dutch.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2009
- planned closingdate1-mei-2009
- Target number of participants6
- Interventions1. Customizing a new developed brace;
2. Body brace interface pressure measurements;
3. Conventional spinal x-rays.
- Primary outcomeTo evaluate the effectiveness of a new developed brace by means of comparing body brace interface pressure with measured Cobbs angles on the control X-rays.
- Secondary outcomeOptimize the scoliosis brace treatment to the individual situation of each scoliosis patient by applying body brace interface pressure measurements in the regular care for patients with idiopathic scoliosis.
- TimepointsAfter inclusion a new developed brace is customized. After finishing the brace pressure measurements will take place in the two braces. Conventional spinal x-rays are made in the two braces.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J. Hermus
- CONTACT for SCIENTIFIC QUERIES J. Hermus
- Sponsor/Initiator Academic Hospital Maastricht (AZM)
- Funding
(Source(s) of Monetary or Material Support)
Economic treasure department subject: Pieken in de Delta
- PublicationsN/A
- Brief summarySeveral studies have questioned the effectiveness of bracing. Especially by the lack of compliance. The lack of compliance (Houghton et al. 1987) has encouraged us to develop a new brace with higher body brace interface pressures and better comfort. We want to evaluate the effectiveness of the new developed brace in comparing to the gold standard Boston brace. Therefor we want to measure the correction of the scoliosis by taking conventional x-rays and performing body brace interface pressures.
- Main changes (audit trail)
- RECORD20-jan-2009 - 19-sep-2014


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