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


- candidate number5907
- NTR NumberNTR1815
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jun-2009
- Secondary IDs09-2-029 MEC MUMC
- Public TitleA comparison between two bracing methods in idiopatic scoliosis: the Boston and a new developed brace.
- Scientific TitleA comparison between two bracing methods in idiopatic scoliosis: the Boston and a new developed brace.
- ACRONYMN/A
- hypothesisThe new brace is efficient in correcting of idiopathic scoliosis compared to the Boston brace measure with spinal x-rays and pressure measurements.
- Healt Condition(s) or Problem(s) studiedScoliosis, Brace, Idiopathic
- Inclusion criteria1. Patients with adolescent idiopathic scoliosis (age 12-16 yrs), 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 with allergy of components of the brace or pressure measurement device;
6. Patients willing, but without parental / guardian permission;
7. Patients without a working knowledge of Dutch.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 9-jun-2009
- planned closingdate5-aug-2009
- Target number of participants6
- Interventions1. Conventional spinal x-rays;
2. Pressure measurements.
- Primary outcomeOur primary objective is to compare the two braces, the classic Boston brace and new developed brace, by means of comparing body brace interface pressure and measured Cobbs angles on the control X-rays.
- Secondary outcomeOur secondary objective is optimize the scoliosis brace treatment to the individual situation of each scoliosis patient by applying body brace interface pressure measurements as well as the Cobbs angles correction in patients with idiopathic scoliosis.
- TimepointsTwo months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. L.W. Rhijn, van
- CONTACT for SCIENTIFIC QUERIES J. Hermus
- Sponsor/Initiator Pieken in de Delta
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Economic Affairs
- PublicationsN/A
- Brief summaryCompliance is necessary to have good results with brace treatment in idiopathic scoliosis. therefore we have developed a brace with probably a higher acceptance and comfort by giving more freedom of motion and a bace closure in front of the brace. We want to test the effectiveness of the new developed brace with the most used boston brace. This is performed with spinal x-rays and pressure measurements.
- Main changes (audit trail)
- RECORD8-jun-2009 - 30-sep-2009


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