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ID
Source
Brief title
Health condition
- correction measured with spinal x-rays in the two braces
- correction force of the braces measured with presuure measurements
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our 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 outcome
Our 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.
Background summary
Compliance 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.
Study objective
The new brace is efficient in correcting of idiopathic scoliosis compared to the Boston brace measure with spinal x-rays and pressure measurements.
Study design
Two months.
Intervention
1. Conventional spinal x-rays;
2. Pressure measurements.
Maastricht Academic Hospital
Postbus 5800
L.W. Rhijn, van
Maastricht 6202 AZ
The Netherlands
lvr@sort.azm.nl
Maastricht Academic Hospital
Postbus 5800
L.W. Rhijn, van
Maastricht 6202 AZ
The Netherlands
lvr@sort.azm.nl
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1705 |
| NTR-old | NTR1815 |
| Other | MEC MUMC : 09-2-029 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |