The new developed brace gives better correction by higher body brace interface pressures than the gold standard Boston brace.
ID
Bron
Verkorte titel
Aandoening
brace, scolioses
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To 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.
Achtergrond van het onderzoek
Several 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.
Doel van het onderzoek
The new developed brace gives better correction by higher body brace interface pressures than the gold standard Boston brace.
Onderzoeksopzet
After 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.
Onderzoeksproduct en/of interventie
1. Customizing a new developed brace;
2. Body brace interface pressure measurements;
3. Conventional spinal x-rays.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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 willing, but without parental / guardian permission;
6. Patients without a working knowledge of Dutch.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1556 |
| NTR-old | NTR1635 |
| Ander register | : |
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