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van CCT (UK)

Assessment of tools regarding the quality and effect control of brace treatment for idiopathic scoliosis.

- candidate number3110
- NTR NumberNTR1247
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-mrt-2008
- Secondary IDs07-2-106 MEC azM/UM
- Public TitleAssessment of tools regarding the quality and effect control of brace treatment for idiopathic scoliosis.
- Scientific TitleAssessment of tools regarding the quality and effect control of brace treatment for idiopathic scoliosis.
- hypothesisThe combination of body brace interface pressure measurements and quality of life questionnaires will improve brace treatment in patients with idiopathic scoliosis
- Healt Condition(s) or Problem(s) studiedScoliosis, Brace, Quality of life
- 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-mei-2008
- planned closingdate1-jan-2010
- Target number of participants27
- InterventionsBody brace interface pressure measurements
Quality of Life questionnaires
- Primary outcomeTo improve brace treatment for idiopathic scoliosis, by means of comparing body brace interface pressure with measured Cobbs angles on the control X-rays in combination with reported quality of life.
- Secondary outcomeOptimize the scoliosis brace treatment to the individual situation of each scoliosis patient by applying body brace interface pressure measurements as well as the brace questionnaire in the regular care for patients with idiopathic scoliosis.
- TimepointsAfter inclusion the pressure measurement will take place as well as completing the first quality of life questionnaire on the first folowing regular control visit to the orthopaedic outpatient clinic. 3 month later the second quality of life questionnaire will be completed
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Academic Hospital Maastricht (azM)
- Funding
(Source(s) of Monetary or Material Support)
Academic Hospital Maastricht (azM)
- PublicationsN/A
- Brief summaryIdiopathic scoliosis is a relatively common deformation starting with or just before the growth spurt. Brace treatment is used to prevent progression and if possible correction of the scoliosis. In order to achieve a good result the brace should be worn for 23 hours, and during the whole growth period. Patients are predominantly girls in the age between 8 to 16 year old. The long treatment in combination with the difficult age of the patients makes sufficient compliance a challenge. The purpose of this single centre, single measurement, non-randomised, observational study is to evaluate the quality and effect of scoliosis brace treatment, by means of correlating body brace interface pressure and scoliosis correction in combination with quality of life questionnaires.
Patients with idiopathic scoliosis treated with a scoliosis brace, between the age of 8 and 16 year old, will be included for one interface pressure measurement session and two successive sets of quality of life questionnaires.
- Main changes (audit trail)
- RECORD10-mrt-2008 - 21-apr-2008

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