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Effect of in- and outpatient brace adaptation protocols on brace compliance in adolescent patients with idiopathic scoliosis


- candidate number25175
- NTR NumberNTR6059
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-aug-2016
- Secondary IDsR15.001 MEC-U
- Public TitleEffect of in- and outpatient brace adaptation protocols on brace compliance in adolescent patients with idiopathic scoliosis
- Scientific TitleEffect of in- and outpatient brace adaptation protocols on brace compliance in adolescent patients with idiopathic scoliosis
- ACRONYMBRACE
- hypothesisAn inpatient brace adaptation protocol increases therapy compliance and brace comfort for the patient compared to an outpatient brace adaptation protocol.
- Healt Condition(s) or Problem(s) studiedAdolescent idiopathic scoliosis (AIS), Scoliosis, Brace
- Inclusion criteria-Female patients with adolescent idiopathic scoliosis
-Age 10 en 13 years
-Lenke type 1
-Coronal Cobb angle of 50
-Pre-menarche
- Exclusion criteria-Scoliosis with the apex of the curve proximal to T7
-Prior surgery to the spine
-prior brace treatment for scoliosis
-Patients who don't have the ability to read and write in the Dutch language
-Patients who are unwilling to cooperate with the study protocol and follow-up schedule.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 26-feb-2016
- planned closingdate26-feb-2020
- Target number of participants40
- Interventionsoutpatient brace adaptation or inpatient brace adaptation
- Primary outcome-Compliance (measured by a thermo sensor)
-Well-being patient (PedsQL, SRS-22)
-Well-being parents (PedsQL Inventory family module, Child competency inventory)
- Secondary outcome-Relation compliance and well-being
-cobbs angle over time
- TimepointsStart bracing is considered enrollment (T=0). Outpatient clinic visits at 2 months and 6 months. After 6 months the visits are every 6 months. Last visit is at stop brace treatment when skeletal maturity is reached (T=e)
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG)
- Funding
(Source(s) of Monetary or Material Support)
Annafonds
- Publications
- Brief summaryIn the past , there has been a lot of debate about the effectiveness of brace treatments for adolescent idiopathic scoliosis (AIS). Recently, the Bracing in Adolescent Idiopathic Scoliosis Trial made an important contribution to this continueing debate as they showed that bracing significantly reduces the risk of progression and the subsequent risk to ondergo surgery. However, this benefit of bracing was only achieved with good compliance (i.e. many hours of brace wear). Few children with AIS wear the brace for the prescribed number of hours per day. Since the brace has to be worn for 20 hours a day over a long period of time, the bracing has a significant impact on daily life of AIS patients. Initiation of the brace treatment is done differently in scoliosis centers world wide. It can be done in an in- and outpatient setting. Whether the setting in which the brace treatment is initiated influences the short- and long-term compliance is unknown. The objective of this study is to evaluate the effect of in- and outpatient brace adaptation on short- and long-term brace compliance.
- Main changes (audit trail)
- RECORD15-aug-2016 - 3-nov-2016


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