No registrations found.
ID
Source
Brief title
Health condition
Adolescent idiopathic scoliosis, AIS, scoliosis, Boston brace, compliance, adaptation protocol, Adolescente idiopathische scoliose
Sponsors and support
Intervention
Outcome measures
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
-cobb¡¯s angle over time
Background summary
In 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.
Study objective
An inpatient brace adaptation protocol increases therapy compliance and brace comfort for the patient compared to an outpatient brace adaptation protocol.
Study design
Start 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)
Intervention
outpatient brace adaptation or inpatient brace adaptation
[default]
The Netherlands
[default]
The Netherlands
Inclusion criteria
-Female patients with adolescent idiopathic scoliosis
-Age ¡Ý10 en ¡Ü13 years
-Lenke type 1
-Coronal Cobb angle of ¡Ü 50¡ã
-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.
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 | NL5776 |
NTR-old | NTR6059 |
Other | MEC-U : R15.001 |