An inpatient brace adaptation protocol increases therapy compliance and brace comfort for the patient compared to an outpatient brace adaptation protocol.
ID
Bron
Verkorte titel
Aandoening
Adolescent idiopathic scoliosis, AIS, scoliosis, Boston brace, compliance, adaptation protocol, Adolescente idiopathische scoliose
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
-Compliance (measured by a thermo sensor)<br>
-Well-being patient (PedsQL, SRS-22)<br>
-Well-being parents (PedsQL Inventory family module, Child competency inventory)
Achtergrond van het onderzoek
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.
Doel van het onderzoek
An inpatient brace adaptation protocol increases therapy compliance and brace comfort for the patient compared to an outpatient brace adaptation protocol.
Onderzoeksopzet
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)
Onderzoeksproduct en/of interventie
outpatient brace adaptation or inpatient brace adaptation
Algemeen / deelnemers
[default]
The Netherlands
Wetenschappers
[default]
The Netherlands
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-Female patients with adolescent idiopathic scoliosis
-Age ¡Ý10 en ¡Ü13 years
-Lenke type 1
-Coronal Cobb angle of ¡Ü 50¡ã
-Pre-menarche
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5776 |
NTR-old | NTR6059 |
Ander register | MEC-U : R15.001 |