The objective of this study is to evaluate whether an in- or outpatient initiation of the brace treatment has an influences short and long term brace compliance.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter is short and long term brace compliance as
measured by a temperature logger in the brace. The temperature logger will be
programmed to store the date time and temperature every 20 minutes. The sensor
has been validated in the past in which a temperature between 32.2 and 37.2
indicates that the brace is worn.
Secondary outcome
Secondary outcome parameters are welbeiing of the AIS patients as measured by
the PedsQL and SRS-22
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 risko
of progression and the subsequent risk to undergo surgery. However, the benefit
of bracing significantly increases with longer 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 word for 20 hours a day over a long period of time,
the bracing has a significant impact on dayly 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.
Study objective
The objective of this study is to evaluate whether an in- or outpatient
initiation of the brace treatment has an influences short and long term brace
compliance.
Study design
A prospective observational cohort design is used in which we compare the
standard care given in 4 different hospitals. Two of these hospitals have the
same outpatient initiation protocol for brace treatment whereas the other two
hospitals have the same inpatient initiation protocol.
Study burden and risks
The patients receive the standard care in the hospitals. There are no
additional risks related to this study.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
Inclusion criteria
Patients 10 years or older with an idiopathic adolescent scoliosis with an indication for brace treatment who have not had an operative treatment for scoliosis in the past
Exclusion criteria
• Scoliose with the apex of the curve proximal to T7
• A previous brace treatment for scoliosis
• A previous surgical treatment for scoliosis
• Patients who are not able to fill in the questionaires
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 |
|---|---|
| CCMO | NL50853.100.14 |