The Maastricht brace is a new develwoped thoracolumbar brace that improves wearability and quality of life, while maintaining efficiency and function
ID
Bron
Verkorte titel
Aandoening
- Skeletspierstelsel- en bindweefselmisvormingen (incl. tussenwervelschijfafwijkingen)
Aandoening
Adolescent idiopathic scoliosis
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
- Overige
Uitkomstmaten
Primaire uitkomstmaten
The main objective of the study is to quantify the effect of conservative treatment of AIS with the use of the new developed Maastricht brace (ABR 09-02-029) by determining the deformation of cobb’s angle over time, using longitudinal radiological assessment with use of anteroposterior and lateral full spine radiographs.
Achtergrond van het onderzoek
Rationale: Our rationale for the study is multi-layered. Brace treatment is only effective if the patient is compliant. An optimally constructed brace is not effective if only worn for two hours a week. To increase compliance the Maastricht brace is optimally constructed to increase wearability and therefore more comfort, while obtaining the same pressure and therefore effect as the current golden standard, the Boston brace. There are several aspect of bracing which are only partly known or scarcely described in current literature. Pulmonary function in brace, and pressure in bracing or the relation between effect of bracing, pulmonary function and optimal pressure within the brace is scarcely described. Motion analysis in patients with AIS with or without brace is only investigated in small groups using older techniques. With this study we would like to develop an optimal treatment plan for AIS with use of the Maastricht brace, and more insight in the pathophysiology of AIS and the effects (or effectiveness) of bracing. Objective: The main objective of the study is to quantify the effect of conservative treatment of AIS with bracing (Maastricht brace or Boston brace) by determining the deformation of cobb’s angle over time, using longitudinal radiological assessment. Secondary objectives are compliance of bracing using thermal sensors (Orthotimer), pulmonary function development in brace, motion analysis of gait impairment (VICON) in a thoracolumbar brace.
Doel van het onderzoek
The Maastricht brace is a new develwoped thoracolumbar brace that improves wearability and quality of life, while maintaining efficiency and function
Publiek
Wetenschappelijk
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. AIS
2. Indication for conservative treatment
3. Age above 12 years old
4. Eligible for follow up
5. Ability to read and write in the Dutch language
6. Patient who are physically and mentally willing and able to comply with the functional evaluation
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Prior surgery to the spine
2. Morbid obesity (BMI>35)
3. Any musculoskeletal or neurological (congenital) disorder
4. Patients who are unwilling to cooperate with the study protocol and follow-up schedule.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Postbus 5800
6202 AZ Maastricht
043 387 6009
secretariaat.metc@mumc.nl
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In overige registers
Register | ID |
---|---|
NTR-new | NL5082 |
NTR-old | NTR5214 |
Ander register | NL53296.068.15 |