curved spine scoliosis
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. AIS 2. Indication for conservative treatment 3. Minimum age of 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 7. Informed consent signed by both one of the parents and the patient 8. Male and female patients
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: The primary objective of the study is determining the contributing factors in bracing for AIS. The contributing factors are determined as factors of influence in the corrective possibilities and therefore end term results of the M-brace, which are currently unknown. The contributing factors are listed as secondary - fifth objective together with patient characteristics such as length and weight. The effect of contributing factors is quantified in changes of Cobb*s angle over time. The changes of Cobb*s angle over time are measured every six months on anteroposterior and lateral full spine radiographs until full bone maturation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective: • Compliance of brace wear o An incorporated thermal sensor (Orthotimer, Appendix 2) is used to quantify ours of brace wear per day. Sensor data is monitored every outpatient clinic visit through a wireless read-out system. Third objective • Pulmonary function and relation of brace wearing o Pulmonary function over time is measured once a year with use of dynamic and static spirometry. The measurements are with and without (very short term) brace wearing. The increased wearability and comfort of the Maastricht brace is expected to optimise pulmonary function and therefore support any form of activity whilst brace wearing. Fourth objective • Pressure distribution and development in brace wearing o Incorporated pressure sensors (Pressure Guardian) are used to quantify force and force distribution in the M-brace. Sensor data is monitored every outpatient clinic visit. It is still unclear how the force changes over time, whether there is a wear effect or if the brace applies the same force in different situations (sitting, standing ea.). Fifth objective • Motion analysis in brace (CAREN) o Motion analysis with and without brace, before, during and after treatment with M-brace. Analysis of gait and development of posture and balance before, during and after brace wear. An over- and or under correction can result in an imbalance in the coronal and or sagittal plane, and therefore a change in motion analysis. As we expect the brace to be optimally fitted, the hypotheses is that the kinematics of the walking pattern, the spaciotemporal parameters (such as walking speed, step length, ao) and measures of stability will be better comparable to short term non-brace wearing. | — |
Countries
Netherlands
Outcome results
None listed