No registrations found.
ID
Source
Brief title
Health condition
Osteoporotic vertebral compression fractures
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the assessment of margins of stability (MOS) at baseline, at six weeks and at six months follow-up.
The patients will walk in a Computer Assisted Rehabilitation ENvironment (CAREN). The effects of walking with and without orthosis will be assessed on ‘Margins Of Stability’ (MOS). The MOS is defined as the distance between a velocity adjusted or ‘extrapolated’ position of the center of mass (XcoM) and the edge of an individiual’s base of support (BOS) at any given instant in time. The MOS is directly related to the impulse (I) required that causes instability. Center of mass (COM) position will be estimated as the average position of the four pelvis markers (right and left anterior and superior iliac spine).
Secondary outcome
1. To assess the effect of the Osteolind® plus orthosis on gait parameters, such as walking velocity, cadence, step time, and step length;
2. To assess the effect of the Osteolind® plus orthosis on quality of life (VAS, Tinetti scale, Qualeffo-41);
3. To assess the effect of the Osteolind® plus orthosis on sagittal alignment as determined on plain radiographs;
4. To assess the effect of the Osteolind® plus orthosis on trunk motion.
5. To assess the effect of the Osteolind® plus orthosis on the incidence of falls.
Study objective
Pilot study
Study design
1 week, 6 weeks and 6 months after visit at ER
Intervention
All subjects are prescribed to wear the thoracolumbar orthosis Osteolind® plus (Werkmeister, Wanfried, Germany) in the acute stage (the first six weeks after presentation at the Emergency department) for the entire day (during the night is optional). In the subacute stage (week six of disease onset) the subjects will be requested to wear the Osteolind® plus orthosis at least 6 hours daily, and after three months for at least 3 hours daily until the final follow-up at six months.
Eva Jacobs
P. Debyelaan 25a
Maastricht 6229 HX
The Netherlands
Tel: +31-43-3884152
E-mail: e.jacobs@maastrichtuniversity.nl
Eva Jacobs
P. Debyelaan 25a
Maastricht 6229 HX
The Netherlands
Tel: +31-43-3884152
E-mail: e.jacobs@maastrichtuniversity.nl
Inclusion criteria
-Female;
-Age 60 years or older;
- Fully ambulatory subject (ability to perform a 15 meter walk test without walking aids);
-Symptomatic osteoporotic vertebral compression fracture;
-Presenting at emergency department MUMC;
- Willing and able to provide informed consent.
Exclusion criteria
-Male;
-Unstable vertebral fractures requiring surgery;
-Fractures due to high energetic trauma;
-Neurologic deficit, active cancer;
-Alcohol or drugs use affecting balance or influencing central nervous system (within 48 hours before testing);
-History of neurogenic or myopathic disorders impairing sensory or motor functions;
-Psychiatric or mental disease;
-Insufficient cognitive or language skills to complete questionnaires.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5111 |
| NTR-old | NTR5243 |
| CCMO | NL52978.068.15 |
| OMON | NL-OMON43909 |