|- candidate number||22294|
|- NTR Number||NTR5243|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-jun-2015|
|- Secondary IDs||NL52978.068.15 METC152021|
|- Public Title||Gait and balance in patients with an osteoporotic vertebral compression fracture: The effect of bracing.|
|- Scientific Title||The effect of a spinal orthosis on gait and balance in patients with symptomatic osteoporotic vertebral compression fractures|
|- ACRONYM||Gait and balance in patients with OVCF|
|- hypothesis||Pilot study|
|- Healt Condition(s) or Problem(s) studied||Osteoporosis|
|- 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.
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||1-jul-2015|
|- planned closingdate|
|- Target number of participants||15|
|- Interventions||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.|
|- 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.
|- Timepoints||1 week, 6 weeks and 6 months after visit at ER |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MD Eva Jacobs|
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||3-jun-2015 - 15-aug-2015|