The data will be used in order to evaluate statistical variability (mean, SD) in an attempt to predict an appropriate sample size prior to the RCT based on the effect size, alpha and beta. The aim of the RCT is to assess the effects of the Osteoline…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective:
1. To assess the effect of the Osteoline® plus orthosis on postural balance
(margins of stability) in patients with OVCF.
Secondary outcome
Secondary Objectives:
1. To assess the effect of the Osteoline® plus orthosis on gait parameters;
2. To assess the effect of the Osteoline® plus orthosis on quality of life
(VAS, Tinetti scale, Qualeffo-41);
3. To assess the effect of the Osteoline® plus orthosis on sagittal alignment
as determined on plain radiographs;
4. To assess the effect of the Osteoline® plus orthosis on trunk motion.
Background summary
Vertebral fractures are the most common clinical manifestations of
osteoporosis. Osteoporotic compression vertebral fractures (OVCFs) can result
in hyperkyphosis; and both are associated with diminished daily functioning and
an increased risk of falling. Spinal orthosis are known to reduce pain and
increase quality of life in patients suffering from OVCFs. The purpose of this
study is to examine whether the use of spinal orthosis also increases the
margins of stability during walking in this patient group and thereby decreases
the risk of falling.
Study objective
The data will be used in order to evaluate statistical variability (mean, SD)
in an attempt to predict an appropriate sample size prior to the RCT based on
the effect size, alpha and beta.
The aim of the RCT is to assess the effects of the Osteoline® plus orthosis on
pain, balance (margins of stability) and gait parameters in patients with OVCF.
Study design
Prospective, single center, baseline-controlled pilot study.
Intervention
All subjects are prescribed to wear the thoracolumbar orthosis Osteolind® plus
in the acute stage for the entire day (during the night is optional). In the
subacute stage 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.
Study burden and risks
The risk of the gait analysis is negligible. A safety harness provides
protection against falling. It will avoid subject falling on or off the
treadmill while performing training. The safety harness is secured with a life
line to the ceiling. The gait analysis (questionnaire included) compromises the
only burden; all other interventions are equal to normal clinical practice. The
gait analysis will take approximately 60 to 90 minutes.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
* Female;
* Age 55 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;
* 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);
* Psychiatric or mental disease;
* Insufficient cognitive or language skills to complete questionnaires.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL52978.068.15 |
| Other | Volgt nog |
| OMON | NL-OMON28889 |