The effect of of a spinal orthosis on gait and balance in patients with symptomatic osteoporotic vertebral compression fractures (OVCFs)

Completed

Conditions: Osteoporotic vertebral compression fracture
vertebral fracture
10017322

Registration Number: NL-OMON43909

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective:<br /><br>1. To assess the effect of the Osteoline® plus orthosis on postural balance<br /><br>(margins of stability) in patients with OVCF.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objectives:<br /><br>1. To assess the effect of the Osteoline® plus orthosis on gait parameters;<br /><br>2. To assess the effect of the Osteoline® plus orthosis on quality of life<br /><br>(VAS, Tinetti scale, Qualeffo-41);<br /><br>3. To assess the effect of the Osteoline® plus orthosis on sagittal alignment<br /><br>as determined on plain radiographs;<br /><br>4. To assess the effect of the Osteoline® plus orthosis on trunk motion.</p><br>