Clinical and biometric analysis of different trunk orthesis
Not Applicable
- Conditions
- healthy probands, therefore not applicable
- Registration Number
- DRKS00005604
- Lead Sponsor
- niversitätsklinikum FreiburgVertreten durch den Leitenden Ärztlichen Direktor Prof. Dr. Dr. h.c. Jörg SiewertDelegiert an den HauptprüferPriv.-Doz. Dr. med. G.W. Herget
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
12 healthy, adult, volunteer probands
Exclusion Criteria
Participation in another clinical trial within the last 30 days before inclusion in the present study
- Planned simultaneous participation in another clinical trial or other clinical research projects during the term of the study
- Probands who receive a non-permitted concomitant treatment
- Pregnancy or breast feeding
- previous operations on the spine
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wearing comfort: is determined by daily wearing time.<br><br>To ensure compliance a minimal daily wearing time of 14 hours for at least 5 out of 7 days is necessary.<br>On 2 out of 7 days( at a maximum) the compliance can be reduced to a minimal daily wearing time of 10 hours.<br>Wearing comfort will be evalutated wiith the questionnaires SF-12 and an individual questionnaire, at the end of each wearing period, on day 7 for each orthosis.
- Secondary Outcome Measures
Name Time Method Stability:<br>Determination of measuring points in the area of the spinous processes from the cervical spine (C7) to the sacral bone (S2),at a maximum of 25 measuring points per spine.<br>If possible, all of these points should be used. <br>If measuring points cannot be achieved due to anatomical varieties, every point possible should be used.<br><br> 4 measurement series will be conducted per participant (3 with orthesis and 1 free of orthesis).<br><br>The process of measurement will be take place via a biometric measurement with video-based system at the end of the survey series.<br><br>Quality of life: via questionnaire SF-12 and individual questionnaire at the end of each wearing period, on day 7 for each orthosis.<br><br>Spine mobility: via the neutral zero measuring sheet, before and after the wearing on day 1 and day 7 for every orthosis.