healthy probands, therefore not applicable
Conditions
Interventions
Group 1: 1 week trunk orthosis 3-point corset
("Medi 3 C")
Group 2: 1 week thorakolumbo-sacral orthosis
(TLSO, "Heju orthosis")
Group 3: 1 week hard cast reinforced Soft Cast corset ("Fritz Corset")
Sponsors
Universitätsklinikum FreiburgVertreten durch den Leitenden Ärztlichen Direktor Prof. Dr. Dr. h.c. Jörg SiewertDelegiert an den HauptprüferPriv.-Doz. Dr. med. G.W. Herget
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 12 healthy, adult, volunteer probands
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wearing comfort: is determined by daily wearing time. To ensure compliance a minimal daily wearing time of 14 hours for at least 5 out of 7 days is necessary. On 2 out of 7 days( at a maximum) the compliance can be reduced to a minimal daily wearing time of 10 hours. 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
| Measure | Time frame |
|---|---|
| Stability: 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. If possible, all of these points should be used. If measuring points cannot be achieved due to anatomical varieties, every point possible should be used. 4 measurement series will be conducted per participant (3 with orthesis and 1 free of orthesis). The process of measurement will be take place via a biometric measurement with video-based system at the end of the survey series. Quality of life: via questionnaire SF-12 and individual questionnaire at the end of each wearing period, on day 7 for each orthosis. Spine mobility: via the neutral zero measuring sheet, before and after the wearing on day 1 and day 7 for every orthosis. | — |
Countries
Germany
Contacts
Public ContactGeorg W. Herget
Klinik für Orthopädie und Unfallchirurgie
Outcome results
None listed