|- candidate number||23503|
|- NTR Number||NTR5598|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-dec-2015|
|- Secondary IDs||55766.044.15 CCMO, www.toetsingonline.nl|
|- Public Title||Effect of automatic change in seating posture|
|- Scientific Title||Investigation into the effect on automatic change of seating posture with the 'Fit-form Vario Zorgfauteuils' on the skin vitality.|
|- hypothesis||With this study we want to test two new modules of a chair specialised for elderly and test whether these new modules improve
skin vitality and doe not disturb the users comfort. The new modules apply automatic changes in seating posture after a certain
time. With the study we will test what change is effective (or not) en how disturbing these changes are.|
|- Healt Condition(s) or Problem(s) studied||Seating posture, Skin blood flow|
|- Inclusion criteria||- Age between 18 and 35 OR 60 years or older|
- Considered to be healthy
- Caucasian/white skin colour. This is essential for the measurement device ‘Oxygen to See’.
|- Exclusion criteria||- Known diseases such as: heart diseases, respiratory diseases, diabetes, other diseases to microcirculation.|
- Skin colour deviations at site of measurement.
- Surgery at the area of measurement (bottom).
- Unable of sitting still for 2 hours.
- Body mass index below 20 (underweight) or above 30 (obese).
- Body length below 1.60m or above 1.90m. The current measurement chair cannot correctly be adjusted for these
- Not able to stand up without assistance from a chair.
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||24-jan-2016|
|- planned closingdate||22-jan-2017|
|- Target number of participants||15|
|- Interventions||Experimental, non-randomised intervention study in which multiple tests are performed with different parameters of automatic
change in seating posture.|
|- Primary outcome||Changes in oxygensaturation, blood flow, interface pressure and comfort during the various test-modules|
|- Secondary outcome||not applicable|
|- Timepoints||one session of maximal 3hours|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MSc I. Hoogendoorn|
|- CONTACT for SCIENTIFIC QUERIES||MSc I. Hoogendoorn|
|- Sponsor/Initiator ||Roessingh Research and Development|
(Source(s) of Monetary or Material Support)
|Wellco International BV|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||18-dec-2015 - 14-feb-2016|