Double blinding will be done by 1st enveloping the devices so that the
individual construction cannot be seen. These will then be identified by
numbers alone and fitted to the footwear by a third party out of site of
the patient and the data collector.
There will be no control group for this stage of the research but the
placebo will be the same shoes without any device in them.

I agree with norman and bart about the need for the orthotic to be used
on 'real' patients but I am hoping that this research will be done
independantly at 3 diabetic foot centres in the UK. This will be done to
ensure that this new product will be credible in the fields of relevance.
At this stage this is for my Msc research.

The devices are being made via a very expensive CAD/CAM system that will
ensure repeatability of the insoles i.e. the low density and tri-density
products will be milled using the same CNC file.

The other comment I would make is re. the ability of an orthoses to resist
compression over a period of time without dramitically changing its
mechanical impact on the foot. Research shows that EVA becomes stiifer
over repeated cylces and actually becomes 'thinner'.
The next stage of my personal research is to compare the same devices over
a 3 month period then compare the F-Scan data against the original 'new'
device data.
Regarding the need for symetry of integrals within the foot, this is what
I attempt to do within my own prescription protcols but without always
having access to in-shoe analysis, this is very subjective. I use a plumb
line to assess COM and subjective feedback from the patinets re. foot
pressure and this seems to work.(Taught by Andy Horwood on the Staffs Uni
MSC)
 Do you know of any other ways?

Thanks

Phil

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