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Annabelle Johnson
05-03-2004, 08:01 AM
Dear list:

I am looking suggestions on how the following methodology, which was for a pilot
study, could be changed to make it a worthwhile, full-size clinical study. I
know it's really poor at the moment, but I'm just
beginning:

I'd particularly welcome suggestions relate to suggesting a more narrow aim /
hypothesis, as well as improvements that would make this more applicable to a
large number of persons.


Aim:

To determine the effect of cushioning on normal gait in everyday use (e.g.
walking).

Materials and Methods

Subjects

Two male and two female asymptomatic young adults (Mean age * years, Standard
Deviation *, n=*) volunteered to participate in this study, none of whom had
reported history of trauma or disease to their lower limbs. Subjects had weight
as assessed using Kistler Force Platform whilst attempting static stance Mean
*N (Standard Deviation *, n=4). Shoe sizes were reported based upon subjects
current footwear as mean 8 UK size (Standard Deviation *, n=4). BMI values lay
either within the normal (n=*) or overweight (n=*) ranges. No subjects were
termed obese.

Footware

Subjects supplied shoes constructed of leather upper without heels. The shoes
were those to which the subject was accustomed to wearing, to ensure results
are indicative of long term use. For one experimental condition the supplied
footwear was supplemented with a foamed polyester insole (Clarks Footwear, UK)
cut to lay within the footwear selected. The insole consisted of parallel
undulations at 8mm intervals perpendicular to the principle axis of the foot.
The thickness ranged between 2.1 and 2.8mm.

Method

Each subject, in randomised order, undertook the study three times, once in
barefoot, once wearing the shoes previously described, and once wearing both
shoes and insoles.

Subjects were asked to walk a distance of 8 meters, across two centrally located
Kistler Force Plates, upon which the subject weight had been previously
determined. Subjects were instructed to look at an imagined point on the far
wall, approximately at eye level.

Subjects were monitored at all times visually, and inconsistencies in gait were
recorded. Should the feet of the subject not be both fully incident upon the
force plates, the starting position was modified by a distance no greater than
50cm such that incidence was achieved. The number of strides utilised, and the
time taken to walk the 8m distance was recorded.

The walk was repeated as many times as necessary to obtain three repeats
satisfying the acceptance criteria outlined below.

Acceptance Criteria

Only persons having more than 20 and fewer than 30 years were accepted for the
study to avoid the influence of skeletally immature persons, and those who may
be beginning to experience geriatric conditions, respectfully. Should the feet
of the subject not be fully incident upon the force plate at any point within
the study, that part of the study was repeated. If visual observation noted any
discrepancy between initial gait and sequential repetitions, the subject was
informed where required and the part of study repeated. If either the
time to walk 8m or the number of strides in any given traversal differed by more
than 10 percent of the initial value, this data was also rejected and repeated
required.

I welcome all input, however critical on this study design.

Many thanks in advance,

Annabelle

--
Annabelle Johnson

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