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Medical Engineering & Physics 30 (2008) 269277

Parametric design of pressure-relieving foot orthosis using

statistics-based finite element method
Jason Tak-Man Cheung, Ming Zhang
Department of Health Technology and Informatics, The Hong Kong Polytechnic University,
Hung Hom, Kowloon, Hong Kong, PR China
Received 15 October 2006; received in revised form 28 April 2007; accepted 3 May 2007

Abstract
Custom-molded foot orthoses are frequently prescribed in routine clinical practice to prevent or treat plantar ulcers in diabetes by reducing
the peak plantar pressure. However, the design and fabrication of foot orthosis vary among clinical practitioners and manufacturers. Moreover,
little information about the parametric effect of different combinations of design factors is available. As an alternative to the experimental
approach, therefore, computational models of the foot and footwear can provide efficient evaluations of different combinations of structural
and material design factors on plantar pressure distribution. In this study, a combined finite element and Taguchi method was used to identify
the sensitivity of five design factors (arch type, insole and midsole thickness, insole and midsole stiffness) of foot orthosis on peak plantar
pressure relief. From the FE predictions, the custom-molded shape was found to be the most important design factor in reducing peak plantar
pressure. Besides the use of an arch-conforming foot orthosis, the insole stiffness was found to be the second most important factor for
peak pressure reduction. Other design factors, such as insole thickness, midsole stiffness and midsole thickness, contributed to less important
roles in peak pressure reduction in the given order. The statistics-based FE method was found to be an effective approach in evaluating and
optimizing the design of foot orthosis.
2007 IPEM. Published by Elsevier Ltd. All rights reserved.

Keywords: Insole; Footwear design; Plantar pressure; Taguchi; Diabetes

1. Introduction footwear without the prerequisite of fabricated footwear and

The use of therapeutic footwear has been found to be
effective in plantar pressure relief and the prevention of foot
ulceration for diabetes [16]. However, it is not clearly under-
stood which design factor contributes most in reducing peak
plantar pressure. Currently, the design of a foot orthosis relies
mainly on subjective views, gross motion tracking and inter-
facial pressure measurements. Due to the large variations of
prescribed footwear and the uncertainty in the reliability and
validity of assessment and intervention methods, consistent
outcomes are yet to be achieved and thus conflicting results
are common in terms of functionality of therapeutic footwear
[710].
Finite element (FE) analysis facilitates the efficient eval-
uation of different structural and material parameters of
Corresponding author.
E-mail address: htmzhang@polyu.edu.hk (M. Zhang).
replicating subject trials. Existing FE models in the literature
have shown the potentials in understanding foot and footwear
biomechanics [1122]. However, the simplified geometrical
properties of these models could not allow accurate sim-
ulations of the footinsole interface. In this study, a 3D
geometrically accurate nonlinear FE model of the foot and
ankle was used to evaluate the parametric effect of different
structural and material configurations of foot orthosis on peak
plantar pressure relief using the Taguchi analysis method.
2. Methods
An FE model of foot orthosis was incorporated into a pre-
viously developed 3D FE model of the human foot and ankle
[23]. The FE model was developed from the reconstruction
of coronal magnetic resonance (MR) images of 2 mm inter-
vals from the right foot of a normal male subject of height

1350-4533/$ see front matter 2007 IPEM. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.medengphy.2007.05.002
270 J.T.-M. Cheung, M. Zhang / Medical Engineering & Physics 30 (2008) 269277

Fig. 1. (a) The FE meshes of the ankle-foot structures, foot orthosis and ground support, (b) the connector elements for the applications of muscular forces
during simulated midstance and (c) the deformed plot of the soft tissue and bony structures. Note: dotted lines represent unformed plot.

174 cm and weight 70 kg in the neutral position. The foot were connected with cartilaginous structures, the interactions
and ankle model (Fig. 1a) consisted of 28 bony segments, among the bony structures were defined as contacting elastic
72 ligaments and the plantar fascia which embedded in a vol- bodies to allow relative bone movements. The foot bones, lig-
ume of encapsulated soft tissue. Except for the phalanges that aments, plantar fascia, and cartilaginous structures between
Table 1
Material properties and element types defined in the FE model
Component Element type Youngs modulus, E (MPa) Poissons ratio, v Cross-sectional area (mm2 )
Bony structures 3D-tetrahedra 7300 0.3
Encapsulated soft tissue 3D-tetrahedra Nonlinear
Cartilage 3D-tetrahedra 1 0.4
Ligaments Tension-only truss 260 18.4
Fascia Tension-only truss 350 58.6
Foot orthosis 3D-brick Nonlinear
Ground support 3D-brick 17,000 upper layer; 1,000,000 lower layer 0.1

The coefficients of the hyperelastic material model used for the encapsulated soft tissue (nonlinear)

C10 C01 C20 C11 C02 D1 D2

0.08556 0.05841 0.03900 0.02319 0.00851 3.65273 0.00000

The coefficients of the hyperfoam material model used for foot orthosis (nonlinear)

Orthotic material 1 2 1 2 1 2
Poron L24 0.2130 0.0621 10.300 3.349 0.32 0.32
Poron L32 0.3365 0.0873 7.272 2.391 0.32 0.32
Nora SLW 0.9754 0.2914 8.870 2.884 0.32 0.32
Nora SL 1.0370 0.3044 7.181 2.348 0.32 0.32
Nora AL 8.8740 7.8270 2.028 1.345 0.32 0.32
 J.T.-M. Cheung, M. Zhang / Medical Engineering & Physics 30 (2008) 269277
the phalanges were assumed as homogeneous, isotropic, and
linearly elastic (Table 1). On the other hand, the encapsulated
soft tissue was defined as hyperelastic (Fig. 2).
The geometry of the foot orthosis was based on the foot
shape of the same subject who underwent MR scanning for
the FE model. The barefoot shape was obtained from a 3D
laser scanner (INFOOT Laser Scanner, I-Ware Laboratory
Co. Ltd., Japan) under three different weight-bearing con-
ditions: single-limb standing (full-weight-bearing, FWB),
double-limb standing (half-weight-bearing, HWB), and
upright sitting (non-weight-bearing, NWB). The FE model of
foot orthosis (Fig. 1a) was composed of the insole, midsole,
and outsole layers.
The elastic foam strain energy function [24] was used
to define the highly compressible elastomers. This energy
function has the form:
 2  
2i i i i 1 i i
U= 1 + 2 + 3 3 + (J 1) (1)
2i i el
i=1
where U is a second order, isotropic hyperfoam strain energy
potential per unit of reference volume, i the principal
stretches, and Jel is the elastic volume ratio with 1 2 3 =
Jel . i , i , and i are material parameters.
In this study, two elastomeric foam materials commonly
used for fabricating foot orthosis were analyzed. Two grades
of polyurethane foam, Poron (Rogers Corporation, Con-
necticut, USA), with Shore A hardness 10 (Poron L24)
and 20 (Poron L32), and three grades of close-cell ethylene
vinyle acetate (EVA) foam, Nora (Freudenberg, Germany),
with hardness 30 (Nora SLW), 40 (Nora SL), and 50
(Nora AL), were analyzed. Each of the orthotic materials
was tested in a Hounsfield material testing machine (Model
H10KM, Hounsfield Test Equipment, UK) with a 1 kN load
cell. The samples which were 20 mm in diameter and 6 mm
in thickness were tested under uniaxial compression of up to
500 N with a testing speed of 1 mm/s. The stressstrain data
of different Poron and Nora materials (Fig. 2) were used
to extract the material parameters of the hyperfoam material
model (Table 1) in ABAQUS.
The footinsole interface was modelled using contact
surfaces with a 0.6 coefficient of friction [25]. A plate
Fig. 2. Stressstrain curves for nonlinear material models for encapsulated
soft tissue and different orthotic materials.
271
assigned with the properties of concrete was used to sim-
ulate the ground support to which the foot orthosis was
rigidly fixed (Fig. 1a). The extrinsic muscle forces during
midstance were estimated from the physiological cross-
sectional area (PCSA) of the muscles [26] and normalized
normal walking electromyography (EMG) data [27] assum-
ing a linear muscle force, EMG, and PCSA relationship
[28]. The musculotendon forces for the Achilles (700 N),
Tibialis Posterior (70 N), Flexor Hallucis Longus (40 N),
Flexor Digitorum Longus (30 N), Peroneus Brevis (30 N),
and Peroneus Longus (40 N) for simulating midstance were
applied at their corresponding points of insertion (Fig. 1b).
The reaction forces for the lateral retinaculum (50 N) and
medial retinaculum (50 N) were estimated according to the
tendon forces of the peroneal and flexor group muscles,
respectively. The ground reaction force (550 N) was applied
underneath the ground support, and the superior surfaces
of the soft tissue, and distal tibia and fibula were fixed
throughout the analysis. Fig. 1c depicts the typical deformed
shape of the soft tissue and bony structures during simulated
midstance.
The effect of five design factors of foot orthosis, namely,
the arch shape, insole thickness, midsole thickness, insole
stiffness, and midsole stiffness on the plantar pressure dis-
tribution during simulated midstance was analyzed. Each
design factor was assigned with four levels (Table 2) for
the parametric analysis. Four different arch shapes, namely,
flat, FWB, HWB, and NWB were considered. The insole
was defined as a uniform layer of a varied thickness (3, 6,
9, 12 mm) to simulate a cushioning layer of polyurethane
(Poron L24, Poron L32) or EVA (Nora SL, Nora SLW)
foam. Except for the flat condition (F), the midsole was com-
posed of an upper layer of the barefoot shape of the subject
and a flat bottom layer. Varied thickness (3, 6, 9, 12 mm)
and material stiffness (Poron L32, Nora SL, Nora SLW,
Nora AL) were also defined for the midsole layer. The out-
sole was defined as a uniform layer of 12 mm thickness with
properties of high-density EVA foam (Nora AL). Different
hardnesses of the insole and midsole ranging from Shore A
value of 1050 were considered.
The Taguchi method, pioneered by Dr. Genichi Taguchi,
was used to study the sensitivity of different structural and
material parameters of pressure-relieving foot orthosis. The
Taguchi method utilizes a fractional factorial design approach
Table 2
Design factors and their levels for parametric analysis
Design factor Level 1 Level 2 Level 3 Level 4
Arch type F FWB HWB NWB
Insole thickness (mm) 3 6 9 12
Midsole thickness (mm) 3 6 9 12
Insole material (hardness) 10 20 30 40
Midsole material (hardness) 20 30 40 50
F: flat, FWB: full-weight-bearing, HWB: half-weight-bearing, NWB: non-
weight-bearing. Hardness values of 10 , 20 , 30 , 40 and 50 correspond
to Poron L24, Poron L32, Nora SLW, Nora SL, Nora AL, respectively.
272 J.T.-M. Cheung, M. Zhang / Medical Engineering & Physics 30 (2008) 269277

to assess the sensitivity of each design factor of a system
and to determine its optimal quality level [29]. An orthog-
onal array, which is a form of fractional factorial design
containing a subset of all possible combinations of test con-
ditions, is used in the Taguchi analysis method [30]. The
columns of an orthogonal array are mutually orthogonal in
which for any pair of columns, all combinations of factor
levels occur at an equal number of times. In this sense, a bal-
anced comparison of levels of any factor can be achieved,
and valid conclusions over the entire region spanned by
the design factors can be obtained with less experimen-
tal effort. In this study, the L16 orthogonal array [29] was
used to establish the configurations of the foot orthoses
for each FE simulated orthotic condition (Table 3). Using
the Taguchi method, only 16 simulations were required to
identify the relative significance of different orthotic design
factors for plantar pressure relief, while a total number of
1024 (45 ) analyses will be required for the full factorial
approach.
The peak plantar pressures at the forefoot, midfoot, and
rearfoot from the 16 FE analyses were predicted. The mean
effect of each level of the four design factors on the mechani-
cal responses was computed. For example, the mean response
of arch type at level 1 [R(A1 )] on peak plantar pressure was
calculated as the mean plantar pressure over trials 14. An
analysis of variance was performed for the sum of squares of
each design factor to determine the sensitivity of each design
parameter [31]. The sum of squares due to arch type would
be equal to
[R(A1 ) Rm ]2 + [R(A2 ) Rm ]2 + [R(A3 ) Rm ]2
+ [R(A4 ) Rm ]2
where R(A1 ), R(A2 ), R(A3 ), and R(A4 ) were the mean response
of arch type at levels 14, respectively, and Rm was a bal-
anced overall mean response over the entire 16 experimental
trials.
Plantar pressure measurement was conducted to provide
a qualitative comparison with the FE predicted sensitivity
trend of the orthotic design factors on peak plantar pressure
relief. For the sake of simplification and because of the lim-
itations of the experimental shoes to accommodate all the
configurations of the foot orthosis, only the most commonly
used insole (Poron L32) and midsole (Nora SL) materials
and a total thickness of not more than 9 mm were consid-
ered. Two different thicknesses (3 and 6 mm) were considered
for the insole layer, while a 3 mm thick midsole layer was
used. In addition to the flat orthotic condition, three custom-
molded shapes, namely, FWB, HWB, and NWB, were
considered.
The foot orthoses were fabricated using a computerized
numerical control (CNC) milling machine (LeadWell CNC
Machines MFG Corp.) (Fig. 3a), and they were manually
trimmed by an orthotist to fit the size of the shoes (EUR
41) for the subject. The covering insole layer was then
glued to the midsole layer (Fig. 3b). A pair of canvas shoes
with a flat outsole of 12 mm thickness was used for the
experiments.
The in-shoe plantar pressure during shod with different
prescribed foot orthoses was measured using the F-scan sys-
tem (Tekscan Inc., Boston, USA) at a sampling frequency of
100 Hz. The F-scan sensors were calibrated by the subjects
body weight (700 N) during single-leg standing. The plantar
pressure measurement was done in a human motion anal-
(2) ysis laboratory, with the subject walking at a self-selected

Table 3
L16 orthogonal array table (the numbers under design factors indicate the levels assigned to each design factor) and the corresponding FE predicted peak plantar
pressures for the 16 configurations of foot orthosis
Trial number Design factor FE predicted plantar pressure (MPa)

Arch type, Insole thickness, Midsole thickness, Insole stiffness, Midsole stiffness, Forefoot Midfoot Rearfoot
A IT MT IS MS
1 1 1 1 1 1 0.214 0.088 0.145
2 1 2 2 2 2 0.216 0.088 0.148
3 1 3 3 3 3 0.235 0.087 0.165
4 1 4 4 4 4 0.240 0.087 0.169
5 2 1 2 3 4 0.195 0.070 0.147
6 2 2 1 4 3 0.194 0.070 0.146
7 2 3 4 1 2 0.122 0.071 0.102
8 2 4 3 2 1 0.141 0.074 0.112
9 3 1 3 4 2 0.180 0.070 0.141
10 3 2 4 3 1 0.164 0.073 0.129
11 3 3 1 2 4 0.149 0.069 0.122
12 3 4 2 1 3 0.121 0.068 0.104
13 4 1 4 2 3 0.155 0.076 0.118
14 4 2 3 1 4 0.132 0.074 0.109
15 4 3 2 4 1 0.165 0.080 0.125
16 4 4 1 3 2 0.157 0.077 0.120
 J.T.-M. Cheung, M. Zhang / Medical Engineering & Physics 30 (2008) 269277 273

Fig. 3. (a) Computerized numerical control (CNC) insole milling and (b) fabricated flat and custom-mold foot orthosis.

and comfortable pace of about 1.15 s per gait cycle on a
10 m walkway. Twelve configurations of the foot orthosis
were tested (Table 4) to identify the effect of different arch-
conforming shapes and thicknesses of a cushioning insole
layer on peak plantar pressure. Three highly repeatable mea-
surements showing a consistent pressure distribution pattern
of the stance phase cycle at the second step after gait ini-
tiation [32] were obtained for each orthotic condition. The
measured plantar pressure distribution of the right foot of the
subject at midstance was used for the data analysis. Mean-
while, the measured pressure print (excluding the toe region)
was divided into the forefoot, midfoot, and rearfoot regions in
three equivalent lengths, and the corresponding peak plantar
pressure in different regions was reported. Informed consent
was obtained from the participating subject before the MR
scanning and plantar pressure measurement.
3. Results
Fig. 4 shows the typical FE predicted and F-scan mea-
sured plantar pressure distribution at midstance. An increase
Table 4
The F-scan measured mean peak plantar pressures with different configurations of foot orthosis
Trial number Configurations of foot orthosis
in contact area especially at the midfoot was predicted with
the use of an arch-supporting foot orthosis. Among all the
simulated conditions, the highest plantar pressure was pre-
dicted at the forefoot, followed by the rearfoot and midfoot.
The peak plantar pressure of the forefoot was found consis-
tently beneath the second metatarsal head, while the peak
plantar pressure of the rearfoot was found at the central heel
region. For the midfoot, peak plantar pressure was predicted
at the lateral midfoot.
The FE predicted peak plantar pressures of the 16 different
orthotic configurations are tabulated in Table 3. The use of
a softer insole material and an arch-supporting foot orthosis
was found to be effective in the reduction of peak plantar
pressure, with the latter having a larger reducing effect. The
mean effect of each design factor at each of the four levels
can be found in Fig. 5. The use of a foot orthosis was found to
reduce the peak plantar pressure with the largest effect on the
forefoot, followed by the rearfoot, and a less obvious effect on
the midfoot. In general, the use of a better arch-conforming
support and softer and thicker material was found to have
a larger reduction of peak plantar pressure. The degree of
importance for each design factor can be further identified
F-scan measurement (MPa)

Arch type Insole (Poron L32) Midsole (Nora SL) Forefoot Midfoot Rearfoot
thickness (mm) thickness (mm)
1 F 0 3 0.133 0.077 0.100
2 F 3 3 0.120 0.070 0.087
3 F 6 3 0.113 0.073 0.090
4 FWB 0 3 0.117 0.073 0.070
5 FWB 3 3 0.097 0.053 0.060
6 FWB 6 3 0.110 0.047 0.060
7 HWB 0 3 0.103 0.06 0.070
8 HWB 3 3 0.090 0.057 0.057
9 HWB 6 3 0.100 0.060 0.060
10 NWB 0 3 0.083 0.063 0.047
11 NWB 3 3 0.073 0.047 0.047
12 NWB 6 3 0.087 0.050 0.043
F: flat, FWB: full-weight-bearing, HWB: half-weight-bearing, NWB: non-weight-bearing. Hardness values of 20 and 40 correspond to Poron L32 and
Nora SL, respectively.
274 J.T.-M. Cheung, M. Zhang / Medical Engineering & Physics 30 (2008) 269277
Fig. 4. The typical (a) FE predicted and (b) F-scan measured plantar pressure distributions with flat and custom-molded foot orthoses during midstance.
by comparing the sum of squares of the predicted plantar
pressure shown in Table 5.
Among the five design factors, the use of an arch-
supporting foot orthosis was found to be the most important
design factor for peak pressure reduction. The insole stiff-
ness was found to be the second most important factor for
peak pressure reduction. Then the rest of the design factors
contributed to a much lesser extent in peak pressure reduc-
Fig. 5. Mean effect of the five design factors at each level on the predicted
peak plantar pressure at the (a) forefoot, (b) midfoot and (c) rearfoot regions.
tion with a descending order from insole thickness, midsole
stiffness, and midsole thickness. The peak plantar pressure
of the midfoot was insensitive to the variations in stiffness
and material of the foot orthosis.
Although the use of an arch-supporting foot orthosis was
found to be the most important design factor for peak plan-
tar pressure reduction (Fig. 5), the difference in amount of
plantar pressure reduction was not obvious among the three
arch-supporting conditions (levels 24). A decrease in insole
stiffness was found to provide an increasing trend in the mag-
nitude of peak planar pressure reduction (Fig. 5). A reduction
in forefoot and rearfoot peak plantar pressure was predicted
with a change from the stiffer material (Nora SLW) with a
hardness of 30 , to the softer material (Poron L32) with a
hardness of 20 . A further reduction in peak plantar pres-
sure was achieved with an even softer material (Poron L24)
with a hardness of 10 . The trend in reduction of peak plantar
pressure between the insole and midsole stiffness was similar
(Fig. 5), but the performance for a different midsole material
was less obvious.
A general decrease in forefoot and rearfoot peak plantar
pressure was predicted with an increase in insole and midsole
thicknesses (Fig. 5), but the degree of reduction was less
pronounced than the effect of the orthotic material used. The
difference in peak forefoot and rearfoot plantar pressure for
an increasing midsole thickness was minimal. Except for a
slight reduction of peak pressure with an increasing midsole
stiffness, the effect of insole stiffness, and insole and midsole
thicknesses on peak pressure reduction of the midfoot was
negligible.
From the sensitivity analysis of the five design factors
(Fig. 5), the predicted magnitude of peak pressure reduction
was assumed to be the highest with the arch type, and insole
and midsole thicknesses assigned at level 4, and the insole and
midsole stiffnesses assigned at level 1. The FE predicted peak
plantar pressure was 0.123, 0.078, and 0.096 MPa, respec-
tively, for the forefoot, midfoot, and rearfoot with an NWB
arch type. Taking the same configurations except with an
HWB arch type, the predicted peak plantar pressure was
0.115, 0.067, and 0.098 MPa for the forefoot, midfoot, and
 J.T.-M. Cheung, M. Zhang / Medical Engineering & Physics 30 (2008) 269277
Table 5
Analysis of variance of predicted peak plantar pressure in the forefoot, midfoot and rearfoot for the 5-factor, 4-level fractional factorial analysis
Factor Sum of squares for plantar pressure (MPa2 )
Forefoot
Arch type 37.44 104 (67.6%)
Insole thickness 2.75 104 (5.0%)
Midsole thickness 0.38 104 (0.7%)
Insole stiffness 14.12 104 (25.5%)
Midsole stiffness 0.66 104 (1.2%)
Values in parentheses are percentage of contribution.
rearfoot regions, respectively. Therefore, it can be speculated
that using an arch support that conforms to the deformed foot
arch structure is important to optimize the performance of the
pressure-relieving orthosis.
The average peak plantar pressures measured from the
three walking trials in different selected configurations of the
foot orthosis are shown in Table 4. The measurements showed
a general reduction in peak plantar pressure with an increas-
ing arch height of foot orthosis. Moreover, the experimental
measurements showed that the use of an arch-conforming
orthotic design was more important in terms of peak pres-
sure relief than the use of a cushioning insole. The use of a
3 mm thick soft insole layer provided a consistent reduction
of peak plantar pressure in the forefoot, midfoot, and rear-
foot regions. However, the use of a thicker insole layer of
6 mm did not provide a further reduction of plantar pressure.
Instead, it resulted in a consistent increase in peak forefoot
pressure.
4. Discussion
In this study, the pressure-relieving capabilities of dif-
ferent material and structural configurations of foot orthosis
were quantified using the FE model of the human foot and
its support. Among the five design factors (arch type, insole
material, insole thickness, midsole material, and midsole
thickness) considered in this study, the use of an arch-
conforming foot orthosis and a softer insole material was
found to be effective in the reduction of peak plantar pressure
with the former, provided a larger pressure reduction. Insole
thickness, midsole stiffness, and midsole thickness were
found to play less important roles in peak pressure reduction.
In general, the plantar pressure measurements agreed
with the FE predictions that the use of a softer insole material
and an arch-supporting foot orthosis was effective in the
reduction of peak plantar pressure with the latter having a
larger reducing effect. In contrast to the FE predictions, a
higher forefoot plantar pressure was measured with the use
of a 6 mm insole than the 3 mm thick insole in the NWB arch
support. The increase in measured pressure was probably
because of the constrictive toe box of the shoes resulting
from the limited in-depth of the footwear for accommodating
the increased insole thickness. It may also be the cause
of a diminished arch support function of the orthosis with
275
Midfoot Rearfoot
190.81 106 (94.5%) 89.86 105 (55.4%)
0.31 106 (0.15%) 7.78 105 (4.8%)
0.31 106 (0.15%) 0.73 105 (0.45%)
1.69 106 (0.8%) 58.01 105 (35.75%)
8.81 106 (4.4%) 5.87 105 (3.6%)
an increasing insole thickness. The measured trend and
magnitude of peak plantar pressure reduction was less
pronounced than the FE predictions. The discrepancy was
probably due to the differences in the effect of interaction
between the foot orthosis and the footwear. It might also be
due to a change in the pattern of walking in different orthotic
conditions and in different trials. Therefore, the effect of an
increasing insole thickness and the optimal combinations of
insole and midsole thickness deserve further experimental
justifications of different configurations of foot orthosis with
standardized extra-depth footwear.
The FE predictions and experimental measurements in
this study agreed with the experimental findings of Tsung
et al. [5] and Bus et al. [1] that the use of custom-molded
insoles was significantly better than that of flat insoles in
terms of peak pressure reduction. It should be noted, how-
ever, that the use of the same custom design may result
in significant differences in performance for individual foot
structure. For instance, Bus et al. [1] found considerable vari-
ability in the efficiency for the same custom design among
individuals, although most pressure redistribution occurred
from the lateral heel to the medial midfoot regions. In addi-
tion, custom-molded orthoses with an additional metatarsal
pad or rearfoot wedges were found to be more effective for
pressure relief than the use of custom-molded orthosis alone
in some studies [33,34]. Meanwhile, other studies [3537]
found that additional arch support, metatarsal padding, or
insole wedging produced negligible or adverse effects on
pressure distribution. These findings further suggested that
the efficiency of a custom-molded foot orthosis for pressure
relief was highly individualized with the differences in foot
structure or arch type. Depending on the flexibility of indi-
vidual foot arch structures, the optimal arch configuration
of the foot orthosis may vary. For instance, a patient with a
more deformable foot arch may require an FWB or HWB
arch type for the custom orthosis. Alternatively, a subject
with a rigid arch structure may require an NWB, a higher
arch type, or an additional padding for foot arch support and
pressure redistribution. It should also be noticed that pres-
sure relief in a certain area provided by the arch-supporting
foot orthosis might be compromised with an increasing pres-
sure in other areas of the plantar foot. The effect of the same
foot orthosis on different foot types or structures such as a
flatfoot, a high-arched foot, and other deformities deserves
further investigations.
276 J.T.-M. Cheung, M. Zhang / Medical Engineering & Physics 30 (2008) 269277
The current findings about the positive effect of using
a soft cushioning insole material for plantar pressure relief
was consistent with the experimental findings of Goske et
al. [17] who found that relatively softer materials were more
effective in reducing peak plantar pressure during normal
weight-bearing. The FE predictions suggested that the stiff-
ness of the insole layer should be of a hardness value less
than 20 in order to maximize its pressure-relieving capa-
bility. However, it should be noted that the optimal insole
stiffness would depend on the expected pressure on the insole,
which is determined from the body weight and the activities
in which the patient is involved. The FE model predicted
a pronounced inverse relationship between insole thickness
and peak plantar pressure, which is consistent with the exper-
imental findings in the literature [38,39]. Depending on the
in-depth of the footwear, a cushioning insole layer of no less
than 9 mm was suggested from the FE predictions. However,
the optimal insole thickness for use in an actual situation,
without compromising proprioception and propulsion effi-
ciency, deserves further investigation.
Depending on the purpose of the foot orthosis such as the
target region of pressure relief and its confounding conditions
of the foot orthosis and shoes, the optimized design of the
pressure-relieving foot orthosis may be highly individualized.
Therefore, the optimized configurations may need to have
further adjustments according to the degree of importance
and predicted responses for each design factor. The purpose
of this is to achieve the best overall performance for individual
foot structure and requirement.
Apart from the simplifications of the structural and mate-
rial properties of the bony and soft tissue structures, the
following assumptions on the FE simulations may affect the
results. First, neglecting the interaction between the foot and
the upper shoe cover would result in a less confined foot posi-
tion and larger foot deformation. Second, only the midstance
phase during walking was analyzed. Third, only the major
extrinsic musculotendon forces were considered, while other
intrinsic muscle forces were not simulated. Fourth, only a
normal foot structure was analyzed, and the efficiency of a
custom-molded foot orthosis for pressure relief may be highly
individualized with the differences in foot structure or arch
type.
In conclusion, the FE predictions suggested that custom-
molded foot orthosis was effective in peak plantar pressure
relief and would play an important role in the prevention of
foot ulcers in diabetes. The cushioning insole layer of an
orthosis should contribute to the majority of the thickness of
the foot orthosis to maximize peak pressure reduction. There-
fore, a custom orthotic device and an extra-depth footwear
should be prescribed to diabetic patients at risk of plantar
ulceration whenever possible and available. The statistics-
based FE method was found to be an effective approach in
evaluating and optimizing the design of foot orthosis. With
the further development of the FE model, comprehensive
knowledge-based criteria for designing foot orthosis can be
established to provide systematic guidelines for clinicians to
prescribe and fabricate an optimized orthosis to maximize its
functional performance.
Acknowledgements
This work was supported by the Hong Kong Jockey Club
endowment, the research studentship from The Hong Kong
Polytechnic University, and the grants from the Research
Grant Council of Hong Kong (PolyU 5249/04E, PolyU
5317/05E).
Conict of interest statement
The authors do not have any conflict of interest in financial
and personal relationships with other people or organisations
that could inappropriately influence the submitted work.
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