Assistive Technology

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An evaluation of the use of a lateral wedged

insole and a valgus knee brace in combination
in subjects with medial compartment knee
osteoarthritis (OA)

Mobina Khosravi, Mokhtar Arazpour & Arash Sharafat Vaziri

To cite this article: Mobina Khosravi, Mokhtar Arazpour & Arash Sharafat Vaziri (2019): An
evaluation of the use of a lateral wedged insole and a valgus knee brace in combination in subjects
with medial compartment knee osteoarthritis (OA), Assistive Technology, DOI:
10.1080/10400435.2019.1595788

To link to this article: https://doi.org/10.1080/10400435.2019.1595788

Published online: 04 Apr 2019.

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ASSISTIVE TECHNOLOGY
https://doi.org/10.1080/10400435.2019.1595788

An evaluation of the use of a lateral wedged insole and a valgus knee brace in
combination in subjects with medial compartment knee osteoarthritis (OA)
Mobina Khosravi, PhDa, Mokhtar Arazpour, PhDa, and Arash Sharafat Vaziri, MDb
a
Orthotics and Prosthetics department, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran (the Islamic Republic of); bOrthopedic
surgery department, Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of)

ABSTRACT ARTICLE HISTORY

Aim: The aim of this study was to evaluate the effect (6 weeks) of the use of a knee brace and a lateral wedge Accepted 7 March 2019
insole, both in isolation and combined, on the knee adduction moment (KAM), pain levels, kinematics
KEYWORDS
(velocity, stride length, cadence), knee ROM, function, and satisfaction in patients with knee osteoarthritis (OA). Knee orthoses; lateral wedge
Methods: Twenty-one patients with medial compartment knee OA were participated in this study. insole; knee adduction
A relatively light three-point valgus knee brace (VB) and full length custom-made lateral wedge insole with moment; walking parameters;
arch support were prepared for each subject. Patients divided into three groups at random. knee osteoarthritis; medial
Results: The use of a custom fit valgus brace with lateral edge insole concurrently can reduce a greater compartment knee OA
peak KAM than use in isolation (30%). In addition, the use of both interventions can improve walking
velocity, cadence, and reduce levels of pain in patients with medial compartment OA.
Conclusion: All parameters except stride length and KAM in comparison with first day of wearing
interventions improved significantly in the combined, concurrent usage group. The use of a lateral wedge
insole and a valgus knee brace in combination can improve the kinetic and kinematic parameters in patients with
medial compartment knee OA.

Introduction
Osteoarthritis (OA) is a painful and debilitating condition of
the knee joint, resulting from persistent loading and
subsequent permanent damage to joint structures such as
cartilage, bone, and the joint capsule (Felson, 2004). As OA
tends to be more prevalent in the elderly, and the population
over 65 is increasing, so the prevalence of OA is also
expected to increase (Jämsen et al., 2012). It is reported that
16% of adults who are 45 years of age or older experience
knee joint symptoms related to the onset of OA, ranging from
mild discomfort to permanent loss of motion and severe pain
(Jämsen et al., 2012).
Orthoses, such as the lateral wedged insole (LWI) and
ortho- tic valgus knee brace (VB), are the most commonly
used con- servative treatment for patients with medial
compartment OA (Chuang et al., 2007; Haim, Rozen, Dekel,
Halperin, & Wolf, 2008). These two interventions are used as
part of the therapeutic process to improve the load distribution
within the knee and where possible to improve the alignment
of the knee (Fang, Taylor, Nouvong, & Masih, 2006; Knopf,
2010; Krohn, 2005).
The valgus brace is an orthotic device to provide medial
compartment pain relief by reducing the load on the medial
compartment through the application of an opposing external
valgus moment around the knee joint. Use of this device has
reportedly resulted in improvements to function, pain levels
and the knee adduction moment (KAM) (Hewett, Noyes,
Barber- Westin, & Hedcmann, 1998; Ohnishi et al., 2013;
Pagani, Böhle, Potthast, & Brüggemann, 2010; Pollo & Jackson,
2006; Pollo, Otis,
Backus, Warren, & Wickiewicz, 2002; Ramsey & Russell, 2009),
thereby increasing levels of ambulation in the affected
individual (Richards, Sanchez-Ballester, Jones, Darke, &
Livingstone, 2005). One study reported that the use of a VB
reduced the KAM immediately by 22% and following this,
5 weeks thereafter a further 8 percent reduction in the KAM
was reported (Laroche et al., 2014).
Among other conservative treatments, laterally wedged insoles
offer a low cost, simple, and safe alternative, with a higher
patient compliance than knee braces (Shimada et al., 2006).
Numerous studies have reported that the use of LWIs can also
reduce the KAM in patients with knee OA (Hinman, Bowles,
& Bennell, 2009; Hinman, Bowles, Payne, & Bennell, 2008;
Jones, Chapman, Forsythe, Parkes, & Felson, 2014; Kerrigan et
al., 2002; Mølgaard, Graven-Nielsen, Simonsen, & Kersting,
2014; Shimada et al., 2006). One study reported that a 5°
inclined lateral wedge type insole reduced the first and second
peak of the KAM significantly after one month’s use (Fu et al.,
2015). However, although 10° lateral wedge was more effective
in KAM reduction, most patients were not satisfied with this
degree of inclination (Hinman et al., 2008; Richards et al.,
2005). In addition, there are contradictory results reported
regarding the effect of LWI on pain levels and mobility (Fang
et al., 2006; Hatef, Mirfeizi, Sahebari, Jokar, & Mirheydari,
2014; Jones et al., 2014).
There are clearly some advantages with the use of both VB
and LWI in treating individuals with knee OA. However,
many treatment plans often include combinations of different

CONTACT Mokhtar Arazpour m.arazpour@yahoo.com University of Social Welfare and Rehabilitation Sciences, Tehran, Iran (the Islamic Republic of). Color
versions of one or more of the figures in the article can be found online at www.tandfonline.com/uaty.
© 2019 RESNA
2 M. KHOSRAVI ET
treatments, and combining the use of VB and LWI may be
treatment strategy for knee OA.
Since the human body is an integrated and complex unit
and members are connected as a closed chain, the interaction
reveals itself more in one extremity. The ankle and knee unit is
an integral unit in the body, so changes in each member affects
another member. Therefore, in the present study, interventions
were given for effectiveness on knee and ankle (subtalar joint)
both. On the other hand, valgus braces can effectively improve
the biomechanical position of the knee joint center, whereas
the lateral wedge insoles can incline the orientation of the
ground reaction force in the lateral direction, thereby reducing
KAM lever arm. It seems combining the use of these two
interventions may result in more significant KAM reduction.
Given that there are only four studies in this field that were
only two studies with follow-up (2 and 4 weeks) (Fu et al.,
2015; Mirzaei, Arazpour, Roodsari, Bahramizadeh, &
Mardani, 2018; Moyer et al., 2013, 2011), there was also a
contradiction in previous studies, high prevalence of this
disorder and high economic losses. It seems that the study of
combined effect of both interventions with follow-up can help
us in more precise prescription and prevention of knee OA
progression. In this regard, the aim of this study was to
evaluate of the use of a VB and an LWI, both in isolation
and combined, on the KAM, pain levels, function, and
satisfaction in patients with knee OA for 6 weeks. The main
hypothesis is of this study was that combining a VB and a
LWI would reduce peak external adduc- tion moments during
walking when compared to the use of a VB or LWI in
isolation.
Methods and materials
Participants
Twenty-one patients (mean height: 162 weight: 79.11 age
:58.96 BMI:30.13 sex: M: F: 61.83/38.16) with medial compart-
ment knee OA were referred by an orthopedic surgeon to the
Javad Moafaghian Institute for orthotic treatment.
The inclusion criteria were as follows: aged between 40
and 70 years; radiologically confirmed cartilage damage,
according to the Kellgren & Lawrence (K/L) scale, of grade
II/III. The presence of medial compartment OA and the
grading of OA severity was also confirmed by X-ray.
The exclusion criteria were: other diseases influencing
walking ability; acute joint effusion; prior surgery; foot disease,
other joint disorders or implants, and contraindications for
orthosis
utilization (skin disorder, infection, diabetes) or the use of
another orthosis (Kellgren & Lawrence, 1957; Lequesne, 1991).
Signed consent forms were obtained from all the study
participants. Ethical approval was obtained from the
appropriate committee at the University prior to the
commencement of this study.
Interventions
Lateral wedged insole (LWI)
Full length custom-made LWIs with arch support were
prepared from cork with a density of 60 durometers. The
insoles were constructed with a 10 mm lateral wedge with arch
supports (Shimada et al., 2006). arch support was
prefabricated. The arch support length was 33% of the insole
length and width 45% of the insole width. the height of the
arch was 1 cm (exclud- ing the rubber foam height) (see Figure
1) (Abdallah & Radwan, 2011). The insoles were trimmed to
fit the patients’ shoes.
Knee brace (VB)
A relatively light (<500 g) three-point valgus knee brace (VB)
was used in this study. VB consisted of a unilateral polycentric
joint on the medial side of the knee, with a soft pad covering
the outside, and cross over straps for fixation. Each VB was
custom molded and used the application of the three-point
pressure principle to apply the appropriate corresponding
forces to correct the Varus knee angulation. Each VB was
fitted by an experienced Orthotist, and comprised of a
neoprene thigh and lower leg sections, which extended in
length to ~2/ 3 of the corresponding leg areas (see Figure 2).
The VB was adjustable and patient control, that is fitted at a
position which did not exert unacceptable pressure on patient
knee.
Data collection
This was a blind randomized control trial study; patients
divided into three groups at random. The first group was
treated only with an LWI; the second group was treated
with only a VB; the third group was treated with both the
LWI and the VB. Each of the orthotic treatments was
employed for 6 weeks continuous usage, which was moni-
tored and confirmed by the lead researcher via telephone.
Data collection was acquired just prior to orthosis use, for
control reference. Each patient did not receive any informa-
tion about the different orthosis adjustments or what effect
could be expected with the insoles. Block-randomization was
 ASSISTIVE 3
Figure 1. Lateral wedge insole with arch support for left foot.
4 M. KHOSRAVI ET
Figure 2. Valgus brace (VB) for left knee.
Figure 3. Extremity Helen-Hayes marker placement.
used to achieve the same number of K/L grade II versus III
ratios in each of the three groups.
Pain, function, and satisfaction evaluation
For subject self-report, a Likert scale satisfaction system was
used, alongside a visual analog scale (VAS) for pain levels
and the Western Ontario and McMaster Universities Arthritis
Index (WOMAC) for function. The VAS, with a scale from 0 to
10, was used purely for pain severity. The WOMAC score was
ascer- tained by a self-administered questionnaire consisting
of 24 items and subdivided into three categories: pain (5
items), stiff- ness (2 items), and difficulty performing daily
activities (17 items). The Likert scale was a semi-quantitative
self-rating liner measurement system, with a scale from 0
(much dissatisfied) to 5 (much satisfied), being used to assess
levels of user satisfaction.
Gait analysis
A three-dimensional gait analyses was conducted at the gait
laboratory within the Javad Moafaghian institute for each
patient under each of the three conditions with reference to the
control (without and with each orthotic treatment) after 6
weeks of usage. We used lower body Helen-Hayes gait model
in Vicon nexus software. A series of 16 retroreflective
markers) 14 mm diameter) were employed, and were placed as
shown in Figure 3. The markers were placed at the bilateral
anterior superior iliac spines, the posterior superior iliac spine,
and lateral epicondyle of the knee (in groups with VB this
marker was placed on neoprene soft pad in the lateral side of
knee), lateral thigh, lateral tibia, lateral malleolus, second
metatarsal head, and calcaneus at the level of the second
metatarsal head. heels and toes markers were carefully
attached on the shoes in groups who used the LWI and the
corresponding kinematic data being collected by six cameras
using the 370 motion analysis system (Vicon Industries, Inc.)
at a sampling frequency of 120 Hz. Kinetic data were
collected using the 370 motion analysis system syn- chronized
with a multicomponent force platform (Kistler, Winterthur,
Switzerland) at 120 Hz. After data collection from the gait
analysis laboratory, data were analyzed jointly by an Orthotist
and a biomedical engineer.
Knee adduction moment (KAM) assessment. Abbreviations to
calculate external moment inverse dynamics were applied on
a 3D-linked segment model. Each lower limb segment (foot,
lower leg and thigh) was modeled as a rigid body with a local
coordinate system with corresponding anatomically-relevant
axes. The inertial properties of each limb segment were
approxi- mated anthropometrically, and translations and
rotations of each segment were reported relative to the neutral
positions that were defined during the initial standing static
trial. The peak magnitudes of the external KAM in the first
halves of stance were identified using an algorithm that
identified these peak values as those that were immediately
preceded by a minimum of five continuously ascending
values and followed by a minimum of five continuously
descending values.
General spatiotemporal gait parameters. Stride length was
obtained using the marker data on the heel; velocity was
obtained by assessing the mean value of the coordinates of the
two markers on the two PSIS, and dividing their displacement
rate per unit time (s). By counting the number of steps per unit
of time (min) a cadence value was acquired. Maximum knee
ROM was obtained by a simple subtraction of the minimum
knee flexion-extension angle from the maximum knee flexion-
extension angle during a given cycle. All gait variables were
averaged across the three trials (Chehab, Favre, Erhart-Hledik,
& Andriacchi, 2014).
Sample size
The sample size was 21 patients and assessment correlations
were based on the resultant knee adduction moment, and
were acquired by inserting the relevant information into the G-
Power software.
 ASSISTIVE 5
Statistical analysis
Table 1. Patient demographic information.
The normality of the dependent variables was confirmed using Lateral Valgus brace
the Shapiro-Wilk test. A multivariate analysis of variance Valgus wedge plus lateral
brace insole wedge p value
(MANOVA) for repeated measurements in the three groups
Number 7 7 7
with all three conditions was conducted. A post hoc analysis Age (years) 59.2 60.3 57.4 (7.48) 0.747
was performed to determine the differences between each (8.07) (5.28)
Weight (kg) 80.4 79.8 77.14 (10.87) 0.808
condition. For intra and inter group comparisons, a paired t- (11.04) (6.66)
test was also used, with a level of significance of p = 0.05 being Height (cm) 163.7 165.8 156.6 (9.19) 0.270
used for all tests. (8.92) (13.68)
Gender (female) 57 % 42% 71% 0.848
Kellgren and Lawrence (п) 43% 57.14% 29% 0.055
Results grading scale for the (ш) 57% 42.86% 71%
dominant leg
Participant clinical characteristics Pain at rest (VAS, 0–100) 7.28 4.71 7.57(0.53) 0.657
person-based (0.75) (0.48)
The clinical characteristics of the patients used within the
study are shown in Table 1. In addition, Table 2 demonstrates
the mean (SD) of the aforementioned parameters in the three between the “with” and “without” LWI. Pain reduction was
test conditions with and without interventions, and with how- ever significant between these two conditions (VAS: p =
orthotic use after a 6 weeks trial period. Table 3 shows the 0.007).
intergroup and intragroup correlations, with and without
interventions (control), plus a comparison of the aforemen-
tioned parameters within the study. Finally, Table 4 shows the Valgus brace plus lateral wedge insole (VB+LWI). A significant
intergroup and intragroup correlations, with interventions on reduction was observed between the “with” and “without”
the first day and after the 6-week follow up period, plus inter- ventions of the VB+LWI in the KAM (p = 0.038, −30%),
a comparison of the aforementioned parameters. speed of walking (0.39, 13%), cadence (p = 0.00, 14%) and
pain (VAS: p = 0.001). The knee ROM was also reduced but
this was not significant (p = 0.342).
Inter- and intragroups comparison to control condition
Intergroups comparison and mean (SD) of mentioned Intra-groups comparison and mean (SD) of the mentioned
parameters in baseline parameters in baseline
Valgus brace (VB). A significant improvement in KAM was Valgus brace in comparison with lateral wedge insole (VB
observed between the “with” and “without” interventions of and LWI). The comparison between the LWI and VB group
the VB (p = 0.02, −28%) and pain levels (VAS: p = 0.00). The revealed a significant difference in knee joint ROM
VB reduced the knee joint ROM (−14%) but it was not (p = 0.003) and stride length (p = 0.009), VB reduced more
significant (p = 0.08). There was no significant improvement the knee ROM and stride length in comparison to the use of
in stride length (−3%), cadence (5%), and velocity (2%) the LWI in isolation. There was no significant difference in
between the “with” and “without” VB conditions. the residual aforementioned parameters (e.g., KAM, speed of
walking, cadence, stride length). The VB group presented
Lateral wedge insole (LWI). There was no significant better- greater effect in pain (VAS: p = 0.001, WOMAC: p = 0.002)
ment in stride length, knee ROM, cadence, speed, and KAM and stiffness (p = 0.002) improvement in comparison with the
(−8%) LWI group.

Table 2. Mean (SD) of aforementioned parameters in the three test conditions with and without interventions and after 6 weeks.
Valgus brace Lateral wedge insole Valgus brace plus lateral wedge
Without Immediate After 6 weeks Without Immediate After 6 weeks Without Immediate After 6 weeks
Max KAM (Nm/Kg) 0.69 0.49 0.47 0.59 0.54 0.51 0.73 0.51 0.479
(0.12) (0.16) (0.16) (0.18) (0.15) (0.17) (0.12) (0.18) (0.11)
Speed (m/s) 0.7 0.71 0.86 0.82 0.89 0.94 0.61 0.69 0.76
(0.24) (0.27) (0.33) (0.21) (0.19) (0.18) (0.08) (0.05) (0.055)
Cadence (stride/min) 43.27 45.37 47.6 45.1 48.5 51.2 35.1 40.2 45.25
(6.55) (6.95) (7.07) (6.07) (5.51) (6.14) (1.24) (2.18) (2.24)
Stride length (m) 0.99 0.96 0.96 1.05 1.16 1.18 1.01 1.01 1.03
(0,096) (0.062) (0.06) (0.16) (0.17) (0.18) (0.12) (0.07) (0.098)
Knee ROM (deg) 42.5 36.5 39.7 49.9 50.1 51.8 40.2 36.6 38.32
(6.33) (5.44) (5.21) (2.54) (5.87) (5.99) (5.08) (8.27) (7.65)
Pain (VAS) 7.28 5.42 4.00 4.71 3.78 3.03 7.57 5.57 3.42
(0.75) (0.97) (0.81) (0.48) (0.56) (0.54) (0.53) (0.53) (0.53)
Function Pain `* 64.85 34.42 `* 67.8 84.1 `* 38.9 60.65
(WOMAC) (21.5) (7.8) (10.31) (9.47) (10.6) (13.4)
Stiffness `* 58.28 40.32 `* 65.4 81.35 `* 41.45 60.07
(14.8) (5.9) (5.55) (5.53) (11.18) (6.0)
Daily activity `* 49.87 29.14 `* 56.8 77.9 `* 45.34 66.07
(18.5) (7.6) (19.4) (14.15) (8.33) (9.63)
Satisfaction (Likert) `* 4.57 4.14 `* 3.85 4.42 `* 3.28 3.71
(0.53) (0.37) (0.69) (0.53) (0.47) (0.71)
6 M. KHOSRAVI ET

Table 3. Intergroup and intragroup, with and without interventions (control), plus comparison of aforementioned parameters.
Intragroup comparison Intergroup comparison
p value 1 p value 2 p value 3 p value 4 p value 5 p value 6
Max adduction moment (Nm/Kg) 0.02 0.54 0.38 0.864 0.986 0.954
Speed (m/s) 0.952 0.48 0.39 0.203 0.983 0.151
Cadence (stride/min) 0.572 0.29 0.00 0.515 0.194 0.023
Stride length (m) 0.489 0.236 0.88 0.009 0.583 0.072
Knee ROM (deg) 0.08 0.92 0.342 0.003 1.00 0.003
Pain (VAS) `0.00 `0.007 `0.001 0.00 0.927 0.001
Function (WOMAC) Pain `* `* `* 0.002 0.937 0.00
Stiffness `* `* `* 0.002 0.641 0.00
Daily activity `* `* `* 0.375 0.766 0.114
Satisfaction (Likert) `* `* `* 0.079 0.002 0.182
p value 1: Intragroup comparison between pre- and postintervention in subjects with VB.
p value 2: Intragroup comparison between pre- and postintervention in subjects with LWI.
p value 3: Intragroup comparison between pre- and postintervention in subjects with LWI and VB.
p value 4: Intergroup comparison between LWI group and VB group.
p value 5: Intergroup comparison between VB group and VB+LWI group.
p value 6: Intergroup comparison between LWI group and VB+LWI group.

Table 4. Intergroup and intra-group, with interventions in the first day and after 6 weeks of follow-up, plus comparison of the aforementioned parameters.
Intragroup comparison Intergroup comparison
p value 1 p value 2 p value 3 p value 4 p value 5 p value 6
Max adduction moment (Nm/Kg) 0.021 0.829 0.72 0.897 1.0 0.9
Speed (m/s) 0.033 0.00 0.002 0.819 0.649 0.313
Cadence (stride/min) 0.00 0.004 0.001 0.454 0.706 0.134
Stride length (m) 0.911 0.121 0.548 0.010 0.562 0.082
Knee ROM (deg) 0.007 0.009 0.013 0.006 0.905 0.002
Pain (VAS) 0.003 0.002 0.001 0.031 0.25 0.542
Function (WOMAC) Pain 0.003 0.00 0.00 0.043 0.699 0.193
Stiffness 0.001 0.00 0.001 0.009 0.184 0.299
Daily activity 0.005 0.00 0.00 0.028 0.255 0.001
Satisfaction (Likert) 0.078 0.03 0.289 0.631 0.367 0.079
p value 1: Intragroup comparison between immediate and after 6 weeks follow-up effect of intervention in subjects with VB.
p value 2: Intragroup comparison between immediate and after 6 weeks follow-up effect of intervention in subjects with LWI.
p value 3: Intragroup comparison between immediate and after 6 weeks follow-up effect of intervention in subjects with LWI and VB.
p value 4: Intergroup comparison between LWI group and VB group between immediate and after 6 weeks of follow-up.
p value 5: Intergroup comparison between VB group and VB+LWI group between immediate and after 6 weeks of follow-up.
p value 6: Intergroup comparison between LWI group and VB+LWI group between immediate and after 6 weeks of follow-up.

Valgus brace in comparison with valgus brace plus lateral
wedge insole (VB and VB+LWI). The VB and VB+LWI
groups showed no significant difference in all parameters,
although all kinematics parameters were slightly improved
though it was not significant; the use of the VB in isolation
however did produce greater levels of user satisfaction.
knee ROM (p = 0.007) but a decreased knee ROM with use of
the VB compared to without. The stride length improvement
was not significant (p = 0.9). Pain levels (VAS and WOMAC:
p = 0.003), stiffness (p = 0.001), and daily activity (p = 0.005)
improved significantly. Patient satisfaction (p = 0.07, −9%)
was however reduced, though again this was not significant.

Lateral wedge insole in comparison with valgus brace plus
lateral wedge insole (LWI and VB+LWI). The comparison
between the LWI group with the VB+LWI group showed
a significant difference in knee joint ROM (LWI: less reduc-
tion) and cadence (LWI: more improvement). There was no
significant difference in KAM though the reduction in VB
+LWI (−30%) was more than LWI (−8%). The VB+LWI and
LWI groups had a significant difference in pain (VAS:
p = 0.001, WOMAC: p = 0.005) and stiffness (p = 0.00). (VB
+LWI: greater improvement).
Lateral wedge insole (LWI). There was no significant
improve- ment in stride length (p = 0.12) and KAM (p = 0.82,
−4%) after 6 weeks usage LWI, residual parameters showed
slight improve- ment (not statistically significant).
Valgus brace plus lateral wedge insole (VB+LWI). A significant
improvement was observed in all aforementioned parameters
except the KAM (p = 0.72, −8%), stride length (p = 0.54, 1%),
and satisfaction ratings (p = 0.28, 13%) when compared to the
first day.

Inter- and intragroup’s comparison after 6 weeks
of follow-up
Inter-groups comparison and mean (SD) of mentioned
parameters after 6 weeks of follow-up
Valgus brace (VB). There was a significant improvement in
KAM (p = 0.021), cadence (p = 0.00), speed (p = 0.003), and
Intra-groups comparison and mean (SD) of mentioned
parameters after 6 weeks of follow-up
Valgus brace in comparison with lateral wedge insole (VB
and LWI). A comparison between the LWI and the VB
group revealed a significant difference in pain (VAS:
p = 0.031, WOMAC: p = 0.43), stiffness (p = 0.009), and
daily activity (0/028). Pain reduction was achieved more in

VB group (VAS: 26%, WOMAC:47% reduction). Stiffness
and daily activity improved more in LWI group (37.3% and
55% improvement, respectively). Also a significant difference
was observed in the knee ROM (p = 0.006) and stride
length (p = 0.01) parameters between both groups. VB
improved knee ROM more (9%) while LWI caused more
stride length betterment (2%).
Valgus brace in comparison with valgus brace plus lateral
wedge insole (VB and VB+LWI). The comparison between
VB and VB+LWI groups showed no significant difference in
all parameters except satisfaction (p = 0.002) with patients
being more satisfied with the VB. After 6 weeks of wearing
interventions, in VB group patients satisfaction decreased (9%
reduction) while VB+LWI led 13% satisfaction improvement.
Lateral wedge insole in comparison with valgus brace plus
lateral wedge insole (LWI and VB+LWI). The comparison
between the LWI and the VB+LWI groups showed
a significant difference in the levels of pain (VAS: p = 0.001,
WOMAC: p = 0.00) and stiffness (p = 0.00). these parameters
improved more in combine group (LWI+VB) Also knee ROM
(0.003) and cadence (0.023) difference between this two group
were statistically significant. LWI+VB improved cadence
(12%) and knee ROM (5%) more than LWI in isolation.
Discussion
The aim of this study was to determine, analyze, and discuss
the effect of using different, conservative orthotic treatment
combinations on subjects who presented with medial com-
partment OA. The results suggest that the use of a VB and
LWI concurrently, over a relatively long-term period, will
provide more KAM reduction, improve relevant walking
parameters, reduce pain, and improve function. However,
user satisfaction scores also suggest that despite these
improvements, other factors contribute to a reduction in the
levels of satisfaction when both devices are used concurrently.
In terms of the data, this study showed an immediate
reduction in the peak KAM of 28% in the VB group, 8% in
the insole group, and 30% in combined, concurrent usage
group. Furthermore, the amount of KAM reduction in both
the VB and VB+LW groups as compared to the control were
significant. The immediate reduction in peak knee adduction
moment shown in the VB, LWI, and combined groups is
similar to that presented by Laroche et al. (2014), Kerrigan
et al. (2002) and Moyer et al. (2013). After the 6 weeks of
follow-up, no significant reduction in peak KAM was seen in
the LWI and VB groups although the amount of reduction in
VB+LWI group was increased still further (8%); a similar
increase was also reported by Henry et al. (Fu et al., 2015)
although these also reported a reduction in peak KAM (−21%)
in the VB+LWI group after 4 weeks (Fu et al., 2015).
Pain can affect the kinetics and kinematics of walking
(Divine & Hewett, 2005). Studies show that OA-associated
pain reduces walking speed, range of motion, cadence, stride
length, and increases the adduction moment during walking
(Gaasbeek, Groen, Hampsink, Van Heerwaarden, & Duysens,
2007). We demonstrated that an immediate improvement in
ASSISTIVE 7
these parameters by using the VB brace and LWI separately
was not significant, but was significant when these devices
were used in combination (LWI+VB, 14%). By contrast,
Knopf et al. found that the mean cadence significantly
increased from 107 to 110 steps/min with the use of a VB
compared with a control (Knopf, 2010). In present study 6
weeks usage of the interventions led to significant improve-
ment in all three groups. Furthermore, as shown in Table 2.
the speed of walking immediately improved in the VB+LWI
group (13%); after 6 weeks, this improvement was mirrored in
the LWI and VB+LWI groups. Schmaltz et al. also found that
the mean walking speed significantly increased with the use of
a VB (Moyer et al., 2013). Conversely, Mirzaie reported no
significant improvement in speed and cadence by using these
two types of orthoses, both separately and combined, after 2
weeks of follow-up (Mirzaei et al., 2018). It would appear that
the duration of orthosis usage is a significant factor with
regard to potential improvements to kinematics parameters.
None of the three groups revealed immediately significant
improvements in stride length, with use of the VB only
actually decreasing step length. After 6 weeks of follow-up,
this was redressed, although no significant step length
improvement was observed. Among previous studies, results
on the effect of brace on step length were different. Gaasbeek
reported stride length reduction due to a decreased knee
ROM, for example (Gaasbeek et al., 2007). These results
were in line with our study. Knopf et al. by contrast reported
a significant increase in stride length on the affected side
(from 0.71 m to 0.73 m) and a significant decrease in the
unaffected side (from 0.75 to 0 and 73 m) (Knopf, 2010).
The use of a VB has not only reduced the peak KAM, but
has also made it easier for the patient to ambulate. The use of
the LWI had more positive effects on patients walking
parameters and also retained more knee ROM. KAM
reduction in the VB and VB+LWI groups were almost the
same, but the combined use of these interventions improved
the walking parameters slightly. Finally, it can be said that the
walking capability of subjects improved slightly with use of
the VB+LWI, although not significantly.
Despite the positive effects of VB usage, there are some
inherent functional disadvantages. Our results showed that
brace can cause reduction in knee flexion ROM during the
swing phase (14%), although this amount was not significant.
According to previous studies, one of the defects of these
braces is knee flexion reduction in swing phase which leads
to stride length and foot clearance reduction (Gaasbeek et al.,
2007; Richards et al., 2005). Gaasbeek reported that use of
their VB initially restricted knee extension (Gaasbeek et al.,
2007), but after 6 weeks usage this had significantly improved.
Improving quality of life for patients with OA is clearly
important. The immediate effect of pain (VAS) reduction in
the VB+LWI was more than in the other groups. Pain (VAS
and WOMAC questionnaire) levels were seen to decrease
more after 6 weeks in all group; reducing pain should also
improve the patients walking parameters. Previous studies
reported significant pain reduction and functional improve-
ment with the use of orthoses (Arazpour et al., 2013; Cherian
et al., 2015; Gaasbeek et al., 2007; Johnson, Starr, Kapadia,
Bhave, & Mont, 2013; Knopf, 2010; Laroche et al., 2014). For
8 M. KHOSRAVI ET
example, Lorache et al. reported that the use of a VB reduced
pain levels from 6.3 ± 1.1 in the first week to 3.0 ± 1.3 in the
fifth week (p < 0.01). In addition, WOMAC scores decreased
almost 30%, with these authors subsequently reporting both
a significant pain reduction and functional improvement
(Laroche et al., 2014). In another study, pain scores were
improved from 6.4 ± 1.7 to 3.3 ± 1.9 after 4 weeks of wearing
a VB (p ≤ 0.01) (Knopf, 2010). Two further studies indicated
that the use of an LWI reduced knee pain and improved
patient function (Cherian et al., 2015; Hinman et al., 2008).
Immediate satisfaction levels in the VB+LWI group was lower
than those reported by patients within the LWI or VB groups.
The VB group had greater levels of satisfaction, although after
6 weeks of usage in VB+LWI and LWI groups patients were
more satisfied when compared from the first day (however, no
one group was significant). Furthermore, after 6 weeks of
usage, the LWI group were more satisfied in comparison
with the VB+LWI . Satisfaction in VB group decreased after
6 weeks of usage.
In general, the patients were accustomed to the use of
orthotic interventions (especially amount of lateral wedge)
caused of creep and viscoelasticity trait of body. In the VB
group were some complained about brace displacement and it
can be one of the most reason of patient’s satisfaction reduc-
tion in comparison of first day. According to previous studies,
one of the main problems of brace usage is their low fit and
downward slide which makes patients constantly have to
adjust the brace (Matsuno, Kadowaki, & Tsuji, 1997;
Stamenović, Kojić, Stojanović, & Hunter, 2009). This may
have helped us to achieve greater levels of patient satisfaction
in this group.
Study limitations
The main limitation of this study was the relatively small
sample size. Further research with a larger sample size to
provide a higher power of statistical significance in more of
the evaluated parameters would enhance the work. Scores of
VAS, WOMAC, and Likert questionnaires reported by elderly
people may also be subjective.
Conclusion
Our findings suggest that the use of a custom fit knee valgus
brace with lateral wedge insole concurrently can reduce
a greater peak KAM than use in isolation (30%). In addition,
the use of both interventions can improve walking velocity,
cadence and reduce levels of pain in patients with medial
compartment OA. Initially, patient satisfaction levels
decreased with concurrent use, but after 6 weeks of usage,
patients became more accustomed to these interventions but
the amount of satisfaction increasing was not statistically
significant. After 6 weeks, all parameters except stride length
and KAM in comparison with first day of wearing improved
significantly in the combined group (KAM and stride length
improvements were not significant after 6 weeks usage in
comparison with first day after wearing interventions). Our
results therefore suggest that the use of a lateral wedge insole
and a valgus knee brace in combination can improve the
kinetic and kinematic parameters in patients with medial
compartment knee OA.
Acknowledgments
We would like to thank the TecnoTan Company for providing the three-
point valgus knee braces that were used in this study.
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