International Journal of Clinical Medicine, 2013, 4, 6-12
Published Online December 2013 (http://www.scirp.org/journal/ijcm)
http://dx.doi.org/10.4236/ijcm.2013.412A2002
Open Access IJCM
The Effects of an Unloading Knee Brace and Insole with
Subtalar Strapping for Medial Osteoarthritis of the Knee
Masataka Deie1, Hayatoshi Shibuya2, Ats u s h i Ok uhar a2, Minoru Toriyama1, Nobuyuki Kumahashi3,
Yuji Uchio3, Yo sh ia ki Sasas hi ge 4, Mitsuo Ochi2
1Department of Physical Therapy and Occupational Therapy Sciences, Graduate School of Health Sciences, Hiroshima University,
Hiroshima, Japan; 2Department of Orthopaedic Surgery, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima,
Japan; 3Departement of Orthopaedics, Shimane University, Izumo, Japan; 4Chugoku Rosai Hospital, Kure, Japan.
Received October 15th, 2013; revised November 5th, 2013; accepted November 30th, 2013
Copyright © 2013 Masataka Deie et al. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In accor-
dance of the Creative Commons Attribution License all Copyrights © 2013 are reserved for SCIRP and the owner of the intellectual
property Masataka Deie et al. All Copyright © 2013 are guarded by law and by SCIRP as a guardian.
ABSTRACT
Objectives: We evaluated whether a valgus knee brace and an insole with subtalar strapping could reduce pain and im-
prove functional scores over 12 months in patients with med ial knee osteoarthritis (OA). Methods: OA was confirmed
by radiography in all patients, who were d ivided into three groups: exercise (n = 44), insole (n = 55), and brace (n = 19).
Clinical knee functions and gait analyses were evaluated. Results: After 12 months, the clinical results for all groups
had improved compared to pretreatment findings. Although the knee varus moment decreased and the gait speed in-
creased when the insole was worn initially, the effects of the insole decreased at 6 and 12 months. In contrast, the knee
varus moment decreased and the gait speed increased when the brace was initially fitted . The effects of the brace were
maintained during th e 12 month s. Conclusions: Th e inso le was effectiv e for p atien t s with Kellgren-Lawrence Grad es II
and III, and the knee brace was effective for patients with Grades III and IV conditions. Furthermore, the knee brace
was more effective when worn for more than 6 months, while the effects of the insoles were not continuous.
Keywords: Medial Osteoarthritis; Insole; Functional Brace; Knee Varus Moment; Gait Analysis
1. Introduction
Patients with knee osteoarthritis (OA) are encountered
increasingly in our aging population. Patients with me-
dial knee OA present varus deformities and increased
mechanical stresses in the medial compartment [1,2],
which together increase pain and functional disabilities
[3]. Varus knee deformities cause patients to shift the
lower limb axis to the medial compartment and walk
with greater peak external knee adduction moment com-
pared to individuals without knee OA [4]. The treatment
for varus knee deformities can initially involve various con-
servative approaches such as muscle-strengthening exer-
cises, medicines, and orthoses. A systematic review re-
garding the benefits of exercise for knee OA [5] revealed
no definitive proof that such exercises are effective in
preventing the progression of knee OA. However, the
current guidelines for OA [6,7] indicate that muscle-
strengthening exercises and medicines effectively reduce
knee joint pain and aid the recovery of knee joint func-
tion.
The effects of orthoses on knee OA are also contro-
versial. Unloading knee braces, which are recommended
for the non-pharmacological management of knee OA by
EULAR [8], may relieve short- and mid-term pain more
effectively than neoprene knee sleeves. They can also
provide short-term improvements infunctional disabili-
ties and quality of life for knee OA patients [9]. Previous
studies demonstrated that braces treat knee OA by ex-
tending the condylar separation of the medial compart-
ment [10], thus reducingthe external knee adduction
moment during gait [11-13] and the medial compartment
load at the knee [13,14]. In the clinical setting, many
patients treated with knee bracing complained that the
braces were heavy and complicated to fit, and that long-
term fittings caused skin problems. Recently, lighter and
more comfortable knee braces were developed; however,

The Effects of an Unloading Knee Brace and Insole with Subtalar Strapping for Medial Osteoarthritis of the Knee
Open Access IJCM
7
the effects of these new functional knee braces are not
well known.
The effects of insoles, which are one of the main or-
thoses used to treat knee OA, are also controversial. Ya-
suda and Sasaki first described the function and effects of
the lateral-wedge insole in 1987 [15], and Toda and Tsu-
kimura [16] subsequently reported that lateral-wedge in-
soles with subtalar strapping were more effective than
convention al insoles in alleviating the symptoms of k nee
OA. Lateral-wedge insoles show considerable potential
in the treatment of symptomatic knee OA because they
are safe and generate fewer costs than knee bracing. Fur-
thermore, foot orthoses are easy to apply, and good pa-
tient adherence to this type of intervention has been re-
ported [17,18]. However, recent studies have suggested
that lateral-wedge insoles are not particularly effective
for treating knee OA [19,20].
This 12-month prospective study therefore sought to
clarify the effects of muscle-strengthening exercises, the
unloading knee brace, and insole with subtalar strapping
on medial OA of the knee by assessing clinical function
and gait. We hypothesized that these orthoses could pro-
vide OA patients with relief from knee pain and improve
knee function compared to muscle-strengthening exer-
cises only.
2. Methods
This study was approved by the Epidemiologic Study
Ethics Review Board of Hiroshima University and con-
formed to the Declaration of Helsinki.
Patients
A total of 151 patients who were diagnosed with me-
dial compartment OA of the knee between June 2008 and
December 2009, and who agreed to this study, were en-
rolled. These patients presented with kn ee OA symptoms
including pain and functional disabilities. Medial com-
partment OA of the knee was confirmed by radiography.
Patients were excluded if they had any of the following:
history of lower limb injuries within the last 2 years, a
neuromuscular disorder, history of stroke or cardiovas-
cular disease, or an y other gait abnormalities. Severity of
knee OA was assessed by radiography and rated using
the Kellgren-Lawrence radiographic scoring system (K-L
scores) [21]. Patients assigned a K-L score of grade IIor
higher were selected and informed as to the aim of this
prospective study. Finally, 118 patients with medial com-
partment OA of the knee were enrolled in the study. The
three different treatment methods were described to the
patients, who then selected their treatment and the side to
be evaluated. Accordingly, the patients were divided into
three groups: the exercise, insole, and brace groups. The
exercise group comprised 44 patients who were asked to
perform three sets of 10 quadriceps muscle exercises
every day. The insole group comprised 55 patients who
were advised to wear the lateral-wedge type of insole
with subtalar strapping (Figure 1) for more than 5 hours
every day. This type of insole was designed specifically
for patients with knee OA. The brace group comprised
19 patients who were advised to wear a functional knee
brace for more than 5 hours every day. The functional
knee brace used in this study was the Unloader® One
(Össur, Reykjavik, Iceland; Figure 2), whichwas de-
signed specifically for patients with knee OA and com-
bines a streamlined, flexible upright with a medial hinge
to create two leverage poin ts when opposing forces from
the Dynamic Dual Force Straps, which cross over the
knee, disperse a counter force across two lateral-aspect
points of the knee. The brace is an off-the-shelf patient-
adjustable device composed mainly of nylon, measuring
approximately 367 mm in length, and weighing appro-
ximately 430 g. The brace is also available in three sizes
(XS, S, M).
Figure 1. Lateral view of an insole used in this study, show-
ing the conventional insole with subtalar strapping.
Figure 2. Front view of the functional knee brace, Unloader®
One (Össur, Reykjavik, Iceland).

The Effects of an Unloading Knee Brace and Insole with Subtalar Strapping for Medial Osteoarthritis of the Knee
Open Access IJCM
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Evaluations
Physical evaluations
Clinical findings such as range of motion (ROM), quad -
riceps muscle power, and x-rays with K-L scores were
evaluated as objective findings, especially for the medial
femoro-tibial joints. Original qu estionnaire results, based
on the SF-8 Health Survey (SF-8), Western Ontario and
McMaster Universities Arthritis Index (WOMAC), and
EuroQol 5 demension (EQ-5D) questionnaires, were also
evaluated before treatment and at 3, 6, and 12 months
after treatment. These indices are used generally to assess
patients with osteoarthritis, and can be used to monitor
the course of the disease. SF-8 reflects the state of the
patients over one month, WOMAC reflects a 48-hour
period, and EQ-5D reflects the patient state over 24
hours.
Gait evaluations
In total, 31 patients agreed to undergo gait analysis
evaluation, including 9 patients in the exercise group, 12
in the insole group, and 10 in the brace group. The pa-
tients were examined be fore treatment, then at 6 months
and 12 months after treatment. The patients’ gaits were
analyzed using a three-dimensional motion analysis sys-
tem (VICON612, Vicon Motion Systems Ltd, Oxford,
UK) with seven infrared cameras (Vicon Motion Systems
Ltd, Oxford, UK) operating at 120 Hz. Kinetic data were
captured from the ground reaction forces at 500 Hz with
four force platforms (AMTI, Watertown, MA) embedded
in the rehabilitation room floor and synchronized to the
kinematic data. Passive reflective markers were placed
bilaterally on the anterior and posterior iliac spines, lat-
eral aspects of the thighs, lateral femoral epicondyles,
lateral aspects of the shanks, lateral malleoli, calcanea,
and second metatarsal head s according to a commercially
available kinematic model (Plug-in-Gait, Vicon® Peak,
Oxford, UK). Patients were instructed to walk at a self-
selected velocity along a 10-meter walkway. Patients
walked without orthoses and then with bracing or in-
soles on the more painful side at each evaluation time
point. This was conducted at least three times for each
condition.
Gait data analysis
Marker coordinate data and ground reaction data were
low-pass filtered (Butterworth fourth-order filter, cut-off
frequency 6 Hz) with plug-in software (ButterPlug, Va-
quita Software, Zaragoza, Spain). Knee and hip joint an-
gles and moment data were calculated using a comer-
cially available biomechanical model (Plug-in-Gait, Vi-
con® Peak, Oxford, UK). Joint moment data were ana-
lyzed in the frontal planes in the lower limb. The knee
adduction moment impulse, the timed integral of all the
knee adduction moments, was calculated for stance dura-
tion and the subdivisions of stance duration. Joint mo-
ment data were extracted for statistical analysis and nor-
malized to body mass (Nm/k g). Walking speed, cadence,
step length, and stride length were extracted from the
biomecha nical m ode l out put.
Statistical analysis
Gait data
Data fitting a normal distribution were analyzed by the
paired samples t-test. Data that were not normally dis-
tributed were analyzed for significant differences in the
joint angle and moment b y the Wilcox on signed-r ank test,
using statistical analysis software (SPSS v16.0, SPSS
Japan, Tokyo, Japan). Results were considered to be sig-
nificant when P < 0.05.
Physical data
To determine the independent and combined effects of
normally distributed variables (walking visual analogue
scale (VAS), resting VAS, femoro-tibial angle (FTA),
extension ROM, and flexion ROM), comparisons be-
tween the groups and over time were performed using
two-way ANOVA. When significant effects or interac-
tions were found, one-way ANOVA was followed by the
Bonferroni post-hoc test to identify th e levels off actor(s)
with significant differences in the means of the variables.
These variables are presented as the mean ± standard
error of the mean (SEM).
Group comparisons of these categorical variables and
K-L grades were performed using the Kruskal-Wallis H
test. The Friedman Repeated Measures ANOVA on Ranks
test was used to analyze changes over time within each
group. When statistical significance was achieved, a St e e l-
Dwass post-hoc test was used to further specify the dif-
ference. Results were considered to be significant when
P < 0.05.
3. Results
Patient characteristics
There were no differences in sex, age, height, weight,
or body mass index among the exercise, insole, and brace
groups (Table 1).
X-ray evaluations
There were significantly more patients with Grade II
OA in the exercise and insole groups than in the brace
group. In contrast, there were significantly more patients
Table 1. There were no differences in sex, age, height,
weight, or body mass index among the exercise, insole, and
brace groups.
Exercise Insole Brace
Patients (n) 44 55 19
Male: Female 18:26 25:30 8:11
Age (y) 65 ± 2.1 67 ± 3.4 69 ± 4.2
Height (cm) 152.6 ± 3.2 153.1 ± 2.6 152.6 ± 2.5
Weight (kg) 57.6 ± 1.7 57.5 ± 1.4 60.5 ± 4.4
BMI (Body Mass Index)24.9 ± 1. 5 24.6 ± 1.7 26.2 ± 2.3

The Effects of an Unloading Knee Brace and Insole with Subtalar Strapping for Medial Osteoarthritis of the Knee
Open Access IJCM
9
with Grades III and IV OA in the brace group compared
to the exercise and inso le groups (Figure 3 ). At the fin al
evaluation there was only one progressive case, in the
exercise group.
Clinical analysis
Subjective findings
There were no statistical changes in the results of the
WOMAC, SF-8 and EQ-5D questionnaires completed
before treatment, and at 3 months, 6 months, and 12
months after treatment. The walking VAS scores im-
proved in all three groups. Although the walking VAS
scores of the brace group were significantly higher than
those of the exercise group before treatment commenced
(P < 0.05), the significant difference among these three
groups disappeared after treatment (Figure 4).
Figure 3. Kellgren-Lawrence classification for patients in
each of the three groups. There were significantly more
patients with Grade II OA in the exercise and insole groups
than in the brace group. In contrast, there were signifi-
cantly more patients with Grades III and IV OA in the
brace group compared to the exercise and insole groups.
Figure 4. The walking VAS score. The graph shows a de-
crease in VAS scores during walking in each group. Al-
though the walking VAS scores of the brace group were
significantly higher than those of the exercise group before
treatment commenced (P < 0.05), there was no significant
difference in VAS scores among the three groups after
treatment.
Objective findings
Gait length and ability to walk up and down stairs im-
proved in all three groups, with the greatest improvement
seen in the brace group. Patients in the brace groups
showed improved knee extension angles, but signifi-
cantly worse extension disturbance, than those in the
exercise and insole groups at each of the follow-up times
(P < 0.05) (Figure 5). Although the FTA of the brace
group was larger than that of the exercise group at all
times, the FTA of the three groups did not significantly
change at any time.
Drop out cases
A total of 24 patients dropped out of this study, in-
cluding 10 cases (22.7%) in the exercise group, 13 cases
(23.6%) in the insole group, and one case (5.3%) in the
brace group.
Gait analysis
The varus moment did not significantly improve in
any of the three groups over the 12 months. However, th e
changes in the ratios of the varus moment before and
after the orthoses were worn show the difference be-
tween the brace and insole. Initially, the knee varus mo-
ment decreased by 9.5% when the insole was worn, but
at 6 months and 12 months the knee varus moment only
decreased by 0.5% and 0.7%, respectively. In contrast,
the varus moment of the knee decreased 5.5% when the
brace was initially fitted. This decreased ratio was main-
tained during t he 12 m ont hs (Figure 6).
The walking speed did not significantly improve in
any of the three groups either. However, the changes in
the ratios of the gait speed before and after the orthoses
were worn show the difference between the brace and
insole. At the start, the gait speed increased 12.3% when
wearing the insole, but at 6 months and 12 months, the
gait speed did not increase when the insole was worn. On
Figure 5. Knee extension angle. The graph shows that while
the patients in the brace group had significantly worse ex-
tension disturbance than those in the exercise and insole
groups at each of the follow-up times, the extension angle in
the brace group was gradually improved.

The Effects of an Unloading Knee Brace and Insole with Subtalar Strapping for Medial Osteoarthritis of the Knee
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Figure 6. Knee varus moment for the three groups over 12
months. The bar graph comparing the knee varus moment
during free gait shows no significant improvements in any
of the three groups over the 12 months. The line traces at
the top represents the changes in ratios before and after the
orthoses were worn. The varus moment decreased by 9.5%
when the insole was worn, but at 6 months and 12 months
the knee varus moment had only decreased furthe r by 0.5%
and 0.7%, respectively. The varus moment decreased by
5.5% when the brace was initially fitted, and this decreased
ratio was maintained during the 12 months.
the other hand, the gait speed initially increased by
16.4% when the brace was fitted, and the gait speed at 6
months and 12 months was much higher than seen at the
start of the study (Figure 7).
4. Discussion
There have been several recent reports about knee or-
thoses. However, to our knowledge, this is the first pro-
spective study describing the effects of a functional brace,
a type of insole, and muscle-strengthening exercises on
the osteoarthritic knee joint. The patients in the exercise
group had significantly lo wer grade OA than thos e in the
brace group. Patients in the exercise group demonstrated
improved gait ability and decreased resting pain after
performing quadriceps exercises for one year. The insole
group included many patients with low and middle-grade
OA, and following treatment the patients demonstrated
an improved ROM and ability to climb up and down
stairs. The patients in the brace group mainly had sign ifi-
cantly severe OA, yet treatment still improved their wal k-
ing VAS, ability to climb up and down stairs, and ROM.
These results demonstrate that conservative treatments
for medial knee OA, such as muscle-strengthening exer-
cises, the insole, and knee brace, effectively improved
gait ability and decreased resting and walking pain when
applied to patients according to their OA grades. This
study shows that the symptoms in patients with severe
OA also improved after treatment with the valgus brace.
Figure 7. Gait speed for the three groups over 12 months.
The bar graph comparing the gait speed during free gait
shows no significant improvements in any of the three
groups over the 12 months. The line traces at the top repre-
sent the changes in ratios before and after the orthoses were
worn. The gait speed increased 12.3% when wearing the
insole, but at 6 months and 12 months, no further increase
was achieved. The gait speed initially increased by 16.4%
when the brace was fitted, and continued to increase at 6
months and 12 months.
The evidence presented in previous studies regarding
whether foot orthoses or knee braces improved pain and
function in patients with medial knee OA has been con-
troversial [15,22,23]. Lateral-wedge insoles that did not
cover the subtalar joint were used in many of these pre-
vious studies. Toda et al. [16,17] reported that the new
type of insole was more effective than the old ones. They
demonstrated that the new insole changed the FTA in
medial knee OA patients and used weight-bearing radio-
graphs to show how the new inso le corrected the FTA by
3 degrees. Furthermore, Kuroyanagi et al. [23] reported
that the new type of insole was more effective at reduc-
ing pain than the conventional insole during gait, as
measured by the gait analysis method. They also reported
that no significant difference was detected between the
new type of insole and the conventional insole when
worn by patients with severe OA (K-L Grade 4). The
results from these previous reports and the current study
indicate that this type of insole would be effective for
patients with Grade II or III OA. In contrast, the brace
group consisted of patients with Grade III or IV OA, the
walking VAS, extension lag, ability to climb up and
down stairs, and ROM improved with treatment. These
results indicated that the functional knee brace effec-
tively relieved pain and improved knee motion function
and gait ability in patients with severe OA.
The dropout rate in this study was not satisfactory,
with over 20% of patients in the insole and exercise
groups not continuing. This indicated that motivation to

The Effects of an Unloading Knee Brace and Insole with Subtalar Strapping for Medial Osteoarthritis of the Knee
Open Access IJCM
11
continue exercising must be maintained and patient com-
pliance with wearing the new type of insole must be im-
proved. In contrast, there was only one dropout case in
the brace group, which could reflect several improve-
ments in this functional knee brace that reduced the
weight by approximately 50% compared to a conven-
tional functional knee brace, and made it easier to wear.
Gait analysis was evaluated for each patient before
treatment and at 3 months, 6 months and 12 months after
treatment. The results revealed that the effects of the in-
sole gradually decreased; however, the effects of the
brace increased. These results showed that patients be-
came used to the fit of the brace and learned to walk
wearing the brace over time, whereas the effects of the
insole were not maintained. We recommend that the in-
sole should be exchanged every three months, but the
functional brace can be worn for more than one year.
There were some limitations associated with this study.
Firstly, this study was prospective in nature, rather than
being a randomized control study. Secondly, patients each
chose their own treatment. The exercise group was com-
posed of K-L Grade II patients and the brace group com-
prised K-L Grade III or IV patients. Finally, the exercise
group is not a true control group, and it remains difficult
to compare non-treatment patients in such studies to
those receiving treatment. However, in this current study
we could conclude that the orthotic treatments were more
effective at treating medial compartment OA of the knee
when the treatment procedures were selected according
to the OA grade.
5. Acknowledgements
This paper was supported by the following grants: JOA-
Subsidized Science Project Research 2007-3 and Com-
prehensive Research on Aging and Health from th e Healt h
and Labor Sciences Research Grants.
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