A Randomized Controlled Trial of Two Types of In-Shoe Orthoses in Children with Flexible Excess Pronation of the Feet

Abstract

Orthoses for children with flexible excess pronation are estimated to cost Australian parents millions of dollars per year; however, there is no high-level evidence that orthoses improve function or reduce pain.
A randomized parallel, single-blinded, controlled trial of custom-made and ready-made orthoses was conducted in children between the ages of 7 and 11 years with bilateral flexible excess pronation. The diagnosis was based on calcaneal eversion and navicular drop. Outcomes included gross motor proficiency, self-perception, exercise efficiency, and pain. Measurements were taken at baseline, and at 3 and 12 months. Of the 178 children who participated at baseline, 160 continued to the end of the trial.
After randomization, baseline characteristics were similar between the three treatment groups (custom-made, ready-made, and control). Statistical modeling demonstrated that although for most outcome measures there were statistically significant trends over time, none of the group comparisons were statistically significant. A sub-group analysis of those presenting with pain found no significant differences at 3 or 12 months.
This study found no evidence to justify the use of in-shoe orthoses in the management of flexible excess foot pronation in children.

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Foot & Ankle International
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The online version of this article can be found at:
DOI: 10.3113/FAI.2007.0715
2007 28: 715Foot Ankle Int
Deirdre Whitford and Adrian Esterman
Pronation of the Feet
A Randomized Controlled Trial of Two Types of In-Shoe Orthoses in Children with Flexible Excess
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FOOT &ANKLE INTERNATIONAL
Copyright © 2007 by the American Orthopaedic Foot & Ankle Society, Inc.
DOI: 10.3113/FAI.2007.0715
A Randomized Controlled Trial of Two Types of In-Shoe Orthoses in Children
with Flexible Excess Pronation of the Feet
Deirdre Whitford, Ph.D.; Adrian Esterman, Ph.D.
Whyalla Norrie, Australia
ABSTRACT
Background: Orthoses for children with flexible excess prona-
tion are estimated to cost Australian parents millions of dollars
per year; however, there is no high-level evidence that orthoses
improve function or reduce pain. Methods: A randomized
parallel, single-blinded, controlled trial of custom-made and
ready-made orthoses was conducted in children between the
ages of 7 and 11 years with bilateral flexible excess prona-
tion. The diagnosis was based on calcaneal eversion and navic-
ular drop. Outcomes included gross motor proficiency, self-
perception, exercise efficiency, and pain. Measurements were
taken at baseline, and at 3 and 12 months. Of the 178 chil-
dren who participated at baseline, 160 continued to the end of
the trial. Results: After randomization, baseline characteristics
were similar between the three treatment groups (custom-made,
ready-made, and control). Statistical modeling demonstrated
that although for most outcome measures there were statistically
significant trends over time, none of the group comparisons were
statistically significant. A sub-group analysis of those presenting
with pain found no significant differences at 3 or 12 months.
Conclusions: This study found no evidence to justify the use
of in-shoe orthoses in the management of flexible excess foot
pronation in children.
Key Words: Children; Orthoses; Pronation; RCT
INTRODUCTION
The use of in-shoe orthoses designed to control excess
pronation in children with flexible pronated feet has been
a matter for debate.
4,12,7
The central issue is whether
excess pronation in a flexible foot causes failure of the
Deirdre Whitford, Ph.D.
University of South Australia
Spencer Gulf Rural Health School
Whyalla Norrie
Nicolson Avenue
South Australia 5608
Australia
E-mail: dee.whitford@unisa.edu.au
For information on prices and availability of reprints, call 410-494-4994 X226
normal biomechanics of the lower limb in gait leading
to pain and dysfunction.
1,7,27
This uncertainty has led to
variation in the clinical management of children with this foot
type. Management strategies include: (a) no intervention;
(b) intervention for all children; or (c) intervention only in
the case of pain. The efficacy of these strategies has not been
demonstrated in clinical trials.
6,24
The flexible pronated foot is characterized in weight-
bearing by eversion of the calcaneus, and commonly, a
lowered medial longitudinal arch.
7
It often is associated with
abduction of the forefoot in the transverse plane and tight-
ening of the calcaneal tendon.
7,9
In nonweightbearing, the
arch appears normal.
7,4
In gait these children are thought to
have an apropulsive (lacking push-off) and inefficient gait
because of failure to resupinate the foot and externally rotate
the tibia during both swing and mid to late stance phases.
7
Two types of in-shoe orthoses are commonly used to
control excess pronation in weightbearing:
2
(1) prescribed
custom–made orthoses; and (2) over-the-counter ready-made
orthoses. A pair of prescribed custom-made orthoses can cost
up to 10 times more than an over-the-counter ready-made
pair. An industry has evolved around the supply of each type
of orthosis in the absence of evidence that pronation causes
disability in children.
32
The purpose of this trial was to demonstrate and compare
the effect of these two types of in-shoe orthoses on gross
motor skills, self-perception, exercise efficiency, and pain
compared with no intervention.
MATERIALS AND METHODS
Recruitment
Contact information broadcast through print, television,
radio, school newsletters, and hospital clinic pamphlets led
interested parents to bring their children for screening to
participate in the trial. Parents of 672 children responded to
information about the trial. Two hundred and fifty-two chil-
dren were excluded on initial telephone screening. The prin-
cipal reasons were previous orthotic therapy, chromosomal
715
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716 WHITFORD AND ESTERMAN Foot & Ankle International/Vol. 28, No. 6/June 2007
abnormalities, and medical pathology. Podiatrists screened
the remaining 420 children for excess pronation and other
exclusion criteria. Two hundred and forty-two children were
rejected for the trial, almost all of them for not meeting the
excess pronation criteria. The remaining 178 were eligible
and participated in the trial (Figure 1). Eleven children
dropped out of the trial between baseline and 3 months (four
in the custom-made group; three in the ready-made group;
four in the control group). A further seven children dropped
out of the trial between 3 and 12 months (three in the custom-
made group; two in the ready-made group; two in the control
group). The principal reasons for dropping out were parental
participation burden and loss of contact. Reasons for drop-
ping out in each group were similar. Compliance with the
treatment protocol was reported as nearly 100% and was
similar between groups.
Inclusion Criteria
Children between the ages of 7 and 11 years with bilateral
flexible excess pronation measured as calcaneal eversion
of 5 degrees or more in resting calcaneal stance position
(RCSP - the subject standing in a resting stance position
in their preferred angle and base of gait i.e. their preferred
standing position),
31
and navicular drop of 10 mm or more.
21
Calcaneal eversion (eversion of the calcaneus in the frontal
plane) was measured (Figure 2) as the angle between the
bisector of the posterior surface of the calcaneus and the
bisector of the posterior surface of the lower leg in RCSP.
18
Navicular drop was measured (Figure 3) as the difference
between (1) the distance from the navicular tuberosity to the
floor in neutral calcaneal stance position (NCSP- same angle
and base of gait as RCSP; but with the talonavicular joint
surfaces maximally juxtaposed); and (2) the distance from
the navicular tuberosity to the floor in RCSP.
18,21,26
These
measures are used in clinical podiatric practice.
21,26
Fig. 1: Trial flow chart.
Exclusion Criteria
Children were excluded from the trial if they had unilat-
eral flexible excess pronation, a history of lower limb
surgery, prior or recent orthotic therapy, any serious medical
pathology such as cancer, any known neuromuscular, motor
coordination, intellectual or learning difficulty, or any chro-
mosomal abnormality.
Trial Design
The trial was a randomized, parallel, single-blinded,
controlled trial consisting of three treatment groups: (1) cus-
tom-made orthoses; (2) ready-made orthoses; and (3) no
treatment. Potential trial subjects were first screened by trial
staff for any exclusion criteria, and then examined by a podi-
atrist to ensure that they met the trial eligibility criteria.
Eligible subjects were then randomized to one of the three
treatment groups. Measurements were taken at baseline, and
at 3 months and 12 months after randomization (Figure 1).
Randomization
Randomization was undertaken using computer generated
lists of equally sized groups.
Intervention
Children assigned to the custom-made orthoses group were
given a biomechanical examination by a podiatrist who then
created right and left Plaster of Paris slipper casts using
the method described by Michaud.
18
These were sent to an
orthotics manufacturing laboratory along with a prescription
form where positive casts were made from the slipper casts.
The final molded thermoplastic orthoses were rigid and the
upper surface covered with vinyl for comfort (Figure 4).
Fig. 2: Calcaneal eversion is measured as the angle between the bisector
of the posterior surface of the calcaneus and a vertical line in the relaxed
calcaneal stance position: preferred foot angle and stance base.
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Foot & Ankle International/Vol. 28, No. 6/June 2007 IN-SHOE ORTHOSES IN CHILDREN 717
B
A
C
A
Fig. 3: Navicular drop is measured as the difference between vertical distances from navicular tuberosity to the supporting surface in neutral calcaneal stance
and relaxed calcaneal stance positions.
Fig. 4: Prescribed orthoses were custom-made in an orthotics laboratory
according to subject specific biomechanical examination data.
Fig. 5: Prefabricated, ready-made orthoses were procured according to the
patient’s shoe size.
Children assigned to the ready-made orthoses group
were given heat-moldable thermoplastic orthoses (Australian
Orthotics Laboratory - Vasyli, Broadbeach, QLD, Australia)
of a less rigid nature than the custom–made ones (Figure 5).
The orthoses had standard intrinsic heel postings of 4 degrees
and a 5-mm metatarsal rise. They were fitted to the child’s
shoes, removed, and heated with a heat gun and replaced into
the child’s shoes. The child then stood in the shoes while the
softened orthoses molded to the child’s feet during cooling.
All children with tight calves, irrespective of group, were
taught calf muscle stretches to be carried out twice a day,
and all parents were instructed about suitable shoes.
Blinding
As in-shoe orthoses are concealed within the child’s
shoes when worn, raters of outcome measures were blinded
to the orthotic status of the child. Prescribing podiatrists,
participants, and parents were not blinded. All data were
de-identified before analysis.
Primary outcome measures
Primary outcomes were
1. Motor proficiency was measured using the Bruininks
Oseretsky Test.
29,38
This consisted of four sub-scales:
running speed and agility (scale 1 to 15); balance (scale
0 to 32); bilateral coordination (scale 0 to 20); and
strength (scale 0 to 42). For all sub-scales, a higher
score represented better performance.
2. Pain was measured using the visual analogue scale
(VAS) for current pain of the Child Form of the Varni
Thompson Pediatric Pain Questionnaire.
36
3. Exercise efficiency was measured as maximal oxygen
uptake (VO
2
max) predicted using the multi-stage 20-
m Shuttle Run Test.
13,14,23,28
The Shuttle Run Test is
suitable for use with children
35
and has good validity
when compared with other measures.
25
The number
of runs that each child completed was recorded and
converted using a published formula into VO
2
max.
14
For VO
2
max, a higher score reflects greater exercise
efficiency. The normal range for VO
2
max is age
dependent.
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718 WHITFORD AND ESTERMAN Foot & Ankle International/Vol. 28, No. 6/June 2007
4. It has been suggested that orthotics may be embar-
rassing for children.
33
Self perception was measured
using the Self Perception Profile for Children
(SPPC).
17,34
The six sub-scales of the SPPC were:
scholastic competence; social acceptance; behavioral
conduct; physical appearance; athletic competence; and
global self worth. All SPPC sub-scales were measured
from one-four, a higher score indicated higher self-
perception.
Other Variables
Body Mass Index (BMI) (weight (Kg
2
)/height (m)),
33
ligamentous laxity,
8
and tight calf muscles,
9,7
were included
as potential confounding variables for outcome measures.
Additional data regarding compliance were gathered at the
end the of trial.
Ligamentous laxity
This was measured using the Beighton Scale,
19
in which
nine movements were examined to determine whether the
child was able to reach a given end point. If the end point was
achieved, the movement was given a score of one indicating
excessive range, if not it was given a score of zero. A score of
five or more out of a possible nine was considered indicative
of generalized joint laxity.
5
Tight calf muscles
Therapists measured right and left ankle dorsiflexion
ranges, with the foot held in subtalar neutral position, in
knee flexion and knee extension. A child was considered
to have tight gastrocnemeus muscles if they measured less
than 10 degrees dorsiflexion in knee extension, and tight
soleus muscles if they measured less than 15 degrees ankle
dorsiflexion in knee flexion. For analysis, a child was defined
as having tight calves if either one or both groups were
measured as tight on either side.
Sub-group Analysis
Because lower limb pain often is used as the critical
criterion for provision of in-shoe orthoses to control excess
pronation,
24
a sub-group analysis was carried out for children
who reported lower limb pain at baseline.
Statistical considerations
Sample size
As no similar randomized controlled trials (RCTs) of
children with excessive pronation have been published using
similar outcome measures, the baseline performance data of
the first 20 children to participate in the trial were used to
calculate the required sample size. With 80% power and an
acceptable type I e rror rate of 5% and based on independent
samples two-sided t-tests, sample sizes needed in each group
based on a 15% improvement in mean score ranged from 11
for running speed and agility to 53 for athletic competence.
Therefore, recruitment was aimed at 60 per group to allow
for a drop-out rate per group of just over 10%.
Analysis
Analyses were undertaken using SPSS 13 for Windows
(SPSS, Inc. Chicago, IL, USA) and Stata 9 (Strata-
Corp, College Station, TX, USA). All continuous outcome
measures were acceptably normally distributed except pain.
For this latter variable, most subjects reported no pain at
baseline, with the remainder having a highly skewed distri-
bution. Inter-rater reliability of navicular drop between two
podiatrists was assessed by intra-class correlation coeffi-
cient using a mixed effects two-way model. For all outcome
measures other than pain, multilevel mixed-effects linear
regression with maximum restricted likelihood was used to
model the relationship between the outcome measure and
time, group comparisons, group-time interaction, BMI, liga-
mentous laxity and tightness of calves. For the VAS pain
score, due to its unusual distribution, this outcome measure
was dichotomized and a log binomial generalized linear
model allowing for clustering by subject undertaken.
RESULTS
Tables 1 and 2 show anthropometric and potentially
confounding variables at baseline by trial group. Inter-rater
reliability for navicular drop was assessed by intraclass corre-
lation coefficient (ICC) for two podiatrists on 19 participants
for the left and right foot separately. For the left foot, the ICC
was 0.403 (
p = 0.043), and for the right foot the ICC was
0.502 (
p = 0.014). Calcaneal eversion and navicular drop
were themselves not highly correlated for either left foot
(
r =−0.38) or right foot (r =−0.21) feet for the children
in our trial.
Tables 3 and 4 show the outcome measures for each
group at each time point. Inspection of these tables shows
time trends for many outcome measures but few differ-
ences between treatment groups. In none of the regression
models attempted was the interaction between type and group
contrast statistically significant. Further, adding BMI, liga-
mentous laxity, or tight calves to the models had little effect
on the group contrast coefficients. The results of the final
regression models are shown in Table 5. Notably, statis-
tically significant time trends were found for all but three
outcome measures, and none of the group comparisons were
statistically significant.
None of the outcome measures appeared to be related
to severity of excess pronation as measured by calcaneal
eversion or navicular drop. Both the Bruininks Oseretsky
Test of Motor Proficiency
38
and the Self Perception Profile
for Children
34
reported results for “normal” children. There
were no significant differences between these reported results
and the mean performance of the children in our trial matched
for age and gender.
Because pain reduction often is stated as an aim in the
provision of in-shoe orthoses to control excess pronation,
12
a
sub-group analysis was carried out for children who reported
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Foot & Ankle International/Vol. 28, No. 6/June 2007 IN-SHOE ORTHOSES IN CHILDREN 719
Table 1: Gender, ligamentous laxity and tight calves (%) by trial group.
Variable
Control
(N = 60)
Ready-made
(N = 59)
Custom-made
(N = 59)
Total
(N = 178)
Male 56.7 52.5 50.8 53.4
Female 43.4 47.5 49.1 46.6
Total 100.0 100.0 100.0 100.0
Ligamentous laxity 30.6 26.2 17.0 24.6
No ligamentous laxity 69.4 73.8 83.0 75.4
Total 100.0 100.0 100.0 100.0
Tight calves 78.3 78.0 83.1 79.8
No tight calves 21.7 22.0 16.9 20.2
Total 100.0 100.0 100.0 100.0
Table 2: Anthropometric and other variables by trial group — mean (SD)
Variable
Control
(N = 60)
Ready-made
(N = 59)
Custom-made
(N = 59)
Total
(N = 178)
Age (years) 9.49 (1.41) 9.78 (1.31) 9.45 (1.45) 9.57 (1.39)
Height (cm) 139.19 (10.49) 138.76 (9.88) 137.79 (10.38) 138.58 (10.20)
Weight (kg) 36.37 (10.38) 35.71 (11.19) 34.26 (9.81) 35.43 (10.44)
BMI (kg/cm
2
) 18.51 (3.37) 18.13 (3.42) 17.64 (3.14) 18.09 (3.31)
Calcaneal eversion—left foot (degrees)
−7.20 (1.96) −7.36 (2.50) −7.92 (2.15) −7.49 (2.23)
Calcaneal eversion—right foot (degrees)
−6.37 (1.69) −6.63 (1.68) −6.64 (1.83) −6.54 (1.73)
Navicular drop— left foot (mm) 14.00 (3.19) 14.64 (3.93) 14.36 (4.12) 14.33 (3.75)
Navicular drop— right foot (mm) 14.68 (4.13) 15.36 (3.88) 14.44 (3.94) 14.83 (3.98)
BMI, body mass index.
pain at baseline. Results for children with pain at baseline
were the same as for the trial population as a whole.
DISCUSSION
There is a lack of consensus in the literature about the
relevance of measures of static excess pronation to dynamic
function
11
and, therefore, as criteria for orthotic therapy.
Further, the measures of pronation currently used in podiatric
clinical practice have been shown to have poor reliability
as demonstrated in this trial. Notably, we found that the
two measures of excess pronation commonly used were only
weakly correlated, which makes their interpretation difficult.
The poor validity and reliability of diagnostic measures of
pronation might have contributed to the lack of effectiveness
seen in this study.
When comparing the custom-made orthoses group and
the ready made orthoses group with the control group, we
found no statistically significant differences in any of the
outcomes measured. However, some of these variables did
change significantly over time in a similar manner in all three
groups. The changes seen were small and not of clinical
importance.
The trial participants performed, on average, as well,
if not better, on all subscales of the Bruininks-Oseretsy
Test of Motor Proficiency (BOTOMP) and Self-Perception
Profile for Children (SPPC) as normal children according
to the normative data provided with the measurement tools.
While this suggests that these children do not require
any intervention to improve function or self-perception the
normative data was for American children and no normative
data was available for Australian children.
The presence of pain is reportedly used as an intervention
criterion by some clinicians. A sub-group analysis of the
children who presented at baseline with pain found no
evidence for the effectiveness of orthoses for pain relief.
There is considerable variability in the effects measured
and the direction of change reported in published studies
of in-shoe orthotic therapy. Some effects measured include
pronation in walking,
16
rear foot mechanics,
2
oxygen con-
sumption,
3,10
tibial rotation,
22
stress fractures,
30
and ground
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720 WHITFORD AND ESTERMAN Foot & Ankle International/Vol. 28, No. 6/June 2007
Table 3: Outcome measures excluding pain by trial group— mean (SD)
Outcome measure Baseline 3 months 12 months
Control
(N
= 60)
Ready-made
(N = 59)
Custom-made
(N = 59)
Control
(N = 55)
Ready-made
(N = 56)
Custom-made
(N = 56)
Control
(N = 52)
Ready-made
(N = 54)
Custom-made
(N = 54)
Motor skills
Running speed 12.32 (1.77) 12.63 (1.70) 12.10 (1.81) 12.29 (1.63) 12.66 (1.72) 12.02 (1.76) 12.59 (1.84) 12.93 (1.64) 12.37 (1.75)
Balance 22.80 (4.68) 23.25 (4.51) 22.24 (5.12) 23.04 (4.76) 24.63 (4.22) 22.73 (4.59) 24.37 (4.43) 25.44 (3.55) 24.13 (4.57)
Bilateral coordination 11.80 (3.00) 11.53 (2.78) 11.25 (3.50) 13.04 (3.15) 13.33 (3.20) 12.23 (3.42) 14.33 (2.56) 14.17 (3.22) 13.63 (3.36)
Strength 19.03 (4.58) 18.97 (4.89) 17.64 (5.10) 20.55 (4.29) 20.39 (4.89) 19.43 (4.79) 21.04 (5.45) 21.59 (4.55) 20.94 (5.46)
Exercise efficiency
VO2Max 45.59 (3.31) 45.73 (3.92) 45.72 (2.68) 46.03 (3.71) 46.14 (4.29) 45.79 (2.79) 44.95 (3.81) 45.10 (4.88) 44.81 (3.19)
Self-perception
Scholastic competence 2.98 (0.62) 2.96 (0.60) 3.05 (0.65) 3.08 (0.65) 3.12 (0.55) 3.15 (0.63) 3.02 (0.71) 3.19 (0.60) 3.14 (0.67)
Social acceptance 2.93 (0.80) 2.96 (0.70) 2.94 (0.77) 3.20 (0.65) 3.06 (0.66) 2.98 (0.74) 3.10 (0.74) 3.14 (0.61) 3.16 (0.73)
Athletic competence 2.95 (0.68) 2.94 (0.73) 2.92 (0.77) 3.14 (0.65) 3.04 (0.73) 3.15 (0.58) 3.20 (0.54) 3.07 (0.67) 3.09 (0.72)
Physical appearance 2.97 (0.81) 3.10 (0.65) 3.07 (0.78) 3.06 (0.82) 3.23 (0.66) 2.98 (0.75) 3.05 (0.73) 3.19 (0.70) 3.07 (0.76)
Behavioral conduct 3.01 (0.68) 3.19 (0.58) 3.12 (0.70) 3.07 (0.76) 3.23 (0.59) 3.12 (0.69) 3.07 (0.72) 3.22 (0.58) 3.04 (0.65)
VO2Max, maximal oxygen uptake.
Table 4: Presence of pain
Outcome measure Baseline 3 months 12 months
Control
(N
= 60)
Ready-made
(N = 59)
Custom-made
(N = 59)
Control
(N = 55)
Ready-made
(N = 56)
Custom-made
(N = 56)
Control
(N = 52)
Ready-made
(N = 54)
Custom-made
(N = 54)
Pain from VAS (%)
Yes 10.0 18.6 20.3 20.0 19.3 16.1 22.0 25.9 32.7
No 90.0 81.4 79.7 80.0 80.7 83.9 78.0 74.1 67.3
Total 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
VAS, visual analog scale.
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Foot & Ankle International/Vol. 28, No. 6/June 2007 IN-SHOE ORTHOSES IN CHILDREN 721
Table 5: Results of mixed models and generalized linear model regressions
Outcome measure Time Ready-made vs Control Custom-made vs Control
B
∗
95%CI (B) Sig. B 95%CI (B) Sig. B 95%CI (B) Sig.
Motor skills
Running speed 0.134 0.043–0.225 0.004 0.315
−0.264–0.895 0.286 −0.235 −0.815–0.345 0.427
Balance 0.929 0.623–1.235
<0.001 1.185 −0.216–2.585 0.097 −0.283 −1.686–1.120 0.693
Bilateral coordination 1.234 1.069–1.400
<0.001 0.012 −1.029–1.053 0.982 −0.657 −1.698–0.385 0.217
Strength 1.308 1.003–1.613
<0.001 −0.072 −1.664–1.521 0.930 −1.092 −2.685–0.501 0.179
Self-perception
Scholastic competence 0.053 0.011–0.095 0.014 0.030
−0.171–0.233 0.765 0.080 −0.122–0.283 0.437
Social acceptance 0.090 0.039–0.141 0.001
−0.013 −0.238–0.213 0.913 −0.028 −0.254–0.198 0.808
Athletic competence 0.080 0.027–0.133 0.003
−0.138 −0.354–0.079 0.213 −0.078 −0.295–0.138 0.478
Physical appearance 0.019
−0.031–0.069 0.451 0.145 −0.094–0.384 0.233 0.025 −0.215–0.264 0.841
Behavioral conduct
−0.001 −0.049–0.047 0.968 0.170 −0.033–0.373 0.100 0.037 −0.166–0.240 0.722
Global self-worth 0.041
−0.023–0.105 0.212 0.052 −0.120–0.225 0.550 −0.002 −0.175–0.171 0.981
Exercise efficiency
VO2Max
−0.358 −0.567–−0.149 0.001 0.077 −1.113–1.267 0.899 0.014 −1.181–1.210 0.981
VAS Pain
∗∗
Presence of pain −0.065 −0.112–−0.018 0.0072 −0.056 −0.191–0.044 0.348 −0.073 −0.191–0.044 0.221
∗
Regression coefficient.
∗∗
Log binomial generalized linear model.
VO2Max, maximal oxygen uptake; VAS, visual analog scale; CI confidence interval.
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722 WHITFORD AND ESTERMAN Foot & Ankle International/Vol. 28, No. 6/June 2007
reaction forces.
20
Wenger et al.
37
demonstrated that shoe
inserts did not change the bony architecture of the foot in
children between the ages of 1 and 6 years. Most previous
studies, however, had been carried out on skeletally mature
subjects, had a design unable to provide high-level evidence,
or lacked statistical power. There was little standardization
of inclusion criteria, types of orthotic interventions, and
measurement of outcomes.
Since prescribed orthoses are expensive and replaced regu-
larly as the child grows, this therapy may represent a substan-
tial financial burden to families with young children. The
use of ready-made orthoses would reduce costs, but to date
there has been little evidence comparing the effectiveness
of these two types of orthoses.
2
Our trial demonstrated that
there was little difference between the two types of orthoses
with respect to the outcomes measured.
The trial was single-blinded in that both the child and their
parents knew which intervention the child received. Given
the nature of the intervention, we thought that it was not
possible to provide a realistic placebo for the control group
that of itself would not affect foot function.
The natural history of flexible excess pronation is un-
known, and although our trial examined the efficacy of
orthoses at 3 a nd 12 months, in 7 to 11 year old chil-
dren, it could be that any dysfunction as a result of excess
pronation might occur at a later age or that the treatment
effect of orthoses might occur over a longer time period.
However, in this study, no relationship was demonstrated
between the severity of the pronation in the children in
weightbearing and their capacity to run, be agile, balance,
or coordinate their bodies; their perception of themselves;
or the pain they reported. While there was sufficient power
in the trial to demonstrate a short or medium-term effect
of in-shoe orthoses on the outcomes measured, no differ-
ences were found between treatment groups over this time
period. There appears to be little justification for the use
of in-shoe orthoses in children of this age with this condi-
tion.
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