Journal Pre-proof

Immediate effects of foot orthoses on lower limb biomechanics, pain, and

confidence in individuals with patellofemoral osteoarthritis

Jade M. Tan, Kane J. Middleton, Harvi F. Hart, Hylton B. Menz, Kay

M. Crossley, Shannon E. Munteanu, Natalie J. Collins

PII: S0966-6362(19)30373-X
DOI: https://doi.org/10.1016/j.gaitpost.2019.10.019
Reference: GAIPOS 7358

To appear in: Gait & Posture

Received Date: 2 April 2019

Revised Date: 2 October 2019
Accepted Date: 12 October 2019

Please cite this article as: Tan JM, Middleton KJ, Hart HF, Menz HB, Crossley KM, Munteanu
SE, Collins NJ, Immediate effects of foot orthoses on lower limb biomechanics, pain, and
confidence in individuals with patellofemoral osteoarthritis, Gait and amp; Posture (2019),
doi: https://doi.org/10.1016/j.gaitpost.2019.10.019

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© 2019 Published by Elsevier.

Immediate effects of foot orthoses on lower limb biomechanics, pain,

and confidence in individuals with patellofemoral osteoarthritis

Authors: Jade M. Tan1,2, Kane J. Middleton2,3, Harvi F. Hart2,4, Hylton B. Menz1,2, Kay M. Crossley,2,

Shannon E. Munteanu1,2, and Natalie J. Collins2,5.

1. Discipline of Podiatry, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe

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University, Melbourne, Australia, 3086.

2. La Trobe Sport and Exercise Medicine Research Centre, La Trobe University, Melbourne, Australia, 3086.

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3. Discipline of Sport and Exercise Science, School of Allied Health, Human Services and Sport, College of Science, Health and

Engineering, La Trobe University, Melbourne, Australia, 3086.

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Department of Physical Therapy, Faculty of Health Sciences, Collaborative Training Program in Musculoskeletal Health

Research, and Bone and Joint Institute, The University of Western Ontario, London, Canada, N6A 3K7

5. School of Health and Rehabilitation Sciences, Faculty of Health and Behavioural Sciences, The University of Queensland,
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Brisbane, Australia, 4072.
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Corresponding author: Jade M. Tan

jade.tan@latrobe.edu.au
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Highlights
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 Foot orthoses cause instant changes to ankle biomechanics in people with PFOA.
 No biomechanical difference between flat inserts (sham) and shoes, indicating a good sham
device.
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 Foot orthoses do not alter knee pain or confidence immediately in people with PFOA.
Abstract

Background

Foot orthoses are a recommended treatment for patellofemoral (PF) pain and a number of lower limb

osteoarthritis (OA) conditions. However, their mechanism of effect is poorly understood.

Research question

To compare the immediate effects of foot orthoses and flat inserts on lower limb biomechanics, knee

pain and confidence in individuals with PFOA.

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Methods

Twenty-one participants (14 females; mean ± SD age 58 ± 8 years) with PFOA underwent three-

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dimensional motion analysis during level-walking, stair ascent and stair descent under three footwear

conditions: (i) their own shoes; (ii) prefabricated foot orthoses; and (iii) flat shoe inserts. Participants
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reported their average levels of knee pain and confidence after each task. Data were analysed with

repeated-measures analysis of variance (ANOVA), effect sizes (partial eta squared), and Bonferroni
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post-hoc tests.
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Results

During level-walking, there was a significant main effect of foot orthoses on peak ankle dorsiflexion
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angle (F2=0.773, p<0.001, ƞ2=0.773) and peak ankle external dorsiflexion moment (F2=0.356,

p=0.046, ƞ2=0.356). Foot orthoses decreased the peak ankle dorsiflexion angle compared to the flat

insert and shoe conditions, and decreased the peak ankle external dorsiflexion moment relative to flat
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inserts. During stair descent, there was a significant main effect of foot orthoses on peak ankle
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external dorsiflexion moment (F2=0.823, p=0.006, ƞ2=0.738), with a trend towards lower peak

dorsiflexion moment for foot orthoses compared to the flat insert and shoe conditions. No significant

main effects were observed during stair ascent. No other lower limb biomechanical changes were

observed across all three conditions. Knee pain and confidence scores were not significantly different

across the three conditions.

Significance

Prefabricated foot orthoses altered sagittal plane biomechanics of the ankle during level-walking and

stair descent in individuals with PFOA. Further research is required to determine whether these

changes are clinically beneficial.

Keywords

Gait analysis

Walking

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Stairs

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Kinematics

Kinetics
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1. Introduction

Patellofemoral (PF) osteoarthritis (OA) affects 43% of individuals with knee pain [1]. PF involvement

often develops before tibiofemoral (TF) OA, and increases the likelihood of TFOA incidence and

disease progression [2]. Furthermore, PFOA is a more prominent source of symptoms compared to

TFOA [3], occurs in middle-aged individuals [2], and affects more females than males [4].

Foot orthoses are an effective treatment for patellofemoral pain (PFP) [5]. Biomechanical studies on

the effects of foot orthoses in individuals with PFP have demonstrated transverse plane knee rotation

[6], hip adduction [6], ankle joint inversion moments [7], and increased vastus medialis and gluteus

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medius activity [8]. These changes could potentially influence PF loading and provide an explanation

for the apparent effectiveness of foot orthoses in the management of PF symptoms.

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A theoretical link between PFP and PFOA has been proposed, with similar features and

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biomechanical impairments observed in both populations [9]. However, due to age-related differences

in foot mobility in individuals with PFP [10], it cannot be assumed that foot orthoses will have a
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similar biomechanical effect in individuals with PFOA. Therefore, the primary aim of this study was

to determine the immediate effects of foot orthoses and flat shoe inserts on lower limb biomechanics
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in individuals with PFOA. The secondary aim of this study was to evaluate the immediate effects of

these interventions on knee pain and confidence. We hypothesised that foot orthoses would increase
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the dorsiflexion angle and moment at the ankle, and improve knee pain and confidence compared to

the flat insert.

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2. Methods

This study used a within-subject, randomised, cross-over design to evaluate the immediate effects of

foot orthoses and flat shoe inserts on lower limb biomechanics, pain, and confidence. Data for this

study was collected at the baseline testing session of a pilot randomised controlled trial (RCT)

evaluating the six-week effects of foot orthoses compared to flat shoe inserts [11]. Ethical approval
for this study was granted by La Trobe University Human Ethics Committee (S15/286) and the trial

was registered on the Australian New Zealand Clinical Trials Registry (ACTRN12616001287426).

Volunteers were recruited from the greater Melbourne community via paid advertisements (e.g. local

newspapers, seniors’ magazines), free advertisements (e.g. community newsletters, flyers on

noticeboards and in clinical waiting rooms), recruitment stands at local markets and fun runs, and

referrals from physiotherapists and podiatrists. In order to increase the generalisability of our findings,

this study used a clinical diagnosis of PFOA based on the National Institute for Health and Care

Excellence (NICE) guidelines [12]. Volunteers were eligible for participation in this study based on

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the following criteria derived for the pilot RCT: (i) aged 50 to 75 years; (ii) anterior or retropatellar

knee pain aggravated by ≥2 PF joint loading activities (e.g. stair ambulation, squatting, rising from

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sitting); (iii) pain during these activities on most days in the past month; (iv) pain severity ≥30mm on

a 100mm Visual Analogue Scale (VAS) during aggravating activities; (v) either no morning joint-
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related stiffness or morning stiffness that lasts no longer than 30 minutes; and (vi) ability to

understand spoken and written English. Volunteers were excluded if they had: (i) concomitant pain
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from other knee structures, hip, or lumbar spine; (ii) recent treatment for knee pain; (iii) any foot
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condition precluding the use of shoe inserts; (iv) knee or hip arthroplasty/osteotomy; (v) neurological

or systemic arthritic conditions; (vi) physical inability to undertake testing procedures; and (vii)

inability to understand spoken and written English. The knee rated most severe by participants with
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bilateral PFOA was selected as the study knee. For those with equal symptoms, the right knee was

chosen.
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2.1. Protocol

A two-stage screening process determined suitability for inclusion. Firstly, a preliminary email or

telephone interview was conducted. Potential participants then attended the gait laboratory for a

comprehensive musculoskeletal examination by an experienced musculoskeletal podiatrist, to ensure

participants were primarily experiencing PFOA symptoms. The musculoskeletal examination

included: (i) palpation of the PF joint and surrounding soft tissue and osseous structures; (ii)
identification of knee effusion; (iii) hip quadrant and lumbar spine range of motion tests to ensure

knee pain did not arise from concomitant structures; and where required (iv) examination of the foot

for any conditions precluding the use of shoe inserts (e.g. ganglions). Participants provided written

informed consent before the musculoskeletal examination was undertaken. At the completion of the

musculoskeletal examination, eligible participants completed clinical measures, patient-reported

outcome measures (PROMs), and biomechanical testing during the same appointment, where

possible.

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2.2. Interventions

Interventions used for this study were prefabricated arch contouring foot orthoses, and flat shoe

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inserts, which were fitted by a podiatrist during the testing session. The order of testing the conditions

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was randomised using an online randomisation program (http://www.randomization.com), and the

intervention allocation was concealed from the participant.

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2.2.1. Prefabricated foot orthoses

Commercially available prefabricated full length arch contouring foot orthoses (Vasyli® Medical,

Labrador, Australia) constructed from high-density (Shore A 75ᵒ) ethylene-vinyl acetate (EVA), with
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inbuilt arch support, and a 6ᵒ varus wedge (Fig. 1) were used as the test insert for this study. The foot

orthoses were covered with a synthetic fabric (Cambrelle®, Camtex Fabrics, Cumbria, CA, USA) top
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cover to ensure no differentiation could be made to the flat insert.

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2.2.2. Flat shoe inserts

A flat shoe insert constructed from high-density (Shore A 75ᵒ) EVA of uniform thickness along its

full length (3mm), with no inbuilt arch or varus wedging, served as the control insert (Fig. 1). The flat

shoe inserts were covered with the same synthetic fabric top cover as the foot orthoses.
2.3. Participant characteristics

Demographic characteristics, medical history and medications were documented using a structured

questionnaire. Height and mass were measured using a stadiometer and digital scales, respectively,

and body mass indices (BMI) calculated as weight (kg)/height (m)2. Footwear was assessed using five

out of the six items from the Footwear Assessment Tool (item six excluded as it was not of interest in

this study) [13]. Clinical tests of foot and ankle mobility were conducted using established and

reliable methods, including: (i) 6-item Foot Posture Index (FPI) [14]; (ii) weight bearing ankle joint

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dorsiflexion (knee to wall test) [15]; and (iii) midfoot and arch height mobility/arch indices [16].

PROMs used to characterise the cohort included: (i) the Knee Injury and Osteoarthritis Outcome

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Score (KOOS) [17]; (ii) the Anterior Knee Pain Scale (AKPS) [18]; and (iii) severity of average and

maximum pain over the preceding week on a 100mm VAS (terminal descriptors 0mm = no pain,

100mm = worst pain possible) [19].

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2.4. Biomechanical data collection
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Lower limb biomechanical data were collected while the participant performed level-walking, stair

ascent, and stair descent tasks under three test conditions: (i) foot orthoses, (ii) flat inserts, and (iii)
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their shoes alone (control). Both shoe inserts were tested in the participant’s own shoe. A neutral shoe

(Mizuno Wave Rider, Mizuno Corporation, Chiyoda, Tokyo, Japan) was used if a participant did not
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have appropriate footwear. Kinematic data were recorded using ten-camera opto-reflective motion

capture system (Vicon Motion Systems Ltd, Oxford, UK; 100 Hz), while two embedded force plates
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(Kistler, type 9865B, Winterthur, Switzerland and AMTI, OR6, MA, USA; 1000 Hz) simultaneously

captured ground reaction force data during walking. A third force plate (AMTI Accugait, AMTI,

Watertown, MA, USA) was used to collect stair ascent and descent data. Vicon Nexus software was

used to capture synchronised kinematic and force plate data. Three-dimensional joint kinematics of

the ankle, knee, and hip were determined using Plug-in-Gait [20]. Each participant underwent
calibration whereby their height, weight, ankle width, knee width, anterior superior iliac spine to

greater femoral trochanter distance, and distance between left and right anterior superior iliac spines

were recorded. Nineteen 14mm diameter retro-reflective markers were positioned bilaterally at the

base of the second metatarsal, bilaterally at the posterior heel, bilaterally on the medial and lateral

malleoli, bilaterally on the lateral aspect of the tibia, bilaterally on the lateral aspect of the femur,

bilaterally on anterior and posterior superior iliac spines, 10th thoracic vertebrae, 2nd thoracic

vertebrae, and the sternum (Supplementary files Fig. 1a and 1b). To calculate knee joint centres,

participants completed a static trial with bilateral knee alignment devices (KAD, Motion Lab Systems

Inc., LA, USA) (Supplementary file Fig. 1a). A single KAD was placed on each knee, with the medial

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pad positioned directly on the medial femoral epicondyle, and the lateral pad positioned directly over

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the TF joint line. After the static trial was completed, each KAD was replaced with a single marker

over the exact location of the lateral pad of the KAD (Supplementary file Fig. 1b), and the medial

malleoli markers were removed.

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Participants then performed level-walking at a self-selected speed along a 12-metre walkway, as well
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as stair ascent and descent tasks, under the three test conditions. Testing was repeated until six
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successful trials were recorded for each of the three test conditions. For a trial to be considered

successful, total foot contact needed to occur on one of the two embedded force plates without

disrupting gait, and all three force plates for stair ambulation.
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Marker trajectories were filtered using a Woltring Filter routine with a 10mm predicted mean squared

error. Hip, knee, and ankle joint kinematics and moments were calculated during the stance phase of
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gait (heel contact to toe off), with stance phase reported as 0 to 100%. Data were averaged across a
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minimum of three trials for level-walking and two trials for stair ambulation, and moment data were

normalised to body mass. All data were extracted using a custom Matlab program (Mathworks Inc;

Natick, MA, USA), with all time-series data temporally normalised to 101 data points using cubic

spline interpolation.

Variables of interest were peak flexion and extension angles and moments of the hip, knee, and ankle

during early stance, peak flexion and extension angles of the hip and ankle during stance phase, peak
plantarflexion and dorsiflexion moments of the ankle during stance phase, and peak knee adduction

moments during early and late stance. These variables were selected based on known biomechanical

differences previously reported in PFP [21] and PFOA [22] cohorts, compared to controls. Kinetic

data were reported as external joint moments.

2.5. Measures of pain and confidence

The primary investigator (JMT) administered PROMs during biomechanical testing. The PROMs

included: (i) knee pain severity using a 100mm VAS (terminal descriptors 0mm = no pain, 100mm =

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worst pain possible) and (ii) knee confidence using a 100mm VAS, with the question phrased as “how

confident did you feel completing that task?” (terminal descriptors 0mm = very confident, 100mm =

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not confident at all).

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2.6. Sample size

As this was a nested study, the sample size was determined for the pilot RCT using an a priori power
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analysis based on the primary outcome measures VAS, KOOS, and AKPS. The minimal clinical

important difference (MCID) for pain VAS is 15mm [19]. Using a standard deviation of 20mm, a

power level of 0.8, an alpha level of 0.05, and accounting for a dropout rate of 10%, a sample size of
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32 participants (i.e. 16 per group) was required for the RCT. A subset of 20 participants was deemed

sufficient to detect meaningful within-subject differences in the biomechanical immediate effects

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study.
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2.7. Data processing and statistical analysis

Statistical analysis was undertaken using IBM SPSS® Statistics version 24.0 (IBM Corp, NY, USA).

Data were time-normalized from 0% to 100% of the stance phase. Stance phase was defined as a

vertical ground reaction force (vGRF) ≥20 Newtons (N), with the first frame considered heel strike
and the final frame considered toe-off. For level-walking, stages of stance were defined as; early ≥0%

to <50% and late ≥50% to 100% of stance phase. For stair ascent and descent, data were extracted as

time point zero being heel strike of the symptomatic limb to toe-off of the ipsilateral limb. All

biomechanical data were reported as peak angles and moments for sagittal plane motion of the hip,

knee, and ankle, and frontal plane motion of the knee during stance phase.

Biomechanical data were visually inspected for trends regarding differences in biomechanics between

the three test conditions. Data were then inspected for normality and parametric tests were used to

report means and standard deviations (SDs). Where data were not normally distributed, non-

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parametric tests were utilised and data reported as medians and interquartile ranges (IQRs).

Biomechanical variables and PROMs were compared across the three test conditions using repeated-

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measures analysis of variance (ANOVA) with Bonferroni post-hoc tests. Effect sizes were determined

using the partial eta squared (ƞ2) statistic, with results interpreted as small (0.2 to 0.6), moderate (0.6

to 1.2), large (1.2 to 2.0), and very large (>2.0) [23].

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3. Results
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From February to July 2016, 129 volunteers underwent screening (email/telephone initially, with

physical screen as indicated) for the pilot RCT in which 30 were eligible. Four participants declined to
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participate due to time demands of being in involved in a study and five participants did not consent

to baseline biomechanical testing. Twenty-one participants (14 females; mean  SD age 58  8 years
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[range 50-75]; BMI 27.0  4.8 kg/m2) with PFOA were enrolled in the biomechanics study (see Table

1). Common reasons for study exclusion were: currently wearing insoles (n = 21); not enough
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pain/pain in the wrong region (n = 17); currently receiving physiotherapy treatment (n = 14); a

surgical history precluding study involvement (n = 6); unable to commit to the time obligations of

being involved in the study (n = 4); too young (n = 3); and reported being diagnosed with rheumatoid

arthritis (n = 3).
The effects of foot orthoses and flat inserts on lower limb biomechanics during level-walking are

presented in Table 2 and Fig. 2. There was a significant main effect of foot orthoses on peak ankle

dorsiflexion angle (F2=0.773, p<0.001, ƞ2=0.773), with post-hoc tests revealing that foot orthoses

reduced peak ankle dorsiflexion angle compared to flat inserts (mean difference [MD]=0.3 [95%CI

1.1 to 2.5]) and shoe alone (MD=0.4 [95%CI 0.6 to 2.6]). In addition, there was a significant main

effect of foot orthoses on peak ankle dorsiflexion moment (F2=0.356, p<0.046, ƞ2=0.356), with post-

hoc tests revealing that foot orthoses reduced peak ankle dorsiflexion moment compared to flat inserts

(MD=0.22Nm/kg [95%CI 0.04 to 1.24]).

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Effects of foot orthoses and flat inserts on lower limb biomechanics during stair ascent and descent

are presented in Table 3. No significant main effects were observed during stair ascent. During stair

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descent, there was a significant main effect of foot orthoses on peak external dorsiflexion moment

(F2=0.823, p=0.006, ƞ2=0.738), with a trend towards lower peak dorsiflexion moment for foot
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orthoses compared to flat inserts (MD=0.68Nm/kg [95%CI -0.39 to 3.87]) and shoes alone
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(MD=0.89Nm/kg [95%CI -1.76 to 3.83]).

There were no significant effects of foot orthoses and flat inserts on pain and confidence scores (Table
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4. Discussion

The primary objective of this study was to determine the immediate effects of foot orthoses and flat
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inserts on lower limb biomechanics in individuals with PFOA. The secondary objective was to
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evaluate the immediate effects of foot orthoses on knee pain and confidence during level-walking and

stair ambulation. Overall, results do not support the hypotheses of an increase in the dorsiflexion

angle and moment at the ankle, or improvements in knee pain and confidence. However, foot orthoses

significantly reduce sagittal plane ankle joint kinematics and joint moments during level-walking and

stair descent compared to a flat insert. Furthermore, there were no statistically significant differences

in knee pain and confidence scores across all three conditions.

Foot orthoses induced distal biomechanical effects in individuals with PFOA without influencing

biomechanics at more proximal segments. The reduced peak ankle dorsiflexion angle during level-

walking may be due to the arch support and 6ᵒ varus wedge incorporated into the foot orthosis, which

encourages more ankle plantarflexion throughout stance phase (Figure 2). Considering dorsiflexion is

a component of foot pronation, and that the biomechanical model used was unable to measure other

components of pronation (e.g. calcaneal eversion), it is possible that the foot orthoses did influence

foot pronation during gait. However, given that our participants did not exhibit a highly pronated foot

posture or increased foot mobility (as indicated by the FPI and Foot Assessment Platform results),

which has been observed in individuals with PFOA [24], we are unable to draw further conclusions as

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to the link between foot kinematics, foot orthoses, and PFOA. Further studies are necessary to

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investigate foot kinematics in more detail using complex biomechanical foot models in this

population.
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The reduced peak ankle dorsiflexion moment was coupled with a decrease in peak ankle dorsiflexion

angle during level-walking but not stair descent whilst wearing the foot orthoses. The decrease in
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peak ankle dorsiflexion moment may be partly due to the known shock absorptive capacity [25] and
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reduction in peak plantar pressure [26] of the foot orthoses. As participants in this study demonstrated

lower foot mobility when compared to young adults [16], the shock absorptive characteristics of foot

orthoses may be therapeutically beneficial, particularly given that stair ambulation is an activity which
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often evokes pain in those with PFOA [2].

We found no biomechanical differences between flat inserts and shoes alone during all three
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functional tasks. This suggests that the flat inserts used in this study could be considered an adequate
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sham device in future clinical trials investigating the effectiveness of foot orthoses [12]. This result

may also help explain the non-significant immediate changes in pain levels observed.

The findings of our study differ to previous research demonstrating immediate biomechanical effects

in individuals with PFP [27], suggesting that responses to foot orthoses are different in PFOA. The

reasons for this are unclear, however the disparity may be due to differences in biomechanical

assessment methods and/or foot mobility. As foot mobility has been shown to influence foot orthosis
efficacy in PFP populations [28], a potential explanation for the observed difference in this study is

that those with PFOA are typically older and may display less foot mobility, similar to older

individuals with PFP [10]. Therefore, reduced foot mobility may limit the capacity of an in-shoe

intervention to alter lower limb biomechanics proximal to the foot.

There were no significant differences in knee pain during level-walking, stair ascent or descent across

the three footwear conditions. This finding contrasts to that of Collins et al. [29], who reported that

foot orthoses reduced pain during level-walking and flat insoles reduced pain during stair ambulation.

This may be explained by the control condition used in each study. In Collins et al. [29], the control

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condition was a contoured sandal, while in our study, participants wore their own shoes, which are

likely to provide more support and comfort than a control sandal.

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The finding of no change in confidence scores between all three conditions is clinically useful. This

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demonstrates that participants can complete pain provoking tasks, whilst using an in-shoe

intervention, without resulting in reduced confidence. This observation has important implications for
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planning treatment in individuals with PFOA, as lack of confidence is a barrier that can often lead to

poor adherence to rehabilitation exercises and treatment [30], which may limit positive outcomes.
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Strengths of this study include a detailed characterisation of a PFOA cohort and the first known

published study investigating the effects of foot orthoses on lower limb biomechanics in individuals
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with PFOA. However, our findings need to be viewed in light of three key limitations. Firstly, we

used a relatively simple biomechanical model that did not include a multi-segment foot model, which
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means that changes within the foot were not evaluated in detail and subtle lower limb changes may

not have been detected. Furthermore, we did not collect any PF joint loading data and therefore, the
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ability to determine if any lower limb biomechanics translate to changes about the PF joint are limited

[22]. Secondly, all participants were tested with the same density (Shore A 75ᵒ), unmodified

prefabricated arch contouring foot orthoses. Foot orthoses are frequently customised by adding

wedges or via heat molding to enhance comfort [12] and/or biomechanical alignment, which could

influence both biomechanical changes and measures of pain and function. Finally, despite a moderate

sample size of 21 participants for a biomechanical study, due to this being a nested study with the
sample size calculated for the RCT, a type 2 error may be responsible for some of the non-significant

findings.

5. Conclusion

In individuals with PFOA, prefabricated arch contouring foot orthoses produce immediate

biomechanical changes at the ankle when compared to a flat insert or the participants’ own shoes

during level-walking and stair descent. However, these changes were not accompanied by immediate

changes in knee pain and confidence. This suggests that changes in distal biomechanics induced by

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foot orthoses may not drive therapeutic effects observed in individuals with PFOA.

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Conflict of interest -p
The authors state there are no competing interests to declare.
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Contributors

JMT recruited and screened the participants, carried out the outcome measures and biomechanical
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data collection, data entry and analysis, and prepared the manuscript. KC, HBM, NC, and SEM were

involved in the methodological design, data analysis and interpretation, and preparation of the
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manuscript. KM assisted in methodological design, biomechanical data analysis, and preparation of

the manuscript. HH assisted in the methodological design, biomechanical data collection, and
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preparation of the manuscript.

Funding sources

This study was partially funded by the National Health and Medical Research Council of Australia

(ID: 1106852; 2016-2019) and the Discipline of Podiatry at La Trobe University, Melbourne campus
(Bundoora). NJC previously held a University of Queensland Postdoctoral Research Fellowship

(2015-2017). HBM is currently a National Health and Medical Research Council Senior Research

Fellow (ID: 1135995). Vasyli® Medical (Labrador, Australia) provided a portion of the foot orthoses

free of charge. The funding sources have no financial or personal relationship with Vasyli® Medical

and therefore the contributions to the study design, analysis and interpretation of data, manuscript, and

publication submission by the head of the podiatry discipline are independent. The work of the

authors was independent of the funders.

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Supplementary tables and figures

Fig 1a. Markers needed in static trial to run static gait model (estimate joint centres for Plug in Gait)
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and participant calibration (create auto labelling for other trials).
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Caption. THR2 thoracic 2, THR10 thoracic 10, STRM sternum, RASI right anterior superior

iliac spine, LASI left anterior superior iliac spine, RPSI right posterior superior iliac spine,
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LPSI left posterior superior iliac spine, RTHI right lateral femur, LTHI left lateral femur,

RKD1 right knee alignment device 1, RKAX right knee axis, RKD2 right knee alignment

device 2, LKD1 left knee alignment device 1, LKAX left knee axis, LKD2 left knee
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alignment device 2, RTIB right lateral tibia, LTIB left lateral tibia, RMED right medial

malleoli, LMED left medial malleoli, RANK right ankle, LANK left ankle, RTOE right toe
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(over 2nd metatarsal), LTOE left toe (over 2nd metatarsal), RHEE right heel, LHEE left heel
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Fig 1b. Markers needed in dynamic trials to run dynamic gait model (calculation of angles from joint

centres).

Caption. THR2 thoracic 2, THR10 thoracic 10, STRM sternum, RASI right anterior superior

iliac spine, LASI left anterior superior iliac spine, RPSI right posterior superior iliac spine,

LPSI left posterior superior iliac spine, RTHI right lateral femur, LTHI left lateral femur,
 RKNE right knee, LKNE left knee, RTIB right lateral tibia, LTIB left lateral tibia, RANK

right ankle, LANK left ankle, RTOE right toe (over 2nd metatarsal), LTOE left toe (over 2nd

metatarsal), RHEE right heel, LHEE left heel

Acknowledgements

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The authors wish to thank all participants who volunteered to take part in this study, Vasyli® Medical

(Labrador, Australia) for providing a portion of the foot orthoses free of charge, and Sally Coburn for

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assisting with a portion of the phone screenings and data collection. This study was partially funded

by the National Health and Medical Research Council of Australia (ID: 1106852; 2016-2019) and the
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Discipline of Podiatry at La Trobe University, Melbourne campus (Bundoora). NJC previously held a
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University of Queensland Postdoctoral Research Fellowship (2015-2017). HBM is currently a

National Health and Medical Research Council Senior Research Fellow (ID: 1135995). The funding
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sources have no financial or personal relationship with Vasyli® Medical and therefore the

contributions to the study design, analysis and interpretation of data, manuscript, and publication

submission by the head of the podiatry discipline are independent. The work of the authors was
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independent of the funders.

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References

[1] Hart HF, Stefanik JJ, Wyndow N, Machotka Z, Crossley KM. The prevalence of radiographic and

MRI-defined patellofemoral osteoarthritis and structural pathology: a systematic review and meta-

analysis. Br J Sports Med. 2017;51:1195-208.

[2] Hinman R, Crossley K. Patellofemoral joint osteoarthritis: an important subgroup of knee

osteoarthritis. Rheumatology (Oxford). 2007;46:1057-62.

[3] Kornaat PR, Bloem JL, Ceulemans RY, Riyazi N, Rosendaal FR, Nelissen RG, et al. Osteoarthritis of

the Knee: Association between Clinical Features and MR Imaging Findings. Radiology. 2006;239:811-

of
7.

[4] Collins NJ, Oei EH, de Kanter JL, Vicenzino B, Crossley KM. Prevalence of radiographic and MRI

ro
features of patellofemoral osteoarthritis in young and middle‐aged adults with persistent

patellofemoral pain. Arthritis Care Res. 2019;71:1068-73. -p

[5] Collins NJ, Crossley KM, Beller E, Darnell R, McPoil TG, Vicenzino B. Foot orthoses and
re
physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial. Br Med J

(Clin Res Ed). 2009;43:169-71.

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[6] Lack S, Barton C, Woledge R, Laupheimer M, Morrissey D. The immediate effects of foot orthoses

on hip and knee kinematics and muscle activity during a functional step-up task in individuals with
na

patellofemoral pain. Clin Biomech. 2014;29:1056-62.

[7] Stefanyshyn DJ, Hettinga BA. Running injuries and orthotics: review article. ISMJ. 2006;7:109-19.
ur

[8] Hertel J, Sloss BR, Earl JE. Effect of foot orthotics on quadriceps and gluteus medius

electromyographic activity during selected exercises. Arch Phys Med Rehabil. 2005;86:26-30.
Jo

[9] Wyndow N, Collins NJ, Vicenzino B, Tucker K, Crossley KM. Is There a Biomechanical Link Between

Patellofemoral Pain and Osteoarthritis? A Narrative Review. Sports Med. 2016;46:1797-808.

[10] Tan JM, Crossley KM, Vicenzino B, Menz HB, Munteanu SE, Collins NJ. Age-related differences in

foot mobility in individuals with patellofemoral pain. J Foot Ankle Res. 2018;11.
[11] Tan JM, Menz HB, Crossley KM, Munteanu SE, Hart HF, Middleton KJ, et al. The efficacy of foot

orthoses in individuals with patellofemoral osteoarthritis: a randomised feasibility trial. Pilot

Feasibility Stud. 2019;5.

[12] Collins NJ, Tan JM, Menz HB, Russell TG, Smith AJ, Vicenzino B, et al. The FOOTPATH Study:

protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of

foot orthoses for patellofemoral osteoarthritis. BMJ open. 2019;9.

[13] Barton CJ, Bonanno D, Menz HB. Development and evaluation of a tool for the assessment of

footwear characteristics. J Foot Ankle Res. 2009;2:1-12.

of
[14] Redmond AC, Crane YZ, Menz HB. Normative values for the Foot Posture Index. J Foot Ankle

Res. 2008;1:1-6.

ro
[15] Konor MM, Morton S, Eckerson JM, Grindstaff TL. Reliability of three measures of ankle

-p
dorsiflexion range of motion. Int J Sports Phys Ther. 2012;7:279-87.

[16] McPoil TG, Vicenzino B, Cornwall MW, Collins N, Warren M. Reliability and normative values for
re
the foot mobility magnitude: a composite measure of vertical and medial-lateral mobility of the

midfoot. J Foot Ankle Res. 2009;2:6.

lP

[17] Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis

Outcome Score (KOOS) - development of a self-administered outcome measure. J Orthop Sports

na

Phys Ther. 1998;28:88-96.

[18] Kujala UM, Jaakkola LH, Koskinen SK, Taimela S, Hurme M, Nelimarkka O. Scoring of
ur

patellofemoral disorders. Arthroscopy. 1993;9:159-63.

[19] Crossley KM, Bennell KL, Cowan SM, Green S. Analysis of outcome measures for persons with
Jo

patellofemoral pain: which are reliable and valid? Arch Phys Med Rehabil. 2004;85:815-22.

[20] Kadaba MP, Ramakrishnan H, Wootten M. Measurement of lower extremity kinematics during

level walking. J Orthop Res. 1990;8:383-92.

[21] Barton CJ, Levinger P, Menz HB, Webster KE. Kinematic gait characteristics associated with

patellofemoral pain syndrome: a systematic review. Gait Posture. 2009;30:405-16.

[22] Fok LA, Schache AG, Crossley KM, Lin YC, Pandy MG. Patellofemoral joint loading during stair

ambulation in people with patellofemoral osteoarthritis. Arthritis Rheum. 2013;65:2059-69.

[23] Hopkins WG. Measures of reliability in sports medicine and science. Sports Med. 2000;30:1-15.

[24] Wyndow N, Collins NJ, Vicenzino B, Tucker K, Crossley KM. Foot and ankle characteristics and

dynamic knee valgus in individuals with patellofemoral osteoarthritis. J Foot Ankle Res. 2018;11:65.

[25] Mills K, Blanch P, Chapman AR, McPoil TG, Vicenzino B. Foot orthoses and gait: a systematic

review and meta-analysis of literature pertaining to potential mechanisms. Br J Sports Med.

2010;44:1035-46.

of
[26] McCormick CJ, Bonanno DR, Landorf KB. The effect of customised and sham foot orthoses on

plantar pressures. J Foot Ankle Res. 2013;6:19-33.

ro
[27] Lack S, Barton C, Malliaras P, Twycross-Lewis R, Woledge R, Morrissey D. The effect of anti-

-p
pronation foot orthoses on hip and knee kinematics and muscle activity during a functional step-up

task in healthy individuals: A laboratory study. Clin Biomech. 2014;29:177-82.

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[28] Matthews M, Rathleff MS, Claus A, McPoil T, Nee R, Crossley K, et al. Can we predict the

outcome for people with patellofemoral pain? A systematic review on prognostic factors and
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treatment effect modifiers. Br J Sports Med. 2017;51:1650-60.

[29] Collins NJ, Hinman RS, Menz HB, Crossley KM. Immediate effects of foot orthoses on pain during
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functional tasks in people with patellofemoral osteoarthritis: A cross-over, proof-of-concept study.

Knee. 2017;24:76-81.
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[30] Jack K, McLean SM, Moffett JK, Gardiner E. Barriers to treatment adherence in physiotherapy

outpatient clinics: a systematic review. Man Ther. 2010;15:220-8.

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Fig 1. Prefabricated full-length Vasyli® foot orthosis (top) and flat shoe insert (bottom).

Fig 1. Prefabricated full-length Vasyli® foot orthosis (top) and flat shoe insert (bottom).

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Fig 2. Ankle kinematics: level-walking.

Caption. *p<0.001
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Fig 2. Ankle kinematics: level-walking.

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 20
Dorsiflexion *
15

10

5
Angle (°)

0
0 20 40 60 80 100
Plantarflexion

-5

-10

-15

-20
100% Stance

Shoe alone Flat inserts Foot orthoses

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*p<0.001

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Tables and figures

Table 1. Participant characteristics.

Total group (N=21)
Age (years) 58 (8)
Sex (female), n (%) 14 (67)
BMI (kg/m2) 27.0 (4.8)
Right knee affected, n (%) 13 (62)
Duration of pain
3 to 6 months, n (%) 2 (9.5)
6 to 12 months, n (%) -
1 to 2 years, n (%) 2 (9.5)
Greater than 2 years, n (%) 17 (81.0)
FPI^§ 3 (1 to 7)
Weight bearing ankle joint dorsiflexion ROM (cm)^ 9.1 (3.2)
Arch height difference (mm)^ 8.8 (5.2)

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Midfoot width difference (mm)^ 8.9 (3.1)
Foot mobility magnitude (mm)^ 14.8 (7.9)
Usual pain VAS (0 to 100mm) 40 (22)

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Worst pain VAS (0 to 100mm) 55 (30)
AKPS (0 to 100) 50 (17)
Values are reported as means (SD) unless otherwise specified.
^ Values are reported for the most symptomatic side.
§ median (range).
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BMI body mass index; FPI Foot Posture Index (-12: highly supinated to +12: highly
pronated); ROM Range of motion; mm = millimeters; VAS visual analogue scale (0mm
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= no pain; 100 mm worst pain possible); AKPS Anterior Knee Pain Scale (0 = worst
score; 100 = best score).
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Table 1. Participant characteristics.

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Table 2. Lower limb biomechanics during level-walking.

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Table 2. Lower limb biomechanics during level-walking.
Foot orthoses Flat inserts Shoe alone ANOVA/2

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(n=21) (n=21) (n=21)
Hip
Peak flexion angle – stance (°) 47.6 (6.6) 47.4 (6.5) 47.6 (6.3) F=0.026, df=2, p=0.829

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Peak extension angle – stance (°) -2.1 (8.5) -2.4 (8.6) -2.2 (8.9) F=0.235, df=2, p=0.153
Peak flexion moment – stance (Nm/kg) 1.30 (0.27) 1.37 (0.43) 1.39 (0.44) F=0.069, df=2, p=0.607
Knee
Peak flexion angle – early stance (°) 23.0 (7.8) 23.1 (6.8) 22.8 (7.1) F=0.022, df=2, p=0.857
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Peak flexion moment – early stance (Nm/kg)§ 0.58 (0.23) 0.62 (0.33) 0.58 (0.25) 2=0.375, df=2, p=0.829
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Peak adduction moment – early stance (Nm/kg)§ 0.69 (0.23) 0.66 (0.38) 0.66 (0.27) 2=0.875, df=2, p=0.646
Peak adduction moment – late stance (Nm/kg)§ 0.30 (0.26) 0.29 (0.29) 0.29 (0.28) 2=1.125, df=2, p=0.570
Ankle
Peak dorsiflexion angle – stance (°) 13.3 (3.4)†‡ 15.1 (3.3) 14.9 (3.2) F=0.773, df=2, p<0.001*
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Peak dorsiflexion moment – stance (Nm/kg) 0.15 (0.28) ‡ 0.16 (0.27) 0.15 (0.27) F=0.356, df=2, p=0.046*
Values are reported as mean (SD) unless otherwise stated
§ median (interquartile range)
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* significant main effect

† significantly different to shoe only condition, Bonferroni post-hoc test
‡ significantly different to flat insert condition, Bonferroni post-hoc test
Stance (0 to 100%); early stance (≥0% to <50%); late stance (≥50% to ≤100%)
Positive values = flexion and dorsiflexion; negative values = extension and plantarflexion
Moments are reported as external
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Table 3. Lower limb biomechanics during stair ascent and descent.

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Table 3. Lower limb biomechanics during stair ascent and descent.

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Foot orthoses Flat inserts Shoe alone ANOVA / 2
Stair Ascent (n=12) (n=12) (n=12)
Hip
Peak flexion angle – stance (°) 75.4 (8.3) 74.9 (8.6) 75.2 (8.7) F=0.350, df=2, p=0.221
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Minimum flexion angle – stance (°) 18.7 (6.1) 17.9 (6.2) 18.1 (6.0) F=0.261, df=2, p=0.346
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Peak flexion moment – stance (Nm/kg) 0.70 (0.11) 0.66 (0.09) 0.67 (0.13) F=0.434, df=2, p=0.136
Knee
Peak flexion angle – early stance (°) 74.5 (5.1) 74.1 (5.3) 74.5 (5.9) F=0.144, df=2, p=0.580
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Peak flexion moment – early stance (Nm/kg) 0.69 (0.08) 0.72 (0.05) 0.69 (0.05) F=0.147, df=2, p=0.573
Peak adduction moment – early stance (Nm/kg) 0.72 (0.21) 0.70 (0.19) 0.69 (0.18) F=0.439, df=2, p=0.132
Peak adduction moment – late stance (Nm/kg) 0.54 (0.12) 0.58 (0.13) 0.54 (0.14) F=0.234, df=2, p=0.393
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Ankle
Peak dorsiflexion angle – stance (°) 21.6 (3.6) 22.3 (4.5) 22.0 (4.2) F=0.082, df=2, p=0.741
Peak dorsiflexion moment – stance (Nm/kg) 1.31 (0.16) 1.30 (0.19) 1.30 (0.21) F=0.028, df=2, p=0.904
Stair descent (n=14) (n=14) (n=14)
Hip
Peak flexion angle – stance (°) 31.4 (9.1) 31.1 (9.2) 31.0 (9.2) F=0.127, df=2, p=0.665
 Minimum flexion angle – stance (°) 19.6 (7.0) 20.2 (9.2) 19.7 (10.2) F=0.242, df=2, p=0.435

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Peak flexion moment – stance (Nm/kg) 0.39 (0.16) 0.55 (0.33) 0.46 (0.25) F=0.089, df=2, p=0.756

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Knee
Peak flexion angle – early stance (°) 25.5 (6.3) 24.0 (3.7) 24.7 (6.3) F=0.289, df=2, p=0.426
Peak flexion moment – early stance (Nm/kg) 0.39 (0.23) 0.37 (0.22) 0.39 (0.26) F=0.251, df=2, p=0.420
Peak adduction moment – early stance (Nm/kg) 0.52 (0.21) 0.51 (0.17) 0.46 (0.12) F=0.259, df=2, p=0.407

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Peak adduction moment – late stance (Nm/kg)§ 0.39 (0.26) 0.37 (0.18) 0.38 (0.17) 2=1.000, df=2, p=0.607
Ankle
Peak dorsiflexion angle – stance (°) 9.9 (4.6) 9.4 (5.1) 9.7 (4.4) F=0.607, df=2, p=0.097

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Peak dorsiflexion moment – stance (Nm/kg) 1.04 (0.23) 1.16 (0.20) 1.08 (0.22) F=0.823, df=2, p=0.006*^
Values are reported as mean (SD) unless otherwise stated
§ median (interquartile range)

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* significant main effect
^ No difference between groups after Bonferroni post-hoc test
Stance (0 to 100%); early stance (≥0% to <50%); late stance (≥50% to ≤100%)
Positive values = flexion and dorsiflexion; negative values = extension and plantarflexion
Moments are reported as external
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Table 4. Baseline pain and confidence during laboratory-based testing.

Table 4. Baseline pain and confidence during laboratory-based testing

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Foot Flat Shoes Foot orthoses Foot orthoses versus Flat inserts versus shoe ANOVA

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orthoses inserts only versus flat inserts shoe alone alone
Knee pain VAS Mean difference (95% confidence interval)
(0 to 100 mm)
Level 17 (20) 21 (24) 22 (23) 4.2 (-2.9 to 11.2) 4.6 (-3.1 to 12.3) 0.4 (-6.7 to 7.6) F= 1.517, df=2, p=0.249

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walking
Stair ascent 23 (19) 20 (14) 26 (16) -3.4 (-13.1 to 6.3) 2.3 (-5.3 to 9.9) 5.7 (-0.4 to 11.8) F= 3.260, df=2, p=0.067
Stair 25 (20) 26 (19) 28 (22) 0.7 (-11.5 to 12.9) 3.5 (-8.8 to 15.7) 2.8 (-9.0 to 14.5) F= 0.310, df=2, p=0.738

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descent
Knee confidence

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VAS (0 to 100 mm)
Level 19 (17) 13 (13) 15 (18) -6.6 (-16.1 to 2.8) -4.3 (-13.8 to 5.2) 2.3 (-7.5 to 12.0) F= 1.692, df=2, p=0.216
walking
Stair ascent 24 (23) 19 (16) 23 (18) -5.2 (-13.9 to 3.4) -0.6 (-17.1 to 15.8) 4.6 (-8.5 to 17.7) F= 1.828, df=2, p=0.195
Stair 25 (21) 27 (23) 27 (22) 2.8 (-12.5 to 18.1) 2.2 (-11.6 to 16.0) -0.6 (-11.3 to 10.0) F= 0.118, df=2, p=0.890
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descent
Values are reported as mean (SD) unless otherwise stated
*p<0.05
VAS = visual analogue scale (0 = no pain/very confident; 100 = worst pain possible/not confident at all); mm = millimeter
Number of participants during level-walking (n=18) and stair ambulation (n=17)
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