Osteoarthritis and Cartilage 26 (2018) 903e911

Clinical and biomechanical changes following a 4-month toe-out gait

modification program for people with medial knee osteoarthritis: a
randomized controlled trial
M.A. Hunt y *, J.M. Charlton y, N.M. Krowchuk y, C.T.F. Tse y, G.L. Hatfield y z
y Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada
z Department of Kinesiology, University of the Fraser Valley, Chilliwack, BC, Canada

a r t i c l e i n f o s u m m a r y

Article history: Objective: To compare changes in knee pain, function, and loading following a 4-month progressive
Received 30 November 2017 walking program with or without toe-out gait modification in people with medial tibiofemoral knee
Accepted 17 April 2018 osteoarthritis.
Design: Individuals with medial knee osteoarthritis were randomized to a 4-month program to increase
Keywords: walking activity with (toe-out) or without (progressive walking) concomitant toe-out gait modification.
Gait modification
The walking program was similar between the two groups, except that the gait modification group was
Knee adduction moment
trained to walk with 15 more toe-out. Primary outcomes included: knee joint pain (WOMAC), foot
Biomechanics
Pain
progression angles and knee joint loading during gait (knee adduction moment (KAM)). Secondary
Randomized controlled trial outcomes included WOMAC function, timed stair climb, and knee flexion moments during gait.
Results: Seventy-nine participants (40 in toe-out group, 39 in progressive walking group) were recruited.
Intention-to-treat analysis showed no between-group differences in knee pain, function, or timed stair
climb. However, the toe-out group exhibited significantly greater changes in foot progression angle
(mean difference ¼ 9.04 (indicating more toe-out), 95% CI: 11.22 , 6.86 ; P < 0.001), late stance
KAM (mean difference ¼ 0.26 %BW*ht, 95% CI: 0.39 %BW*ht, 0.12 %BW*ht, P < 0.001) and KAM
impulse (0.06 %BW*ht*s, 95% CI: 0.11 %BW*ht*s, 0.01 %BW*ht*s; P ¼ 0.031) compared to the pro-
gressive walking group at follow-up. The only between-group difference that remained at a 1-month
retention assessment was foot progression angle, with greater changes in the toe-out group (mean
difference ¼ 6.78 , 95% CI: 8.82 , 4.75 ; P < 0.001).
Conclusions: Though both groups experienced improvements in self-reported pain and function, only the
toe-out group experienced biomechanical improvements.
Trials registry number: NCT02019108.
© 2018 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Introduction is generally regarded as an important proxy for tibiofemoral load

Excessive and altered loading within the knee joint are believed
to play major roles in knee osteoarthritis (OA) progression1e4.
While not necessarily a full reflection of the loading environment
within the knee joint5, the external knee adduction moment (KAM)
* Address correspondence and reprint requests to: M.A. Hunt, Department of
Physical Therapy, University of British Columbia, 212-2177 Wesbrook Mall, Van-
couver, BC V6T 1Z3, Canada. Tel: 1-604-827-4721; Fax: 1-604-822-1870.
E-mail addresses: michael.hunt@ubc.ca (M.A. Hunt), jesse.charlton@ubc.ca
(J.M. Charlton), natasha.krowchuk@ubc.ca (N.M. Krowchuk), calvin.tse@ubc.ca
(C.T.F. Tse), gillian.hatfield@ufv.ca (G.L. Hatfield).
distribution during walking2,6,7. The KAM has received the most
attention in the knee OA gait literature8, and is an important
outcome measure in many conservative treatment studies for this
disease9. Significant relationships exist between baseline peak
KAM or impulse (area under the KAM-time curve) magnitude and
the risk of OA progression, whether assessed as radiographic pro-
gression10, cartilage volume loss from magnetic resonance imag-
ing11, or rates of undergoing total knee joint arthroplasty12. Taken
together, these findings point to an important need to identify and
develop effective load-reducing treatments for knee OA.
Modifying aspects of one's gait pattern has been well-studied
for its immediate effects on the KAM in people with knee OA.

https://doi.org/10.1016/j.joca.2018.04.010
1063-4584/© 2018 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
904 M.A. Hunt et al. / Osteoarthritis and Cartilage 26 (2018) 903e911
Consistent changes in KAM magnitudes following single-session
gait modifications have been shown in systematic reviews13. The
most common gait modification in the knee OA literature is
changing one's foot progression angle e the angle between the foot
when it is in contact with the ground, and the forward line of
progression of the body13. In general, most studies have found that
toeing in reduces the early stance KAM14, while toeing out reduces
the late stance KAM15.
A recent pilot study showed that a 10-week toe-out gait modi-
fication program produced significant reductions in late stance
KAM values as well as knee pain16. Similar findings have been re-
ported following a 6-week toe-in gait modification program, with
reductions in knee pain and early stance KAM reported17. Impor-
tantly, toe-out gait may also have important implications for OA
disease progression. Chang et al.18 showed that each 5 increase in
foot progression angle in the toe-out direction had an associated
odds ratio of 0.60 (95% CI: 0.37, 0.98) for medial radiographic
tibiofemoral progression over an 18-month timeframe. These
findings suggest that increasing toe-out magnitudes during gait
may have a protective effect against OA progression, and thus
beneficial long-term consequences.
While there is a growing body of evidence reporting on the
potential biomechanical and clinical benefits of increasing toe-out
during gait by people with medial tibiofemoral knee OA, the
quality of evidence is limited by a lack of randomized controlled
trial data in this area. Therefore, the primary aim of the present
study was to conduct a randomized controlled trial comparing
clinical and biomechanical changes associated with a 4-month
walking program with or without toe-out gait modification for
people with medial tibiofemoral knee OA. It was hypothesized that
the walking program that included toe-out gait modification would
produce significantly greater reductions in knee pain and KAM
values than the program without toe-out gait modification.
Methods
Participants
Community-dwelling individuals were recruited via an existing
laboratory database as well as advertisements in print media. In-
clusion criteria were: (1) definitive medial tibiofemoral osteophytes
on X-ray; (2) joint space narrowing greater in the medial tibiofe-
moral compartment compared to the lateral compartment; (3)
history of knee pain longer than 6 months; and (4) average knee
pain of at least 3 out of 10 over the 1 month period prior to initial
screening. Exclusion criteria were: (1) knee surgery or intra-
articular pain relief injection within 6 months; (2) current or past
(within 6 months) oral corticosteroid use; (3) history of knee joint
replacement or tibial osteotomy; (4) any other condition affecting
lower limb function; (5) participation in a new structured exercise
program within the past 3 months, or planning to commence ex-
ercise or other treatment for knee OA in the next 4 months; and, (6)
an inability to travel to the university to attend testing and training
sessions. The study was approved by the Institution's Clinical
Research Ethics Board and all participants provided written
informed consent.
Sample size was determined based on randomization with
stratification, and covarying for baseline values in the statistical
analysis. Using effect size estimates of 0.8 for WOMAC pain and 1.0
for KAM impulse, based on pilot data using a similar design16, it was
determined that 33 participants in each group was required to
attain 90% power to detect significant differences in pain and KAM
outcomes between groups with an alpha of 0.05. Using a conser-
vative estimate of 10% attrition, the aim was to recruit 73 partici-
pants for this study.
Study design
This was a parallel group, assessor-blinded, randomized
controlled trial. Interested participants were initially screened for
inclusion and exclusion criteria over the telephone and eligible
individuals then underwent a physical screen. Screening was
overseen by a researcher not involved in data collection or analysis.
This physical screen was conducted to confirm the presence of
knee pain, and to perform a preliminary walking assessment to
quantify self-selected foot progression angle. Participants per-
formed three trials of self-selected, over ground walking while three
reflective skin markers tracked the movement of the sacrum, the
second toe, and posterior calcaneus of the study limb (defined as the
self-declared osteoarthritic limb in those with unilateral symptoms,
or the most painful limb in the case of bilateral symptoms). The
mean foot progression angle across the three trials was calculated.
As the goal of the toe-out modification program was to increase the
self-selected, baseline foot progression angle by 15 in the toe-out
direction, 15 of toe-out at the physical screening was selected as
the threshold. This was done due to (1) the difficulty in achieving
toe-out angles of 30 by people with knee OA15, and (2) the fact that
those who already exhibit large amounts of toe-out would likely not
be candidates for toe-out gait modification in the clinical setting.
Those who passed physical screening were referred for radio-
graphic evaluation. Standing, semi-flexed, postero-anterior radio-
graphs were obtained and graded for disease severity using the
Kellgren and Lawrence (KL) OA classification system19.
Individuals who met the radiographic criteria listed above were
invited to the laboratory for a baseline (Week 0) testing session
where self-report questionnaire, objective physical function, and
biomechanical data were collected. Following completion of base-
line testing, the randomization procedure was conducted by a study
biostatistician who was not involved in any aspect of data collection
or training. Randomization was initiated by the study research
coordinator, who provided the biostatistician with each partici-
pant's study ID, sex, and KL grade. The biostatistician then
responded via email with the group allocation, and maintained the
randomization parameters and list offsite. Group allocations were
determined prior to study commencement, and randomization was
stratified by sex (male, female) and disease severity (mild or
moderate grouped together, severe).
Participants returned to the university the following week (Week
1) to begin their training program, and were informed of their group
allocation at this time. Each home-based program lasted 4 months
and was supplemented with eight training sessions with the study
trainer at Weeks 1, 2, 4, 6, 8, 10, 12 and 15 of the intervention, with
typical sessions lasting 20 min in Week 1 and increasing to 40 min by
Week 15. All training sessions, regardless of group allocation, were
conducted by the same trainer in the same rehabilitation gymna-
sium. The first training session for each participant was always a one-
on-one session with the trainer, with subsequent sessions conducted
in groups of one to three individuals; in cases of group sessions, only
individuals from the same group allocation were present in the
gymnasium to prevent cross-contamination of groups.
Follow-up testing occurred 4 months after baseline testing, with
a final retention testing session conducted 1 month later. The same
outcome measures, completed in the same testing order, and by the
same blinded assessor, were collected at each testing session. No
training or instructions of any kind were provided between these
final two testing sessions.
Interventions
For both groups, the intent was to increase the weekly amount
of walking out in the community by 40% over and above that
 M.A. Hunt et al. / Osteoarthritis and Cartilage 26 (2018) 903e911
exhibited prior to enrollment. Initial values were assessed via dis-
cussion with participants at the first training session, and pre-
scribed weekly increases were determined individually at each
training session in consultation with the trainer.
Toe-out (TO) gait modification program
Participants randomized to the TO program were trained to
perform walking with 15 more toe-out than the self-selected
amount measured at the baseline testing session. Our previous
pilot study showed modest improvements of 6.7 in self-selected
toe-out angle following 10-weeks of toe-out gait retraining
intending to increase toe-out by 10 , that resulted in marginally
statistically significant improvements in late stance KAM (P ¼ 0.04)
and self-reported pain (P ¼ 0.02), and non-significant decreases in
KAM impulse (P ¼ 0.20)16. Thus, a larger toe-out increase was
selected for this study.
Toe-out modification during the training sessions was facilitated
with mirror-guided biofeedback of performance. Participants
placed their study foot on a protractor device at the target toe-out
angle for that session, and verbally instructed the therapist in the
placement of a piece of green tape on the mirror to best cover the
reflection of the foot in this target position. The tape remained on
the mirror during the training session to guide foot placement
during treadmill walking (Fig. 1)20. To promote motor learning, a
faded feedback paradigm was used21 with removal of real-time
biofeedback commencing at session 4 (mean percentage of
walking time with feedback: Week 6 ¼ 90%; Week 8 ¼ 75%; Week
10 ¼ 60%; Week 12 ¼ 45%; Week 15 ¼ 35%). Self-reported difficulty
Fig. 1. Toe-out gait modification was performed on a treadmill with the participant
facing a full-length mirror. A piece of tape was placed on the mirror as a target for foot
placement during each step.
905
in achieving the target angle was recorded at each training session
using an 11-point numerical rating scale (NRS) with terminal de-
scriptors of (0 ¼ “no difficulty” and 10 ¼ “unable to perform”).
Participants were instructed to maintain the increased toe-out
angle outside the training sessions whilst walking in the
community.
Progressive walking (PW) program
Participants randomized to the PW program underwent all
training procedures as those in the TO group, with the exception of
receiving no training or instruction related to toe-out walking. This
included walking on the treadmill in front of a mirror during
training sessions, but without foot placement guide tape as per the
TO training protocol.
Outcome measures
Pain and physical function
At each testing session, participants completed the Western
Ontario and McMaster Universities Arthritis Index (WOMAC) Likert
version22. Average knee pain over the previous week was also
assessed using an 11-point NRS with terminal descriptors of 0 ¼ “no
pain” and 10 ¼ “worst pain imaginable”. Overall perceived change
at follow-up compared to baseline was assessed using a 15-point
Likert scale (7 ¼ “a very great deal worse” 0 ¼ “about the
same”, þ7 ¼ “a very great deal better”)23. Finally, participants
completed the timed stair climb test where they were instructed to
ascend 12 stairs “as quickly as possible”, and the fastest time from
the two attempts was recorded24,25.
Gait biomechanics
Gait data were recorded for barefoot, over ground walking trials
at a self-selected speed. Twenty-two retro-reflective markers were
affixed to the participant according to a modified Helen Hayes
marker set26, and their movements were captured using twelve
high-speed digital cameras (Motion Analysis Corp., Santa Rosa, CA)
sampling at 100 Hz. An initial standing static trial was collected
using additional markers placed over the medial malleoli and
femoral epicondyles to determine segment orientations and joint
centers of rotation. Kinematic data from the cameras were syn-
chronized with two force platforms (OR6-6, Advanced Mechanical
Technologies Inc.) visually concealed in the floor of a 10 m walkway
and sampling data at 2000 Hz. Participants were provided no in-
structions pertaining to walking mechanics during any of the gait
assessments.
Inverse dynamics techniques and commercially available soft-
ware (Orthotrak, Motion Analysis Corp.) were used to calculate gait
variables including: KAM (early stance peak, late stance peak, im-
pulse), peak external knee flexion moment (KFM) during stance,
and mean foot progression angle during foot-flat (positive
values ¼ toe-in orientation, negative values ¼ toe-out orientation).
The mean value from five walking trials was calculated for each
biomechanical variable.
Adherence, concurrent treatments, and adverse events during
interventions
Adherence to both training programs was assessed as the total
number of supervised walking sessions attended for each partici-
pant. Compliance with the prescribed walking increases was ob-
tained from log book data completed by participants detailing their
daily amount of walking for the duration of the study, and weekly
totals (in hours) were calculated. Additionally, an 11-point NRS
(0 ¼ “not confident at all”, 10 ¼ “very confident”) in the log book
was used to assess self-reported confidence in the ability of those in
the TO group to maintain the increased toe-out angle whilst
906 M.A. Hunt et al. / Osteoarthritis and Cartilage 26 (2018) 903e911
walking in the community. Finally, concurrent treatments and
adverse events reported during the intervention were assessed
using open-ended questions in the log book maintained by the
participants. For the purposes of analysis, adverse events were
defined as those lasting longer than 2 weeks in duration, or
requiring additional treatment.
Statistical analysis
The primary outcomes were WOMAC pain, KAM impulse, and
foot progression angle, and the primary endpoint was the follow-
up assessment. All other biomechanical and clinical outcomes
were considered secondary in nature. Between-group comparisons
were the primary analyses, with within-group comparisons used
for informational purposes. Analysis of covariance (ANCOVA)
models were fit predicting each outcome variable evaluated at both
time points (follow-up and retention), with group as predictor, and
while controlling for baseline values. For biomechanical outcomes
(knee adduction and flexion moments, as well as foot progression
angle), additional models were computed while additionally con-
trolling for concurrent gait speed at the associated time point
(follow-up or retention). For baseline data, crude means were
computed. Adjusted least squares means (LS means) with standard
errors and 95% confidence intervals were computed for each group
at both follow-up and retention27. Adjusted LS means were
computed in similar models for within-group (delta) scores. Finally,
model-adjusted group effects were computed, along with P-values
and 95% confidence intervals, for all outcomes.
All data were analyzed using an intention-to-treat analysis, and
the primary analyses assumed that data were missing completely at
random (MCAR). In sensitivity analyses, multiple imputation was
performed as per the methods described by van Buuren28. Results
and conclusions were compared to the MCAR analysis, and any
differences noted. All statistical analyses were conducted by a
biostatistician blinded to group allocation and who was not
involved in any other aspect of the study. Analyses were performed
using SAS v9.4 (SAS Institute, Cary, North Carolina).
Results
Between May 2014 and February 2017, 497 individuals under-
went telephone screening (Fig. 2). Seventy-nine individuals passed
all screening, and underwent baseline testing and randomization
(Table I). Questionnaire data was completed by 74 individuals at
follow-up and 67 individuals at retention, while gait and stair climb
data were obtained from 70 and 66 individuals at these time points.
Group data at all time points are summarized in Table II, while
within- and between-group differences are reported in Table III.
Both groups experienced improvements in self-reported pain and
function (i.e., 95% confidence intervals of change did not cross zero),
and while these improvements were larger in the TO group, no
differences were statistically significant (P > 0.079). A total of 28
participants in the PW group (median score ¼ 2.5, indicating be-
tween “a little bit better” and “somewhat better”), and 34 in the TO
group (median score ¼ 4.0, indicating “moderately better”) re-
ported a perceived improvement overall symptoms at follow-up.
No within- or between-group differences were observed in the
timed stair climb test.
The TO group exhibited an average increase in their self-selected
foot progression angle of 8.87 and 6.96 in the toe-out direction at
follow-up and retention, respectively (Fig. 3). No changes were
observed in the PW group, and between-group differences were
significant at both time points, with the TO group exhibiting
approximately 9 and 7 more toe-out change at follow-up and
retention (9.04 , 95% CI: 11.22 , 6.86 at follow-up,
P < 0.001; 6.78 , 95% CI: 8.82 , 4.75 at retention, P < 0.001).
This translated into significantly larger reductions at follow-up in
the TO group for the late stance KAM (0.26 %BW*ht, 95%
CI: 0.39 %BW*ht, 0.12 %BW*ht, P < 0.001) as well as the KAM
impulse (0.06 %BW*ht*s, 95% CI: 0.11 %BW*ht*s, 0.01 %
BW*ht*s, P ¼ 0.031). While improvements, based on confidence
interval assessment, in these two variables were maintained in the
TO group at retention, no statistically significant between-group
differences remained (P ¼ 0.056 and P ¼ 0.058). No statistically
significant between-group differences were observed in any other
biomechanical variable (P > 0.103). Re-analysis of the data using
multiple imputation produced similar results; the only difference
compared to the non-imputed analysis was a non-significant be-
tween-group difference in KAM impulse at follow-up (0.07 %
BW*ht*s, 95% CI: 0.16 %BW*ht*s, 0.02 %BW*ht*s, P ¼ 0.113).
Attendance at the training sessions was similar between the
groups, with the PW group attending a mean 7.1 ± 2.1 of eight
sessions, and the TO group attending a mean 7.2 ± 1.9 sessions. A
total of 31/39 (79.5%) of those in the PW group, and 33/40 (82.5%) in
the TO group, attended all eight training sessions. For those in the
TO group, training with the final target angle (15 increase in toe-
out) commenced on the second or third session for most partici-
pants, and feedback was progressively removed commencing on
the fourth session for all participants. By the eighth session, par-
ticipants were receiving mirror-based feedback for a mean
34.9 ± 22.7% of treadmill walking time. Self-reported difficulty in
achieving the target angle for a given training session improved
from 2.8 ± 2.2 out of 10 at the first training session to 0.9 ± 1.2 at the
final training session.
Compliance to the home-based program was high in both
groups. Self-reported weekly walking time increased over the
duration of the intervention in both the PW (6.5 ± 6.9 h to
7.7 ± 5.3 h) and TO (6.7 ± 5.4 h to 8.3 ± 5.1 h) groups. The mean
individual percentage changes within each group were (48% ± 74%)
and (59% ± 99%) in the PW and TO groups, respectively. Further,
self-confidence in the TO group participants' perceived ability to
maintain the increased toe-out angle outside the laboratory
improved from 4.6 ± 2.3 out of 10 in Week 1e7.9 ± 2.3 during the
final week of the intervention.
Four participants in the PW group reported an adverse event:
two episodes of hip pain (one lasting 3 weeks, and one lasting the
duration of the intervention); one episode of foot pain lasting
4 weeks, and one episode of lower back pain lasting 4 weeks. There
were eight adverse events reported in the TO group: five episodes
of hip pain (four lasting 3 weeks and one lasting 8 weeks); one
episode of big toe pain lasting the duration of the intervention; one
episode of lower back pain lasting 5 weeks, and one episode of
posterior thigh pain lasting 3 weeks. Finally, four participants in the
PW group reported seeking additional treatment during the inter-
vention: two participants purchased shock absorbing shoe insoles
in Week 7; one participant took one dosage of Chinese herbs in
Week 2; and one participant purchased shoes with heel inserts in
Week 10. One participant in the TO group reported taking “sup-
plements” between Weeks 3 and 5 of the intervention.
Discussion
This study is the first randomized controlled trial, to our
knowledge, to assess the clinical and biomechanical effects of a gait
modification program in people with knee OA. While other studies
may have incorporated gait modification into the overall inter-
vention29, the current study assessed the effects of a toe-out gait
modification program in isolation. Findings indicate that while the
expected changes in gait kinematics (i.e., foot progression angle)
and kinetics (late stance KAM and KAM impulse) were observed
 M.A. Hunt et al. / Osteoarthritis and Cartilage 26 (2018) 903e911 907

Assessed for eligibility by Excluded (n=352)

phone screen - Not interested in participating (n=63)
- Knee pain < 3/10 (n=53)
(n=497) - Other lower limb or back pain (n=40)
- Currently in, or planning to start, exercise program (n=36)
- Unable to meet time requirements for study (n=35)
- No longer interested after phone screen (n=30)
- Other (n=23)
- Recent knee injections (n=20)
- Self-declared BMI > 34 kg/m2 (n=17)
- Previous lower limb joint replacement (n=15)
Assessed for eligibility by - Inflammatory arthritis (n=11)
physical screen - Age < 50 years (n=9)
(n=145)

Excluded (n=50)
- Self-selected toe-out angle > 15° (n=39)
Participants
Enrolment:

- Other lower limb or joint pain (n=7)

- Measured BMI > 34 kg/m2 (n=2)
- Scheduled joint replacement (n=1)
- Unable to meet time requirements for study (n=1)
Assessed for eligibility by
radiographic screen
(n=95)

Excluded (n=16)
- No longer interested after radiographic screening (n=7)
- Lateral tibiofemoral OA > medial tibiofemoral OA (n=6)
- No radiographic evidence of OA (KL < 2) (n=3)

Randomized
(n = 79)
Participants
Allocation:

Allocated to Allocated to
Progressive Walking Toe-out Gait Modification
(n=39) (n=40)
Treatment

8 x training sessions plus home 8 x training sessions plus home

phase

walking program emphasizing walking program emphasizing

increased walking amount increased walking amount while
increasing toe-out angle

Assessed at Month 4 (n=36): Assessed at Month 4 (n=38):

Self-report only (n=36) Self-report only (n=38)
Assessment:

Biomechanics and stair climb Biomechanics and stair climb

Participants
Month 4

(n=33) (n=37)

Lost to follow-up (n=3): Lost to follow-up (n=2):

Unrelated health issues: n=2 Unrelated health issues: n=1
Unable to commit further: n=1 Unable to commit further: n=1

Continue program without Continue program without

supervision for 1 month supervision for 1 month

Assessed at Month 5 (n=32): Assessed at Month 5 (n=35):

Self-report only (n=32) Self-report only (n=35)
Assessment:

Biomechanics and stair climb Biomechanics and stair climb

Participants
Month 5

(n=31) (n=35)

Lost to follow-up (n=4): Lost to follow-up (n=3):

Unable to commit further: n=2 Unable to commit further: n=2
Unrelated health issues: n=1 Unable to contact: n=1
Family emergency: n=1

Fig. 2. Participant study flow diagram.

immediately following the intervention, these changes did not
translate into improved clinical outcomes in those performing gait
modification.
This study builds on previous work investigating foot progres-
sion angle modification in uncontrolled studies. While Shull et al.17
and Hunt and Takacs16 both found improvements in knee pain and
joint loading with toe-in and toe-out gait modification, respec-
tively, the primary limitation of those studies was the lack of con-
trol group. As walking programs can improve pain and function for
people with knee OA25, it was possible that any clinical changes in
previous gait modification studies may have been the result of in-
creases in physical activity levels, and not due to the altered loading
908 M.A. Hunt et al. / Osteoarthritis and Cartilage 26 (2018) 903e911

Table I flexion angles remained unchanged; these factors are known to

Mean (SD) baseline participant characteristics. Radiographic disease severity is
based on Kellgren and Lawrence grading criteria for mild (grade 2), moderate (grade
3), and severe (grade 4) radiographic osteoarthritis
Descriptive data Progressive
walking (n ¼ 39)
Age (years) 65.4 (9.6)
Sex (M/F) 11/28
Height (m) 1.66 (0.09)
Body mass (kg) 75.6 (13.2)
Body mass index (kg/m2) 27.4 (3.5)
Radiographic severity
Mild (n (%)) 18 (46)
Moderate (n (%)) 14 (36)
Severe (n (%)) 7 (18)
environment within the knee. Results from the current study
would appear to support that notion. Specifically, both groups
exhibited improved self-reported pain and function at both time
points e based on examination of confidence interval limits of
differences. Though the TO group exhibited larger improvements in
all self-report outcomes, no statistically significant differences were
observed. Using a minimal clinically important difference of 17% for
WOMAC pain30, 18/36 (50%) of those in the PW group, and 21/38
(55%) in the TO group experienced clinically important improve-
ments in pain at follow-up. These findings are consistent with the
statistical analysis indicating similar effects on pain in both groups.
The effects of foot progression gait modification on the KAM are
well-known in the literature, with many studies in healthy and
osteoarthritic populations reporting significant KAM reductions
with both toe-in and toe-out gait modification13. In the present
study, reductions in the late stance KAM and KAM impulse were
observed in the TO group, both statistically greater than the PW
group at the follow-up assessment. These findings point to an
improved loading environment that may be protective against
disease progression over the longer-term11,18. Importantly, no
changes in other loading parameters that may potentially negate
KAM improvements were observed. Specifically, early stance KAM
magnitudes, as well as peak KFMs, remained unchanged with the
toe-out gait modification. This was likely due to the focus on
changing only foot progression angle during training, whilst
ensuring that gait characteristics such as stance width and knee
influence early KAM and KFMs, respectively31,32. As a result, future
studies or clinical implementation that utilize foot progression gait
modification should attempt to ensure maintenance of these
Toe-out important kinematic characteristics.
(n ¼ 40)
Findings from the PW group appear to support previous studies
64.6 (7.6) examining changes in clinical and biomechanical outcomes with
13/27
exercise in people with knee OA. For example, improvements in
1.64 (0.10)
73.6 (13.2) self-reported pain and function following exercise in this popula-
27.3 (3.5) tion are well known33. However, studies examining the effects of
lower limb strengthening on KAM magnitudes have failed to show
19 (48)
any significant reductions, and most studies have actually reported
17 (42)
4 (10)
a small but statistically non-significant increase in KAM34e37. Data
from the PW group in the current study suggest similar findings.
Increases in early stance peak KAM values were approximately 8%
at both follow-up and retention. Factors such as increased walking
speed and reductions in compensatory characteristics that may
arise in conjunction with pain relief35, may be responsible for these
increases in medial tibiofemoral loading. Indeed, one potential
unintended consequence of improvements in physical activity
following an exercise program for knee OA is the potential for
increased knee joint loading.
Accordingly, a primary benefit of the use of a gait modification
program such as increasing toe-out is the ability to achieve im-
provements in symptoms and physical activity levels, without the
associated increases in KAM magnitudes. That the TO group did not
exhibit statistically significant greater improvements in pain and
function over and above a walking program alone may be unim-
portant. The fact that those in the TO group achieved improve-
ments in both knee symptoms and loading, while the PW group
only experienced improvements in symptoms is of note. Interest-
ingly, however, between-group differences in late stance KAM and
KAM impulse at retention were absent. At this time point, the dif-
ference in foot progression angle was less than 7, compared to 9 at
follow-up. In our previous uncontrolled pilot study, the mean
change in foot progression angle was 6.7, and the resultant P-
values for late stance KAM and KAM impulse were P ¼ 0.04 and
P ¼ 0.20, respectively16. It would appear that an increase in toe-out
of at least 7 may be required to evoke significant KAM improve-
ments. Research identifying the minimum amount of change
required to produce meaningful improvements in knee symptoms
and loading is needed to best guide clinical implementation.

Table II
Mean (standard error) data by group across all time points. Note that numbers in brackets in top row correspond to the number of participants providing self-report/objective
function and biomechanical outcomes at each time point for each group

Baseline Follow-up (Month 4) Retention (Month 5)

Progressive Toe-out Progressive Toe-out Progressive Toe-out (n ¼ 35)

Walking (n ¼ 40/40) Walking (n ¼ 38/37) Walking
(n ¼ 39/39) (n ¼ 36/33) (n ¼ 32/31)

Self-report outcomes
WOMAC pain (0e20) 6.4 (0.4) 7.6 (0.5) 5.4 (0.5) 4.2 (0.5) 5.3 (0.5) 4.2 (0.5)
WOMAC physical 21.4 (1.5) 28.1 (1.9) 16.7 (1.6) 13.0 (1.6) 17.7 (1.6) 14.9 (1.5)
function (0e68)
NRS pain (0e10) 3.7 (0.3) 4.7 (0.4) 2.3 (0.3) 2.0 (0.3) 2.6 (0.3) 1.9 (0.3)
Objective function
Timed stair climb (s) 5.74 (0.43) 6.01 (0.29) 5.51 (0.21) 5.72 (0.20) 5.44 (0.23) 5.33 (0.22)
Biomechanical outcomes
Gait speed (m/s) 1.20 (0.03) 1.18 (0.02) 1.21 (0.02) 1.23 (0.02) 1.25 (0.01) 1.23 (0.01)
Foot progression angle ( ) 5.57 (0.77) 6.83 (0.63) 5.74 (0.79) 14.78 (0.74) 5.80 (0.74) 12.58 (0.69)
KAM1 (%BW*ht) 2.38 (0.14) 2.41 (0.21) 2.57 (0.06) 2.43 (0.06) 2.57 (0.07) 2.41 (0.07)
KAM2 (%BW*ht) 2.63 (0.16) 2.67 (0.19) 2.69 (0.07) 2.44 (0.05) 2.70 (0.07) 2.50 (0.07)
KAM impulse (%BW*ht*s) 0.86 (0.06) 0.84 (0.07) 0.87 (0.02) 0.82 (0.02) 0.87 (0.02) 0.81 (0.02)
KFM (%BW*ht) 3.20 (0.24) 3.01 (0.23) 3.18 (0.17) 3.14 (0.16) 3.35 (0.17) 3.38 (0.16)

Note: Follow-up and Retention values were computed after adjusting for baseline values (all outcomes), and additionally for gait speed at the associated time point
(biomechanical outcomes only).
 M.A. Hunt et al. / Osteoarthritis and Cartilage 26 (2018) 903e911 909

Table III
Mean (95% CI) within- and between-group differences at Follow-up and Retention, calculated as Toe-out group minus Progressive Walking group

Baseline to Follow-up Baseline to Retention Mean difference between groups

Progressive Toe-out Progressive Toe-out Baseline to P-value Baseline to P-value

Walking Walking Follow-up Retention

Self-report outcomes
WOMAC pain (0e20) 1.5 2.7 1.5 2.5 1.1 0.117 1.1 0.133
(2.5, 0.5) (3.6, 1.7) (2.5, 0.5) (3.5, 1.6) (2.6, 0.3) (2.5, 0.3)
WOMAC physical 7.7 11.4 6.6 9.4 3.7 0.111 2.7 0.232
function (0e68) (10.9, 4.5) (14.6, 8.3) (9.8, 3.4) (12.4, 6.3) (8.3, 0.9) (7.3, 1.8)
NRS pain (0e10) 1.8 2.1 1.5 2.2 0.3 0.495 0.8 0.079
(2.4, 1.2) (2.7, 1.5) (2.1, 0.9) (2.8, 1.7) (1.1, 0.5) (1.6, 0.1)
Objective function
Timed stair climb (s) 0.37 0.16 0.33 0.44 0.21 0.462 0.11 0.737
(0.78, 0.05) (0.55, 0.24) (0.80, 0.14) (0.89, 0.01) (0.36, 0.78) (0.76, 0.54)
Biomechanical outcomes
Gait speed (m/s) 0.03 0.05 0.07 0.05 0.02 0.507 0.02 0.395
(0.01, 0.07) (0.01, 0.08) (0.04, 0.10) (0.03, 0.08) (0.03, 0.07) (0.06, 0.02)
Foot progression angle ( ) 0.17 8.87 0.18 6.96 9.04 <0.001* 6.78 <0.001*
(1.41, 1.74) (10.36, 7.39) (1.66, 1.29) (8.35, 5.58) (11.22, 6.86) (8.82, 4.75)
KAM1 (%BW*ht) 0.13 0.01 0.11 0.06 0.14 0.125 0.17 0.103
(0.00, 0.26) (0.13, 0.11) (0.04, 0.26) (0.20, 0.08) (0.31, 0.04) (0.37, 0.03)
KAM2 (%BW*ht) 0.02 0.24 0.01 0.19 0.26 <0.001* 0.20 0.056
(0.08, 0.11) (0.33, 0.15) (0.14, 0.16) (0.33, 0.04) (0.39, 0.12) (0.40, 0.01)
KAM impulse (%BW*ht*s) 0.01 0.04 0.00 0.06 0.06 0.031* 0.06 0.058
(0.02, 0.05) (0.08, 0.01) (0.04, 0.05) (0.10, 0.02) (0.11, 0.01) (0.12, 0.00)
KFM (%BW*ht) 0.09 0.06 0.28 0.31 0.03 0.876 0.03 0.897
(0.24, 0.43) (0.26, 0.38) (0.06, 0.61) (0.01, 0.62) (0.50, 0.43) (0.43, 0.49)

Differences are based on data computed after adjusting for baseline values (all outcomes), and additionally for gait speed at the associated time point (biomechanical outcomes
only). * denotes P < 0.05.

Fig. 3. Ensemble average curves for the Progressive Walking (left) and Toe-out (right) groups. Top graphs correspond to knee adduction moment profiles during stance, while lower
graphs indicate foot progression angles (negative ¼ toe-out) throughout the gait cycle. Lines correspond to baseline (solid), follow-up (hashed), and retention (dotted) ensemble
averages.

The strengths of this study were the randomized controlled
design, the use of a retention time point, and the clinically feasible
method of gait modification. Previous work has shown that mirror-
based movement modification is feasible38, and not appreciably
different than training with sophisticated motion capture systems
with real-time biofeedback20. The primary limitations of this study
were the length of the intervention, the use of barefoot walking
during biomechanical testing, and the exclusion criteria. While
standardized gait testing without shoes negates the confounding
effect of shoe type on gait measures, the reduction in ecological
validity may have a negative impact on generalizability of findings.
Since the ability to travel to and from the university for the multiple
testing and training sessions was required, these results may not
necessarily be generalizable to certain subgroups of the population.
910 M.A. Hunt et al. / Osteoarthritis and Cartilage 26 (2018) 903e911
In conclusion, a 4-month walking program that involved toe-out
gait modification produced significant improvements in knee joint
loading, and similar improvements in knee pain compared to a
similar walking program without toe-out gait modification. Future
research identifying methods to improve the feasibility and effec-
tiveness of delivering gait modification in the clinical setting, as
well as an assessment of the potential economic benefits, is needed.
Author contributions
All authors were involved in aspects of the conception and design
of the study, or acquisition of data, or analysis and interpretation of
data. Further, all authors contributed to drafting the article or
revising it critically for important intellectual content, as well as
providing final approval of the version to be submitted.
M. Hunt was involved in study design, procurement of funding,
data analysis, as well as drafting and final approval of the
manuscript.
J. Charlton was involved in participant training, manuscript
revision, and final approval of the manuscript.
N. Krowchuk was involved in participant recruitment, manu-
script revision, and final approval of the manuscript.
C. Tse was involved in data collection and analysis, manuscript
revision, and final approval of the manuscript.
G. Hatfield was involved in data collection and analysis, manu-
script revision, and final approval of the manuscript.
M. Hunt takes responsibility for the integrity of the work as a
whole.
Competing interests
None.
Role of funding source
None.
Acknowledgments
Funding for this study was received from The Arthritis Society
(SOG-13-024) (Canada). Salary support was provided by the
Michael Smith Foundation for Health Research (MAH), the Cana-
dian Institutes of Health Research (MAH, JMC, GLH), and the Natural
Sciences and Engineering Research Council of Canada (CTT). The
authors thank Dr Eric Sayre for performing the statistical analyses
for this study, and Dr Charles Goldsmith for developing and
implementing the randomization procedures.
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