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

distribution during walking2,6,7. The KAM has received the most
Excessive and altered loading within the knee joint are believed attention in the knee OA gait literature8, and is an important
to play major roles in knee osteoarthritis (OA) progression1e4. outcome measure in many conservative treatment studies for this
While not necessarily a full reflection of the loading environment disease9. Significant relationships exist between baseline peak
within the knee joint5, the external knee adduction moment (KAM) 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-
* Address correspondence and reprint requests to: M.A. Hunt, Department of ing11, or rates of undergoing total knee joint arthroplasty12. Taken
Physical Therapy, University of British Columbia, 212-2177 Wesbrook Mall, Van- together, these findings point to an important need to identify and
couver, BC V6T 1Z3, Canada. Tel: 1-604-827-4721; Fax: 1-604-822-1870. develop effective load-reducing treatments for knee OA.
E-mail addresses: [email protected] (M.A. Hunt), [email protected]
Modifying aspects of one's gait pattern has been well-studied
(J.M. Charlton), [email protected] (N.M. Krowchuk), [email protected]
(C.T.F. Tse), gillian.hatfi[email protected] (G.L. Hatfield). 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 Study design

gait modifications have been shown in systematic reviews13. The
most common gait modification in the knee OA literature is This was a parallel group, assessor-blinded, randomized
changing one's foot progression angle e the angle between the foot controlled trial. Interested participants were initially screened for
when it is in contact with the ground, and the forward line of inclusion and exclusion criteria over the telephone and eligible
progression of the body13. In general, most studies have found that individuals then underwent a physical screen. Screening was
toeing in reduces the early stance KAM14, while toeing out reduces overseen by a researcher not involved in data collection or analysis.
the late stance KAM15. This physical screen was conducted to confirm the presence of
A recent pilot study showed that a 10-week toe-out gait modi- knee pain, and to perform a preliminary walking assessment to
fication program produced significant reductions in late stance quantify self-selected foot progression angle. Participants per-
KAM values as well as knee pain16. Similar findings have been re- formed three trials of self-selected, over ground walking while three
ported following a 6-week toe-in gait modification program, with reflective skin markers tracked the movement of the sacrum, the
reductions in knee pain and early stance KAM reported17. Impor- second toe, and posterior calcaneus of the study limb (defined as the
tantly, toe-out gait may also have important implications for OA self-declared osteoarthritic limb in those with unilateral symptoms,
disease progression. Chang et al.18 showed that each 5 increase in or the most painful limb in the case of bilateral symptoms). The
foot progression angle in the toe-out direction had an associated mean foot progression angle across the three trials was calculated.
odds ratio of 0.60 (95% CI: 0.37, 0.98) for medial radiographic As the goal of the toe-out modification program was to increase the
tibiofemoral progression over an 18-month timeframe. These self-selected, baseline foot progression angle by 15 in the toe-out
findings suggest that increasing toe-out magnitudes during gait direction, 15 of toe-out at the physical screening was selected as
may have a protective effect against OA progression, and thus the threshold. This was done due to (1) the difficulty in achieving
beneficial long-term consequences. toe-out angles of 30 by people with knee OA15, and (2) the fact that
While there is a growing body of evidence reporting on the those who already exhibit large amounts of toe-out would likely not
potential biomechanical and clinical benefits of increasing toe-out be candidates for toe-out gait modification in the clinical setting.
during gait by people with medial tibiofemoral knee OA, the Those who passed physical screening were referred for radio-
quality of evidence is limited by a lack of randomized controlled graphic evaluation. Standing, semi-flexed, postero-anterior radio-
trial data in this area. Therefore, the primary aim of the present graphs were obtained and graded for disease severity using the
study was to conduct a randomized controlled trial comparing Kellgren and Lawrence (KL) OA classification system19.
clinical and biomechanical changes associated with a 4-month Individuals who met the radiographic criteria listed above were
walking program with or without toe-out gait modification for invited to the laboratory for a baseline (Week 0) testing session
people with medial tibiofemoral knee OA. It was hypothesized that where self-report questionnaire, objective physical function, and
the walking program that included toe-out gait modification would biomechanical data were collected. Following completion of base-
produce significantly greater reductions in knee pain and KAM line testing, the randomization procedure was conducted by a study
values than the program without toe-out gait modification. biostatistician who was not involved in any aspect of data collection
or training. Randomization was initiated by the study research
Methods coordinator, who provided the biostatistician with each partici-
pant's study ID, sex, and KL grade. The biostatistician then
Participants responded via email with the group allocation, and maintained the
randomization parameters and list offsite. Group allocations were
Community-dwelling individuals were recruited via an existing determined prior to study commencement, and randomization was
laboratory database as well as advertisements in print media. In- stratified by sex (male, female) and disease severity (mild or
clusion criteria were: (1) definitive medial tibiofemoral osteophytes moderate grouped together, severe).
on X-ray; (2) joint space narrowing greater in the medial tibiofe- Participants returned to the university the following week (Week
moral compartment compared to the lateral compartment; (3) 1) to begin their training program, and were informed of their group
history of knee pain longer than 6 months; and (4) average knee allocation at this time. Each home-based program lasted 4 months
pain of at least 3 out of 10 over the 1 month period prior to initial and was supplemented with eight training sessions with the study
screening. Exclusion criteria were: (1) knee surgery or intra- trainer at Weeks 1, 2, 4, 6, 8, 10, 12 and 15 of the intervention, with
articular pain relief injection within 6 months; (2) current or past typical sessions lasting 20 min in Week 1 and increasing to 40 min by
(within 6 months) oral corticosteroid use; (3) history of knee joint Week 15. All training sessions, regardless of group allocation, were
replacement or tibial osteotomy; (4) any other condition affecting conducted by the same trainer in the same rehabilitation gymna-
lower limb function; (5) participation in a new structured exercise sium. The first training session for each participant was always a one-
program within the past 3 months, or planning to commence ex- on-one session with the trainer, with subsequent sessions conducted
ercise or other treatment for knee OA in the next 4 months; and, (6) in groups of one to three individuals; in cases of group sessions, only
an inability to travel to the university to attend testing and training individuals from the same group allocation were present in the
sessions. The study was approved by the Institution's Clinical gymnasium to prevent cross-contamination of groups.
Research Ethics Board and all participants provided written Follow-up testing occurred 4 months after baseline testing, with
informed consent. a final retention testing session conducted 1 month later. The same
Sample size was determined based on randomization with outcome measures, completed in the same testing order, and by the
stratification, and covarying for baseline values in the statistical same blinded assessor, were collected at each testing session. No
analysis. Using effect size estimates of 0.8 for WOMAC pain and 1.0 training or instructions of any kind were provided between these
for KAM impulse, based on pilot data using a similar design16, it was final two testing sessions.
determined that 33 participants in each group was required to
attain 90% power to detect significant differences in pain and KAM Interventions
outcomes between groups with an alpha of 0.05. Using a conser-
vative estimate of 10% attrition, the aim was to recruit 73 partici- For both groups, the intent was to increase the weekly amount
pants for this study. of walking out in the community by 40% over and above that
 M.A. Hunt et al. / Osteoarthritis and Cartilage 26 (2018) 903e911 905

exhibited prior to enrollment. Initial values were assessed via dis- in achieving the target angle was recorded at each training session
cussion with participants at the first training session, and pre- using an 11-point numerical rating scale (NRS) with terminal de-
scribed weekly increases were determined individually at each scriptors of (0 ¼ “no difficulty” and 10 ¼ “unable to perform”).
training session in consultation with the trainer. Participants were instructed to maintain the increased toe-out
angle outside the training sessions whilst walking in the
community.
Toe-out (TO) gait modification program
Participants randomized to the TO program were trained to Progressive walking (PW) program
perform walking with 15 more toe-out than the self-selected Participants randomized to the PW program underwent all
amount measured at the baseline testing session. Our previous training procedures as those in the TO group, with the exception of
pilot study showed modest improvements of 6.7 in self-selected receiving no training or instruction related to toe-out walking. This
toe-out angle following 10-weeks of toe-out gait retraining included walking on the treadmill in front of a mirror during
intending to increase toe-out by 10 , that resulted in marginally training sessions, but without foot placement guide tape as per the
statistically significant improvements in late stance KAM (P ¼ 0.04) TO training protocol.
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 Outcome measures
selected for this study.
Toe-out modification during the training sessions was facilitated Pain and physical function
with mirror-guided biofeedback of performance. Participants At each testing session, participants completed the Western
placed their study foot on a protractor device at the target toe-out Ontario and McMaster Universities Arthritis Index (WOMAC) Likert
angle for that session, and verbally instructed the therapist in the version22. Average knee pain over the previous week was also
placement of a piece of green tape on the mirror to best cover the assessed using an 11-point NRS with terminal descriptors of 0 ¼ “no
reflection of the foot in this target position. The tape remained on pain” and 10 ¼ “worst pain imaginable”. Overall perceived change
the mirror during the training session to guide foot placement at follow-up compared to baseline was assessed using a 15-point
during treadmill walking (Fig. 1)20. To promote motor learning, a Likert scale (7 ¼ “a very great deal worse” 0 ¼ “about the
faded feedback paradigm was used21 with removal of real-time same”, þ7 ¼ “a very great deal better”)23. Finally, participants
biofeedback commencing at session 4 (mean percentage of completed the timed stair climb test where they were instructed to
walking time with feedback: Week 6 ¼ 90%; Week 8 ¼ 75%; Week ascend 12 stairs “as quickly as possible”, and the fastest time from
10 ¼ 60%; Week 12 ¼ 45%; Week 15 ¼ 35%). Self-reported difficulty 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
Fig. 1. Toe-out gait modification was performed on a treadmill with the participant
(0 ¼ “not confident at all”, 10 ¼ “very confident”) in the log book
facing a full-length mirror. A piece of tape was placed on the mirror as a target for foot was used to assess self-reported confidence in the ability of those in
placement during each step. 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 P < 0.001; 6.78 , 95% CI: 8.82 , 4.75 at retention, P < 0.001).
adverse events reported during the intervention were assessed This translated into significantly larger reductions at follow-up in
using open-ended questions in the log book maintained by the the TO group for the late stance KAM (0.26 %BW*ht, 95%
participants. For the purposes of analysis, adverse events were CI: 0.39 %BW*ht, 0.12 %BW*ht, P < 0.001) as well as the KAM
defined as those lasting longer than 2 weeks in duration, or impulse (0.06 %BW*ht*s, 95% CI: 0.11 %BW*ht*s, 0.01 %
requiring additional treatment. BW*ht*s, P ¼ 0.031). While improvements, based on confidence
interval assessment, in these two variables were maintained in the
Statistical analysis TO group at retention, no statistically significant between-group
differences remained (P ¼ 0.056 and P ¼ 0.058). No statistically
The primary outcomes were WOMAC pain, KAM impulse, and significant between-group differences were observed in any other
foot progression angle, and the primary endpoint was the follow- biomechanical variable (P > 0.103). Re-analysis of the data using
up assessment. All other biomechanical and clinical outcomes multiple imputation produced similar results; the only difference
were considered secondary in nature. Between-group comparisons compared to the non-imputed analysis was a non-significant be-
were the primary analyses, with within-group comparisons used tween-group difference in KAM impulse at follow-up (0.07 %
for informational purposes. Analysis of covariance (ANCOVA) BW*ht*s, 95% CI: 0.16 %BW*ht*s, 0.02 %BW*ht*s, P ¼ 0.113).
models were fit predicting each outcome variable evaluated at both Attendance at the training sessions was similar between the
time points (follow-up and retention), with group as predictor, and groups, with the PW group attending a mean 7.1 ± 2.1 of eight
while controlling for baseline values. For biomechanical outcomes sessions, and the TO group attending a mean 7.2 ± 1.9 sessions. A
(knee adduction and flexion moments, as well as foot progression total of 31/39 (79.5%) of those in the PW group, and 33/40 (82.5%) in
angle), additional models were computed while additionally con- the TO group, attended all eight training sessions. For those in the
trolling for concurrent gait speed at the associated time point TO group, training with the final target angle (15 increase in toe-
(follow-up or retention). For baseline data, crude means were out) commenced on the second or third session for most partici-
computed. Adjusted least squares means (LS means) with standard pants, and feedback was progressively removed commencing on
errors and 95% confidence intervals were computed for each group the fourth session for all participants. By the eighth session, par-
at both follow-up and retention27. Adjusted LS means were ticipants were receiving mirror-based feedback for a mean
computed in similar models for within-group (delta) scores. Finally, 34.9 ± 22.7% of treadmill walking time. Self-reported difficulty in
model-adjusted group effects were computed, along with P-values achieving the target angle for a given training session improved
and 95% confidence intervals, for all outcomes. from 2.8 ± 2.2 out of 10 at the first training session to 0.9 ± 1.2 at the
All data were analyzed using an intention-to-treat analysis, and final training session.
the primary analyses assumed that data were missing completely at Compliance to the home-based program was high in both
random (MCAR). In sensitivity analyses, multiple imputation was groups. Self-reported weekly walking time increased over the
performed as per the methods described by van Buuren28. Results duration of the intervention in both the PW (6.5 ± 6.9 h to
and conclusions were compared to the MCAR analysis, and any 7.7 ± 5.3 h) and TO (6.7 ± 5.4 h to 8.3 ± 5.1 h) groups. The mean
differences noted. All statistical analyses were conducted by a individual percentage changes within each group were (48% ± 74%)
biostatistician blinded to group allocation and who was not and (59% ± 99%) in the PW and TO groups, respectively. Further,
involved in any other aspect of the study. Analyses were performed self-confidence in the TO group participants' perceived ability to
using SAS v9.4 (SAS Institute, Cary, North Carolina). 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
Results final week of the intervention.
Four participants in the PW group reported an adverse event:
Between May 2014 and February 2017, 497 individuals under- two episodes of hip pain (one lasting 3 weeks, and one lasting the
went telephone screening (Fig. 2). Seventy-nine individuals passed duration of the intervention); one episode of foot pain lasting
all screening, and underwent baseline testing and randomization 4 weeks, and one episode of lower back pain lasting 4 weeks. There
(Table I). Questionnaire data was completed by 74 individuals at were eight adverse events reported in the TO group: five episodes
follow-up and 67 individuals at retention, while gait and stair climb of hip pain (four lasting 3 weeks and one lasting 8 weeks); one
data were obtained from 70 and 66 individuals at these time points. episode of big toe pain lasting the duration of the intervention; one
Group data at all time points are summarized in Table II, while episode of lower back pain lasting 5 weeks, and one episode of
within- and between-group differences are reported in Table III. posterior thigh pain lasting 3 weeks. Finally, four participants in the
Both groups experienced improvements in self-reported pain and PW group reported seeking additional treatment during the inter-
function (i.e., 95% confidence intervals of change did not cross zero), vention: two participants purchased shock absorbing shoe insoles
and while these improvements were larger in the TO group, no in Week 7; one participant took one dosage of Chinese herbs in
differences were statistically significant (P > 0.079). A total of 28 Week 2; and one participant purchased shoes with heel inserts in
participants in the PW group (median score ¼ 2.5, indicating be- Week 10. One participant in the TO group reported taking “sup-
tween “a little bit better” and “somewhat better”), and 34 in the TO plements” between Weeks 3 and 5 of the intervention.
group (median score ¼ 4.0, indicating “moderately better”) re-
ported a perceived improvement overall symptoms at follow-up. Discussion
No within- or between-group differences were observed in the
timed stair climb test. This study is the first randomized controlled trial, to our
The TO group exhibited an average increase in their self-selected knowledge, to assess the clinical and biomechanical effects of a gait
foot progression angle of 8.87 and 6.96 in the toe-out direction at modification program in people with knee OA. While other studies
follow-up and retention, respectively (Fig. 3). No changes were may have incorporated gait modification into the overall inter-
observed in the PW group, and between-group differences were vention29, the current study assessed the effects of a toe-out gait
significant at both time points, with the TO group exhibiting modification program in isolation. Findings indicate that while the
approximately 9 and 7 more toe-out change at follow-up and expected changes in gait kinematics (i.e., foot progression angle)
retention (9.04 , 95% CI: 11.22 , 6.86 at follow-up, 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 joint loading with toe-in and toe-out gait modification, respec-
translate into improved clinical outcomes in those performing gait tively, the primary limitation of those studies was the lack of con-
modification. trol group. As walking programs can improve pain and function for
This study builds on previous work investigating foot progres- people with knee OA25, it was possible that any clinical changes in
sion angle modification in uncontrolled studies. While Shull et al.17 previous gait modification studies may have been the result of in-
and Hunt and Takacs16 both found improvements in knee pain and 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 influence early KAM and KFMs, respectively31,32. As a result, future
based on Kellgren and Lawrence grading criteria for mild (grade 2), moderate (grade
3), and severe (grade 4) radiographic osteoarthritis
studies or clinical implementation that utilize foot progression gait
modification should attempt to ensure maintenance of these
Descriptive data Progressive Toe-out important kinematic characteristics.
walking (n ¼ 39) (n ¼ 40)
Findings from the PW group appear to support previous studies
Age (years) 65.4 (9.6) 64.6 (7.6) examining changes in clinical and biomechanical outcomes with
Sex (M/F) 11/28 13/27
exercise in people with knee OA. For example, improvements in
Height (m) 1.66 (0.09) 1.64 (0.10)
Body mass (kg) 75.6 (13.2) 73.6 (13.2) self-reported pain and function following exercise in this popula-
Body mass index (kg/m2) 27.4 (3.5) 27.3 (3.5) tion are well known33. However, studies examining the effects of
Radiographic severity lower limb strengthening on KAM magnitudes have failed to show
Mild (n (%)) 18 (46) 19 (48)
any significant reductions, and most studies have actually reported
Moderate (n (%)) 14 (36) 17 (42)
Severe (n (%)) 7 (18) 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
environment within the knee. Results from the current study speed and reductions in compensatory characteristics that may
would appear to support that notion. Specifically, both groups arise in conjunction with pain relief35, may be responsible for these
exhibited improved self-reported pain and function at both time increases in medial tibiofemoral loading. Indeed, one potential
points e based on examination of confidence interval limits of unintended consequence of improvements in physical activity
differences. Though the TO group exhibited larger improvements in following an exercise program for knee OA is the potential for
all self-report outcomes, no statistically significant differences were increased knee joint loading.
observed. Using a minimal clinically important difference of 17% for Accordingly, a primary benefit of the use of a gait modification
WOMAC pain30, 18/36 (50%) of those in the PW group, and 21/38 program such as increasing toe-out is the ability to achieve im-
(55%) in the TO group experienced clinically important improve- provements in symptoms and physical activity levels, without the
ments in pain at follow-up. These findings are consistent with the associated increases in KAM magnitudes. That the TO group did not
statistical analysis indicating similar effects on pain in both groups. exhibit statistically significant greater improvements in pain and
The effects of foot progression gait modification on the KAM are function over and above a walking program alone may be unim-
well-known in the literature, with many studies in healthy and portant. The fact that those in the TO group achieved improve-
osteoarthritic populations reporting significant KAM reductions ments in both knee symptoms and loading, while the PW group
with both toe-in and toe-out gait modification13. In the present only experienced improvements in symptoms is of note. Interest-
study, reductions in the late stance KAM and KAM impulse were ingly, however, between-group differences in late stance KAM and
observed in the TO group, both statistically greater than the PW KAM impulse at retention were absent. At this time point, the dif-
group at the follow-up assessment. These findings point to an ference in foot progression angle was less than 7, compared to 9 at
improved loading environment that may be protective against follow-up. In our previous uncontrolled pilot study, the mean
disease progression over the longer-term11,18. Importantly, no change in foot progression angle was 6.7, and the resultant P-
changes in other loading parameters that may potentially negate values for late stance KAM and KAM impulse were P ¼ 0.04 and
KAM improvements were observed. Specifically, early stance KAM P ¼ 0.20, respectively16. It would appear that an increase in toe-out
magnitudes, as well as peak KFMs, remained unchanged with the of at least 7 may be required to evoke significant KAM improve-
toe-out gait modification. This was likely due to the focus on ments. Research identifying the minimum amount of change
changing only foot progression angle during training, whilst required to produce meaningful improvements in knee symptoms
ensuring that gait characteristics such as stance width and knee 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 during biomechanical testing, and the exclusion criteria. While
design, the use of a retention time point, and the clinically feasible standardized gait testing without shoes negates the confounding
method of gait modification. Previous work has shown that mirror- effect of shoe type on gait measures, the reduction in ecological
based movement modification is feasible38, and not appreciably validity may have a negative impact on generalizability of findings.
different than training with sophisticated motion capture systems Since the ability to travel to and from the university for the multiple
with real-time biofeedback20. The primary limitations of this study testing and training sessions was required, these results may not
were the length of the intervention, the use of barefoot walking 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 7. Andriacchi T, Mundermann A. The role of ambulatory me-
gait modification produced significant improvements in knee joint chanics in the initiation and progression of knee osteoarthritis.
loading, and similar improvements in knee pain compared to a Curr Opin Rheumatol 2006;18:514e8.
similar walking program without toe-out gait modification. Future 8. Mills K, Hunt MA, Ferber R. Biomechanical deviations during
research identifying methods to improve the feasibility and effec- level walking associated with knee osteoarthritis: a systematic
tiveness of delivering gait modification in the clinical setting, as review and meta-analysis. Arthritis Care Res 2013;65:
well as an assessment of the potential economic benefits, is needed. 1643e65.
9. Arnold JB, Wong DX, Jones RK, Hill CL, Thewlis D. Lateral
Author contributions wedge insoles for reducing biomechanical risk factors for
All authors were involved in aspects of the conception and design medial knee osteoarthritis progression: a systematic review
of the study, or acquisition of data, or analysis and interpretation of and meta-analysis. Arthritis Care Res 2016;68:936e51.
data. Further, all authors contributed to drafting the article or 10. Miyazaki T, Wada M, Kawahara H, Sato M, Baba H, Shimada S.
revising it critically for important intellectual content, as well as Dynamic load at baseline can predict radiographic disease
providing final approval of the version to be submitted. progression in medial compartment knee osteoarthritis. Ann
M. Hunt was involved in study design, procurement of funding, Rheum Dis 2002;61:617e22.
data analysis, as well as drafting and final approval of the 11. Bennell KL, Bowles KA, Wang Y, Cicuttini F, Davies-Tuck M,
manuscript. Hinman RS. Higher dynamic medial knee load predicts greater
J. Charlton was involved in participant training, manuscript cartilage loss over 12 months in medial knee osteoarthritis.
revision, and final approval of the manuscript. Ann Rheum Dis 2011;70:1770e4.
N. Krowchuk was involved in participant recruitment, manu- 12. Hatfield GL, Stanish WD, Hubley-Kozey CL. Three-dimensional
script revision, and final approval of the manuscript. biomechanical gait characteristics at baseline are associated
C. Tse was involved in data collection and analysis, manuscript with progression to total knee arthroplasty. Arthritis Care Res
revision, and final approval of the manuscript. 2015;67:1004e14.
G. Hatfield was involved in data collection and analysis, manu- 13. Simic M, Hinman RS, Wrigley TV, Bennell KL, Hunt MA. Gait
script revision, and final approval of the manuscript. modification strategies for altering medial knee joint load: a
M. Hunt takes responsibility for the integrity of the work as a systematic review. Arthritis Care Res 2011;63:405e26.
whole. 14. Shull PB, Shultz R, Silder A, Dragoo JL, Besier TF, Cutkosky MR,
et al. Toe-in gait reduces the first peak knee adduction
Competing interests moment in patients with medial compartment knee osteoar-
None. thritis. J Biomech 2013;46:122e8.
15. Simic M, Wrigley TV, Hinman RS, Hunt MA, Bennell KL.
Role of funding source Altering foot progression angle in people with medial knee
None. osteoarthritis: the effects of varying toe-in and toe-out angles
are mediated by pain and malalignment. Osteoarthr Cartil
Acknowledgments 2013;21:1272e80.
16. Hunt MA, Takacs J. Effects of a 10-week toe-out gait modifi-
Funding for this study was received from The Arthritis Society cation intervention in people with medial knee osteoarthritis:
(SOG-13-024) (Canada). Salary support was provided by the a pilot, feasibility study. Osteoarthr Cartil 2014;22:904e11.
Michael Smith Foundation for Health Research (MAH), the Cana- 17. Shull PB, Silder A, Shultz R, Dragoo JL, Besier TF, Delp SL, et al.
dian Institutes of Health Research (MAH, JMC, GLH), and the Natural Six-week gait retraining program reduces knee adduction
Sciences and Engineering Research Council of Canada (CTT). The moment, reduces pain, and improves function for individuals
authors thank Dr Eric Sayre for performing the statistical analyses with medial compartment knee osteoarthritis. J Orthop Res
for this study, and Dr Charles Goldsmith for developing and 2013;31:1020e5.
implementing the randomization procedures. 18. Chang A, Hurwitz D, Dunlop D, Song J, Cahue S, Hayes K, et al.
The relationship between toe-out angle during gait and pro-
gression of medial tibiofemoral osteoarthritis. Ann Rheum Dis
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