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Original article
Title:
Validity of gait parameters of healthy young adults using a motion-sensor-based gait analysis
system (ORPHE ANALYTICS) during walking and running
Yuki Uno a, Issei Ogasawara a, b, Shoji Konda a, b, Natsuki Yoshida a, Akira Tsujii b, Ken Nakata a
a
Department of Health and Sport Sciences, Graduate School of Medicine, Osaka University,
Osaka, Japan
b
Department of Sports Medical Biomechanics, Graduate School of Medicine, Osaka University,
Osaka, Japan
Corresponding author:
Ken Nakata and Issei Ogasawara
Department of Health and Sport Sciences, Graduate School of Medicine, Osaka University
1-17, Machikaneyama-cho, Toyonaka city, Osaka 560-0043, Japan
Tel: +81-6-6850-6032
Fax: +81-6-6850-6030
Email: [email protected], [email protected]
Word count: 2989
1
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
medRxiv preprint doi: https://doi.org/10.1101/2022.10.17.22281166; this version posted October 17, 2022. The copyright holder for this preprint
Acknowledgement:
This work was supported by MEXT "Innovation Platform for Society 5.0" Program Grant Number
JPMXP0518071489. The funder had no role in the study design, collection, analysis, and
interpretation of data, manuscript preparation, and decision to submit the article for publication.
2
Abstract
Background: Motion sensors are widely used for gait analysis. ORPHE ANALYTICS is a motion-
sensor-based gait analysis system. The validity of commercial gait analysis systems is of great
interest to clinicians because calculating position/angle-level gait parameters using motion sensor
data potentially produces an error in the integration process; moreover, the validity of ORPHE
ANALYTICS has not yet been examined.
Research question: How valid are the position/angle-level gait parameters calculated using
ORPHE ANALYTICS relative to those calculated using conventional optical motion capture?
Methods: Nine young adults performed gait tasks on a treadmill at speeds of 2–12 km/h. The
motion sensors were mounted on the shoe midsole (plantar-embedded) and shoe instep (instep-
mounted). The three-dimensional marker position data of the foot as well as the acceleration and
angular velocity data of the motion sensors were collected. The position/angle-level gait
parameters were calculated from motion sensor data obtained using ORPHE ANALYTICS and
optical motion capture data. Intraclass correlation coefficients [ICC(2,1)] were calculated for
relative validities, and Bland–Altman plots were plotted.
Results: Eight items, namely, stride duration, stride length, stride frequency, stride speed (plantar-
embedded), vertical height (plantar-embedded), stance phase duration, swing phase duration, and
sagittal angleIC, exhibited excellent relative validities [ICC(2,1) > 0.9]. In contrast, the sagittal
angleTO demonstrated good relative validity [ICC(2,1) = 0.892–0.833], while the frontal angleIC
exhibited moderate relative validity [ICC(2,1) = 0.566–0.627].
Significance: ORPHE ANALYTICS, a motion-sensor-based gait analysis system, was found to
exhibit excellent relative validity for most gait parameters. This finding suggests its feasibility for
gait analysis outside the laboratory setting.
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Highlights:
l Gait-parameter validities were examined for treadmill-based gait tasks at 2–12 km/h.
l Most gait parameters showed excellent relative validity with optical motion capture.
l Shoe midsole-embedded sensors had higher validities than instep-mounted sensors.
l ORPHE ANALYTICS is potentially useful in clinical measurements.
Keywords:
validation study, reliability, wearable devices, inertial measurement unit (IMU), foot-mounted
sensor, spatio-temporal gait parameter
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Introduction
Motion sensors (inertia sensors) have become widely used for the motion measurement of any type
of object owing to their rapid technological development and have recently been applied to gait
analysis[1]. Motion sensors are highly compact and lightweight, allowing their attachment to the
body without spatially restricting the object of measurement. These features potentially overcome
the significant limitations of optical cameras and reflective-marker-based motion capture systems
commonly used in motion measurement, which are only feasible in a limited laboratory space[2].
The motion sensor will expand the range of applications, such as a more natural gait assessment
in daily life and frequent measurements without visiting a specific facility[3].
Several commercial packages that take advantage of motion-sensor compactness and lightweight
are currently available[4–7]. One commercial product is ORPHE ANALYTICS (ORPHE Inc.,
Tokyo, Japan), which is a gait analysis system that can evaluate position/angle-level gait
parameters (such as stride length and foot-ground angle) using the acceleration and angular
velocity data of shoes during walking and running. These data are collected using a 20-g sensor
mounted on a shoe’s midsole or instep. Therefore, provided individuals wear their smart shoes,
assessing their gait patterns without constraining the measurement environment is possible.
Position/angle-level gait parameters are commonly utilised in conventional gait assessments[8]
because conventional gait analyses have frequently used optical motion capture, which can
measure the position and angle of the targeted body segment or shoe. Furthermore, position/angle-
level gait parameters are easier to understand than derivative quantities, such as accelerations and
angular velocities. This background probably motivates the calculation of position/angle-level gait
parameters in motion-sensor-based gait analysis. However, because motion sensors cannot directly
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measure the position/angle-level kinematic properties, numerical integration of the measured
acceleration or angular velocity data is necessary. The numerical integration process poses certain
challenges, such as the production of numerical errors. These errors are affected by sensor
specifications[9,10] and mounting position[11,12]. Therefore, the use of motion-sensor-based
commercial gait analysis systems to determine how consistently position/angle-level gait
parameters are obtained from motion sensors is of great interest. ORPHE ANALYTICS has not
yet been used to verify how consistent the position/angle-level gait parameters calculated using
this motion-sensor-based system and its software are with the corresponding parameters obtained
using the conventional optical motion capture.
Therefore, this study aimed to validate the reliability of ORPHE ANALYTICS by assessing the
agreement of position/angle-level gait parameters between ORPHE ANALYTICS and optical
motion capture during walking and running in healthy participants. We evaluated the relative
validity between the gait parameters from the two different modalities using intraclass correlation
coefficients (ICCs) and visualised them using Bland–Altman plots. We hypothesised that the gait
parameters calculated using ORPHE ANALYTICS exhibit excellent relative validities (ICC>0.9)
to those calculated using optical motion capture.
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Methods
Participants
Nine healthy volunteers who had not undergone surgical treatment of the lower extremity within
one year before the experiment participated in the study [six men and three women; mean age:
25.4 (2.2) y; mean height: 166.6 (9.7) cm; mean weight: 60.3 (10.7) kg; mean shoe size: 25.7 (1.3)
cm]. A priori power analysis suggested a required trial sample size of N=117, with power=0.8,
alpha=0.05, null assumption of ICC=0.7, and alternative hypothesis=0.8, based on the formula
provided by Zou[13]. The Osaka University Hospital Ethics Committee approved this study
(approval no. 19537), and all participants provided informed consent.
Procedure
The participants wore shoes (SHIBUYA 2.0, ORPHE Inc., Tokyo, Japan) with midsole space to
embed the motion sensor (ORPHE Inc., Tokyo, Japan; size: 45 mm×29 mm×14 mm, weight: 20
g; Figure 1a). This motion sensor samples the three-axial accelerations and angular velocities using
a built-in sensor (LSM6DSOX, STMicroelectronics; acceleration: ± 16 G, angular velocity: ±
2000 °/s) at a sampling frequency of 200 Hz. The recorded data were stored in built-in flash
memory. Two motion sensors were utilised for each foot. One sensor was embedded in the midsole
space (plantar-embedded, Figure 1a), and the other was securely fixed onto the shoe instep using
dedicated mounting equipment (instep-mounted, Figure 1b). Fourteen reflective markers were
attached to the shoe landmarks to specify the posture and position of the motion sensor on the foot
(Figure 1c).
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Figure 1. (a) Motion sensor embedded in the shoe midsole; (b) Motion sensor mounted on the
shoe instep and dedicated mounting equipment; (c) Marker position on the shoe
(a) The shoe has space for sensor placement, and the centre of the sensor locates 40% of the shoe length from
the heel edge. (b) Motion sensor mounted on the shoe instep using dedicated mounting equipment that can be
fixed to the shoelace. (c) The names and position definitions of the reflective markers are as follows: LMP, the
lateral edge of the metatarsophalangeal joint; TOE, most anterior edge of the shoe; PLS, posterior lateral side
of motion sensor; ALS, anterior lateral side of motion sensor; PMS, posterior medial side of motion sensor;
HEEL, most posterior edge of shoe midsole; INS, on the centre of the sensor mounted on instep equipment of
the shoe.
Participants performed walking and running tasks on a treadmill (MyRun, Technogym, Cesena,
Italy). The walking task required double support phases and was performed at target speeds of 2,
4, and 6 km/h. The running task required no double support phases and was performed at target
speeds of 6, 9, and 12 km/h. The three foot-strike conditions, that is, the self-selected foot,
forefoot, and rearfoot strike patterns, were performed only in the 12-km/h running task. The
different foot-strike patterns’ purpose was to replicate natural running variability and increase the
associated data variation. Foot-strike pattern differences have been reported to affect gait-event
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detection timing in gait analysis using foot-mounted motion sensors[14]. Two experimenters
(UY and YN) monitored task requirements. At the beginning of each trial, the participant
maintained a static standing position on the treadmill for 10 s and subsequently performed a
vertical jump to synchronise the motion sensors and motion capture system. Thereafter, the
participants were asked to increase the treadmill speed by themselves to the target speed and
maintain the assigned gait speed for 1 min. Tasks were performed from the slower to the faster
condition for the participants’ safety. Three-minute resting periods were provided between each
trial to reduce the effect of fatigue. The participants could discontinue their trial at any time
when they experienced difficulty in completing further trials (see Supplementary Table S1 for
details of the tasks completed by the participants). The reflective-marker positions were
measured using 12 optical cameras (OptiTrack Prime 17 W, NaturalPoint, Inc., Corvallis, OR,
USA) at a 360-Hz sampling frequency. The three-axial accelerations and angular velocities of
the four motion sensors (plantar/instep on both sides) were sampled at 200 Hz.
Data processing
The marker position data were smoothed using a second-order Butterworth digital filter (low-pass,
zero-lag, cut-off frequency:10 Hz). The motion sensor centre position, anteroposterior axis, and
mediolateral axis used in parameter calculation were defined as follows. The motion sensor centre
was the midpoint between the ALS and PMS markers. The anteroposterior axis was defined as the
unit vector extending from PLS to the ALS marker. The support vector was defined as the unit
vector extending from the PMS to the PLS for the right foot and from the PLS to the PMS for the
left foot. The vertical axis was defined as the cross-product of the support vector and
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anteroposterior axis vector. The mediolateral axis was defined as the cross-product of the
anteroposterior and vertical axis vectors.
The timing of the initial foot contact (IC) for each gait cycle was defined as the instance at which
the target marker’s peak vertical acceleration appeared[15]. The target marker was selected in
every step according to the foot’s orientation when the vertical distance between any of the foot
markers and the treadmill surface was < 50 mm. The HEEL marker was assigned as the target
marker when the angle between the motion sensor's anteroposterior axis and global horizontal
plane was < –15° (toe-up), the LMP marker was assigned when the angle ranged from −15° to −5°
(near-flat), and TOE marker was assigned when the angle was > −5° (toe-down) (Figure S1). The
timing of the toe-off (TO) was defined when the TOE marker exceeded 10 mm above the minimum
vertical height for each cycle[16]. One gait cycle was defined from one IC to the next for each
foot[17]. The gait parameters listed in Table 1 were calculated using each gait cycle’s motion
capture data.
The gait parameters based on the motion sensor data were calculated using ORPHE ANALYTICS
(version 1.4.2; ORPHE Inc., Tokyo, Japan) for each gait cycle (Table 1).
We defined the gait cycles to be analysed and calculated the gait-cycle detection ratio because
ORPHE ANALYTICS did not detect the gait cycle ideally. The motion sensor and optical motion
capture data were time-synchronised with the initial vertical jump’s landing timing, as described
in the method. This procedure was not exact-time synchronisation but sufficient for gait-cycle-
wise correspondence between modalities. To analyse the period after the treadmill speed reached
the target speed, the first 15 gait cycles detected from the motion sensor data were discarded. The
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period from 350 ms before the 16th gait cycle to 350 ms after the last gait cycle was defined as the
analysis period. Regarding the gait cycles calculated from the optical motion capture data, the gait
cycles covered in the analysis period were analysed. The gait-cycle detection ratio was calculated
as the number of gait cycles for analysis by the motion sensor divided by that for analysis by the
optical motion capture.
Outlier processing was performed to exclude gait cycles containing abnormal gait-parameter
values after calculating the gait-cycle detection ratio. Quartiles were calculated for each trial based
on the stride length and duration obtained from the motion sensor and motion capture data. Gait
cycles that included stride length or duration outside 1.5 times the interquartile range above the
upper quartile point or below the lower quartile point were excluded from the analysis. The
percentage of excluded gait cycles was subsequently calculated.
Statistical analysis
The average gait-parameter values for each trial were calculated separately for the left and right
sides, and statistical processing was performed. To evaluate the relative validity of the gait
parameters calculated using motion sensor data against that of those calculated using the motion
capture, ICC(2,1) values were calculated for the overall (walking and running), walking, and
running conditions. ICC(2,1) values were interpreted as follows: excellent (>0.90), good (0.75‒0.90),
moderate (0.50‒0.75), and poor (<0.50)[18].
To visualise the bias and precision between the gait parameters from the motion sensor data and
those from the motion capture data, Bland–Altman plots[19] were plotted. Statistical indices, such
11
as mean difference, 95% limits of agreement of the difference (LoA95%), and percentage LoA
(LoA%), in the Bland–Altman plot were also calculated for the overall, walking, and running
conditions to evaluate absolute reliability. The LoA% was interpreted as follows: very good (<5%),
good (5–10%), moderate (10–20%), poor (20–50%), and very poor (>50%)[20]. However, the
LoA% of the sagittal angleIC and frontal angleIC could not be calculated because these gait
parameters’ average values were normally distributed around 0, rendering it inappropriate to
evaluate in percentages.
Results
Gait-cycle detection ratio in ORPHE ANALYTICS
The status of trial execution and data acquisition is shown in Supplementary Table S1. As regards
the plantar-embedded motion sensor, the gait-cycle frequencies detected by the motion sensor and
optical motion capture data were 5,931 and 5,981, respectively, and the gait-cycle detection ratio
was 99.16%. Regarding the instep-mounted motion sensor, the gait-cycle frequencies detected by
the motion sensor and optical motion capture data were 6,343 and 6,372, respectively, and the gait-
cycle detection ratio was 99.54% (Supplementary Table S2).
Gait-cycle percentages including outliers
The percentages of gait-cycle data excluded from the analysis as outliers were 10.84% and 9.52%
for the plantar-embedded and instep-mounted motion sensors, respectively (Supplementary Table
S3).
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Relative validity of ORPHE ANALYTICS against optical motion capture
The gait-parameter ICCs from ORPHE ANALYTICS and optical motion capture are shown in
Table 2. Stride length, stride duration, stride frequency, stride speed, vertical height, stance phase
duration, swing phase duration and sagittal angleIC exhibited excellent relative validities (ICC>0.9)
in both plantar-embedded and instep-mounted motion sensors. The frontal angleIC demonstrated
moderate agreement (ICC=0.566–0.627), while the sagittal angleTO exhibited good agreement
(ICC=0.892–0.833).
Absolute reliability of ORPHE ANALYTICS against optical motion capture
The Bland–Altman plots of the gait parameters from ORPHE ANALYTICS and the optical motion
capture are shown in Figures 2 and 3, and the statistical indices are shown in Table 3. Stride
duration, stride frequency, vertical height (plantar-embedded), and stride speed (plantar-
embedded) exhibited very good-to-good absolute reliability (LoA%=1.0–9.8). Stride length, stride
speed (instep-mounted), vertical height (instep-mounted), stance phase duration, swing phase
duration, and sagittal angle TO demonstrated moderate-to-poor absolute reliability (LoA%=10.0–
20.4). The vertical height’s LoA% was extremely poor for the instep-mounted model compared
with that for the plantar-embedded model (Table 3). Proportional errors were visually recognised
for stride length and speed (Figure 2b,d, Figure 3b,d).
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Figure 2. Bland–Altman plot of gait parameters from the motion sensor embedded in the shoe
midsole (plantar-embedded) and optical motion capture
(a) stride duration, (b) stride length, (c) stride frequency, (d) stride speed, (e) vertical height, (f) stance phase
duration, (g) swing phase duration, (h) sagittal angleIC, (i) frontal angleIC, (j) sagittal angleTO
MS: motion sensor, OMC: optical motion capture
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Figure 3. Bland–Altman plot of gait parameters from the motion sensor mounted on the shoe
instep (instep-mounted) and optical motion capture
(a) stride duration, (b) stride length, (c) stride frequency, (d) stride speed, (e) vertical height, (f) stance phase
duration, (g) swing phase duration, (h) sagittal angleIC, (i) frontal angleIC, (j) sagittal angleTO
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Discussion
In this study, ORPHE ANALYTICS-derived gait parameters were compared with those from
optical motion capture data during walking and running tasks at speeds of 2–12 km/h in nine
healthy adults. The relative validities of the stride length, stride duration, stride frequency, stride
speed, vertical height, stance phase duration, swing phase duration, and sagittal angleIC for both
plantar-embedded and instep-mounted motion sensors were excellent (ICC>0.9) with respect to
the optical motion capture (Table 2); however, those of the sagittal angleTO and sagittal angleIC
were good, while those of the frontal angleIC were moderate. These results partially support our
hypothesis.
The relative validities of ORPHE ANALYTICS-derived gait parameters were not low compared
with those of a previous meta-analysis involving commercial products such as Physilog, Mobility
Lab, and Stryd, among others (ICC: stance phase time, 0.81–0.97; swing phase time, 0.56–0.81;
stride duration, 0.55–0.99; stride frequency, 0.96–0.99; stride length, 0.75–0.99)[21]. The Bland–
Altman plots revealed that stride length and speed had proportional relationships, and as the values
increased, those calculated using ORPHE ANALYTICS became smaller than those calculated
using the optical motion capture. This study’s results, based on treadmill use by healthy adults,
endorse the reliability of ORPHE ANALYTICS in clinical applications.
Differences between plantar-embedded and instep-mounted motion sensors
Regarding the mounting position, ORPHE ANALYTICS’ validity relative to optical motion
capture was generally better for the plantar-embedded than for the instep-mounted motion sensor
(Tables 2 and 4). Major differences were observed primarily in vertical height, stride length, stride
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speed, and sagittal angleTO. A previous study reported that the error against the reference was
smaller for a sensor embedded in the shoe midsole than for that mounted on the shoe instep[12,22].
This was due to an error in the integral calculation caused by the relatively high vibration
susceptibility of the sensor mounted on the shoe instep[12]. Although we used dedicated mounting
equipment to fix the motion sensor to the shoelace, complete suppression of the influence of
vibration was difficult. While dedicated mounting equipment is advantageous in that the sensor
can be attached to a variety of shoe types, the original shoes with space for storing the sensor have
the advantage of higher gait analysis validity.
Less absolute reliability in sagittal angleTO, swing phase duration, and stance phase duration
The Bland–Altman plots revealed relatively large LoA% in swing phase duration during walking
as well as stance phase duration and sagittal angleTO during running (Table 3). These errors were
caused by differences in toe-off timing detection. Toe-off timing detection accuracy directly
influences these parameters. Due to walking’s short swing phase duration, the time deviation of
the toe-off timing detection relative to the swing phase duration becomes larger. Hence, the LoA%
of the swing phase duration during walking is more prominent, exhibiting a trend similar to that in
previous studies[6,23]. Conversely, the LoA% of the swing phase duration was slightly smaller
during running because the swing phase duration was relatively longer. Even in previous motion-
sensor-based gait analyses, the rule-based detection of toe-off timing from motion sensor data has
been reported to be complex and inaccurate[14,24]. The difficulty in detecting toe-off timing may
also influence the large absolute error of the sagittal angleTO during running.
The proportional errors in stride speed and stride length
19
As the treadmill speed increased, the ORPHE ANALYTICS-derived stride speed and length
tended to be smaller than those calculated using optical motion capture data (Figures 2b, 2d, 3b,
3d). These results are consistent with those reported in previous studies that analysed running using
motion sensors[12,25]. Falbriard et al. [25] noted certain limitations in estimating stride speed
through the simple integration of accelerations during running. They attempted a correction using
a linear function for the stride speed estimated by integrating 500-Hz sampling frequency
accelerations. Considering these arguments, we suggest the following caution when interpreting
the values. First, high relative validity implies its suitability for explaining changes in relative
values, for example, evaluating changes in the same-person’s speed. However, to refer to absolute
values, a better estimation can be made by correcting for proportional agreement. When stride
speed and length were corrected based on the regression lines obtained from this study’s results,
the LoA% decreased and exhibited excellent reliability (Supplementary Figure S2). Interpreting
stride speed and length using ORPHE ANALYTICS based on the assumption of existent
proportional differences is necessary.
Limitations
This study had certain limitations. ORPHE ANALYTICS validation was conducted using a
treadmill because a conventional optical motion capture was used for comparison, and obtaining
many samples for walking and running was necessary. In many clinical situations, treadmill-based
gait is used as a task and measured using motion capture to measure speed-controlled data. In our
validation, we initially provided a standard for the comparison of ORPHE ANALYTICS with
optical motion capture data during treadmill-based walking and running.
20
Only healthy young adults participated in this study. To examine a wide range of gait speeds and
foot-strike patterns, we selected healthy young adult participants with a high potential for exercise.
However, gait patterns vary with age and disease status. Further validation is necessary for older
people and patients with diseases whose gait patterns may affect gait-parameter calculation using
motion sensors[6].
Conclusion
In this study, we evaluated the relative validity and absolute reliability of gait parameters
calculated using the motion-sensor-based gait analysis system ORPHE ANALYTICS against
those calculated using optical motion capture in 2–12 km/h gait involving nine healthy young
adults.
Stride duration, stride length, stride frequency, stride speed (plantar-embedded), vertical height
(plantar-embedded), stance phase duration, swing phase duration, and sagittal angleIC exhibited
excellent relative validity. However, sagittal angleTO and frontal angleIC exhibited good and
moderate relative validities, respectively.
ORPHE ANALYTICS enables gait analysis regardless of the measurement environment and is
expected to be applied in daily-life measurements. This study’s results will serve as a reliability
standard for the future use of this gait analysis system.
21
Conflicts of Interest Statement
UY is an employee of ORPHE, Inc., which provided the ORPHE ANALYTICS. OI, KS, and TA
are affiliated with the Department of Sports Medical Biomechanics, Graduate School of Medicine,
Osaka University, which is supported by ORPHE, Inc. YN is a part-time employee at ORPHE, Inc.
KN received a research grant from ORPHE, Inc.
22
Reference
[1] D. Kobsar, J.M. Charlton, C.T.F. Tse, J.-F. Esculier, A. Graffos, N.M. Krowchuk, D. Thatcher, M.A.
Hunt, Validity and reliability of wearable inertial sensors in healthy adult walking: a systematic
review and meta-analysis, J Neuroeng Rehabil. 17 (2020) 62. https://doi.org/10.1186/s12984-
020-00685-3.
[2] S.R. Simon, Quantification of human motion: gait analysis-benefits and limitations to its
application to clinical problems., J Biomech. 37 (2004) 1869–80.
https://doi.org/10.1016/j.jbiomech.2004.02.047.
[3] L.C. Benson, C.A. Clermont, E. Bošnjak, R. Ferber, The use of wearable devices for walking and
running gait analysis outside of the lab: A systematic review., Gait Posture. 63 (2018) 124–138.
https://doi.org/10.1016/j.gaitpost.2018.04.047.
[4] K. Fukushi, C. Huang, Z. Wang, H. Kajitani, F. Nihey, K. Nakahara, On-Line Algorithms of Stride-
Parameter Estimation for in-Shoe Motion-Sensor System, IEEE Sens J. 22 (2022) 9636–9648.
https://doi.org/10.1109/JSEN.2022.3164057.
[5] K. Carroll, R.A. Kennedy, V. Koutoulas, M. Bui, C.M. Kraan, Validation of shoe-worn Gait Up
Physilog®5 wearable inertial sensors in adolescents, Gait Posture. 91 (2022) 19–25.
https://doi.org/10.1016/j.gaitpost.2021.09.203.
[6] R. Morris, S. Stuart, G. McBarron, P.C. Fino, M. Mancini, C. Curtze, Validity of Mobility Lab
(version 2) for gait assessment in young adults, older adults and Parkinson’s disease, Physiol
Meas. 40 (2019) 095003. https://doi.org/10.1088/1361-6579/ab4023.
[7] F. García-Pinillos, L.E. Roche-Seruendo, N. Marcén-Cinca, L.A. Marco-Contreras, P.A. Latorre-

Román, Absolute Reliability and Concurrent Validity of the Stryd System for the Assessment of
Running Stride Kinematics at Different Velocities, J Strength Cond Res. 35 (2021) 78–84.
https://doi.org/10.1519/JSC.0000000000002595.
[8] M.W. Whittle, Clinical gait analysis: A review, Hum Mov Sci. 15 (1996) 369–387.
https://doi.org/10.1016/0167-9457(96)00006-1.
[9] L. Zhou, E. Fischer, C. Tunca, C.M. Brahms, C. Ersoy, U. Granacher, B. Arnrich, How We Found Our
IMU: Guidelines to IMU Selection and a Comparison of Seven IMUs for Pervasive Healthcare
Applications, Sensors. 20 (2020) 4090. https://doi.org/10.3390/s20154090.
[10] J. Rudisch, T. Jöllenbeck, L. Vogt, T. Cordes, T.J. Klotzbier, O. Vogel, B. Wollesen, Agreement and
consistency of five different clinical gait analysis systems in the assessment of spatiotemporal
gait parameters, Gait Posture. 85 (2021) 55–64. https://doi.org/10.1016/j.gaitpost.2021.01.013.
[11] G. Pacini Panebianco, M.C. Bisi, R. Stagni, S. Fantozzi, Analysis of the performance of 17
algorithms from a systematic review: Influence of sensor position, analysed variable and
computational approach in gait timing estimation from IMU measurements, Gait Posture. 66
(2018) 76–82. https://doi.org/10.1016/J.GAITPOST.2018.08.025.
23
[12] M. Zrenner, A. Küderle, N. Roth, U. Jensen, B. Dümler, B.M. Eskofier, Does the Position of Foot-
Mounted IMU Sensors Influence the Accuracy of Spatio-Temporal Parameters in Endurance
Running?, Sensors. 20 (2020) 5705. https://doi.org/10.3390/s20195705.
[13] G.Y. Zou, Sample size formulas for estimating intraclass correlation coefficients with precision
and assurance, Stat Med. 31 (2012) 3972–3981. https://doi.org/10.1002/SIM.5466.
[14] L. Benson, C. Clermont, R. Watari, T. Exley, R. Ferber, Automated Accelerometer-Based Gait

Event Detection During Multiple Running Conditions, Sensors. 19 (2019) 1483.
https://doi.org/10.3390/s19071483.
[15] H. Stolze, J.P. Kuhtz-Buschbeck, C. Mondwurf, A. Boczek-Funcke, K. Jöhnk, G. Deuschl, M. Illert,

Gait analysis during treadmill and overground locomotion in children and adults,
Electroencephalography and Clinical Neurophysiology - Electromyography and Motor Control.
105 (1997) 490–497. https://doi.org/10.1016/S0924-980X(97)00055-6.
[16] F. Alvim, L. Cerqueira, A.D.A. Netto, G. Leite, A. Muniz, Comparison of five kinematic-based
identification methods of foot contact events during treadmill walking and running at different
speeds, J Appl Biomech. 31 (2015) 383–388. https://doi.org/10.1123/jab.2014-0178.
[17] J. Perry, others, Observational gait analysis handbook, Pathokinesiology Serv. Phys. 36 (1989).
[18] T.K. Koo, M.Y. Li, A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for
Reliability Research, J Chiropr Med. 15 (2016) 155–163.
https://doi.org/10.1016/j.jcm.2016.02.012.
[19] J.M. Bland, D.G. Altman, Statistical methods for assessing agreement between two methods of
clinical measurement., Lancet. 1 (1986) 307–10. http://www.ncbi.nlm.nih.gov/pubmed/2868172.
[20] A. Godfrey, S. del Din, G. Barry, J.C. Mathers, L. Rochester, Instrumenting gait with an
accelerometer: a system and algorithm examination., Med Eng Phys. 37 (2015) 400–7.
https://doi.org/10.1016/j.medengphy.2015.02.003.
[21] B.J. Horsley, P.J. Tofari, S.L. Halson, J.G. Kemp, J. Dickson, N. Maniar, S.J. Cormack, Does Site
Matter? Impact of Inertial Measurement Unit Placement on the Validity and Reliability of Stride
Variables During Running: A Systematic Review and Meta-analysis, Sports Medicine. 51 (2021)
1449–1489. https://doi.org/10.1007/s40279-021-01443-8.
[22] A. Küderle, N. Roth, J. Zlatanovic, M. Zrenner, B. Eskofier, F. Kluge, The placement of foot-
mounted IMU sensors does affect the accuracy of spatial parameters during regular walking,
PLoS One. 17 (2022) e0269567. https://doi.org/10.1371/JOURNAL.PONE.0269567.
[23] E.P. Washabaugh, T. Kalyanaraman, P.G. Adamczyk, E.S. Claflin, C. Krishnan, Validity and
repeatability of inertial measurement units for measuring gait parameters., Gait Posture. 55
(2017) 87–93. https://doi.org/10.1016/j.gaitpost.2017.04.013.
[24] S. Mo, D.H.K. Chow, Accuracy of three methods in gait event detection during overground
running, Gait Posture. 59 (2018) 93–98. https://doi.org/10.1016/j.gaitpost.2017.10.009.
24
[25] M. Falbriard, A. Soltani, K. Aminian, Running Speed Estimation Using Shoe-Worn Inertial Sensors:
Direct Integration, Linear, and Personalized Model, Front Sports Act Living. 3 (2021).
https://doi.org/10.3389/fspor.2021.585809.
25
Figure Legends
Figure 1
(a) Motion sensor embedded in the shoe midsole; (b) Motion sensor mounted on the shoe instep and
dedicated mounting equipment; (c) Marker position on the shoe
(a) The shoe has space for sensor placement, and the centre of the sensor locates 40% of the shoe length from the heel edge. (b) Motion sensor
mounted on the shoe instep using dedicated mounting equipment that can be fixed to the shoelace. (c) The names and position definitions of the
reflective markers are as follows: LMP, the lateral edge of the metatarsophalangeal joint; TOE, most anterior edge of the shoe; PLS, posterior
lateral side of motion sensor; ALS, anterior lateral side of motion sensor; PMS, posterior medial side of motion sensor; HEEL, most posterior
edge of shoe midsole; INS, on the centre of the sensor mounted on instep equipment of the shoe
Figure 2
Bland–Altman plot of gait parameters from the motion sensor embedded in the shoe midsole (plantar-
embedded) and optical motion capture
(a) stride duration, (b) stride length, (c) stride frequency, (d) stride speed, (e) vertical height, (f) stance phase duration, (g) swing phase duration,
(h) sagittal angleIC, (i) frontal angleIC, (j) sagittal angleTO
Figure 3
Bland–Altman plot of gait parameters from the motion sensor mounted on the shoe instep (instep-
mounted) and optical motion capture
(a) stride duration, (b) stride length, (c) stride frequency, (d) stride speed, (e) vertical height, (f) stance phase duration, (g) swing phase duration,
(h) sagittal angleIC, (i) frontal angleIC, (j) sagittal angleTO
26
Table
1. Table 1. Gait parameters and their definitions
2. Table 2. Intraclass correlation coefficients of the gait parameters from ORPHE ANALYTICS
and optical motion capture
3. Table 3. Statistical indices of the Bland–Altman plots
27
Supplementary Material
1. Table S1. Status of trial execution and data acquisition
2. Table S2. Stride-detection ratio for the conditions
3. Table S3. Percentage of outliers for each condition
4. Figure S1. Definitions of target markers for detecting initial foot contact timing
5. Figure S2. Scatter plots and regression lines of the stride length and speed from ORPHE
ANALYTICS and the optical motion capture as well as the Bland–Altman plots of corrected
data using regression lines
28
Table 1. Gait parameters and their definitions
Parameter name Unit Explanation Definition of motion capture data analysis Name in ORPHE ANALYTICS*
Stride duration sec A time required for 1 gait cycle A time required for IC to next IC Stride duration
Stride length m Anteroposterior displacement of the Difference between the anteroposterior position of the motion sensor centre at IC Stride length
foot during 1 gait cycle and next IC + (stride duration) * (treadmill speed)
Stride frequency steps/sec Number of gait cycles per 1 second The inverse of stride duration Stride frequency
Stride speed m/sec Average speed of foot during 1 gait Stride length / stride duration Stride speed
cycle
Vertical height m Maximum height of foot during 1 gait Maximum height of the centre of motion sensor during 1 gait cycle Vertical height
cycle
Stance phase duration sec A time that the foot is in contact with Time required for IC to next TO Ground contact time
the ground during 1 gait cycle
Swing phase duration sec A time that the foot is in the air during Time required for TO to next IC Swing time
1 gait cycle
Sagittal angleIC degree The angle between ground and foot in The angle between the motion sensor anteroposterior axis and its projection Strike angle
the sagittal plane at IC vector to the horizontal plane at IC
Frontal angleIC degree The angle between ground and foot in The angle between the motion sensor mediolateral axis and its projection vector Pronation
the frontal plane at IC to the horizontal plane at IC
Sagittal angleTO degree The angle between ground and foot in The angle between the motion sensor anteroposterior axis and its projection Toe off angle
the sagittal plane at TO vector to the horizontal plane at TO
Note: IC: initial foot contact; TO: toe-off; *: cited at https://orphe.io/en/analytics.
29
Table 2. Intraclass correlation coefficients of the gait parameters from ORPHE ANALYTICS and optical motion capture
Condition Overall Walking Running
Position Plantar-embedded Instep-mounted Plantar-embedded Instep-mounted Plantar-embedded Instep-mounted
Parameter ICC(2,1) 95%CI ICC(2,1) 95%CI ICC(2,1) 95%CI ICC(2,1) 95%CI ICC(2,1) 95%CI ICC(2,1) 95%CI
Stride length 0.983 (0.949, 0.992) 0.963 (0.794, 0.986) 0.980 (0.964, 0.989) 0.971 (0.950, 0.983) 0.927 (0.000, 0.984) 0.855 (−0.022, 0.968)
Stride duration 1.000 (1.000, 1.000) 1.000 (1.000, 1.000) 0.999 (0.999, 1.000) 1.000 (0.999, 1.000) 1.000 (0.999, 1.000) 1.000 (1.000, 1.000)
Stride frequency 1.000 (1.000, 1.000) 1.000 (1.000, 1.000) 0.999 (0.998, 0.999) 0.999 (0.998, 0.999) 1.000 (0.998, 1.000) 1.000 (0.999, 1.000)
Stride speed 0.991 (0.962, 0.996) 0.979 (0.848, 0.993) 0.996 (0.993, 0.998) 0.993 (0.987, 0.996) 0.932 (0.001, 0.986) 0.855 (−0.022, 0.969)
Vertical height 0.996 (0.979, 0.999) 0.963 (0.376, 0.990) 0.750 (-0.060, 0.926) 0.572 (−0.019, 0.816) 0.998 (0.991, 0.999) 0.885 (−0.014, 0.976)
Stance phase duration 0.993 (0.991, 0.995) 0.993 (0.991, 0.995) 0.974 (0.955, 0.985) 0.975 (0.958, 0.986) 0.920 (0.792, 0.965) 0.917 (0.834, 0.959)
Swing phase duration 0.907 (0.870, 0.934) 0.904 (0.867, 0.931) 0.766 (0.625, 0.859) 0.764 (0.626, 0.856) 0.976 (0.924, 0.990) 0.976 (0.949, 0.988)
Sagittal angleIC 0.939 (0.820, 0.972) 0.945 (0.895, 0.968) 0.947 (0.896, 0.971) 0.926 (0.874, 0.957) 0.897 (0.422, 0.967) 0.913 (0.676, 0.967)
Frontal angleIC 0.566 (−0.064, 0.817) 0.627 (0.474, 0.736) 0.541 (0.010, 0.786) 0.607 (0.407, 0.751) 0.475 (−0.098, 0.801) 0.507 (0.044, 0.761)
Sagittal angleTO 0.892 (0.843, 0.925) 0.833 (0.752, 0.885) 0.922 (0.333, 0.977) 0.921 (0.439, 0.975) 0.715 (0.480, 0.854) 0.577 (0.294, 0.768)
Note: excellent (>0.90), good (0.75‒0.90), moderate (0.50‒0.75), and poor (< 0.50)[18].
30
Table 3. Statistical indices of the Bland–Altman plots
Condition Overall Walking Running
Position Plantar-embedded Instep-mounted Plantar-embedded Instep-mounted Plantar-embedded Instep-mounted
Parameter Mean diff. ± LoA% Mean diff. ± LoA% Mean diff. ± LoA% Mean diff. ± LoA% Mean diff. ± LoA% Mean diff. ± LoA%
LoA95% LoA95% LoA95% LoA95% LoA95% LoA95%
Stride length (m) −0.058 ± 0.174 10.0 −0.105 ± 0.224 13.1 0.016 ± 0.103 8.1 −0.003 ± 0.127 10.1 −0.111 ± 0.135 6.5 −0.176 ± 0.165 8.1
Stride duration (s) −0.002 ± 0.013 1.3 −0.001 ± 0.011 1.1 −0.003 ± 0.019 1.5 −0.003 ± 0.016 1.3 −0.001 ± 0.003 0.4 −0.001 ± 0.004 0.5
Stride frequency (steps/s) 0.001 ± 0.012 1.1 0.001 ± 0.012 1.0 −0.000 ± 0.017 2.0 0.000 ± 0.017 2.0 0.002 ± 0.006 0.4 0.001 ± 0.006 0.4
Stride speed (m/s) −0.081 ± 0.200 9.8 −0.14 ± 0.275 13.6 0.006 ± 0.075 6.9 −0.012 ± 0.098 9.0 −0.142 ± 0.172 6.4 −0.228 ± 0.219 8.2
Vertical height (m) −0.009 ± 0.020 6.6 0.027 ± 0.035 20.4 −0.016 ± 0.018 10.9 0.009 ± 0.015 20.4 −0.004 ± 0.013 3.4 0.040 ± 0.020 8.4
Stance phase duration (m) −0.003 ± 0.069 13.1 −0.005 ± 0.069 13.3 −0.009 ± 0.097 11.5 −0.011 ± 0.095 11.3 0.002 ± 0.036 11.9 −0.001 ± 0.04 13.4
Swing phase duration 0.002 ± 0.065 14.5 0.004 ± 0.065 14.5 0.007 ± 0.090 21.9 0.010 ± 0.088 21.5 −0.002 ± 0.036 7.6 0.000 ± 0.040 8.4
Sagittal angleIC (˚) −2.245 ± 6.355 N/A −1.609 ± 6.459 N/A −0.937 ± 4.428 N/A −0.752 ± 5.100 N/A −3.171 ± 6.868 N/A −2.203 ± 7.021 N/A
Frontal angleIC (˚) 3.849 ± 5.756 N/A 1.551 ± 7.770 N/A 2.858 ± 5.528 N/A −0.784 ± 5.560 N/A 4.551 ± 5.513 N/A 3.168 ± 7.498 N/A
Sagittal angleTO (˚) −1.107 ± 7.868 −12.6 −1.701 ± 9.691 −15.6 −3.124 ± 4.867 −7.3 −2.994 ± 5.199 −7.8 0.321 ± 8.371 −14.2 −0.806 ± 11.519 −19.4
Note: Mean diff.: mean difference, N/A: not available (the ICCs of sagittal angleIC and frontal angleIC were not calculated because those values were distributed positively and negatively, and those averages
were close to 0, making it inappropriate to evaluate in percentages.). The LoA% was interpreted as follows: very good (<5%), good (5–10%), moderate (10–20%), poor (20–50%), and very poor (>50%)[20].
31
Supplementary Table S1. Status of trial execution and data acquisition
Walking Running
ID sex 2km/h 4km/h 6km/h 6km/h 9km/h 12km/h 12km/h forefoot strike 12km/h rearfoot strike
1 Male ● ● ● ● ● ● ● ●
2 Female ● ● ● ● ●
†
3 Female ● ● ● ● ●
4 Female ● ● ● ● ● ● ● ●
5 Male ● ● ● ● ● ● ● ●
6 Male ● ● ● ● ● ● ● ●
7 Male ● ● ● ● ● ● ● ●
†
8 Male ● ● ● ● ● ● ●
9 Male ● * * * * * * *
●: Data with no deficits; †: Deficient left plantar-embedded sensor data. *: Deficient right instep-mounted sensor
data; no marker: the trial was not executed.

Supplementary Table S2. Gait-cycle detection ratio for the conditions
Condition Plantar-embedded Instep-mounted

Overall 10.84 % (578/5334) 9.52 % (543/5701)
Walking 8.50 % (122/1436) 9.25 % (139/1503)
Running 11.70 % (456/3898) 9.62 % (404/4198)
Forefoot strike 13.36 % (91/681) 13.60 % (105/772)
Rearfoot strike 11.06 % (77/696) 6.64 % (50/753)
Gait-cycle detection ratio (%) (number of gait cycles detected based on motion sensor data divided by the number of
gait cycles detected based on motion capture data). Running: All running tasks, including the forefoot and rearfoot
strike conditions
Supplementary Table S3. Percentage of gait cycles, including outliers for each condition
Condition Plantar-embedded Instep-mounted

Overall 10.84 % (578/5334) 9.52 % (543/5701)
Walking 8.50 % (122/1436) 9.25 % (139/1503)
Running 11.70 % (456/3898) 9.62 % (404/4198)
Forefoot strike 13.36 % (91/681) 13.60 % (105/772)
Rearfoot strike 11.06 % (77/696) 6.64 % (50/753)
Percentage of gait cycles, including outliers: number of gait cycles excluded in outlier processing divided by the
number of gait cycles detected by the motion sensor. Running: All running tasks, including the forefoot and rearfoot
strike conditions
Supplementary Figure S1. Definition of target markers for detecting the initial foot contact timing. (a) The HEEL
marker was assigned as the target marker when the angle between the anteroposterior axis of the motion sensor and
global horizontal plane was less than –15° (toe-up). (b) The LMP marker was assigned when the angle ranged from
−15° to −5° (near-flat). (c) The TOE marker was assigned when the angle was more than –5° (toe-down).
Supplementary Figure S2. Scatter plots and regression lines of the stride length and speed from ORPHE ANALYTICS and the optical motion
capture as well as the Bland–Altman plots of corrected data using regression lines. (a) Scatter plot: stride length (plantar); (b) Bland–Altman plot:
stride length (plantar); (c) scatter plot: stride speed (plantar); (d) Bland–Altman plot: stride speed (plantar); (e) scatter plot: stride length (instep);
(f) Bland–Altman plot: stride length (instep); (g) scatter plot: stride length (instep); (h) Bland–Altman plot: stride length (instep).

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medRxiv preprint doi: https://doi.org/10.1101/2022.10.17.22281166; this version posted October 17, 2022.

The copyright holder for this preprint

system (ORPHE ANALYTICS) during walking and running

Ken Nakata and Issei Ogasawara

1-17, Machikaneyama-cho, Toyonaka city, Osaka 560-0043, Japan

Email: [email protected], [email protected]

Word count: 2989

ANALYTICS has not yet been examined.

relative validities, and Bland–Altman plots were plotted.

exhibited moderate relative validity [ICC(2,1) = 0.566–0.627].

Significance: ORPHE ANALYTICS, a motion-sensor-based gait analysis system, was found to

gait analysis outside the laboratory setting.

l Shoe midsole-embedded sensors had higher validities than instep-mounted sensors.

l ORPHE ANALYTICS is potentially useful in clinical measurements.

sensor, spatio-temporal gait parameter

in daily life and frequent measurements without visiting a specific facility[3].

Position/angle-level gait parameters are commonly utilised in conventional gait assessments[8]

measure the position/angle-level kinematic properties, numerical integration of the measured

specifications[9,10] and mounting position[11,12]. Therefore, the use of motion-sensor-based

commercial gait analysis systems to determine how consistently position/angle-level gait

using the conventional optical motion capture.

agreement of position/angle-level gait parameters between ORPHE ANALYTICS and optical

to those calculated using optical motion capture.

(approval no. 19537), and all participants provided informed consent.

a built-in sensor (LSM6DSOX, STMicroelectronics; acceleration: ± 16 G, angular velocity: ±

anteroposterior and vertical axis vectors.

optical motion capture.

percentage of excluded gait cycles was subsequently calculated.

moderate (0.50‒0.75), and poor (<0.50)[18].

parameters’ average values were normally distributed around 0, rendering it inappropriate to

Gait-cycle detection ratio in ORPHE ANALYTICS

cycle detection ratio was 99.54% (Supplementary Table S2).

Gait-cycle percentages including outliers

Relative validity of ORPHE ANALYTICS against optical motion capture

Absolute reliability of ORPHE ANALYTICS against optical motion capture

duration, and sagittal angle TO demonstrated moderate-to-poor absolute reliability (LoA%=10.0–

for stride length and speed (Figure 2b,d, Figure 3b,d).

midsole (plantar-embedded) and optical motion capture

MS: motion sensor, OMC: optical motion capture

instep (instep-mounted) and optical motion capture

MS: motion sensor, OMC: optical motion capture

endorse the reliability of ORPHE ANALYTICS in clinical applications.

Differences between plantar-embedded and instep-mounted motion sensors

the advantage of higher gait analysis validity.

The proportional errors in stride speed and stride length

proportional differences is necessary.

optical motion capture data during treadmill-based walking and running.

moderate relative validities, respectively.

standard for the future use of this gait analysis system.

Conflicts of Interest Statement

KN received a research grant from ORPHE, Inc.

[7] F. García-Pinillos, L.E. Roche-Seruendo, N. Marcén-Cinca, L.A. Marco-Contreras, P.A. Latorre-

[14] L. Benson, C. Clermont, R. Watari, T. Exley, R. Ferber, Automated Accelerometer-Based Gait

[15] H. Stolze, J.P. Kuhtz-Buschbeck, C. Mondwurf, A. Boczek-Funcke, K. Jöhnk, G. Deuschl, M. Illert,

dedicated mounting equipment; (c) Marker position on the shoe

embedded) and optical motion capture

(h) sagittal angleIC, (i) frontal angleIC, (j) sagittal angleTO

MS: motion sensor, OMC: optical motion capture

mounted) and optical motion capture