Medical Engineering & Physics 32 (2010) 312323

Contents lists available at ScienceDirect

Medical Engineering & Physics
j our nal homepage: www. el sevi er . com/ l ocat e/ medengphy
Real-time subject-specic analyses of dynamic internal tissue loads in the
residual limb of transtibial amputees
Sigal Portnoy
a
, Judith van Haare
b
, Richard P.J. Geers
d
, Anat Kristal
c
, Itzhak Siev-Ner
c
,
Henk A.M. Seelen
d,f
, Cees W.J. Oomens
e
, Amit Gefen
a,
a
Department of Biomedical Engineering, Tel Aviv University, Ramat Aviv, Israel
b
Department of Movement Sciences, Maastricht University, Maastricht, The Netherlands
c
Department of Orthopaedic Rehabilitation, Chaim Sheba Medical Center, Israel
d
Rehabilitation Foundation Limburg, Hoensbroek, The Netherlands
e
Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands
f
Department of Rehabilitation Medicine, Maastricht University, Maastricht, The Netherlands
a r t i c l e i n f o
Article history:
Received 7 September 2009
Received in revised form
20 December 2009
Accepted 23 December 2009
Keywords:
Deep tissue injury
Pressure ulcer
Prosthesis
Rehabilitation
a b s t r a c t
Transtibial amputation (TTA) prosthetic-users may risk the integrity of their residuum while trying to
maintain everyday activities. Compression of the muscle ap between the truncated bones and the pros-
thetic socket may cause pressure ulcers and deep tissue injury (DTI). We hypothesize that mechanical
stresses in the muscle ap are higher when walking over complex terrains than during plane gait, and
so, the residuum could be at risk for DTI when walking over these terrains. Accordingly, we evaluated
internal soft tissue stresses in the residuum at the vicinity of the tibia in 18 prosthetic-users (7 vascular,
11 traumatic). For this purpose, we developed a portable monitor that calculated subject-specic internal
stresses in the residuumin real-time. Each subject was studied while walking on plane oor, grass, stairs
and slope. We found that internal stresses were the highest while subjects descended a slope, during
which internal peak and root mean square (RMS) stresses were approximately 40% and 50% greater than
in plane gait, respectively. Peak and RMS stresses calculated while descending a slope were approxi-
mately 2 times higher for the sub-group of vascular subjects compared to traumatic, but were similar
between the two sub-groups for other ambulation tasks. Overall, the present internal stress monitor is
a practical tool for real-time evaluation of internal stresses in the residuum of TTA prosthetic-users in
the clinical setting or outdoors. Pending integration of appropriate dynamic tissue injury thresholds, the
device can be utilized for alerting to the danger of DTI.
2009 IPEM. Published by Elsevier Ltd. All rights reserved.
1. Introduction
Preservation of a healthy residuum is a major concern after
transtibial amputation (TTA). The muscle ap, folded over the trun-
cated shinbones during TTA is particularly susceptible to injury
during load-bearing [1]. Internal injury may be caused by large
dynamic deformations of the soft tissues, which are cyclically com-
pressedduringgait betweenthetruncatedbones andtheprosthetic
socket. This deformation-related injury has been recently catego-
rized as deep tissue injury (DTI), which is a severe pressure ulcer
(PU) [24]. DTI initiates at the bone proximity, and is therefore
visibly undetectable until skin breakdown occurs.

Corresponding author at: Department of Biomedical Engineering, Faculty of

Engineering, Tel Aviv University, Tel Aviv 69978, Israel. Tel.: +972 3 640 8093;
fax: +972 3 640 5845.
E-mail address: gefen@eng.tau.ac.il (A. Gefen).
Dudek et al. [5] found that 40% of their lower limb amputa-
tion subjects suffered skin problems. Recently, Meulenbelt et al.
[6] found that the most common skin problem in a test-group of
805 lower limb amputees (410 TTA subjects) was PUs (57%). The
prevalence of DTI in prosthetic-users has not yet been studied.
Approximately 80% of lower limb amputees suffer from periph-
eral vascular diseaseand/or diabetes [7]. Theneuropathyassociated
withthesediseases hampers paindetection, thus increasingtherisk
of DTI.
An important factor that inuences the stability of subjects with
TTA during gait is the complexity of the terrain. Previous stud-
ies demonstrated the daily confrontations of prosthetic-users on
their lawn [8], stairs [9] and other complex terrains [10]. Dou et al.
[10] measured interface pressures at different sites on the skin of a
TTA residuumand concluded that conventional pressure measure-
ments taken in a gait laboratory cannot predict pressures applied
to the residuum during dynamic ambulation on complex terrains.
Unfortunately, none of these studies produced a biomechanical
1350-4533/$ see front matter 2009 IPEM. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.medengphy.2009.12.006
S. Portnoy et al. / Medical Engineering & Physics 32 (2010) 312323 313
analysis of internal mechanical conditions in TTA residual limbs
during gait, particularly for non-at terrains.
Dynamic real-time knowledge of internal loads in soft tis-
sues of the residuum can be used as a biofeedback tool, alerting
patients tophysically adjust their gait characteristics, thus optimiz-
ing mechanical stresses experiencedby soft tissues, andpreventing
DTI. Relieving tissue loads by improving the prosthetic t may pre-
vent DTI or enable healing of an existing ulcer, while allowing the
patient continued use of the prosthesis [11].
We hypothesize that (i) Internal mechanical stresses in the
residuum can be monitored continuously in real-time by means
of a portable device that can be used outdoors. (ii) Stresses in the
soft tissues overlying the tibia are higher when walking over com-
plex terrains than during plane gait. (iii) There could be differences
in mechanical stresses in soft tissues of the residuum between
vascular and traumatic TTA subjects, considering the neuropathy
associated with vascular causes for TTA which may affect propri-
oception. We then hypothesize that traumatic TTA subjects can
better optimize loads in their residuum, and are therefore more
protected from DTI than vascular patients. We aim at determining
subject-specic dynamic stresses in soft tissues of the residuum of
TTA prosthetic-users at the tibial vicinity.
2. Methods
2.1. The portable internal stress monitor
We built twoduplicate monitors that calculate dynamic internal
mechanical stresses in the soft tissues of the residuumin real-time.
These monitors were used in a two-center study which took place
in Israel and the Netherlands.
2.1.1. Analytical biomechanical model
In the previous studies, the most signicant stress concentra-
tions were found in the muscle ap region under the tibia [1,12].
Accordingly, we approximated the mechanical soft tissuebone
interactions at that region. We evaluated mechanical stresses using
an analytical solution to an axisymmetric indentation problem[13]
of a at-endedcylinder (tibia), intoa compressibleelastic layer (soft
Fig. 1. An axisymmetric indentation problemof a at-ended cylinder, representing
the truncated tibia of the residuum (with a radius a), thrust by a force F(t) into a
compressible elastic layer (with mechanical properties G and ), which represents
the overlying soft tissues (with initial thickness h). The soft tissue layer is assumed
to be bonded to a rigid substrate that represents the socket of the prosthesis. The
geometric parameters, a and h, are measured on anteriorposterior X-rays of each
subject.
Fig. 2. An example of the nite element model, representing the axisymmetric
indentation problem of a at-ended cylinder (tibia) thrust by a force F(t) into a
compressible elastic layer (soft tissues), bonded to a rigid substrate (socket of the
prosthesis). The von Mises stresses are averaged across all the elements situated
directly under the tibia. Several simulations with different a/h ratios were analyzed,
to obtain the correction term in Eq. (3).
tissues), bonded to a rigid substrate (prosthesis; Fig. 1). The radius
of the tibia, a, andthe thickness of the soft tissues, h, were measured
for each subject-specic model, on an anteriorposterior X-ray of
the residuum of each subject, as demonstrated in Fig. 1 [13].
For the purpose of real-time analyses, the tibia was assumed to
be rigid, and the soft tissues were assumed to be homogeneous,
isotropic and linear elastic, with an effective material stiffness for
the muscle ap, fat and skin. Indentation of the tibia into the soft
tissues at a time t, dened as (t) (Fig. 1), is calculated by [13]:
(t) =
F(t) h
a
2
( +2G)
(1)
where F(t) is the limb-socket force (Fig. 1), and G and are the
effective shear modulus and Lame constant of the soft tissues,
respectively. The strain energy stored in the soft tissues U(t) is [13]:
U(t) =
( +2G)a
2
(t)
2
2h
(2)
and the von Mises stress,
v
(t) is [13]:

v
(t) =
_
A
a
h
+B
_

_
[

(t)
zz
(t)]
2
+
zz
(t)
2
+

(t)
2
+6
z
(t)
2
2
(3)
where the stress components are:

zz
(t) = ( +2G)
(t)
h
;

(t) =
(t)
h
;

z
(t) = ( +2G)
(t)
h
Table 1
The relative effect of all model parameters, i.e. the tibial radius (a), the ap thickness
(h), interface forces (F) andthe coefcient of frictionbetweenthe truncatedtibia and
the soft tissue (), on the internal von Mises stresses (Eq. (3)).
Parameter Increase fromto Internal stresses Reference
a [mm] 1020 76% [12]
0.40.7 34%
h [mm]
a
250 22% [12]
F [N] 740860 16% [12,18]
a
Finite element studies showed that for thin soft tissue layers (h<a), stress con-
centrations shifted laterally of the tibial body, and so, average stresses under the
tibia decreased for thinner overlying soft tissue.
314 S. Portnoy et al. / Medical Engineering & Physics 32 (2010) 312323
andis the coefcient of frictionbetweenthe tibia andsoft tissues,
assumed to be 0.5. Since there are no published experimental data
regarding tissue-on-tissue coefcients of friction, we found it rea-
sonable to accommodate this non-slipstate witha relatively high
that is brought about by the existence of interlacing bers between
the bones and muscle, and possible tissue adhesion. The term
A(a/h) +B is a numerical correction term that adjusts for the effect
of variation of the tibial radius to soft tissue thickness ratio (a/h)
across individuals: 0.213.51 (N=18). The values of the constants
AandBwere obtainedbymeans of large deformationnite element
(FE) analyses (ABAQUS v6.8, SIMULIA, RI, USA). The axisymmetric
FE models (Fig. 2) reproduced the previously described tibiasoft
tissues model geometry(Fig. 1). Consistently, thetibiawas assumed
to be rigid and the soft tissues were assigned G=10.7kPa and
=42.9kPa [14]. The tibia was meshed with 2-node linear axisym-
metric rigid elements (RAX2 in ABAQUS, 80 elements). The soft
tissues were meshed with 4-node generalized bilinear axisymmet-
ric quadrilateral elements (CGAX4RH, 37507500 elements). The
inferior surface of the soft tissues was constrained for all trans-
lations and rotations, and a coefcient of friction of 0.5 was set
between the bone and soft tissues consistent with the analytical
model (Eq. (3)). In preliminary FE analyses, the effect of skin-socket
friction and sliding on internal tissue stresses was found to be neg-
ligible. Specically, we found that when applying a coefcient of
friction of 0.5 between the soft tissues and the inner prosthetic
socket [15], the von Mises stresses decreased by <1%. Applying fric-
tionless condition at this interface resulted in a decrease of 5% in
internal stresses; however, free-slip is unlikely since prosthetic-
users always wear silicone sleeves or socks, which rub against
the liner of the socket [15,16]. We applied a higher mesh density
directly under the tibia (Fig. 2) to account for the expected stress
concentrations there. We analyzed 14 FE models in total, where
we varied a/h between 1 and 8. In a recent paper [17] we reported
displacements of the tibia into the soft tissues in residual limbs of
5 TTA patients during upright standing in an Open-MRI. We found
that the ratios of tibial indentation depth over undeformed soft
tissue thickness /h were 0.070.15 in 4 subjects and 0.45 in the
fth subject who demonstrated soft tissue atrophy. These values
were measured while the residuum was contained inside a plaster
socket-substitute. The substitute socket does not fully represent
the actual prosthetic socket, which is rectied to prevent the distal
end of the residuum from bearing most of the loads. We therefore
assume that the above-listed ratios [17] are overestimated with
respect to real-world conditions. Accordingly, we applied down-
ward displacement of the tibia so that /h ratios (Fig. 1), were 0.036,
0.05 or 0.06. We then averaged the von Mises stresses across all the
elements situated directly under the tibia (Fig. 2) to be consistent
with Eq. (3), i.e. to extract one representative stress scalar corre-
sponding to the /h loading situation (Fig. 2). We averaged stresses
rather than focus on the peak stress since peaks in an indentation
model result from the sharp corners of the indenter (tibia), which
are surgically avoided in TTA procedures (see X-ray in Fig. 1). The
objective function for obtaining optimal A, B was a minimal root
meansquare (RMS) error betweennumericallycorrectedvonMises
stress calculations,
v
(Eq. (3)), and average von Mises stress from
the geometrically matched FE model,
v,FE
:
RMS error =

1
N

v,FE

v,FE
_
2
(4)
Fig. 3. Average von Mises stresses in simulated variations in synthetic transtibial amputation prosthetic gait data. The synthetic gait data were a nominal sinusoidal limb-
socket force F(t) with peak of 800N. We simulated variations in (a) the tibial radius, a, (b) the soft tissue thickness, h, (c) the coefcient of friction between the tibia and soft
tissues, , and (d) the maximal applied force, within reasonable physiological ranges, specied in Table 1.
S. Portnoy et al. / Medical Engineering & Physics 32 (2010) 312323 315
The lowest RMS error was obtained for A=0.0083 and B=0.33,
where the RMS error was 11%, 8.8% and 9.5% for /h ratios of 0.036,
0.05 or 0.06, respectively.
2.1.2. Sensitivity analyses
We studied the effects of simulated variations in synthetic TTA
prosthetic gait data onresultedsoft tissue stresses
v
. The synthetic
gait data were a nominal sinusoidal limb-socket forceF(t) withpeak
of 800N. We varieda, h, andwithinphysiological ranges specied
in Table 1 [12] (Fig. 3ac). We also altered the peak of F(t) by 7.5%,
which is physiological for intra-subject data [18] (Fig. 3d). In all
sensitivity analyses, the shear modulus and Lame coefcient of the
soft tissues were G=10.7kPa and =42.86kPa, respectively. The
results of these sensitivity analyses (Fig. 3) imply that soft tissue
stresses are mostly affected by the tibial radius a (Table 1). Next in
inuenceis tibiasoft tissuefriction, thenthesoft tissuethickness
h, and last is the limb-socket force F(t). It should be noted that a
higher caused greater shearing in the soft tissues, and therefore
stresses increased.
2.1.3. Prototype of the real-time subject-specic portable stress
monitor
We created two duplicate real-time portable monitors to allow
for the two-center study. The device requires two subject-specic
input parameters: the distal tibial radius a and the soft tissue thick-
ness h (measured from anteriorposterior X-ray; Fig. 1). Real-time
interface forces between the residuum and socket, F(t), are mea-
sured at a frequency of 24Hz using a set of four paper-thin exible
force sensors (FlexiForce, Tekscan Co., MA, USA), attached together
to form a squared 22 array (Fig. 4a). The sensors are attached
under the truncated tibia (Fig. 4c). Force data from the sensors are
summedandthe total interface force under the tibia is convertedto
digital data via a drive circuit and data-acquisition card (USB-6008
OEM, National Instruments Co., TX, USA), combined together to one
holter-like unit (Fig. 4c). Digital force data are then transmitted to
a handheld computer (Fujitsu-Siemens Pocket LOOX N560, Fujitsu
Co., Japan; Fig. 4).
For each interface force measurement, the stress monitor pro-
vides, in real-time, the instantaneous average internal von Mises
stress in the soft tissues under the tibia. Stresses are presented
using a LabView8 module for handheld PC (National Instruments).
Clinically oriented software was developed for this purpose. First,
the user locates a subject-specic input le with the subjects
details (Table 2) and geometry parameters (a and h) (Fig. 4b;
Patient Data tab). The user then selects the terrain characteristic
(Fig. 4b; Input tab). When Exit is pressed, the monitor outputs
a text le comprised of three columns: the time (in milliseconds),
the sum of interface forces (in N) and the mean internal von Mises
stress (in kPa).
We rst tested the performances of the monitor using a TTA
residuum phantom [12] that contains truncated plastic bones
enveloped by compliant silicone representing soft tissues. Sensors
(FlexiForce) were embedded in the silicone to allowmeasurements
of internal pressures inside the phantom during external loading.
The phantom was positioned inside a TTA prosthesis and loaded
with weights applied to the phantoms knee [12], and was then
monitored by the present device. Internal
v
calculated under the
tibia of the phantomincreased linearly with the knee load (Pearson
correlation coefcient R=0.999), and were 5-fold higher than the
contact pressures at the inferior surface of the phantomlimb when
the phantomwas loaded with weights at 2.5kg steps. The phantom
studies revealedthat %-difference betweensensor-measuredinter-
nal pressures andmonitor system-calculatedinternal stresses were
less than 8% for loads of 10kg applied to the phantoms knee. Addi-
tionally, a linear t to the %-difference versus phantom-knee-load
plot indicated that each additional kilogram above 5kg reduced
Fig. 4. Real-time contact forces between the residuum and prosthetic socket, F(t),
are measured by the stress monitor device using (a) a set of four paper-thin and
exible force sensors that form a squared 22 array. Testing of the interface force
input from each sensor separately is performed pre-trial using a designated code.
(b) The subjects details are uploaded using a second code and presented to the
user in the Patient Data tab. In the Input tab, the user may select the terrain
characteristic of the trial and view the recorded data online in the output tab
after pressing start. (c) The sensors are attached to the residual limb at its distal
end, directly under the truncated tibia. Analogue force data from the sensors are
converted to digital data via a drive circuit and data-acquisition card, combined
together to one holter-like unit that is attached to the clothing of the subject with a
belt-clip. Digital force data are then transmitted to the device.
316 S. Portnoy et al. / Medical Engineering & Physics 32 (2010) 312323
Fig. 5. Example of raw time-dependent von Mises stresses calculated under the tibia of a transtibial amputation patient (traumatic 23 years old male, weight: 70kg)
ambulating on (a) paved oor, (b) grass, (c) ascending stairs and (d) up slope, and (e) descending stairs and (f) down slope. Scales are different in each plot for clarity.
the error by 3% (R=0.96), so that the systems errors become
negligible for loads above 14kg. This nding is very encouraging
considering that knee joint forces in prosthetic-users are above
20%-bodyweight for at least 80%of thestancephase[19]. Wedenote
that the measurement error of our monitor would be clinically
insignicant for the most of the stance phase in subjects whose
bodyweight exceeds 70kg.
1
2.2. Human studies
Eighteen TTA subjects participated in this study (Table 2): mean
age 43 years standard deviation (SD) of 18 years, bodyweight
1
The mean bodyweight of subjects in our present study was 79kg; see Section
2.2.
7917kg, years post-amputation 3.62.8, 11 traumatic and 7
vascular subjects. Inclusion criteria were TTA; age >20 years; that
subjects frequently use their prosthesis and do not experience con-
siderable volume changes of their residuum. We excluded subjects
with PUs or an unstable residuumvolume. Helsinki approvals were
obtained (#5345/2008 from Sheba Medical Center, Ramat-Gan,
Israel and #NL20755.022.07 from the Rehabilitation Foundation
Limburg, Hoensbroek, the Netherlands) and each participant gave
their informed consent.
An X-ray was required to determine a and h of each indi-
vidual. The average tibial radius was 16.6mm (SD=2.9mm)
and the ap thickness was 32mm (SD=24.3mm). Subjects
walked for 1min at a natural pace on the following ter-
rains: paved oor, stairs (height =17cm; depth=30cm), lawn
grass and 15

slope. A guardrail was available on the

staircase. During each trial, the stress monitor recorded and
S. Portnoy et al. / Medical Engineering & Physics 32 (2010) 312323 317
Table 2
Subject information for the participants.
Subject Gender Age (years) Weight (kg) Cause of TTA Amputated limb Time since
TTA (years)
Comorbidities Active a (mm) h (mm) a/h
1 Male 23 85 Traumatic Left 4 None Yes 19.9 50.7 0.39
2 Male 25 70 Traumatic Left 4 None Yes 12.9 10.9 1.18
3 Male 23 70 Traumatic Left 3 None Yes 13.6 20.9 0.65
4 Male 27 50 Traumatic Left 3 None Yes 17.4 24 0.73
5 Male 27 50 Traumatic Right 3 None Yes 15.9 11.6 1.37
6 Male 31 72 Traumatic Right 3 None Yes 22.5 85.7 0.26
7 Male 39 70 Traumatic Left 4 History of wounds
a
Partially
b
16.6 8.1 2.05
8 Male 21 90 Traumatic Right 4 None Yes 20 5.7 3.51
9 Male 39 80 Traumatic Right 2 History of wounds
a
Partially
b
17.7 5.9 3.00
10 Female 70 80 Vascular Left 8 Worn hip Partially
b
12 9 1.33
11 Male 44 125 Vascular Left 1 None Yes 18.5 56 0.32
12 Male 71 82 Vascular Left 6 Diabetes Yes 21.5 22 0.98
13 Male 74 80 Vascular Left 2 Diabetes Yes 16 30 0.53
14 Male 42 89 Vascular Left 1 None Partially
b
20 32 0.63
15 Male 47 78 Traumatic Right 1 None Partially
b
16 28 0.57
16 Male 64 102 Vascular Left 1 Knee arthritis, cardiac Partially
b
17 68 0.25
17 Male 64 85 Vascular Right 2 Diabetes Yes 14 66 0.21
18 Male 51 72 Traumatic Left 12 None Yes 15.5 42 0.37
a
History of wounds means that the subject suffered from past supercial wounds or pressure ulcers, which were completely healed at the time of the trial.
b
Partial activity is dened as usage of the prosthesis for an overall daily duration that does not exceed 34h.
presented the internal soft tissue stresses under the tibia in
real-time.
2.3. Data and statistical analyses
We rst plotted raw
v
(t) data (LabView 8.5) for all the sub-
jects (an example is shown in Fig. 5 for subject 3 in Table 2) and
inspected the data visually for coherence over time, wave-shaped
loading cycles at frequencies that correspond to prosthetic gait [8]
and overall quality and noise levels. The RMS of the
v
(t) stress
wave was calculated as:

RMS
v
=

_
1
n
n1

i=0
|x
i
|
2
(5)
Fig. 6. Peak von Mises stresses averaged for ve subsequent steps of four different patients ambulating on different terrains.
318 S. Portnoy et al. / Medical Engineering & Physics 32 (2010) 312323
where there are n samples x
i
in the selected signal segment. The
loadingrate was calculatedas the difference betweenthe peak
v
(t)
value and the minimal stress that preceded it, divided by the time
difference between these values.
Peak and RMS
v
as well as the loading rate and stresstime
integral of the loadingcycles,
_

v
(t) dt, were thenaveragedacross
manually selected ve subsequent steps for each terrain, per each
individual. Data recorded 2s after initiation and before completion
of walking on each terrain were omitted so that data included in
the analyses represented clear locomotion patterns. Measurement
noise was reduced using a low-pass lter with cut-off frequency of
0.2Hz (LabView).
The plane terrain was chosen as the reference gait condition.
Accordingly, the stresses, loading rate and stresstime integral
averaged over ve load-bearing cycles from other trials of a sub-
ject, on other terrains, were normalized by his/her plane-terrain
mean corresponding data. Differences between means of peak and
RMS
v
, the loading rate and stresstime integral for each ter-
rain were analyzed using one-way analysis of variance (ANOVA;
SPSS 10.0, SPSS Inc., Chicago, IL, USA) for the factor of terrain type.
TukeyKramer multiple-pairwise comparisons were performed
post hoc, to identify specic statistically signicant differences
between terrain types. Additionally, a two-way ANOVA for the
factors of terrain type and cause of amputation, i.e. traumatic or
vascular, was performed to test any differences between means of
peak and RMS
v
, the loading rate and stresstime integral for each
terrain. A similar two-way ANOVA was performed for factors of
terrain type and time since amputation, i.e. up to two years since
TTA (N=7) and above two years since TTA (N=11). Finally, a third
two-way ANOVA was performed for factors of terrain type and the
ratio of tibial radius to ap thickness, a/h, where thinner muscle
ap a/h>1 (N=6) and thicker muscle ap a/h<1 (N=12) were the
two groups tested. Following the two-way ANOVA analyses, we
used unpaired 2-tailed t-tests with Bonferroni corrections to con-
duct multiple-pairwise comparisons where the ANOVA indicated
signicant differences, in order to identify terrain types where
differences between the traumatic and vascular sub-groups mani-
fested.
Lastly, thecoefcient of variability(COV) of thepeakandRMS
v
,
the loading rate and stresstime integral for each terrain were cal-
culated to determine whether COV depended on the terrain type.
The COV data were analyzed using one-way ANOVA for the fac-
tor of terrain type, followed by TukeyKramer comparisons. We
considered p<0.05 statistically signicant.
3. Results
The stress monitor successfully calculated dynamic von Mises
stresses in the soft tissues of the residuum of all subjects while
ambulating on complex terrains. Peak forces measured under the
tibia while subjects descended a slope (during which maximal
loading in the residuum occurred) were 14.3N with SD=12.9N.
Example raw data of soft tissue stresses for subject #3 (Table 2)
are presented in Fig. 5 for walking on a plane oor, grass, ascend-
ing stairs, ascending slope, descending stairs and descending slope.
Frequencies of
v
(t) stress waves in plane gait were 1.240.24Hz
across all subjects. No signicant difference was found between

v
(t) frequencies of the vascular and traumatic sub-groups.
Examples of individual data of peak
v
(t) (Fig. 6), RMS of
v
(t)
(Fig. 7), loading rates (Fig. 8) and stresstime integrals (Fig. 9), aver-
aged across ve subsequent steps, are plotted for four TTA subjects
whose peak internal stresses exceeded a 5kPa threshold (#3, 7, 13,
16; see Table 2 for subjects details). Together, these plots demon-
strate the considerable inter-terrain variabilities, as well as the
Fig. 7. Root mean square von Mises stresses averaged for ve subsequent steps of four different patients ambulating on different terrains.
S. Portnoy et al. / Medical Engineering & Physics 32 (2010) 312323 319
Fig. 8. Loading rate of the von Mises stresses averaged for ve subsequent steps of four different subjects ambulating on different terrains.
inter-subject variabilities. Overall, peak internal soft tissue stresses
always remained below 5kPa for 10 out of the 18 subjects.
The mean normalized peak and RMS internal stresses, loading
rates and stresstime integrals averaged across ve subsequent
steps (referenced to plane gait) and across the entire subject group
(N=18) are presented in Fig. 10. Peak stresses decreased on aver-
age while subjects walked on grass or ascended stairs or slope, and
increased on average while subjects descended stairs and slope
compared to plane gait (Fig. 10a). Normalized peak stresses calcu-
lated while subjects descended the slope were signicantly higher
than while walking on grass or ascending the slope (p<0.001), or
than while walking on paved oor or ascending stairs (p<0.05)
(Fig. 10a). Similarly, normalized RMS stresses were signicantly
higher while descending the slope compared to while ascending
the slope or walking on grass (p<0.05; Fig. 10b). Specically, while
descending the slope, internal peak and RMS stresses were 40%
and 50% higher than during plane gait, respectively. Similarly, peak
and RMS stresses were found to be 60% and 55% higher, respec-
tively, while descending the slope compared to climbing a slope.
We found no signicant differences when comparing the normal-
ized loading rate (Fig. 10c) and normalized stresstime integral
(Fig. 10d) across terrains. Mostly, it seemed that the rate of inter-
nal tissue loading was increased by 50% when descending a slope
compared to while walking on the paved oor, but as the variabil-
ity in this parameter was relatively high (Fig. 10c), this was not
statistically signicant.
The normalizedpeak andRMS stresses andthe stresstime inte-
gral were all signicantly higher in the vascular sub-group than
in the traumatic sub-group for the descending slope test (p<0.05;
Fig. 11). Specically, peak stresses, RMS stresses and stresstime
integrals were 80%, 145% and 120% higher for vascular subjects
compared to traumatic subjects during down-slope gait. The peak
and RMS stresses calculated while descending a slope increased by
100% for the vascular sub-group whereas in the traumatic sub-
group, these stresses remained approximately unchanged (Fig. 11a
and b). The stresstime integrals calculated while descending a
slope increased 2-fold for the vascular subjects, but decreased by
20% for the traumatic subjects, compared to plane gait (Fig. 11d).
We found no statistically signicant differences when using a
two-way ANOVA to simultaneously analyze the effect of terrain
type and the years since TTA on internal soft tissue loads. Sim-
ilarly, no signicant differences were found when analyzing the
effect of terrain type and a/h. Finally, we found no signicant dif-
ferences in COV across terrains. The highest COV was found for
the normalized loading rate: 49.99.4% (averaged across terrains
for all subjects). The lowest COV was found for the normalized
RMS stresses: 20.52.4%. For the peak stresses and stresstime
integrals, COV values were 462.3% and 29.44.4%, respectively.
4. Discussion
In this study, internal stresses in the soft tissues under the
tibia of the residuumof 18 prosthetic-users were evaluated during
gait activities, using a newly developed portable real-time stress
monitor. Raw data of internal von Mises stresses (e.g. Fig. 5) cor-
responded well with previously reported ground reaction forces of
TTAsubjects whowalkedonplane[19] or inclinedsurfaces [20]: We
have consistently observed notch-shaped stresstime curves for
plane gait (Fig. 5a), whichbecame sinusoidal-shapedwhensubjects
walked down slope (Fig. 5f).
320 S. Portnoy et al. / Medical Engineering & Physics 32 (2010) 312323
Fig. 9. The von Mises stresstime integral averaged for ve subsequent steps of four different subjects ambulating on different terrains.
Peak internal stresses of 10 subjects did not exceed 5kPa.
According to a muscle cell-death threshold formulated in [21],
these stresses hold no immediate risk of DTI to the muscle ap.
We attribute the lowinternal stresses mainly to the subjects pros-
thetic t, divertingtheloads tomoreproximal locations onthelimb.
Other factors that mayhavecontributedtotheloadreductionat this
location are usage of shock-absorbing prosthetic feet, component
alignment, gait characteristics and the geometry of the residuum.
The parameters characterising the geometry of the residuum in
our model (Table 1), i.e. the tibial radius and soft tissue thickness
have high impact on internal stresses. Additionally, factors such as
the walking speed, stability and energy efciency may account for
different patterns of load distribution.
We chose to present datasets of two traumatic subjects (#3 and
#7) and two vascular subjects (#13 and #16; Figs. 69) whose peak
internal stresses exceeded the injury threshold [21]. These exam-
ples highlight the variability observed within the studied group,
demonstrating that both traumatic subjects developed a higher
loading rate compared to the two vascular subjects (Fig. 8). A low
loading rate might suggest that subjects were more cautious while
applying loads to their residuum. This however, is not supported by
reduced stresses in the chosen examples for the vascular subjects
(Figs. 6 and 7), as would be expected if these subjects took care
not to load their residuum. We therefore assume that the higher
bodyweight of the two vascular subjects and their comorbidi-
ties inuenced their tissue loading rate (Fig. 8). The high stresses
(>5kPa) calculated for eight TTA subjects are most likely related
to the quality of their prosthetic t, component alignment and aids
[9,22]. Interestingly, peak stresses calculatedunder the tibia of sub-
ject #16 (Fig. 6c) were belowthe injury threshold for plane gait, yet
exceeded the threshold while this subject ambulated on stairs or
slope, therefore potentially endangering his residuumduring these
activities.
Since absolute values of internal stresses in the residuum of
prosthetic-users may be affected by aforementioned factors, for
the purpose of comparing between terrains, we focused our post-
analyses on the relative change in internal peak and RMS stresses,
loading rate and stresstime integral with respect to plane gait,
chosen as the reference activity (Figs. 10 and 11). Generally, peak
stresses were elevated while subjects descended stairs or slope,
probablyduetothebodyweight impact whenhittingthestair/slope
with the prosthesis, pressing the residuum deeper into the socket.
Peak
v
(t) was signicantly higher for descending a slope than
for plane gait, but there was no signicant difference between
descending stairs and plane gait. We assume that the reason for
this nding is the availability of a guardrail at the staircase and
its absence near the slope. Since most subjects were assisted by
the guardrail while descending the staircase, their residuum was
spared fromhigh impact loads. The prosthetic foot may also played
a role [23]: the energy storage and return (ESAR) prosthetic foot
demonstrated increased range of motion in late dorsiexion dur-
ing normal gait, compared to conventional prosthetic feet. While
descending slope, however, subjects using the ESAR foot reported
perception of increased difculty. The authors attributed this to
the increased weight acceptance and breaking force during this
activity and also to the heel properties of the ESAR foot [23]. The
use of an energy-storing foot may assist in propelling the leg for-
ward during gait [24] but it may hamper stair climbing, therefore
inuencing tissue stresses under the tibia during activities where
shock-absorption is relevant. In regard to climbing the staircase,
Schmalz et al. [9] found that when climbing stairs, prosthetic-users
compensate for loss of normal muscular activity by avoiding nor-
S. Portnoy et al. / Medical Engineering & Physics 32 (2010) 312323 321
Fig. 10. Normalized (a) peak von Mises stress, (b) root mean square von Mises stress, (c) loading rate and (d) stresstime integral averaged for ve subsequent steps and
referenced to plane gait for all the subjects (N=18). *p<0.05 and **p<0.01.
Fig. 11. Normalized (a) peak von Mises stress, (b) root mean square von Mises stress, (c) loading rate and (d) stresstime integral averaged for ve subsequent steps and
referenced to plane gait for traumatic subjects (N=11) and vascular subjects (N=7). *p<0.05.
322 S. Portnoy et al. / Medical Engineering & Physics 32 (2010) 312323
mal knee exion moments and putting more demand on the hip
extensors. In the present study however, we did not nd statisti-
callysignicant differences intissueloadingbetweenstair climbing
and plane gait (Fig. 10).
Dou et al. [10] found that while ambulating on several terrain
types, interface loads shift across the residuum. Specically, sur-
face pressures at the anterior distal tibial end during slope descent
were 30%higher comparedtoslope ascent. This conditionis desir-
able as loads are diverted from the injury-susceptible area to more
load-tolerable areas, theoretically diminishing the risk for injury.
Adding sensors at other areas might be benecial but their cost in
computation time should be considered.
The stability and walking speed of prosthetic-users ambulating
on grass was found to be affected by the use of different prosthetic
feet [24,25]. In the present study, we found no signicant differ-
ence in tissue loading parameters between plane gait and walking
on grass, but since participants ambulated using their own pros-
thesis, there were different feet used across the group. Paysant et
al. [8] compared the free walking speed, step length, step rate and
energyexpenditurebetweenTTAprosthetic-users andhealthysub-
jects when walking on asphalt oor, mown lawn and high grass.
These authors concluded that on high grass the walking speed of
TTA subjects decreases, which can account for the slight decrease
in stresses observed herein (Fig. 10a and b).
Hafner et al. [23] noted that although vascular subjects present
decreased walking velocity and stride length, as well as other
gait changes, researches do not segregate traumatic and vascu-
lar subjects for analysis. Accordingly, we compared peak and RMS

v
(t), loading rate and stresstime integrals between the traumatic
(N=11) and vascular (N=7) sub-groups. We found signicant dif-
ferences in peak and RMS stresses and stresstime integrals for
slope descent (Fig. 11a, b, and d). These differences were likely
associatedwithneuropathy, age [23], higher bodyweight or comor-
bidities in the vascular group which can affect gait characteristics.
Neuropathy, particularly, might have caused poorer propriocep-
tion in the vascular sub-group. Though neuropathy detection tests
were not performed herein, neuropathy might have prevented
some vascular subjects fromdetectingload-relatedpain. Last, given
the relatively small sub-group sizes, we cannot rule out that there
was, statistically, a better prosthetic t in the traumatic sub-group,
decreasing impact loads.
Our monitors limitations concern the modeling assumptions.
The representation of the tibia as a cylinder is somewhat inac-
curate, neglecting the tibial bevelment performed during surgery.
Consequently, tissue stresses may be underestimated. Also, there
is no distinction in our model between muscle, fat, skin and con-
nective tissues. We previously [26] used three-dimensional FE
modelingtostudyeffects of variabilityinmuscleapstiffnesses and
effects of contractile versus accid aps, on internal ap stresses
in TTA residual limbs. We found that von Mises stresses were
2-fold higher in contracted/spastic muscles compared to ac-
cid muscles, indicating that ap contractions can be considered
for tissue stress calculations in future versions of our stress mon-
itor, e.g. by also measuring electromyographic activity. Another
limitation is that our monitor provides average stresses (Eq. (3))
rather than localized stresses near sharp tibial edges. Hence, there
could be undetected stress concentrations. Despite these limita-
tions, the present technology provides quantitative evaluation,
internal tissue load analysis as related to DTI, and no indoors con-
nement.
Analternative modeling approachto the one used hereinis real-
time FE to determine soft tissue strains and stresses. Real-time FE
has been used in surgery simulations [27,28], in studying PUs in
prosthetic-users [10] or wheelchair-users [29], and diabetic foot
ulcers [30], but inthese studies, more powerful computer platforms
than a handheld computer were required.
A minor inconvenience of the present prototype is the wiring
connecting the force sensors to the computer (Fig. 4c). A more
convenient solution would be employing wireless sensors or inte-
grating them into the socket [31].
In summary, the subject-specic portable internal stress mon-
itor described herein is a convenient tool for real-time evaluation
of dynamic internal stresses in the soft tissues of the residuum of
TTA prosthetic-users ambulating in their natural surroundings, for
the purpose of alerting to the danger of DTI.
Acknowledgements
This work was supported by the Rehabilitation Foundation Lim-
burg, the Netherlands (AG, CWJO, HS), the Chief Scientists Ofce of
the Ministry of Health, Israel (Grant #2028-3, AG), and the Internal
Research Fund at Tel Aviv University (AG).
Conict of interest statement
The authors state that they have no conict of interest.
References
[1] Portnoy S, Yizhar Z, Shabshin N, Itzchak Y, Kristal A, Dotan-Marom Y, et al.
Internal mechanical conditions in the soft tissues of a residual limb of a trans-
tibial amputee. J Biomech 2008;41:1897909.
[2] Black J. Deep tissue injury: an evolving science. Ostomy Wound Manage
2009;55:4.
[3] GefenA. Deeptissueinjuryfromabioengineeringpoint of view. OstomyWound
Manage 2009;55:2636.
[4] Stekelenburg A, Gawlitta D, Bader DL, Oomens CW. Deep tissue injury: how
deep is our understanding? Arch Phys Med Rehabil 2008;89:14103.
[5] Dudek NL, Marks MB, Marshall SC, Chardon JP. Dermatologic conditions asso-
ciated with use of a lower-extremity prosthesis. Arch Phys Med Rehabil
2005;86:65963.
[6] Meulenbelt HE, Geertzen JH, Jonkman MF, Dijkstra PU. Determinants of skin
problems of the stump in lower-limb amputees. Arch Phys Med Rehabil
2009;90:7481.
[7] Kulkarni J, Pande S, Morris J. Survival rates indysvascular lower limb amputees.
Int J Surg 2006;4:21721.
[8] Paysant J, Beyaert C, Datie AM, Martinet N, Andre JM. Inuence of terrain on
metabolic and temporal gait characteristics of unilateral transtibial amputees.
J Rehabil Res Dev 2006;43:15360.
[9] Schmalz T, Blumentritt S, Marx B. Biomechanical analysis of stair ambulation
in lower limb amputees. Gait Posture 2007;25:26778.
[10] Dou P, Jia X, Suo S, Wang R, Zhang M. Pressure distribution at the stump/socket
interface in transtibial amputees during walking on stairs, slope and non-at
road. Clin Biomech 2006;21:106773.
[11] Salawu A, Middleton C, Gilbertson A, Kodavali K, Neumann V. Stump ulcers and
continued prosthetic limb use. Prosthet Orthot Int 2006;30:27985.
[12] Portnoy S, Yarnitzky G, Yizhar Z, Kristal A, OppenheimU, Siev-Ner I, et al. Real-
time patient-specic nite element analysis of internal stresses in the soft
tissues of a residual limb: a new tool for prosthetic tting. Ann Biomed Eng
2007;35:12035.
[13] Yang F. Asymptotic solution to axisymmetric indentation of a compressible
elastic thin lm. Thin Solid Films 2006;515:227483.
[14] Mak AF, Liu GH, Lee SY. Biomechanical assessment of below-knee residual limb
tissue. J Rehabil Res Dev 1994;31:18898.
[15] Sanders JE, Greve JM, Mitchell SB, Zachariah SG. Material properties of
commonly-used interface materials and their static coefcients of friction with
skin and socks. J Rehabil Res Dev 1998;35:16176.
[16] Zhang M, Turner-Smith AR, Roberts VC, Tanner A. Frictional action at lower
limb/prosthetic socket interface. Med Eng Phys 1996;18:20714.
[17] Portnoy S, Siev-Ner I, Shabshin N, Kristal A, Yizhar Z, Gefen A. Patient-specic
analyses of deep tissue loads post transtibial amputation in residual limbs of
multiple prosthetic users. J Biomech 2009;42:268693.
[18] JiaX, ZhangM, LeeWC. Loadtransfer mechanics betweentrans-tibial prosthetic
socket and residual limb dynamic effects. J Biomech 2004;37:13717.
[19] Su PF, Gard SA, Lipschutz RD, Kuiken TA. Gait characteristics of persons with
bilateral transtibial amputations. J Rehabil Res Dev 2007;44:491501.
[20] Vickers DR, Palk C, McIntosh AS, Beatty KT. Elderly unilateral transtibial
amputee gait on an inclined walkway: a biomechanical analysis. Gait Posture
2008;27:51829.
[21] Linder-Ganz E, Engelberg S, Scheinowitz M, Gefen A. Pressuretime cell death
thresholdfor albino rat skeletal muscles as relatedto pressure sore biomechan-
ics. J Biomech 2006;39:272532.
[22] Sanders JE, Bell DM, Okumura RM, Dralle AJ. Effects of alignment changes on
stance phase pressures and shear stresses on transtibial amputees: measure-
ments from 13 transducer sites. IEEE Trans Rehabil Eng 1998;6:2131.
S. Portnoy et al. / Medical Engineering & Physics 32 (2010) 312323 323
[23] Hafner BJ, Sanders JE, Czerniecki J, Fergason J. Energy storage and return pros-
theses: does patient perception correlate with biomechanical analysis? Clin
Biomech (Bristol, Avon) 2002;17:32544.
[24] Hafner BJ. Clinical prescription and use of prosthetic foot and ankle mecha-
nisms: a review of the literature. J Prosthet Orthot 2005;17:511.
[25] Rao SS, Boyd LA, Mulroy SJ, Bontrager EL, Gronley JK, Perry J. Segment velocities
in normal and transtibial amputees: prosthetic design implications. IEEE Trans
Rehabil Eng 1998;6:21926.
[26] Portnoy S, Siev-Ner I, Yizhar Z, Kristal A, Shabshin N, Gefen A. Surgical and
morphological factors that affect internal mechanical loads in soft tissues of
the transtibial residuum. Ann Biomed Eng 2009;37:2583605.
[27] Picinbono G, Delingette H, Ayache N. Non-linear anisotropic elasticity for real-
time surgery simulation. Graphical Models 2003;65:30521.
[28] Cotin S, Delingette H, Ayache N. Real-time elastic deformations of soft tissues
for surgery simulation. IEEE Trans Vis Comput Graph 2009;5:6273.
[29] Linder-Ganz E, Yarnitzky G, Yizhar Z, Siev-Ner I, Gefen A. Real-time nite
element monitoring of sub-dermal tissue stresses in individuals with spinal
cord injury: towards prevention of pressure ulcers. Ann Biomed Eng
2009;37:387400.
[30] YarnitzkyG, Yizhar Z, GefenA. Real-timesubject-specic monitoringof internal
deformations and stresses in the soft tissues of the foot: a newapproach in gait
analysis. J Biomech 2006;39:267389.
[31] Sanders JE, Zachariah SG, Jacobsen AK, Fergason JR. Changes in interface pres-
sures and shear stresses over time on trans-tibial amputee subjects ambulating
with prosthetic limbs: comparison of diurnal and six-month differences. J
Biomech 2005;38:156673.