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research-article2014
POI0010.1177/0309364614536762Prosthetics and Orthotics InternationalAgrawal et al.

INTERNATIONAL
SOCIETY FOR PROSTHETICS
AND ORTHOTICS

Original Research Report

Prosthetics and Orthotics International

Comparison of four different categories 1­–10


© The International Society for
Prosthetics and Orthotics 2014
of prosthetic feet during ramp ambulation Reprints and permissions:
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in unilateral transtibial amputees DOI: 10.1177/0309364614536762
poi.sagepub.com

Vibhor Agrawal1,2, Robert S Gailey1,2, Ignacio A Gaunaurd1,2,


Christopher O’Toole3, Adam Finnieston4, and Ronald Tolchin5

Abstract
Background: Comparative effectiveness of prosthetic feet during ramp ambulation in unilateral transtibial amputees, who
function at different Medicare Functional Classification Levels, has not been published.
Objective: To determine differences in symmetry in external work between four categories of prosthetic feet in K-Level-2
and K-Level-3 unilateral transtibial amputees during ramp ascent and descent.
Study design: Randomized repeated-measures trial.
Methods: Ten subjects completed six testing sessions during which symmetry in external work was calculated using
F-scan in-sole sensors. Between testing sessions 1 and 2, subjects received standardized functional prosthetic training.
In Sessions 3–6, subjects tested four feet—solid ankle cushion heel, stationary attachment flexible endoskeleton, Talux
(categories K1, K2, and K3, respectively), and Proprio-Foot (microprocessor ankle)—using a study socket and had a
10- to 14-day accommodation period with each foot.
Results: During ramp descent, K-Level-2 subjects demonstrated higher symmetry in external work values with Talux and
Proprio-Foot compared to the solid ankle cushion heel foot. K-Level-3 subjects also had higher symmetry in external
work values with the Talux foot than the solid ankle cushion heel foot. Ramp ascent symmetry in external work values
were not significantly different between feet.
Conclusions: Prosthetic foot category appears to influence symmetry in external work more during decline walking than
incline walking. K-Level-2 unilateral transtibial amputees achieve greater symmetry from K3 dynamic response prosthetic
feet with J-shaped ankle and microprocessor ankles while descending ramps.

Clinical relevance
The findings suggest that K-Level-2 unilateral transtibial amputees benefit from K3 dynamic response prosthetic feet with
J-shaped ankle. These results support the prescription of K3 feet for K-Level-2 amputees who frequently negotiate ramps.

Keywords
Biomechanics of prosthetic/orthotic devices, biomechanics, gait analysis, gait, prosthetic feet, prosthetics,
physiotherapy, rehabilitation

Date received: 13 February 2012; accepted: 23 April 2014

Background 1Department of Physical Therapy, Miller School of Medicine, University


of Miami, Coral Gables, USA
In the United States, the governmental definition of foot/ 2Research Department, Miami Veterans Affairs Healthcare System,
ankle assemblies (Table 1) defines five Medicare Miami, USA
Functional Classification Levels (MFCL) for amputees 3The Miami Project to Cure Paralysis, Miami, USA

(K-Level-0 through K-Level-4) with corresponding cate- 4Arthur Finnieston Prosthetics and Orthotics, Miami, USA
5Baptist Hospital Neuroscience Center, Spine Center, Miami, USA
gories (K0–K4) for prosthetic feet.1,2 Prosthetic prescrip-
tion and subsequent reimbursement frequently mandates
Corresponding author:
that the amputee’s assigned MFCL correspond to a pros- Vibhor Agrawal, Department of Physical Therapy, University of Miami,
thetic foot that has the same class assignment. However, to 5915 Ponce De Leon Blvd, Coral Gables, FL 33146, USA.
date, there has been little objective data demonstrating the Email: agrawal.vr@gmail.com

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2 Prosthetics and Orthotics International

Table 1. DMERC prosthetic policy definition of foot/ankle assemblies by Medicare Functional Classification Levels.

MFCL Description MFCL Foot/ankle


modifiers assemblies
Level 0 Does not have the ability or potential to ambulate or transfer K0 Not eligible for
safely with or without assistance, and a prosthesis does not prosthesis
enhance quality of life or mobility.
Level 1 Has the ability or potential to use prosthesis for transfers or K1 External keel, SACH
ambulation in level surfaces at a fixed cadence. Typical of the foot, or single-axis ankle/
limited and unlimited household ambulators. foot
Level 2 Has the ability or potential for ambulation with the ability to K2 Flexible keel foot or
transverse low-level environmental barriers such as curbs, stairs, multiaxial ankle/foot
or uneven surfaces. Typical of the limited community ambulator.
Level 3 Has the ability or potential for ambulation with variable cadence. K3 Flex foot system, energy
Typical of the community ambulator who has the ability to storing foot, multiaxial
transverse most environmental barriers and may have vocational, ankle/foot, dynamic
therapeutic, or exercise activity that demands prosthetic response, or flex-walk
utilization beyond simple locomotion. system or equivalent
Level 4 Has the ability or potential for prosthetic ambulation that exceeds K4 Any ankle/foot system
basic ambulation skills, exhibiting high impact, stress, or energy appropriate
levels. Typical of the prosthetic demands of the child, active adult,
or athlete.

DMERC: Durable Medical Equipment Regional Carrier; MFCL: Medicare Functional Classification Levels; SACH: solid ankle cushion heel.

functional correlation between MFCL and the assignment to promote greater symmetry in external work (SEW) dur-
of prosthetic components. ing level walking in K-Level-2 amputees due to its ankle
Unilateral transtibial amputees (TTAs) have a tendency design and a heel-to-toe footplate.5 To date, influence of
to load the intact limb more than the prosthetic limb during foot design related to the prosthetic foot category on SEW
level ground walking.3,4 The resulting kinetic asymmetry during incline and decline walking in unilateral TTAs has
is influenced by prosthetic gait training5 and the category not been investigated.
of prosthetic foot used.5–7 Comparisons between level Traditional methods of assessing lower limb loading
ground walking and incline/decline walking reveal higher involve analyzing GRFs at discrete points during a gait
demands on the musculoskeletal system and greater cycle. Since the lower limbs experience variable GRFs
ground reaction forces (GRFs) during ramp ambulation in during the stance period, assessment of forces at discrete
non-amputees.8 If TTAs have higher intact limb loads dur- points does not provide a complete picture of the conse-
ing level walking and the non-amputee population experi- quences of loading throughout the entire stance period.
ences greater forces during incline/decline walking, it Furthermore, traditional methods using direct compari-
would stand to reason that during incline/decline walking sons of discrete events between prosthetic feet have not
TTAs would load their intact limb more than level walking consistently demonstrated the sensitivity to detect sig-
and the asymmetry in forces would be magnified. nificant differences between feet during level walk-
The only related study found on ramp GRFs with TTAs ing.12,13 The SEW measure has been employed as an
reported that elderly unilateral TTAs (K-Level-2) who alternative to traditional biomechanical measures for
used a solid ankle cushion heel (SACH) foot (category K1 assessing kinetic and functional differences between
foot) to negotiate ramps experienced significantly higher prosthetic feet.5,14
GRFs on the intact limb compared to the prosthetic limb.9 External work is the change in energy of the body center
They also exhibited a shorter single limb support time on of mass (CoM) that is brought about by GRFs.14 External
the prosthetic limb than the intact limb. The authors attrib- work can be calculated from the displacement of the CoM
uted the kinetic and temporal asymmetry to the design fea- and the GRFs applied to the CoM during the entire stance
tures of the SACH foot, such as its limited stance phase period.14 The SEW measure calculates external work by
ankle motion and lack of power generation.9 Dynamic the intact and prosthetic limbs and generates an index of
response (DR) prosthetic feet (category K3) have greater symmetry between the limbs. This measure determines
energy return and provide greater ankle dorsiflexion dur- collectively the similarities in GRFs, CoM displacement,
ing stance period than the SACH foot because of their car- and step time between the intact and prosthetic limbs.
bon fiber composition and “J-shaped” ankle design.10,11 A While the SEW measure has been successfully used to
K3 prosthetic foot with a J-shaped ankle has been shown detect functional differences between prosthetic feet

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Agrawal et al. 3

Table 2. Demographic characteristics of subjects for the test–retest reliability study.

Age Gender Amputated Cause of Time since amputationa


(years)a side amputation (years)
64 Male Left PVD 3
55 Female Right Trauma 7
45 Female Left Trauma 3
59 Male Right PVD 2
47 Male Right Tumor 2
Median 55 (45–64) 3 (2–7)
Range 45–64 2–7
Mean ± SD 54 ± 8 3.4 ± 2.1

PVD: peripheral vascular disease; SD: standard deviation.


aNumbers have been rounded to the nearest whole number.

during level walking and stair negotiation, ramp ascent deviation (SD)) age and time since amputation of the sub-
and descent would be another appropriate application.5,15 jects were 55.84 ± 6.5 years and 22.4 ± 18.8 months,
The purpose of this study was to determine the func- respectively. The median (range) age and time since ampu-
tional differences, as measured by SEW, between four cat- tation were 57.5 (43–64) years of age and 21 (6–72)
egories of prosthetic feet during ramp ascent and descent months, respectively. The same team of researchers per-
in K-Level-2 and K-Level-3 unilateral TTAs. It was formed sensor calibration and data collection using previ-
hypothesized that following standardized ramp training, ously validated procedures.16,17 During each testing
unilateral TTAs will demonstrate differences in SEW val- session, a new F-scan sensor was individually prepared for
ues between four categories of prosthetic feet during ramp each subject’s standardized shoe provided by the labora-
ascent and descent. Amputees classified with these func- tory. Sensors were warmed up inside the shoes for 10
tional levels were selected because they represent potential min.16 They were then calibrated using the manufacturer
ramp ambulators who may benefit from the design propri- recommended calibration and a force plate calibration
eties of the four test prosthetic feet. with two Kistler force plates embedded in a 10-m-long
level walkway. Vertical GRFs from force plates and F-scan
sensors were compared and a calibration factor for F-scan
Methods sensors was calculated, as described by Mueller et al.17
The study protocol was reviewed and approved by the Data were collected for 10 s at a sampling frequency of 50
Institutional Review Board at the Miami VA Medical Hz. Subjects then ascended and descended a 24-foot-long
Center and informed written consent was obtained from all custom fabricated wooden ramp, inclined at 5°—designed
subjects prior to study enrollment. The inclusion criteria per the Americans with Disabilities Act guidelines—
for study participation were males and/or females between without using handrails. They were tested twice within a
the age 40 and 65 years with limb loss related to dysvascu- 48- to 72-h period using standardized shoes (Aetrex
lar reasons, trauma, and tumor and who wore a comforta- Ambulator, type T1220) and socks. Intraclass correlation
bly fitting prosthesis for at least 6 months. All subjects coefficient (ICC) was used to determine the correlation
were able to negotiate ramps independently without an between test–retest SEW values.
assistive device. Potential subjects were screened by a
physician and prosthetist and were excluded if they had
Intervention study
any medical conditions or prosthetic limitations that would
cause pain or a potential health risk during the study. Data Ten unilateral TTAs (five K-Level-2 and five K-Level-3
collection was started upon physician and prosthetist clear- subjects) (Table 3) underwent six testing sessions to test
ance. The study was conducted in two phases: Phase I— four categories of prosthetic feet. The test feet were: (1)
Reliability study and Phase II—Intervention study. SACH foot (Kingsley Manufacturing Co., Costa Mesa,
CA, USA), (2) Stationary Attachment Flexible
Endoskeleton (SAFE) foot (Campbell-Childs Inc., White
Reliability study City, OR, USA), (3) Talux foot (Ossur hf, Reykjavik,
Since the reliability of F-scan sensors (Tekscan Inc., Iceland) and (4) the Proprio-Foot (Ossur hf) (microproces-
Boston, MA, USA) has only been established for level sor ankle). These four prosthetic feet were selected to rep-
walking in TTAs,5 test–retest reliability of these sensors resent each category of foot as described in Table 1, that is,
was determined during incline and decline walking with K1—the SACH foot identified by name in the Durable
five unilateral TTA subjects (Table 2). The mean (standard Medical Equipment Regional Carrier (DMERC) prosthetic

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4 Prosthetics and Orthotics International

Table 3. Demographic characteristics of subjects for the intervention study.


MFCL class Age Gender Amputated Cause of Time since Height (cm) Mass Original Time in
(years)a side amputation amputation (kg) prosthetic current
(years)a foot prosthesis
(months)
K-Level-2 59 Male Right PVD 2 180.3 107.3 Otto Bock 18
Dynamic
Motion
K-Level-2 64 Male Left PVD 3 167.6 100 Endolite 24
Multiflex
K-Level-2 61 Male Right PVD 6 191.8 105.9 Seattle Catalyst 24
K-Level-2 58 Male Left PVD 2 185.4 102.7 SACH 12
K-Level-2 61 Male Left PVD 2 175.3 115.6 Endolite 24
Multiflex
K-Level-3 47 Male Right Tumor 2 172.7 77.6 Seattle Litefoot 12
K-Level-3 55 Female Right Trauma 7 167.6 88.8 Otto Bock 24
Dynamic
Motion
K-Level-3 43 Male Right Trauma 1 166.4 101.8 SACH 8
K-Level-3 53 Male Left Trauma 33 175.3 100 Otto Bock 6
Dynamic
Motion
K-Level-3 57 Male Left Trauma 37 167.6 93.2 Otto Bock 72
Springlite
Median 57.5 174.0 100.9 21
Range 43–64 166.4–191.8 77.6–115.6 6–72
Mean ± SD 55.8 ± 6.5 175 ± 8.6 99.3 ± 10.6 22.4 ± 18.8

MFCL: Medicare Functional Classification Levels; PVD: peripheral vascular disease; SACH: solid ankle cushion heel; SD: standard deviation.
aNumbers have been rounded to the nearest whole number.

policy definition of foot/ankle assemblies; K2—the SAFE accommodation period with F1, they participated in 1–4 h
foot a truly flexible keel foot; K3—the Talux foot because of training to learn to maximize the use of this foot design.
it is a Flex-Foot with a J-shaped ankle and DR design (also Any issues with socket fit or alignment were addressed
named by DMERC) combined with multiaxial capabilities within 48 h of notification and all prosthetic or training-
because of the elastomer block. The Proprio-Foot, a K3 related issues were resolved during one return visit. At
foot, was included as a microprocessor-controlled ankle testing Session 3, effects of F1 on subjects’ gait were
(MPA) that provides active dorsiflexion and plantarflexion measured. Following testing, subjects were fit with the
during ramp walking. Data collection procedures were randomly selected second test foot (F2) and again were
identical to the reliability study described above. given 1–4 h of foot-specific training during the 10- to
At Session 1 (Baseline), subjects used their existing 14-day accommodation period. The effects of F2 on sub-
prosthetic socket and foot. There was a 2-week period jects’ gait were determined in Session 4. The same testing
between Sessions 1 and 2, during which subjects received and training procedure was repeated for the third and
up to 4 h of standardized functional prosthetic training, as fourth test feet during Sessions 5 and 6, respectively. All
described below. During this time period, their residual socket fittings and prosthetic alignment procedures were
limb was also scanned to create a computer-aided design performed by the same board-certified prosthetist.
(CAD) image (BioSculptor; Maramed Inc., Miramar, FL, Standardized functional prosthetic training was admin-
USA) which was used to fabricate a total surface bearing istered to minimize gait deviations resulting from habit or
socket having suction suspension with an Iceross Seal-in lack of training and also to maximize the use of each pros-
liner (Ossur Inc.) or a cushion liner and external sleeve. thetic foot’s functional properties. All subjects were able to
The purpose of standardizing the socket design and sus- ascend and descend the ramp leg-over-leg without the use
pension was to minimize the socket-related variables that of the handrail although they were instructed to hold onto
could influence gait performance during testing. During the handrail if required for safety. For ramp ascent, subjects
Session 2 (Training), subjects were tested again in their were instructed to place each foot flat on the surface in
existing socket and foot to determine the effects of training front of the other foot, keeping a width of approximately 10
on their gait and were fit with the study socket and one of cm between feet. During training, cues were given to assist
the four randomized test feet (F1). The same study socket with the maneuver when necessary, such as roll over the
was used for subsequent testing sessions and throughout toe, keep the trunk flexed forward, and keep the movement
the duration of the study. During the 10- to 14-day continuous (i.e. do not hesitate). No cues were given during

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Agrawal et al. 5

testing. During descent, the physical therapist used a gait A SEW value of 100% indicates equal work by each
belt to slow the transition of body weight over the pros- limb, value greater than 100% indicates more work by
thetic foot. Verbal cueing was provided to encourage more the prosthetic limb, and a value less than 100% indicates
time over the prosthetic heel (for the cushion feet design) more work by the intact limb. Shapiro–Wilk test for nor-
and over the forefoot for maximum deflection of the foot- mality of SEW values was performed for the sample
plate. With all four prosthetic feet, a slow and controlled based on K-level, at Baseline, after initial prosthetic
decent down the ramp with both limbs was promoted. training, and after prosthetic foot prescription. The intra-
During each 1-h training session, subject’s gait profi- class correlation coefficient (ICC) was calculated to
ciency was assessed on predefined criteria. They were determine the test–retest reliability of the SEW values
trained only in areas in which training was needed. When using Model 1,3. A paired t-test was used to determine
they satisfactorily met the predefined criteria, training differences in gait symmetry between the Baseline and
was concluded. All training sessions were standardized Training sessions to test the effect of standardized func-
and were administered by the same physical therapist. tional prosthetic training. Repeated measures analysis of
variance (ANOVA) was used to determine differences
Data analysis between feet after completion of the training protocol.
When ANOVA revealed significant differences, for post
After the subject’s third step with the prosthetic limb from hoc analysis, pairwise comparisons using related pairs
ascent or descent initiation, the next three consecutive t-tests were used to identify the source of differences.
steps with both the intact and prosthetic limbs were uti- The critical alpha was set at 0.05.
lized for work calculations. External work was calculated
using the following equation
Results
t2
 

W = F ⋅ ds
t1
Subject characteristics for the reliability and intervention
studies are described in Tables 2 to 4, respectively.

where W is the work in Joules, F is the GRF vector in Shapiro–Wilk test of normality

Newton, s is the displacement of CoM in meter, t1 is the
time at the beginning of a step, and t2 is the time at the end The results for the Shapiro–Wilk test for normality indi-
of a step. GRFs obtained from F-scan sensors were used to cate that the SEW values were normally distributed for
calculate vertical CoM acceleration using the following K-Level-2 subjects during decline walking and for
equation K-Level-3 subjects during incline and decline walking.
The SEW values for K-Level-2 subjects during incline
av =
( Fv − mg ) walking were normally distributed for all conditions
m except for the SACH foot (p = 0.02).

where av is the acceleration in the vertical direction (m/s2),


Fv is the vertical GRF (N), m is the body mass (kg), and g Reliability study
is the acceleration due to gravity (m/s2). The ICC for test and retest SEW values was 0.87 for ramp
The acceleration thus calculated was integrated to obtain ascent and 0.89 for ramp descent. The high ICC indicated
CoM velocity in the vertical direction. By integrating velocity that SEW can be measured consistently using F-scan sen-
and using the geometry of the ramp, vertical CoM displace- sors with unilateral TTA’s walking on ramps and also cor-
ment was calculated. Since F-scan sensors measure only the roborated the stability of subjects’ gait during ascent and
normal force, vertical force was obtained from normal force descent.
by using cosine of 5°, which was the angle of the ramp.
SEW between limbs was calculated for each stride
using the following equation,14 and a mean SEW value Intervention study
was obtained by averaging the three strides
Tables 4 and 5 show the mean (SD) SEW values during
ramp ascent and descent for both groups at the six testing
 WI − W p  sessions.
SEW = 100 − 100 ×  
 WI + W p 
 
Ramp ascent. After receiving standardized functional
where SEW is expressed in percentage; WI is the work prosthetic training, K-Level-3 subjects had a significant
done by the intact limb due to vertical GRF, in Joules; WP (p < 0.05) increase in SEW values (16% increase over
is the work done by the prosthetic limb due to vertical Baseline). In the K-Level-2 subjects, there was a 5%
GRF, in Joules. increase in SEW values following Training, which was

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6 Prosthetics and Orthotics International

Table 4. Mean ± SD SEW values (in percentage) in K-Level-2 and K-Level-3 amputee subjects before and after standardized gait
training for ramps.

K-Level-2 subjects K-Level-3 subjects

Ascending Descending Ascending Descending


ramp SEW ramp SEW ramp SEW ramp SEW
(%) (%) (%) (%)
Baseline 67.91 ± 15.2 72.15 ± 21.3 72.87 ± 8.60 75.57 ± 12.0
Training 71.04 ± 18.3 80.9 ± 12.2 88.72 ± 16.0a 92.77 ± 5.4a

SD: standard deviation; SEW: symmetry in external work.


aSignificantly different from Baseline (p = 0.05).

Table 5. Mean ± SD SEW values (in percentage) for K-Level-2 and K-Level-3 amputee subjects while ascending and descending a
24-foot ramp with four test feet.

K-Level-2 subjects K-Level-3 subjects

Ascending Descending Ascending Descending


ramp SEW ramp SEW ramp SEW ramp SEW
(%) (%) (%) (%)
K1_Foot 74.03 ± 13.9 87.43 ± 5.0 78.08 ± 13.8 80.3 ± 11.9
K2_Foot 73.61 ± 21.7 80.02 ± 15.4 75.84 ± 8.6 79.50 ± 14.4
K3_Foot 83.51 ± 11.2 101.49 ± 7.7b,c 87.22 ± 23.1 96.13 ± 7.3b
MPA_Foot 74.76 ± 10.6 98.28 ± 6.1b 86.26 ± 19.8 87.47 ± 13.3

SD: standard deviation; SEW: symmetry in external work; MPA: microprocessor-controlled ankle.
bSignificantly different from the K1 foot (p = 0.05).
cSignificantly different from the K2 foot (p = 0.05).

not statistically significant (p < 0.05). There were no sig- K-Level-2 or K-Level-3 groups; however, the K3 and
nificant differences between any pair of test feet. MPA feet resulted in greater SEW values in the majority
of subjects in both groups. Vickers et al.9 reported sig-
Ramp descent. Following prosthetic training, there was a nificant variations in GRFs during incline and decline
significant increase in SEW values for the K-Level-3 group walking, not only with the prosthetic limb but also with
(23% over Baseline), while in the K-Level-2 group (12% the intact limb. The results of this study demonstrate that
over Baseline) increase in SEW was not statistically signifi- adaptations that impact external work due to vertical
cant (p < 0.05). In K-Level-2 subjects, a higher SEW value force while ascending a 5° ramp are not influenced by
with the Talux K3 foot (p < 0.05) was found when compared the type of prosthetic foot used. Although not an original
to both the K1 and K2 feet. The MPA foot had significantly objective of the study, it was found that the prosthetic
higher SEW than the K1 foot (p < 0.05) and the difference in training administered to the subjects resulted in numeri-
SEW between MPA foot and the K2 foot did not reach statis- cally higher SEW values for the K-Level-2 subject group
tical significance (p = 0.06). In the K-Level-3 subjects, SEW and significantly higher SEW values for the K-Level-3
values were significantly higher with the K3 foot (p < 0.05) group. The methodology for this study ensured that all
when compared to the K1 foot. Again the K3 foot approached subjects received training, specific to each prosthetic
statistical significance, but was not significantly different foot’s design in order to maximize their performance
from the K2 foot (p = 0.07). The Talux foot had the greatest with the foot’s functional properties. As a result, the
SEW values in four of the five K-Level-2 subjects and in improved symmetry following the ramp ascent was
four of the five K-Level-3 subjects. There were no signifi- maintained with all test feet.
cant differences between the K3 foot and the MPA foot. During incline walking, lower limb muscles generate
power that is required to move the body’s CoM against the
force of gravity. Since the test prosthetic feet were not
Discussion designed to generate power, external work with the pros-
thetic limb may have been accomplished through the use of
Ramp ascent residual limb musculature. During the standardized pros-
During ramp ascent, there were no significant differ- thetic training, subjects were taught to appropriately con-
ences in SEW values between prosthetic feet in either tract the knee and hip extensor muscles as well as properly

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Agrawal et al. 7

contract their residual limb muscles to maintain balance match the grade of the slope. The Proprio-Foot’s ankle
and use each prosthetic foot as designed for performing the joint has limited dorsiflexion during the stance period
activity. Therefore, following the completion of the training which likely impacts the transition of body weight over the
protocol, SEW values improved in both K-Level-2 and stationary foot during the late stance period. The differ-
K-Level-3 subjects and the test feet were not found to be ences in functional ankle dorsiflexion between the K3 and
different during ramp ascent. MPA feet may explain the observed differences in SEW
Contrary to the results of Fradet et al.18—who used a values, vertical GRF peak values, and loading times
7.5° slope—this study did not find a significant difference between these DR feet (Tables 4 to 7).
between the Proprio-Foot and other test feet during incline In both the non-DR feet, the pylon is directly attached
walking. The benefits of active dorsiflexion of the Proprio- to the foot without a mechanical axis at the ankle. This
Foot may become more apparent on ramps with higher rigid ankle design eliminates functional ankle dorsiflex-
incline angles (e.g. a 7.5° slope, as described by Fradet ion during the stance period of gait. The absence of dorsi-
et al.) or a larger sample size may be needed to detect sig- flexion during stance causes premature knee flexion
nificant differences with the Proprio-Foot on a 5° incline. resulting in an early heel rise.19 Because of the shorter,
flexible keel, the body tends to progress more rapidly to
terminal stance as the CoM essentially runs out of base-
Ramp descent
of-support. The maximum forward progression of the
Both the K-Level-2 and K-Level-3 groups demonstrated center of pressure (CoP) (expressed as a percentage (%)
highest SEW values with the K3 foot, with statistically sig- of foot length) was approximately 70% and 79% with the
nificant differences between the K3/MPA feet and K1/K2 SACH and SAFE, respectively, compared to 85% with
feet. Standardized training also resulted in statistically Talux/Proprio feet (Table 8). The resulting instability dur-
higher SEW for the K-Level-3 group and numerically ing late stance likely caused the contralateral limb to
higher symmetry in the K-Level-2 group. The differences advance more rapidly to catch the body as it fell forward.
in SEW values could be attributed to the design and func- The sudden deceleration of body CoM as it transitioned
tional properties of the K3 feet. from the prosthetic to intact limb resulted in a greater ver-
The K3 foot (Talux foot) used in this study has a dynamic tical GRF peak on the intact limb—particularly in the K2
heel that promotes plantarflexion during early stance and a group—and a faster loading time on the intact limb
J-shaped ankle design that simulates anatomical tibial (Tables 6 and 7). The functional properties of non-DR feet
advancement (or dorsiflexion) as the body progresses over thus resulted in greater work by the intact limb and lower
the stationary foot in late stance.19 Macfarlane et al.20 SEW values with K1/K2 feet in both groups. These results
reported that amputees capable of balancing over the fore- suggest that K3 prosthetic feet can have significant func-
foot during late stance with a Flex-Foot were able to take a tional benefits for those K-Level-2 unilateral TTAs who
slower and longer step with the intact limb resulting in frequently negotiate ramps, as the K3 feet promote greater
greater symmetry during ambulation. The similarity in SEW during decline walking.
designs between the Flex-Foot and the Talux foot indicates The SEW measure determines the similarities in GRFs,
that the temporal gait characteristics seen with these feet CoM displacement, and step time between the intact and
would be comparable. In this study, at the time of training, prosthetic limbs. Since these gait parameters are influenced
subjects were instructed to balance over the prosthetic fore- by the design related to prosthetic foot category, the foot
foot and to take a controlled, slower step with the intact design that mimics the function of physiological foot/ankle
limb. The combination of training and functional properties during ramp walking would result in greater inter-limb sym-
of the prosthetic foot resulted in similar time needed to metry. In addition to the contributions from the prosthetic
reach the peak force (loading time) with the intact and pros- foot, the use of residual limb musculature can significantly
thetic limbs, in both subject groups (Table 6). Also, the for- influence gait dynamics while ascending and descending a
ward deflection of the J-shaped ankle spring likely permits ramp. During ramp descent, the SEW measure is correlated
a systematic lowering of the CoM in terminal stance, which with traditional methods of gait assessment, such as the ver-
allows a smooth transfer of weight to the intact limb. This tical GRF peak (r = −0.5) and loading time of the intact limb
functional property of the K3 foot resulted in reduced load- (r = 0.9), as well as the maximum forward progression of the
ing of the intact limb as the first peak of the vertical GRF CoP on the prosthetic foot (r = 0.7). Subjects with low SEW
curve with the K3 foot found to be lower than K1 and K2 values demonstrated greater vertical GRF peak and faster
feet in both subject groups (Table 7). The symmetry in ver- loading on the intact limb, as well as shorter CoP progres-
tical GRF peak and loading times between the intact and sion on the prosthetic foot. However, unlike these traditional
prosthetic limbs further corroborates the high SEW values methods—which assessed discrete points of the stance
recorded with the K3 foot. period and could only indicate trends about prosthetic feet—
The MPA foot (Proprio-Foot) also has a heel–toe foot- the SEW measure was able to detect statistically significant
plate design, which permits late stance stability, and an differences between feet. As the SEW measure combines
MCA joint that actively plantarflexes in late swing to different gait parameters during the entire stance period into

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8 Prosthetics and Orthotics International

Table 6. Mean ± SD time required to reach the first peak of vertical ground reaction force (expressed as percent of gait cycle) in
K-Level-2 and K-Level-3 amputee subjects while descending a 24-foot ramp.

K-Level-2 subjects K-Level-3 subjects

Amp limb Sound limb Prosthetic limb Intact limb


(% GC) (% GC) (% GC) (% GC)
K1_Foot 16.75 ± 3.3 14.66 ± 3.1 17.93 ± 3.8 13.88 ± 3.2
K2_Foot 17.67 ± 3.6 14.78 ± 3.1 19.56 ± 3.3 13.66 ± 4.4
K3_Foot 18.09 ± 5.3 18.19 ± 4.8 18.32 ± 4.4 17.65 ± 2.3
MPA_Foot 17.44 ± 4.1 17.64 ± 2.2 17.88 ± 2.1 16.41 ± 2.8

SD: standard deviation; GC: gait cycle; MPA: microprocessor-controlled ankle.

Table 7. First peak of vertical ground reaction force (mean ± SD), in percent body weight of K-Level-2 and K-Level-3 amputee
subjects while descending a 24-foot ramp.

K-Level-2 subjects K-Level-3 subjects

Amp limb force Sound limb force Amp limb force Sound limb force
(% BW) (% BW) (% BW) (% BW)
K1_Foot 115.07 ± 26.5 144.44 ± 24.5 103.44 ± 14.3 102.74 ± 18.6
K2_Foot 129.20 ± 27.3 120.38 ± 12.9 109.66 ± 21.1 101.63 ± 8.6
K3_Foot 110.92 ± 22.9 111.16 ± 28.1 108.9 ± 14.1 97.43 ± 10.3
MPA_Foot 109.18 ± 10.9 111.14 ± 24.7 110.26 ± 16.2 106.7 ± 6.5

SD: standard deviation; BW: body weight; MPA: microprocessor-controlled ankle.

Table 8. Forward progression of the center of pressure could potentially be implemented in a clinical setting rela-
(mean ± SD), expressed as a percentage of foot length in tively easily. Future research to test this measure on a
K-Level-2 and K-Level-3 amputee subjects while descending a larger population of subjects with different amputation
24-foot ramp. levels is needed to further determine the clinical applica-
K-Level-2 subjects K-Level-3 subjects bility of this measure with regard to different pathologies
(foot length %) (foot length %) such as osteoarthritis or neuropathic foot disease.
K1_Foot 70.51 ± 1.9 69.61 ± 1.67
K2_Foot 80.25 ± 4.1 76.96 ± 4.7 Limitations
K3_Foot 86.47 ± 3.1 85.4 ± 1.6 The study was underpowered in terms of sample size.
MPA_Foot 85.22 ± 1.6 84.9 ± 2.0 While SEW values were significantly different between
SD: standard deviation; MPA: microprocessor-controlled ankle. prosthetic feet during ramp descent, differences during
ramp ascent may not have been evident due to a relatively
small size. In addition, the accommodation time with pros-
a single value, it appears to have the sensitivity for detecting thetic feet and minimal exposure to incline/decline ambu-
subtle gait differences between prosthetic feet on ramp lation during the accommodation period due to
incline and decline. geographical topography of Miami may have reduced the
Since increased loading of the intact limb and high opportunities for practice between testing sessions.
loading rates are associated with the higher prevalence of Standardized prosthetic ramp training had an impact on
osteoarthritis in the TTA population,21 the SEW measure performance because it was specific to the design of each
could potentially be used as a measure for determining the foot and promoted use of each component, such as a cush-
efficacy of prosthetic feet in a clinical setting. Currently ion heel, rubber toes, heel-to-toe footplate, foot keel,
available self-report outcome measures only assess per- J-shaped design, and microprocessor ankle. Since ramp-
ceived difficulty associated with ramp ambulation and the specific training is not always available in all clinical envi-
performance-based measures do not quantify movement ronments, the clinically observed differences between
during incline and decline walking. Since the SEW meas- feet may vary as some feet could be more intuitive to use
ure can quantify gait asymmetry during ramp ambulation, than others. Future work could examine the differences
it could be used to supplement existing clinical outcome of SEW in TTAs who received training to maximize the
measures. With the recent advancements in wireless in- use of a prosthetic foot’s design properties for ramp
sole technology and mobile computing, the SEW measure ambulation as opposed to those TTA who naturally

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Agrawal et al. 9

adapted to prosthetic foot without formal training; that is, Author contribution
is there a prosthetic foot design that promotes SEW during All authors contributed equally in the preparation of this
ramp ambulation and does not require training? manuscript.
Similar to other commercially available in-sole sensor
systems, the F-scan sensors can only measure normal Declaration of conflicting interests
forces during gait. In able-bodied gait on sloping surfaces, The authors declare that there is no conflict of interest.
the magnitude of normal and vertical forces is very simi-
lar—differing by less than 1%—while ascending and Funding
descending a 5° ramp.20 The shear force also has a compo-
nent in the vertical direction, which is the trigonometric This material is the result of the work supported with resources
and use of the Bruce W Carter Department of Veterans Affairs
sine of the angle of the slope. For a 5° ramp, this compo-
Medical Center, Miami, FL, USA. The authors would like to
nent of shear force has a negligible contribution to the ver- thank Ossur® Americas for their support of this research study
tical force, and hence was ignored in this analysis. Future and the South Florida Veterans Affairs Foundation for Research
studies could examine SEW differences between feet at and Education, Miami, FL, USA, for administering the research
higher grades of ramps, as the vertical and shear GRFs project.
change appreciably with the angle of inclination.8
The inability of F-scan sensors or any other currently References
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