THE RIGHTFIT PROSTHETICS INITIATIVE
Rochelle Dumm, Jason Lansdown, Joseph Hirsch, Priya Parameswaran, Valeria Vasconcellos
Johns Hopkins University, Baltimore, MD
E-mail: rdumm1@jhu.edu, Web: www.RightFitProsthetics.com
INTRODUCTION
Globally, there are over 10 million
amputees, and over fifty percent are lower-
limb amputees, according to the World
Health Organization (WHO). Every year,
over five-hundred thousand new lower
extremity amputations result from traumatic
injuries, diabetes, and other chronic
diseases. In other countries with high
prevalence of landmines, war, and natural
disasters, trauma is the primary cause
(Strait). Unfortunately, 80% of people who
are in need of a prosthetic device are unable
to obtain one (Necmioglu). Without a leg,
patients are often unable to contribute to
society, and many cannot afford to travel to
a prosthetic clinic or pay for the device and
its maintenance over time. To meet that
need, we have developed an adjustable and
modular thermoforming prosthetic socket
that can be reshaped to maintain an intimate
fit with the patient’s residual limb, thus
maximizing function and comfort. With our
device, we can help amputees integrate back
into their communities worldwide.
DESIGN
We have developed a novel technique for
socket fabrication that utilizes a low-
temperature thermoplastic. The material,
once heated in warm water can be directly
molded over an individual’s residual limb or
over a modified positive plaster mold. Once
formed, the socket can be re-molded to
improve fit and accommodate changes in
limb shape and volume over time.
Our socket design addresses three of the
most prominent obstacles to prosthetic care
in the developing world: prohibitive cost,
time, and travel distance. The thermoplastic
can be re-molded and recycled for
replacement sockets, reducing initial and
long-term maintenance costs. Directly
molding the socket reduces fabrication time
from days to hours. Additionally, socket
fabrication does not require specialized
equipment, so a technician could fit a device
in a hospital or even a home. Lastly, our
socket is designed to be compatible with
components on the market, so organizations
that receive donated components can apply
our technology to the parts they already
have. We intend to connect with and
distribute care through local health or
rehabilitation clinics within each country,
but the flexibility of our solution widens the
potential sphere of influence.
METHODS
A mechanical assessment of the socket was
performed in adherence to the ISO 10328
standard for “Prosthetics – Structural testing
of lower-limb prostheses.” The protocol and
testing set-up were based on a study
conducted by Campbell (2012). The socket
was affixed to a load cell via a ball socket
joint and loaded vertically, ramping to
failure at 100 N/s (Fig. 1a).
The mechanical testing was then simulated
using a computer model in Creo. Static loads
of increasing force were delivered to the
model until failure occurred (Fig. 1b).

a b
Figure 1: a) Mechanical testing of socket
mimics loading during terminal stance. b)
Computer model loaded to failure.
Lastly, during a field study in India, our
team visited medical colleges, hospitals,
non-governmental organizations (NGOs),
and start-up accelerators in Hyderabad and
Bangalore. Test sockets were fabricated to
determine the environmental effect on the
thermoplastic.
RESULTS AND DISCUSSION
The results from our computer simulation
further confirm the findings from our
mechanical testing, which revealed that
while the thermoplastic can withstand forces
exerted on a prosthesis during normal gait,
the socket must be reinforced for the design
to comply with ISO standards without
increasing the overall weight of the design.
The computer model we have generated in
Creo will help optimize the material
properties necessary to achieve ISO
standards. Possible modifications include
embedding mesh into the thermoplastic or
adding an external support bracket, similar
to the distal adapter used for immediately
post-operative prostheses (IPOPs).
During our field assessment, we concluded
that India would be an excellent location for
additional clinical trials and collaborations.
However, India should be considered a
secondary market given the competitiveness
and the strong local roots of other prosthetic
devices e.g. the Jaipur foot. Before entering
the Indian market, RightFit should develop a
presence in another location (e.g. South
America, Africa, or the US).
SUMMARY AND CONCLUSIONS
The goal of the RightFit Prosthetics
Initiative is to design appropriate prosthetics
that holistically fit patients’ lives, improving
access to appropriate prosthetics while
reducing the time and cost required to make
a device. A prosthesis is a unique and
integral part of an amputee’s life. We want
to design a solution that will help provide
rehabilitation, mobility, and independence.
REFERENCES
Necmioglu, S., et al. (2004). Prosthetics and
Orthotics International. 28: 37-43.
Strait, E. (2006). “Prosthetics in Developing
Countries.”
"A Manual for the Rehabilitation of People
with Limb Amputation," (2004), World
Health Organization. <http://www.posna.
org/news/amputations.pdf>.
Campbell, A., et al. (2012). Prosthetics and
Orthotics International. 36: 181-89.
ACKNOWLEDGEMENTS
We would like to Dr. Stephen Belkoff, Mark
S. Hopkins, CPO, and Dr. Marlis Gonzalez-
Fernandez of the Johns Hopkins University;
previous collaborators Ian Graham and
Kevin Keenahan; Infinite Biomedical
Technologies (IBT); Medical and
Educational Perspectives (MEP); and
Dankmeyer Prosthetics and Orthotics.
 ANKLE-FOOT COUPLING WITH RUBBER CUSHION
FOR WALKING ON UNEVEN TERRAIN

Akira Kato, Ryosuke Tsumura, Tomohiro Hoshina and Naomi Okamura

Waseda University, Shinjuku, Tokyo, Japan

E-mail: n-okamura@toki.waseda.jp, Web: www.leading-sn.waseda.jp

INTRODUCTION and absorbing the shock. The hardness of

In Cambodia, there are many people who
were lost their foot by an anti-personnel
mine. 73% of the total workforce in
Cambodia engages in agriculture[1]. When
they do farm work using the lower limb
prosthesis, they have to walk safely on an
uneven terrain such as a truck farm, a paddy
field and wilderness.
the rubber we used is equivalent to natural
rubber that is major product in Cambodia.
Figure 1 shows the structure of MARC. The
rubber cushion inserted between the leg and
foot adapter. The outer walls of the rubber
cushion suppress the rotation around z-axis.
In addition, the rubber cushion has holes
above the heel to absorb the shock of the
heel strike.

Conventional lower limb prosthesis just We validated a basic effort of MARC by

realizes the shape and the hardness of the
foot such as SACH foot. To walking on an
uneven terrain, the angle of the tolecular
joint (permits dorsiflexion-planter flexion)
and the subtalar joint (permits inversion-
eversion) should adapt to the ground. To
realize these joint function, Masum et al. [2]
proposed a powered ankle-foot prosthesis
using a spring and damper. However, it is
challenging to design prostheses that work
with the materials and technologies
available in developing countries.
In this paper, we proposed a design for the
ankle-foot coupling called Multi-Axis
Rubber Coupling (MARC). That can adapt
the ankle joint angle to the ground surface
while walking on an uneven terrain. It can
be produced with cheap materials that are
available in developing countries.
comparing the ankle joint angle under 3
conditions: 1) the artificial leg with MARC
and SACH foot, 2) with only SACH foot, 3)
without the artificial leg (normal barefoot
walk). The ankle joint angle was measured
using the 3D motion capture system
(Raptor-E). We used a leftward-sloping
board as the uneven terrain that is inclined
5° for comparing to the flat ground.
Cross-section view
Ball joint
Rubber
cushion
Shock-
absorbing
hole

METHODS

MARC is composed of the ball joint for

adapting motions in multi-axis direction and Figure 1: Structure of MARC consist of
the rubber cushion for controlling joint angle the ball joint and the rubber cushion
RESULTS AND DISCUSSION stance phase, the angle of SACH foot with
MARC changed as the barefoot. In contrast,
Figure 2 shows the dorsiflexion-planter the angle of the SACH foot was not changed
flexion angle during a gait cycle under the in both flat and slope conditions. These
conditions of the flat ground and the slope. results mean MARC realized the role of the
While the stance phase, the angle of SACH subtalar joint that was not realized by only
foot with MARC moves more likely to that SACH foot.
of barefoot than SACH foot. SACH foot that
is made of the rubber can move at the MP SUMMARY/CONCLUSIONS
joint. However, SACH foot mostly
impossible to move at the tolecular joint as To walk on the uneven terrain, the ankle
shown in Figure 2. Therefore, MARC can joint movement is important for successful
append the role of the tolecular joint to adaption to the terrain. In this paper, we
SACH foot. proposed MARC as the ankle-foot coupling
for walking on the uneven terrain such as a
Figure 3 shows the inversion-eversion angle truck farm. We used only the ball joint and
during a gait cycle under the conditions of the rubber cushion that are available in
the flat ground and the slope. While the developing countries.
20
Dorsiflexion/Planter flexion (°)

20
20 We validate MARC by calculating the joint
20
10 angle during walking on the flat ground and
10
10
10 the left-ward slope. The results show that
000 dorsiflexion-planter flexion and inversion-
0 eversion movements using MARC are more
-10
-10
-10 likely to the barefoot than SACH foot only.
-10 Flat Slope
-20
-20
-20
Barefoot
SACH foot with MARC
-20 SACH foot In future work, we will validate a feasibility
-30
‐30
-30 of MARC by doing the experiment with
-30 0 50 100 more subjects and the lower limb amputees.
Gait cycle (%) Simultaneously, we should evaluate the
Figure 2: The result of dorsiflexion-planter efficiency of MARC as the durability and
flexion during a gait cycle reliability.

8 REFERENCES
Inversion/Eversion(°)

4 [1] “Cambodia and FAO Achievements and

success stories” (2011).
0 FAO Representation in Cambodia.
Flat Slope
-4 Barefoot
[2] H. Masam, S.Bhaumik, R. Ray (2014).
SACH foot with MARC ICIAME, 288-235.
SACH foot
-8
0 50 100 ACKNOWLEDGEMENT
Gait cycle (%)

Figure 3: The result of the inversion-eversion We sincerely thank to Teruki Shibata and
during a gait cycle Kazuhiko Tokuda from TAZAWA MFG. co.
 DEVELOPMENT OF A LOW-COST ENERGY STORAGE AND RETURN CARBON
FIBER PROSTHETIC FOOT

JOSHUA SCOTT BOWEN, JAVIER ALBERTO ZEPEDA

UTEP, El Paso, TX, USA
Web: www.limbs.org

INTRODUCTION METHODS

This main objective of this project is to
develop an Energy Storage and Return
(ESAR) prosthetic foot that satisfies the
demands of amputees in the developing
world. This project will focus on a low-cost,
repairable, adaptable, energy storage and
return design that offers a flexible prosthetic
foot configuration for a wide range of
patients. The projected cost of the prototype
will be below $100.00. Thus, this prosthetic
foot will target the medium-low class in the
developing countries.
Prototypes were design to be repairable and
adaptable. Therefore, a set of techniques and
methodologies were implemented to
facilitate the replication of the prosthetic
foot in developing countries.
Each toe and heel layer was manufactured
from carbon fiber using a compression
molding technique. An aluminum mold and
5 C-Clamps were used to keep the mold in
place during the curing period of the carbon
fiber. The ankle connector is a Delrin wedge
cut and shaped using a conventional milling
machine. Then a final cosmetic finish was
given to the prototype by using a dremel and
belt sand.

(Figure 1 : CAD model of the final design)

The project will focus on activity levels

subjected to harsh environments. More
importantly, properties like high terrain
adaptability, high fatigue life and corrosion
resistance criteria must be met. Therefore,
(Figure 2: Compression mold used to manufacture the toe and heel layer. (A)
Toe molds separated. (B) Toe molds clamped together during curing. (C)
Heel molds separated (D) Heel molds clamped for curing.)

the desired functions to be met are those that

facilitate a patient to incorporate him back to
daily activities. The patients must be able to
have physical activity without restricting
them in any way and by offering them an
acceptable cosmetic prosthesis appearance.
RESULTS AND DISCUSSION
The static load test was performed using a
tension-load machine provided by UTEP
Materials Engineering department. Fatigue
testing was performed using a custom ISO
22675 fatigue tester provided by Limbs
international lab. The prototype successfully
passed the international ISO 10328 static
test at the P4 level. Conversely, the ISO
22675 fatigue test failed at 450,000 Cycles
which was the point where delamination
abruptly occurred in the carbon fiber lamina.
The P4 test level used for testing the
prototype relate to a patient weight of 176
lbs. (80kg) (ISO, 2006a, 2006b).
(Figure 3: Toe Force/Deflections curves generated by loading and off-
loading the prosthetic feet. The Ossur Vari-Flex Size 27 Category 4
prosthetic compared to the prototype prosthetic Foot (PPF)).
(Figure 4: Heel Force/Deflections curves generated by loading and off-
loading the prosthetic feet. The Ossur Vari-Flex Size 27 Category 4
prosthetic compared to the prototype prosthetic Foot (PPF)).
It was seen that the energy return of the
prosthesis fell below the desired results. The
results the Ossur variflex size 27 category 4
prosthetic foot shown was an energy loss of
26.3% for the toe section and 8.4% for the
heel section, compared to the Prototype
prosthetic foot which shown a 31.8% and
39.2% energy losses for the toe and heel
sections.
SUMMARY/CONCLUSIONS
During fatigue testing, interlaminar stresses
were concentrated at a common spot where
the ankle and toe section interact. This led to
an early delamination stage at the toe
section. An improvement to the current
design must be implemented in order to
achieve a more uniform stress distribution.
Additionally, the hysteresis results
suggested that a better heel design is needed
in order to enhance the energy storage and
return of the prosthesis. Carbon fiber
manufacturing methods offer wide
prosthetic foot stiffness configurations that
customize patient’s needs. Carbon fiber is an
anisotropic material that offers an excellent
fatigue life and the best weight, deflection,
strength and cost ratio among composite
materials. In conclusion, design
improvement is a key factor for the further
development of this prototype and based on
the manufacturing methods and materials
used to replicate this prosthetic foot,
reliability and affordability of this prosthetic
foot can be readily available to patients in
developing countries.
REFERENCES
Aleccia, J., Brecher, J., & Ray, C. (2010).
Limb loss a grim, growing global crisis.
Jensen, J. S., & Treichl, H. B. (2007).
Mechanical testing of prosthetic feet utilized
in low-income countries according to ISO-
10328 standard. Prosthetics and Orthotics
International, 31(2), 177–206.
Fey, N. P., Klute, G. K., & Neptune, R. R.
(2011). The influence of energy storage and
return foot stiffness on walking mechanics
and muscle activity in below-knee amputees.
Clinical Biomechanics (Bristol, Avon),
26(10), 1025–32.
ACKNOWLEDGEMENTS
Roger V Gonzalez, PhD, Joshua Scott Bowen,
Author and Aaron Nystrom, Director of
Engineering Operations LIMBS International
 WOVEN GRASS NECK COLLAR FOR TRAUMA AND REHABILITATION
Katelyn Rye, Sarah Stafford, Delphine Dean and John DesJardins
Clemson Bioengineering, Clemson, SC, USA
E-mail: sgstaff@g.clemson.edu, Web: www.clemson.edu/ces/bioe/
INTRODUCTION
Head, neck and spine injuries account for up
to 17% of all fractures in Tanzania (Rutta,
2001). Citizens in developing countries have
limited access to cervical neck collars
Immobilization in a hospital bed is one of
the only viable treatment options, but this
puts undue strain on hospital resources, and
reduces patient quality of life.
Therefore, to address these issues, the aims
of this sustainable design initiative are to
develop a cost competitive, comfortable and
supportive brace that is locally sourced. By
testing these braces against commercial
braces, we plan to provide our Tanzanian
partners with verified designs that our team
has proven effective.
Working with the Tanzanian weavers, we
Figure 1: Neck collars tested.
On left, the 1st (blue) and 2nd
(red) generation woven collar
designs. On right, standard
commercial soft (top) and hard
(bottom) collars.
have gone through two generations of
designs for neck braces made from basket
woven grass materials. The 1st generation
woven collar (blue collar) was designed in
Tanzania from a model commercial cervical
collar. This designed was assessed and
refined to create an improved 2nd generation
woven collar (red collar) that could better
stabilize the neck by increasing the length of
the lateral struts and incorporating an
improved tightening mechanism.
In addition to providing a solution for
patients with neck injuries, this system could
act as a local economic driver promoting the
development of small businesses aimed at
producing woven grass neck braces and
other orthopaedic orthoses on a larger scale.
DESIGN AND METHODS
The collars were all hand-woven by basket
weavers in Haydom, Tanzania using locally
sourced grasses and reeds. The 1st
generation neck brace design was created to
closely mimic the size and dimensions of a
standard hard “Philadelphia” collar. It was
noted that within a month, the weaving
loosens substantially so that the collars
become significantly shorter and larger than
their original dimensions. The 2nd generation
collars were created from the modified
design specifications to account for the
woven materials’ mechanical properties.
While the collars are shorter than a standard
hard collar, the weave is tighter and lateral
struts are incorporated to provide more rigid
support. To simulate long-term used, the
woven collars were subjected to prolonged
(1 week) exposure to a hot (37C) and humid
(>90%) environment using an incubator.
Testing of the woven grass
collars was carried out following
guidelines detailed in the journal
Orthotics and Prosthetics.
Figure 2: Forward/backward flexion,
Test layout axial rotation and lateral flexion
were measured during forcible patient
perturbations to determine functional
stiffness of the woven neck braces, as
compared to biomedical-standard collars.
Two subjects were tested in this preliminary
work. Each wore all four braces and
underwent three trials. The subjects sat
stationary against a wall and wore a helmet
with an attached antenna to track their
angular neck movement (Fig. 2). The patient
sat in front of a large-scale protractor and
moved their head in the indicated directions
until the neck brace inhibited their
movement. The subjects were asked not to
forcefully try to extend further then the neck
brace allowed. The degrees of motion were
recorded for each trial and averages and
standard deviations were calculated.
RESULTS AND DISCUSSION
Unlike the 1st generation collars, the 2nd
generation collars were able to maintain
their shape and dimension over long
(>6months) times. In addition, their shape
and mechanical properties remained stable
even after prolonged exposure to hot and
humid environments.
As seen is Figures 3 and 4, the 2nd
generation collar better restricted motion
compared to the 1st generation collar
because it more closely matched the
anatomy of the human neck. The 2nd
generation collar showed improvement in
restricting motion based off changes in
design that allowed the neck brace to tighten
more effectively. The 2nd generation collar
restricted neck movement more than the
foam collar for both subjects in all planes of
motion. The hard brace was significantly
stiffer than any of the other braces and had
the greatest percent restriction.
Figures 3 and 4 (Top Right): The stiffness
of the 2nd generation brace fall between the
stiffness of the hard and soft braces
SUMMARY/CONCLUSIONS
Testing through The American Orthotic and
Prosthetic Association testing procedures
suggest that this system may offer a
uniquely powerful solution to the problem of
neck injury stabilization for patients in the
developing world. This project accelerates
the development of an economically
sustainable small-business model for locally
manufactured medical devices using locally
sourced materials, thus supporting the
Tanzanian economy.
REFERENCES
Rutta, E., et al. "Epidemiology of Injury
Patients at Bugando Medical Centre,
Tanzania." East African Medical Journal
78.3 (2001): 161-64.
Wayne Allen Kaufman, et al. “Comparison
of Three Prefabricated Cervical Collars.”
Orthotics and Prosthetics 39.4 (1986):
21-28.
ACKNOWLEDGEMENTS
We would like to thank our advisors Dr.
Delphine Dean, Dr. John DesJardins, and
Dr. Jorge Rodriguez, as well as Clemson
Creative Inquiry and Madaktari Africa