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Journal of the Mechanical Behavior of Biomedical Materials 99 (2019) 169–185

Contents lists available at ScienceDirect

Journal of the Mechanical Behavior of


Biomedical Materials
journal homepage: www.elsevier.com/locate/jmbbm

A review on the orthotics and prosthetics and the potential of kenaf T


composites as alternative materials for ankle-foot orthosis
Farah Syazwani Shahara, Mohamed Thariq Hameed Sultana,b,c,*, Seng Hua Leed,
Mohammad Jawaidb, Ain Umaira Md Shaha,b, Syafiqah Nur Azrie Safrib,
Praveena Nair Sivasankarane
a
Department of Aerospace Engineering, Faculty of Engineering, Universiti Putra Malaysia, 43400, UPM Serdang, Selangor, Malaysia
b
Laboratory of Biocomposite Technology, Institute of Tropical Forestry and Forest Products (INTROP), Universiti Putra Malaysia, 43400, UPM Serdang, Selangor,
Malaysia
c
Aerospace Malaysia Innovation Centre (944751-A), Prime Minister's Department, MIGHT Partnership Hub, Jalan Impact, 63000, Cyberjaya, Selangor Darul Ehsan,
Malaysia
d
Laboratory of Biopolymer and Derivatives, Institute of Tropical Forestry and Forest Products (INTROP), Universiti Putra Malaysia, 43400, UPM Serdang, Selangor,
Malaysia
e
School of Engineering, KDU University College Sdn Bhd (76997-T), Utropolis Glenmarie Campus, Jalan Kontraktor U1/14, Seksyen U1, 40150, Shah Alam, Selangor,
Malaysia

A R T I C LE I N FO A B S T R A C T

Keywords: Since ancient Egypt, orthosis was generally made from wood and then later replaced with metal and leather
Ankle-foot orthosis which are either heavy, bulky, or thick decreasing comfort among the wearers. After the age of revolution, the
Kenaf composite manufacturing of products using plastics and carbon composites started to spread due to its low cost and form-
Orthosis history fitting feature whereas carbon composite were due to its high strength/stiffness to weight ratio. Both plastic and
carbon composite has been widely applied into medical devices such as the orthosis and prosthesis. However,
carbon composite is also quite expensive, making it the less likely material to be used as an Ankle-Foot Orthosis
(AFO) material whereas plastics has low strength. Kenaf composite has a high potential in replacing all the
current materials due to its flexibility in controlling the strength to weight ratio properties, cost-effectiveness,
abundance of raw materials, and biocompatibility. The aim of this review paper is to discuss on the possibility of
using kenaf composite as an alternative material to fabricate orthotics and prosthetics. The discussion will be on
the development of orthosis since ancient Egypt until current era, the existing AFO materials, the problems
caused by these materials, and the possibility of using a Kenaf fiber composite as a replacement of the current
materials. The results show that Kenaf composite has the potential to be used for fabricating an AFO due to its
tensile strength which is almost similar to polypropylene's (PP) tensile strength, and the cheap raw material
compared to other type of materials.

1. Introduction and compressive strength, high durability under impact, cheap, and
easy to don on or off (Berry, 1981).
Orthosis can be defined as an artificial external assistive device The major differences between an orthotic devices and prosthetic
which supports the limbs or spine to prevent or assist any movement devices is that the prosthetic devices are used to replace the limb
made by the patients. As for prosthesis, it can be defined as an artificial completely (Nurhanisah et al., 2018) whereas orthotics devices are used
body part which completely replaces the missing body part. to enhance the functionality of the limbs (Kuettel, 2016) which has any
The similarities between both orthotic devices (orthosis) and pros- deficiencies or deformities making it unable to function properly.
thetic devices (prosthesis) were that both were designed to support a From the previous researches, it was found that the amount of or-
specific part of the body to enable the patient to move or functioned thotic research articles produced are significantly less compared to
properly. Both orthotics and prosthetics share the same ideal specifi- prosthetics research articles (Miro et al., 2013). This shows that or-
cation, which are light, high stiffness to resist shear stress, high tensile thotics has a bigger opportunity for growth in research. There are a lot

*
Corresponding author. Department of Aerospace Engineering, Faculty of Engineering, Universiti Putra Malaysia, 43400, UPM Serdang, Selangor, Malaysia.
E-mail address: thariq@upm.edu.my (M.T. Hameed Sultan).

https://doi.org/10.1016/j.jmbbm.2019.07.020
Received 28 June 2019; Received in revised form 19 July 2019; Accepted 20 July 2019
Available online 24 July 2019
1751-6161/ © 2019 Elsevier Ltd. All rights reserved.
F.S. Shahar, et al. Journal of the Mechanical Behavior of Biomedical Materials 99 (2019) 169–185

of possibilities that had not been discovered in this specific area. In was found still attached to its owner. It was made from three wood
addition, with the current technology development, there are a lot of pieces and held together by seven leather laces. The largest wood piece
areas that can be explored in order to improve the existing orthosis, was carved to resemble a toe which then tied to the other two small
especially its materials. Thus, this review will focus more on orthotic plates and was kept in place with a textile extended across the plates
devices instead of the prosthetic devices. and around the plates (Brier et al., 2015; Nerlich et al., 2000).
From the comparison of the three prosthetics, Brier et al. concluded
1.1. Orthotics and prosthetics history (ancient history – 3000 BC until 500 that the Albany toe was made in order to make the deceased whole in
AD) preparation for the next life. They stated that the ceramic component
used to make the toe was not suitable for daily use and fragile when
Orthotics and prosthetic history could be traced back since the an- compared to the other two prosthesis from the British Museum.
cient era of Egypt dated roughly around 5000 years ago as the art of Around 1000 BC to 476 AD, when the Greco-Roman World was still
splint and brace making has been applied on a fractured limbs ex- thriving, medical practices around this period has a significant influ-
cavated in the 20th century by the Hearst Egyptian Expedition of ence towards modern medicine. Many famous physicians were born
University of California headed by Dr. George A. Reisner (Elliott Smith, during this time period such as Hippocrates, Herophilos, Dioscorides,
1908; SIR GRAFTON ELLIOT SMITH, 1936). These splints were the and Galen of Pergamon. The most outstanding physician which had
oldest splints discovered throughout history and it was reported to influenced the development of medical practices was Hippocrates,
come from the 5th Egyptian Dynasty which is equivalent to 2750–2625 which also known as the “Father of medicine”. Around 460 BC until 370
B.C. Instead of just fulfilling their main aim of collecting the splints for BC, Hippocrates had used splints made of leather and wood to fix a
the museum exhibits, the head of that particular institution gave per- fractured tibia (Bisaccia et al., 2016). The splints were made of two
mission for Dr. Reisner to make a scientific investigation on the ex- leather rings where one of the rings were placed around the knee while
cavated remains and splints (Elliott Smith, 1908). Sir Grafton Elliot the other were placed on the ankle. Both rings were connected to each
Smith was also given the opportunity to examine the ancient splints other via a long rod made of cherry wood. The rods were placed lat-
which finally lead to the discovery of the surgical history (Elliott Smith, erally with respect to the ankle and knee in order to allow unrestricted
1908; SIR GRAFTON ELLIOT SMITH, 1936). The splints and braces movement of the ankle and give some skin exposure for easier inspec-
were used to give support and protect fractured or broken bones after tion when needed.
undergoing any surgery. After the Greco-Roman World period, the world transitioned into
The splints were placed in the Cairo museum for five years as part of the medieval period, also well known as the Dark Ages at its early stage.
the museum exhibition before it was taken to be examined by Dr. The medieval period begins after the fall of Roman Empire around 476
Reisner and his team. It was found that the splints were still attached to until it ends around 1500. There was no significant progress or devel-
a young girl's broken limb around the age of 14 years old. From further opment of medical practices occur after the fall of the Roman Empire
investigation, the splints were used to hold a fractured femur of the until the Renaissance era came. During this period, war has become
female mummy. The four splints were made from a rough, slender more prevalent and the decline of population also had affected the
wood strip, and wrapped up with the linen bandage before being fixed growth of medical practice during that era. However, fractures and
to the limb. broken bones has become a common issue due to the war. Thus, at that
Another notable discovery was achieved by Brier and his team in time period, fractures and broken bones were treated with a plaster
2015 had also proves the existence of prosthesis since the ancient mould or splint. The plaster mould was made from flour and egg whites.
Egyptian era by using the radiologic examination of two mummies Instead of the development in medical application, this era more fo-
(Brier et al., 2015). The mummies were brought to the Albany Institute cusses on the manufacturing of splint armours. These was made by
of History and Art 100 years ago and had remained unstudied until attaching metal splints to a leather backing. Most of the modern or-
1989. thosis were designed according to these armours which functioned as
From the 1989 investigation, the researchers found a prosthetic toe body protection and in some cases for body support.
from one of the mummies which was identified as Ankhefenmut.
However, due to the limitation of the CT scans technology at that time, 1.2. Orthotics and prosthetics history (modern history – 1501 AD until
the prosthetic toe was believed to be made of ceramics due to the dif- present)
ference in scan density. It was unclear whether the prosthesis was used
as a functional element or merely intended to make Ankhefenmut After the medieval period, the world enters the renaissance era
whole for the next world entry. which marks as the transition of the medieval period into modernity.
Thus, with the current CT scan analysis, a detailed image of the This era started around the year of 1500 until 1800. During the mid to
artificial toe can be retrieved. It was found that the part which was late 1500s, a French surgeon named Ambroise Pare had introduced
attached to the foot was made of ceramic, whereas the part which re- modern amputation and then created prosthetic devices which includes
presents the missing toe seems to be thin and made with resin coated adjustable harness, knee lock control, and other engineering features
wood. This Albany toe was compared with the other two prosthetic toes that are being used in today's devices.
placed in the British Museum to figure out whether the Albany toe was His major motivation in creating prosthesis was in order to help the
made to be used functionally or aesthetically. soldiers that had lost their limbs during the war. During his service, he
The functionality of the artificial toe was further clarified with the found out that most soldiers would rather commit suicide instead of
discovery of two other prosthetic toe which is now located in the British living without limbs. Thus, with his knowledge and expertise as an
Museum. The two toes have been in the museum since 1981. The first anatomist, he created artificial limbs that could work as good as a
toe was made from plaster coated linen, and has been painted to appear biological limb. His most notable design was a mechanical hand which
more lifelike (Brier et al., 2015; Falder et al., 2003). The coating on the was operated with multiple catches and springs, worn by French Army
toe was well preserved, but there is a sign of wear as seen from the thin Captain during battle (Hernigou, 2013). The captain exclaimed that the
coating at the surface of the lower part of the prosthesis indicating its mechanical hand was able to work exactly like a real hand. The pro-
everyday usage. Thus, this has further proved that it is a working totype of the mechanical hand was made from iron or steel. Other than
prosthesis and it is not only used as cosmetic restoration for the after- prosthetics, Ambroise Pare also invented a perforated steel orthosis or
life. better known as the metal corset which could help in correcting the
The second Egyptian toe was found in 1998 was excavated from spinal column structure or scoliosis. The corset was made from either
Tomb 95 located on the west bank of Nile, Egypt. Unlike the first toe, it iron or steel with a leather lining at its edge. The orthosis was designed

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with several holes on it to reduce the weight of orthosis. He also orthosis is usually in the spine's traumatic injury management.
highlighted that there was a high rate of children with club foot borne Upper limb orthosis can be applied to five upper extremity regions
during that time period. Thus, he introduced an orthosis for club foot which are shoulder, arm, elbow, wrist, and hand. Some example of
correction by using metal, wood, and fabric (Markatos et al., 2015). cases which utilises upper limb orthosis are Hemiplegia, Rheumatoid
In 1876, Hugh Owen Thomas invented the Thomas splint which is Arthritis, and burns.
used to treat the deformities at the lower limb (Gray and Santy- The lower limb orthosis is divided into five types based on which
Tomlinson, 2018). It was a simple design with the main objective of part it supports or enclosed. The types that had been identified are Foot
immobilizing the lower limb. The splint was made from a padded metal orthosis (FO) (Clark et al., 2006), Ankle-Foot Orthosis (AFO) (Alam
ring which is attached to a leather that was attached to an angled bar et al., 2014; Polliack et al., 2001), Knee orthosis (KO) (Alam et al.,
that extends from the groin to below the foot on both side of the leg. 2014; Iijima et al., 2014), Knee-Ankle-Foot orthosis (KAFO) (Polliack
After the renaissance era, the development of orthosis and pros- et al., 2001), and finally Hip-Knee-Ankle-Foot orthosis (HKAFO)
thesis had a rapid change in material development. Even though the (Polliack et al., 2001).
basic design of both orthosis and prosthesis does not change much since Foot orthosis (FO) is known as shoe inserts, arch supports, or insoles
the ancient times, there is quite a significant change towards the ma- is a device which contoured the whole foot and fix the abnormal motion
terials used due to the age of industrialisation. Unlike in the previous or position of a foot. This orthosis usually designed to fit inside the
eras, the industrialisation age was able to give more possibilities in the footwear to control any abnormal foot function or reduce the pain areas
manufacturing orthosis and prosthesis due to invention of machines. around the foot. It acts as cushion and helps in stabilising the foot to
In the 1960's, Yates and Lehneis had written the first article about improve the gait movement or reduce any pain experienced by the foot.
replacing metal orthosis with the thermoformed plastics (Shamp, Some medical cases that uses FO includes arthritis, plantar fasciitis, shin
1983). At the start of its introduction as an orthotic material replace- splints, tarsal tunnel syndrome, and flat feet.
ment, a lot of the researchers debated and kept on comparing the Knee orthosis (KO) covers the area around above and below knee
conventional metal to the thermoformed plastics. However, after some joint. KO are more commonly known as a knee brace. This orthosis
investigation, it was found that plastic has more advantages compared functions as a support or helps in alignment of the knee. It helps reduces
to metal. It is light, hygienic, form-fitting, and noise-free. Unlike metal pain in cases such as osteoarthritis. In some cases, it helps in preventing
orthoses, plastic orthoses are thin enough to be worn within the user's the knee from the instability during flexion or extension. KO are also
clothes, thus increasing the cosmetic value. Since then, thermoformed popular among athletes whereby they used the orthosis as a way to stay
plastics has started to dominate the orthotic and prosthetic field. active and enhance the position and movement of the knee while at the
In 1966, carbon fiber composites had its first experimental testing same time reducing the pain or pressure exerted towards the knee
made by Nigel Ring (Klasson, 1995). The composites were well known joints.
as a material which has a high strength to weight ratio. In other words, Knee-Ankle-Foot Orthosis (KAFO) focuses its function on the
it has the strength of a metal and the weight of plastic depending on movement of joints of the ankle and knee. It is designed to provide
how it was manufactured and designed. Thus, carbon composites have support to the knee, ankle, and foot while aligning the joints to com-
become one of the most favourable material to be used aside from pensate the muscle weakness during gait movement. During stance
plastics. phase, the orthosis will lock the knee in place ensuring that the user is
As the time passes, many experts start to define splints and braces as able to stand or ambulate safely without buckling. The orthosis spans
one of the orthotic devices. Orthotics can be defined as a branch of the from the thigh up to the foot and it is usually prescribed for patients
medical field where it focusses on the design, fabricating, and fitting of with Rickets, Bow Leg, and Knocked Kneed.
an orthosis. The definition of an orthosis is an external device which is Hip-Knee-Ankle-Foot Orthosis (HKAFO) is actually a combination of
used as a support in order to fix a certain part of the body by applying two KAFOs which link to the hip by a pelvic band. Unlike KAFO which
some force onto it, to keep it from moving and cause extra harm. It also only provides locked knee joint, HKAFO also provide locked hip joints
provides support for body movement when there is any muscle defor- for stability in traverse and sagittal plane. The hip joint and pelvic
mity and nerve weakness at certain body parts. section provides hip movements such as from front to back, side to side,
After several centuries has passed, orthotic and prosthetic devices rotation while minimizing the risk of the hips from dislocating. This
has become more user friendly and aesthetically pleasing. The leather orthosis usually indicated for cerebral palsy, paralysis, or Duschenne
straps has been changed into Velcro straps which is much smoother and Muscular Dystrophy.
reduce skin irritation. The steel splints or braces has been changed into Finally, an Ankle-Foot Orthosis (AFO) was designed to cover from
a lighter material such as aluminium or carbon fiber. Finally, for lower the foot up to below the knee. It is intended to control the movement
limbs orthosis which were using the heavy and bulky shoes as the foot and alignment of the ankle, and also compensate for the nerve or
support has also been replaced with lighter material such as poly- muscle weakness around the foot. Due to the common problem of foot
propylene and carbon fiber. Fig. 1 shows the timeline summary of or- drop among Malaysian, this paper review will be directed towards the
thosis development since ancient civilization. ankle-foot orthosis (AFO) research. There are two main categories of
However, due to the limitations or problems caused by these ex- the AFO designs which are articulated (jointed, flexible around the
isting materials, a new material will be put into consideration. Thus, heel) and non-articulated (rigid). For an articulated AFO, its joint/
this review paper is intended to discuss further on the existing orthosis hinges assume the function of the ankle joint and helps in lifting the
materials, the advantages and disadvantages of these materials, and the foot up during the swing phase in cases such as foot drop. As for a non-
possibility of using a natural fiber composite as a replacement of the articulated AFO, it restrains ankle movement in cases such as broken or
current materials. fractured bones. This paper will particularly discuss on AFO for foot
drop due to its simple biomechanics and material selection compared to
2. Orthotic devices other orthosis.

Orthotic devices (Orthosis) can be divided into three types based on 2.1. Drop foot/foot drop
the anatomical structure of the human body which are the spinal or-
thosis, upper limb orthosis, and lower limb orthosis. Spinal orthosis is a Drop foot which is also known as foot drop is an anatomical pro-
back brace that was designed to support the spine and keeps it place to blem where there is a weakness or paralysis at the anterior portion of
reduce the chances of the spine from curving as the patients gets older muscles of the lower leg (Liu et al., 2013). It is characterised as the
such as scoliosis. However, the most significant indication for this difficulty in lifting the front part of the foot, making it drag on the

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Fig. 1. Summary of the orthosis material's development timeline.

ground when walking. This problem in gait movement may be tem- such as the Parkinson's disease.
porary or permanent depending on the main cause of the foot drop. iii. Muscle or nerve disorders: There are various kind of muscle or
Foot drop may be caused by several different factors which relates nerve disorders that could cause foot drop such as stroke, cerebral
to the weakness or paralysis of the foot muscles. Some of the factors are palsy, polio, or Charcot-Marie-Tooth disease.
(Graham, 2014):
The symptoms of a foot drop are:
i. Nerve injuries: The lifting of the foot is mainly controlled by the
peroneal nerve which is a part of the peripheral nervous system. i. Difficult or unable to lift the foot
Any injury on this specific nerve could cause an inability to bend or ii. Foot drags on the ground while walking
lift the foot upward at the ankle. Some examples are sports injuries, iii. Thigh is raising higher than normal to avoid dragging (high step-
diabetes, large amount of weight loss, or long hours of sitting cross- ping gait)
legged or squatting. iv. The foot gives out pain or feels numb when moving or lifting
ii. Brain or spinal cord disorders: Diseases or disorders which dis-
rupt the normal brain or spinal cords could also cause foot drop The gait cycle is a combination of two primary walking phase which

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are the stance phase and swing phase. The combination the stance too heavy, bulky, and hard to be concealed inside the user's clothes.
phase and swing phase can also be divided into eight phases. It starts Furthermore, sometimes this type of this design promotes excessive
with the initial contact, followed by loading response, mid-stance, sweating around the enclosed area which decreases the user's com-
terminal stance, and end with pre swing in the stance phase. After that fortability and promotes skin irritation and oedema. The materials that
it continued with initial swing, mid swing, and finally late swing re- was usually used for this design are metal, leather, and carbon fiber
spectively in the swing phase (Bonnefoy-Mazure and Armand, 2015). composite.
In a normal gait cycle, during the initial contact, the foot will in- As for the non-articulated AFO, this design is a direct opposite of the
itially be in contact with the ground, thus known as foot strike. When articulated AFO. The non-articulated design was designed with a fixed
foot started to leave the ground and transitions into the swing phase, it stiffness so that the patient would not be able to move their ankle while
is known as foot off. Once the gait movement enters the swing phase, walking (Alam et al., 2014). Most of the AFOs using this type of design
the foot will never be in contact with the ground a certain period of were made from thermoplastics. Thus, this type of AFO are usually
time. During this phase, all the foot portions will be in a forward mo- light, aesthetically pleasing, and can be concealed inside the user's
tion. clothes. However, non-articulated AFO does not allow any movement
However, in foot drop gait cycle, the movement of the foot will a bit around the ankle, causing the gait movement of the users seem un-
more different during the foot strike, foot off, and swing phase. In initial natural and limited. The stability of their movements was also taken
contact, instead of the normal heel-toe foot strike, the front foot will away. Due to high contact area with the skin, irritations or rashes are
either slap or drag on the ground or completely planted on the ground. much worse compared to an articulated AFO when it is used for a long
As it transitions into the terminal contact, the foot will be unable to period of time.
support their body weight causing more pressure to be placed on the
leg. Once it enters the swing phase, the knee will be flexed more than
3. Fabrication process of ankle-foot orthosis (AFO)
normal to accommodate the inability to dorsiflex and resembles the gait
movement when climbing the stairs. This particular movement is also
The primitive orthosis was generally created as a simple device
known as the high stepping gait.
made from wood and leather. As the years goes by, the world enters
The treatment for foot drop may differ depending on the cause of
industrial revolution era where many new machines, technologies, and
the foot drop. Some of the treatment includes exercises to strengthen
techniques were invented, thus making manufacturing using metal
the muscles and maintain the joint motion of the foot to improve the
spreads to every field including the orthotics field (Mulgaonkar et al.,
gait. Another treatment was by stimulating the peroneal nerve with
2008). Orthotics field began to evolve rapidly as it enters the era of
electric during footfall which also known as Functional Electrical
modernity and its designs are becoming more functional, user-friendly,
Stimulations (FES). In worst cases, the patients has to undergo a surgery
and eco-friendly.
to repair or decompress the damaged nerve. Finally, for mild cases of
As the developments made in material science has become more
foot drop, doctors usually treat the disability by using the Ankle-Foot
significant, new materials which were made into composites such as
Orthosis. This device will be able to help in correcting the patients’ gait
carbon composites, and plastics due to 3D printing, has become one of
either temporarily or permanently depending on the severity of the foot
the most widely used application for consideration of the orthosis de-
drop. It could help these patients to walk better and safely. The orthosis
sign material (Takhakh A and Abbas S, 2018).
will be fitted to the foot to hold the foot in a normal position.
Currently, AFOs can be made by using one of the methods stated
below (Munguia and Dalgarno, 2013):
2.2. ANKLE-FOOT orthosis (AFO)
i. Thermoforming polymer sheets around a plaster cast impression
In foot drop cases, an Ankle-Foot Orthosis (AFO) is a device or
ii. Pre-preg carbon fiber sheet layup using plaster cast base as re-
product which help in supporting and controlling the position and
ference surface
motion of the ankle while walking. It compensates the weakness or
iii. 3D printing
deformities of the peroneal nerve or muscle by supporting and stabi-
lising the foot and ankle during the swing phase gait in the gait cycle.
For foot drop treatment, an AFO with 90° foot drop stop was usually 3.1. Thermoforming polymer sheets around plaster cast impression
assigned to the patients and designed using a variety of materials. It was
assigned when the plantar flexors are normal but dorsiflexors are weak Thermoforming an AFO usually used a thermoplastic such as poly-
(plantar flexion stops at the neutral position of 90°) or vice versa. propylene (PP) as its material. A significant property of a thermoplastic
Generally, AFO was constructed in the shape of an “L”, where the was that the materials will always softens when heated. Due to this
horizontal portion was placed under the foot and the vertical portion factor, it is easier to mould a PP into a desired orthosis design/shape.
was placed behind the calf. AFO can be divided into two types which Fig. 2 shows the process in fabrication of a thermoformed AFO.
are articulated AFO (has jointed ankle to provide control) and non-ar- In thermoforming, there are four factors which are significant in
ticulated AFO (rigid). ensuring a successful operation, which are:
The articulated AFO can be defined as a jointed AFO where the
jointed part at the ankle was joined mechanically and has the flexibility i. Heating temperature
to move the ankle upwards or downwards during walking. As for the
non-articulated AFO, it is a solid or rigid AFO where it supports the foot The heating temperature depends on the type of polymer used,
and ankle in one place and does not allow any movement unlike the where a homopolymer must be heated with temperature around 175 °C
articulated AFO. Both types of AFO design has its own advantages and until 180 °C whereas a copolymer must be heated with temperature
disadvantages. around 165 °C until 170 °C.
For an articulated AFO, the biggest advantage of this design is its
flexibility in letting the movement of ankles for dorsiflexion and plan- ii. Heating duration
tarflexion (Alam et al., 2014). It does not limit the gait movement of its
user and has higher stability and better gait movement compared to the Next, the heating duration of the PP sheet will vary according to the
non-articulated AFO. In addition, the movement of climbing, walking thickness of the sheet. It is recommended that the PP thickness is
up and down the hill, walking and crouching appeared more natural. around 3 mm–5 mm for an orthosis depending on the patient's weight.
However, the disadvantage of this type of design is that it is sometimes The standard estimation for the heating duration can be calculated by,

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Fig. 2. The steps involve in the typical thermoforming process (Munguia and Dalgarno, 2013).

Fig. 3. Fabrication process of the carbon fiber AFO (Munguia and Dalgarno, 2013; FIORGENTZ - Orthopädietechnik mit Systemen, 2019).

Heating duration = (5 min× t) + 10 min (1) prevent the sheets from sticking by covering the oven tray with a Teflon
sheet. The Teflon sheet must be free from any defects and clean to
Where. prevent damage to the PP sheet.
t = thickness of PP sheets.
As an example, for a 3 mm sheets,
3.2. Pre-Preg carbon fiber sheet layup using plaster cast base as surface
Heating duration=(5 min× t) + 10 min reference
Heating duration=(5 minutes × 3) + 10 minutes = 25 minutes
The meaning of pre-preg is that it is a technology or technique in
which reinforced fiber of the composite materials is pre-impregnated
iii. Temperature homogeneity in the oven with a resin/polymer matrix in a certain ratio. This technology made
the manufacturing of light, high-quality, and strong orthoses was made
Some ovens may not heat evenly and has a problem in heat dis- possible. Most research indicated that using a woven composite is more
tribution. It is important to ensure that the heats spread evenly in the recommended compared to a unidirectional composite to fabricate an
oven to get a good quality of the thermoformed sheets. orthosis due to its higher strength and stiffness, which could help in
supporting lower limb. The matrix will usually be coupled with an
iv. Teflon lining condition epoxy resin instead of other type of resins such as phenolic for its
fabrication since an orthosis does not require high temperature re-
While the PP sheets was heating in the oven, it is important to sistance.

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There are two major reason using a pre-preg carbon fiber in orthosis vi. Easily mouldable for custom made orthosis
fabrication which are the performance and the cost. The pre-preg can
be easily processed which results in lower fabrication cost, reduced The following sub-sections will discuss on the materials that has
energy consumption, and could also control the amount of fiber content been used and researched for the past several years since orthosis has
used in fabrication. Furthermore, a pre-preg carbon fiber has good fa- been introduced until now.
tigue, tensile, and stiffness which is highly required for a safer and
strong orthosis. Pre-preg could also resist corrosion which may harm
the patient's health when using the orthosis. Fig. 3 shows the general 4.1. Wood orthosis
fabrication process of a pre-preg carbon fiber AFO.
The major difference between the plastic AFO fabrication process Wood orthosis has existed since the ancient civilization era. The
and the carbon fiber based AFO is that the carbon fiber AFO were advantages of using wood for an orthosis fabrication are due to its re-
fabricated by laying several layers of sheets with different orientation newability, machinability, good strength to weight ratio, does not rust,
around the plaster cast until achieving the desired thickness instead of and aesthetically pleasing. However, the downside is that the properties
thermoforming the sheets with a prescribed thickness (Zou et al., 2014). of wood are highly variable. The variability of wood mechanical
properties could be affected by its species, moisture content, or even the
3.3. 3D printing orientation of the load against the grain. The mechanical properties of
the wood are comprised of tension, compression, flexure, and finally
Unlike thermoforming PP sheets and laying up pre-preg composites shrinkage and swelling.
which has been used for several decades, 3D printing technique is fairly Generally, the density of woods are ranged from 160 kg/m3
new in the orthotics field due to limited material availability and the (Borrega and Gibson, 2015), (The Engineering ToolBox., 2017) up to
materials’ low strength compared to its traditionally manufactured 1350 kg/m3 (The Engineering ToolBox., 2017), (Naylor, 2014) where
parts. Thus, currently there is an extensive research being carried out in the lightest wood was Balsa wood and the densest or heaviest wood is
order to improve this technique which may be useful in reducing the the lignum vitae. The most common type of wood that has been used
time taken for an orthosis manufacturing. were the bark of the cork of an oak tree or balsa wood (Edelstein and
3D printing which is also known as additive manufacturing is a Bruckner, 2002). It was estimated that the Balsa wood density was
technique in which a digital model was created to make a solid 3D recorded around ± 160 kg/m3 (Green et al., 1999; Newaz et al., 2016;
model. In 3D printing, the digital model of an orthosis can be obtained Pertiwi et al., 2017) whereas in comparison an oak wood density
by using the CAD/CAM technology to create a 3D model from the ranged around 600 kg/m3 until 900 kg/m3 (Green et al., 1999; Newaz
ground up with a 3D modelling software or from the data generated et al., 2016; Pertiwi et al., 2017), (Green et al., 1999; Newaz et al.,
from a 3D scanner. After that, the prototype will be printed layer by 2016; Pertiwi et al., 2017). In other word, a Balsa wood is much lighter
layer by using the 3D printer. Currently, orthosis are mostly printed than a cork of the oak tree. Thus, Balsa wood were sometimes used as a
using plastic materials such as polypropylene and ABS which are shoe lifts or arch supports due to its light weight.
available in a filament form. Fig. 4 shows the process of fabrication In order to ensure safety and stability, an orthosis needs to have a
using 3D printing. good tensile strength, compressive strength, and flexural strength. Both
tensile strength and compressive strength of wood can be divided into
4. Orthosis existing materials two type, which is the strength along the grain, and the strength per-
pendicular to the grain. Its strength is the strongest when tension was
Throughout the years, AFO materials has evolved gradually starting exerted along the grain. It was estimated that the range for the wood
from wood, metal and leather, plastic, and carbon fiber composite re- tensile strength along the grain is around 1.9 MPa (Kosipo wood)
spectively as shown in Fig. 5. AFO is an orthosis which supports or (MatWeb. Tropical Kosipo W, 2019) to 161 MPa (European Ash wood)
protects the ankle and foot of a user while also repairing the user's gait (MatWeb, 2558). As for the compressive strength along the grain, it was
movement and stability. An AFO's most ideal requirements are: estimated that the value of the strength are around 20 MPa (Poplar
wood) (Green et al., 1999; MatWeb, 2942) up to 44 MPa (Hickory
i. Strong enough to provide support wood) (Green et al., 1999; MatWeb, 2019a, 2019b). The flexural
ii. Flexible to provide comfort while walking strength of wood are ranging from 19 MPa (Green et al., 1999; MatWeb,
iii. Breathable to reduce or prevent excessive sweating 2019c) (Balsa wood) up to 179 MPa (Ebony wood) (Green et al., 1999;
iv. Lightweight to reduce energy exerted while walking MatWeb, 2019d). Generally, wood has a low modulus of elasticity. The
v. Thin orthosis to enhance aesthetic looks and easier fitting into modulus of elasticity of wood are ranging approximately from
clothes 5800 MPa (Cedar wood) (Green et al., 1999; MatWeb, 2668) up to
12,000 MPa (Hickory wood) (Green et al., 1999; Meier, 2003; MatWeb,

Fig. 4. General fabrication process of AFO by using 3D printing.

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F.S. Shahar, et al. Journal of the Mechanical Behavior of Biomedical Materials 99 (2019) 169–185

Fig. 5. The evolution of AFO materials.

2868; MatWeb, 2019e). Thus, depending on the wood species and its becomes very heavy and need higher energy expenditure. Thus, making
mechanical strength, the material may or may not be suitable to be used the users put out an extra effort while walking with these AFOs on. In
as an orthosis material. The selection of wood material highly depen- addition, the thickness of the leather and metal causes these types of
dent on the type of orthosis that will be developed. materials to be unsuitable being worn in a highly humid area. The effect
As discussed previously, the earliest wood orthosis that was ever towards the users would be excessive sweating and bad odour due to
made, was discovered being worn by a young female Egyptian mummy. the absorption of sweat into the leather.
The splints were made from slender tree barks and wrapped with linen In 1912, Edgar Stanley Weaver invented an invalid body support
clothes around the mummy's legs to treat her fractured femur (Elliott that made use of both leather and metal (Weave, 1912). His invention
Smith, 1908). Another wooden orthosis that has been kept in historical relates to body paralytic support device to enable users/patients to
records was the wooden splints made by Almiron M. Day during Civil regain regular body movement functions. Another inventor named
War in 1850's (Mickelson, 2015; Bennington Museum, 2505). The Douglas A. Slinger invented a foot list assist for foot drop in 1999 and
splints that he made was adjustable with the inclusion of wooden knobs published his patent in 2002 (Slinger, 2002). The design helped a
below the foot plate. There were three clothe straps to hold a leg in person to walk better in an almost normal manner. A metal plate was
place, and one clothe strap to hold the foot plate in a right-angled de- placed under the foot strap to enable the user walk on abrasive surfaces.
gree. Finally, in 1942, Charles Eames invented the Eames Splints and An elastic cord was connected to the foot strap towards the hip belt.
presented them to the US Navy during the 2nd World War (Owen, 1998; Both the foot strap and belt were made of leather. Another design
Eames, 1942). The Eames splints were made of plywood, which made proposed by Sherk helped in reducing skin shear (Sherk, 2008). Sherk
the splints to be lightweight. Furthermore, it was made in modular created a metal AFO with floating T strap leather covered foam which
form, so that it can be manufactured and transported in large numbers was attached to the shoe to ensure the reduction in skin shear upon skin
during the war era. contact. The problem with these materials is that they are heavy and
bulky.

4.2. Metal and leather orthosis


4.3. Plastics orthosis
One of the oldest materials that has ever been used was leather
(Banga et al., 2015). Leather is a material which was made from animal Plastics are widely known as a semi-synthetic material. It can be
skin that was treated chemically through a process known as tanning. divided into two types which are thermoplastics and thermosets.
The tanning process will toughen the skin, increase its flexibility, and its Thermoplastics are plastics which can be turned into a liquid when
strength. The leathers that was used in the orthosis design will always heated and freezes into a glassy solid when cooled properly. This ma-
resemble a shoe, whereas the cuffs that hold the limbs in place were terial is convenient for orthosis fabrication due to the fact that it can be
designed like a cloth or straps with lace. A treated leather usually has moulded on a plaster model and made an orthosis quickly. Some ex-
high tensile strength, tear resistant, and a good heat insulator. The ample of thermoplastics are Acrylic, Polypropylene (PP), Polyethylene
downsides of using leather are the chemical wastes after each tanning (PE), and Nylon. As for thermosets, these materials are usually in liquid
process will cause pollution, and has low biodegradability. The ap- form before being cured and can be moulded into their final form after
proximate average value of the density of a leather is 860 kg/m3 (The being cured. Thermosets that has been moulded cannot be reshaped.
Engineering ToolBox., 2009). Epoxies, silicones, Polyurethanes, and Polyester resin are some of the
In lower limb orthosis production, leather was usually paired up thermosets that are commonly used in orthotic devices.
with metal supports to withstand the force acting against the limbs. The Advantages of using plastics in orthotics application is that plastics
most common metals used in orthosis production are metal alloys, are poor conductors of heat and electricity, inflammable, and do not
steels, and any light metals with high tensile strength. The density of corrode and rust. These properties will ensure that the fabricated or-
metals could be as light as a Magnesium alloy which is 1700 kg/m3 52 or thosis would not harm the users regardless whether it is physically or
as heavy as Tungsten alloy which is 20,000 kg/m3 52. The tensile chemically. Its high mouldable aspects could also ensure that the or-
strength of metals are ranging from 11 MPa (Tin) (Ashby, 2016) up to thosis can be mould into any shape or sizes which would perfectly fit
2200 MPa (Stainless Steel) (Ashby, 2016). Metal has high stiffness, thus the users. Other than that, plastics are lightweight, durable, easy to
its modulus of elasticity will range around 13,000 MPa (Lead Alloys) colour, and energy saving. Thus, orthosis made from plastics are the
(Ashby, 2016) up to 380,000 MPa (Tungsten Alloys) (Ashby, 2016). lightest among other orthosis made from different materials while re-
The advantages of using a metal-leather orthosis is that is usually taining its strength, and more aesthetically pleasing. The density of
comes in a modular design. Thus, the shoe could be removed from the plastics falls within the range of 36 kg/m3 up to 2200 kg/m3 52. As for
metal fixtures or supports and exchange with a different shoe. The its tensile strength, it is around 0.24 MPa up to 170 MPa (Ashby, 2016).
downside of using this type of orthosis is that it is bulkier than any other The modulus of elasticity of plastics may vary widely depending on the
orthosis with low cosmetic value. In addition, the addition of both type of resins, reinforcing agents, and processing methods. It ranged
metal and leather density within an orthosis causes this type of orthosis from 0.7 MPa up to 4100 MPa (Ashby, 2016). The negatives of using

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Table 1
Summary of current AFO materials’ advantages and disadvantages.
Materials Advantages Disadvantages

Wood - Renewable - Variability of wood properties


- Good strength to weight ratio
- Does not rust
- Aesthetically pleasing
Metal and Leather - High tensile strength - Produce harmful chemical wastes during production
- Tear resistant - Low biodegradability
- Good heat insulator - Bulky and heavy
- Usually comes in a modular design - Low cosmetic value
- High energy expenditure
- Cause excessive sweating and bad odour
Plastics - Easily mouldable and reduces production time - Indestructible which cause environmental pollution
- Poor heat and electricity conductor - Production of harmful gasses during AFO production
- Inflammable - Causes skin irritation after long term of usage
- Corrosive and rust resistant
- Lightweight and durable
- Good aesthetics value
- Low energy expenditure
Carbon Fiber Composite - Good strength to weight ratio - High production cost
- Good aesthetics value - Not often eco-friendly
- Corrosive resistant - Low reusability
- Fatigue resistant - Design and manufacturing were too time consuming
- Rust resistant - Not cost-effective for short term users

plastics is that it is indestructible which could potentially pollute the are from thermosets or thermoplastics resins.
environments. Even though, its wastes are melted to be removed, the Other than plastics, CFRP is one of the most widely known material
gas formed during the melting process are still very harmful for health used to manufacture an AFO among all other polymer composites.
and helps in thinning the ozone layer. AFOs made by using plastics are CFRP is a composite made from carbon fiber as its reinforcements, and
usually lighter than the rest of the materials available in the market. polymers as its matrix. This type of material is lightweight while still
However, it also causes skin irritation when it is used for a long period retaining the strength of a metal (Mostafa et al., 2016). It is also much
of time. more aesthetical when compared to other materials. The density of
Currently, with the existence of the additive manufacturing, plastic CFRPs are ranging from 1500 kg/m3 until 1600 kg/m3 52. As for its
has become the most sought-after material. Additive manufacturing tensile strength, it ranges from 550 MPa until 1100 MPa (Ashby, 2016).
makes use of the 3D printing and 3D CAD model to produce an orthosis. Finally, its modulus of elasticity could reach as high as 69,000 MPa
The orthosis will be printed out layer by layer the printer according to until 150,000 MPa (Ashby, 2016).
the 3D model generated from CAD/CAM software. This could actually There are several advantages and disadvantages in using composites
reduce cost of production of the orthosis since it does not need to use a for this application. Some of the advantages are the weight reduction
plaster cast model as a reference as in the conventional method. The properties while still retaining its high strength. It also resists corrosions
possibility of redesigning and endless optimization also helps in pro- and fatigue. Due to the way it was made, a composite mechanical
ducing a better and functional orthosis while reducing the chance of property can be tailored according to client's or application's require-
design failure. ment. Thus, making it useful for applications that needed two different
Banga et al. created a 3D printed non-articulated AFO with four properties that opposes each other without sacrificing the either one of
different designs made from Polypropylene (PP) and Polyethylene (PE) them. The disadvantages of using composites are the cost of its pro-
(Banga et al., 2018). Their method consists of 4 steps, start with de- duction, not often eco-friendly, and low reusability.
signing 3D CAD model, followed by FEA of the model, then results Zou et al. has proposed using CF sheets for their design (Zou et al.,
retrieval, and finally modify any required parts. These steps were re- 2014). It was found that when they did a comparison between CF AFO
peated until an optimum design has been achieved. They concluded and polypropylene AFO, the CF AFO performed better in the actual
that the designs could reduce excessive heating and sweating during the mechanical testing. Bertram et al. stated that CF is highly suitable for
long-term usage. Kobayashi et al. also had used polypropylene in order AFO due to its high stiffness and low density (Stier et al., 2015). They
to design a custom articulated AFO comprised of the clevis style hinge also stated that the disadvantages of using fiber composites was that the
(Kobayashi et al., 2017). Their AFO's resistance to plantarflexion, dor- design and manufacturing were too time consuming. Furthermore, CF
siflexion and alignment can be adjusted independently. Another design composites are one of the most expensive material that is currently
uses the hybrid between polypropylene and the canvas. The hybrid AFO available in the market (Mostafa et al., 2017). Thus, making it harder
are lighter and enable faster walking speed (Do et al., 2014). A low-cost for the users with low incomes to obtain one for themselves. Besides,
production researched by Munguia and Dalgarno enables AFO design to the users that only needs to wear the AFOs temporarily will definitely
have better optimization by using 3D printing. The material they used think that CF AFO is not cost-effective. Table 1 summarises on the
for the 3D printing was polyamide (Munguia and Dalgarno, 2013). advantages and disadvantages of current AFOs.

4.4. Carbon fiber reinforced polymer (CFRP) composite orthosis 5. Reported work on the existing materials used in AFO

A composite is a material that was made from two or more different From the previous sub-sections, it can be seen that there were var-
materials with distinct properties to complement each other and create ious designs and materials that has been used for manufacturing or-
a completely different properties from its original materials. In ortho- thosis over the past several years. Among of all the materials, plastics
tics, most of the products were made from polymer composites. and CFRP has been used most. The ideal specification of an orthosis is
Generally, polymer composites were manufactured from reinforcement that it is lightweight, strong under tension and compression, stiff, and
materials such as Aramid, Carbon fiber, and Glass fiber while its matrix durable (resist fracture under impact). Fig. 6, Fig. 7, and Fig. 8 shows

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F.S. Shahar, et al. Journal of the Mechanical Behavior of Biomedical Materials 99 (2019) 169–185

Fig. 6. Comparison of densities between different materials.

the comparison of densities, tensile strength, and Young's Modulus orientation, wood (oak – perpendicular to grain: 7 MPa) could also
between several materials used in orthotic field respectively. become weaker than an aluminium (70 MPa). Thus, considering the
From Fig. 6, it shows that wood (160 kg/m3 - 1350 kg/m3) and ideal specification of an orthosis where it must be strong under tension
plastics (36 kg/m3 - 2200 kg/m3) are materials with the lowest den- and compression while retaining its weight, the most suitable material
sities, followed by composites (1500 kg/m3 – 2000 kg/m3), and finally to be considered would fall into the composites and wood category.
metals (1700 kg/m3 - 20,000 kg/m3). In order to have a lightweight An orthosis design must also have high stiffness which could resist
orthosis, the density of materials used for its manufacturing must have a bending and shear stress. This particular mechanical property could
low density. The weight of the orthosis will affect the energy ex- ensure that an orthosis could support the limb and keep the orthosis in
penditure while walking. The lighter the weight of the orthosis, the alignment without breaking. From Fig. 8, it can be seen that plastic
lower energy expenditure while walking. Thus, the user will not feel (0.7 MPa–4100 MPa) has the least stiffness, followed by wood
fatigue as easily. This is especially important for users who needs high (5800 MPa - 12,000 MPa), composites (15,000 MPa–150,000 MPa), and
energy level for sports such as wall climbing, hiking, cycling, and much metal (13,000 MPa–380,000 MPa) respectively.
more. These sports need the users to be as light as possible for effi- By comparing all three figures, it can be seen that composites satisfy
ciency, speed, and strength conservation. most of the specification needed for an orthosis which is lightweight,
In an ideal lightweight orthosis design, density are usually asso- high tensile strength, and high stiffness. These three properties will
ciated with the strength of the materials used to manufacture the de- always be correlated and could be explained through specific strength
vice. In an orthosis design, the most preferable material would be and specific stiffness. Where,
materials with high strength to weight ratio. Therefore, from Fig. 7, it
MNm ⎞ Tensile Strength, σ (MPa)
can be seen that composites (140 MPa–1100 MPa) has the higher tensile Specific Strength ⎛⎜ ⎟ =

strength compared to wood and plastics (0.24 MPa–170 MPa), due to ⎝ kg ⎠ Density, ρ 3
kg
m ( ) (2)
the properties it retains or reinforced from one or more strong materials
such as carbon fiber, glass fiber, metal alloys and much more. However, MNm ⎞ Young′s Modulus, E (MPa)
Specific Stiffness ⎛⎜ ⎟ =
it has less strength when compared to metals (11 MPa–2200 MPa). By
comparing all of the materials in Fig. 7, wood has the least tensile
⎝ kg ⎠ Density, ρ 3
kg
m ( ) (3)
strength which ranged from 1.9 MPa up to 161 MPa. Unlike metal and These two equations will determine the strength/stiffness to weight
plastics which has uniform strength due to its isotropic (uniform inner ratio which are widely used by engineers and researchers in aerospace
structure) nature, wood is well known as an anisotropic material where industry, medical care and sports to develop a product with the most
its strength differ in different directions. Thus, with the correct wood suitable stiffness/strength to weight ratio (Sultan et al., 2009). There-
species, and wood orientation (along the grain/perpendicular to grain), fore, in order to obtain an optimum ratio for the development of an
the strength of wood (oak – along the grain: 78 MPa) would be able to orthosis, one of the variables such as the strength, stiffness or density
surpass the strength of aluminium (70 MPa). By changing its will be manipulated. From Equation (2) (Eqn. (2)), it can be seen that

Fig. 7. Comparison of tensile strength between different types of materials.

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F.S. Shahar, et al. Journal of the Mechanical Behavior of Biomedical Materials 99 (2019) 169–185

Fig. 8. Comparison of stiffness of different types of materials.

Fig. 9. Comparison of specific strength of different types of materials.

Fig. 10. Comparison of specific stiffness of different types of materials.

high strength and low density will produce materials with high specific expensive compared to other materials. Thus, for an orthosis that was
strength. In other words, an orthosis which is lightweight with high intended to be used temporarily, it is not cost-effective. In order to
strength can be produced. Similarly in Equation (3) (Eqn. (3)), high reduce the cost, researchers used the next best material which satisfy
specific stiffness can be achieved by having low density and high most of the specifications which is plastics. In addition, with the
stiffness. Thus, fulfilling the ideal specification of orthosis having a emergence of 3D printing in the industrial field, manufacturing plastic
lightweight and high stiffness properties. Fig. 9 and Fig. 10 shows the AFO using this technology could reduce the cost further and remove the
comparison of materials based on their specific strength and specific need to use a plaster model to shape the AFO.
stiffness. It was found that there is small amount of research conducted using
By comparing each materials specific strength and specific stiffness carbon fiber composite AFO compared to AFOs which are manufactured
as shown in Figs. 9 and 10, it can be concluded that carbon fiber using plastics. Table 2 shows a compilation of research that has been
composites has the most ideal specific strength and specific stiffness. conducted over the past several years. From Table 2, it can be con-
Thus, it has been widely utilised in manufacturing of an orthosis. cluded most of the research are using either polypropylene or carbon
However, the downside of using this material is that it is more fiber composite as AFO fabrication material. Currently, there are still no

179
Table 2
Reported work on AFO.
Year Author Objective Body Material Fabrication Method Results Gap
part
F.S. Shahar, et al.

2019 Barrios-Muriel et al. 1 Define a procedure to obtain the skin Ankle- Nylon 12 PA 3D printing LoNEs could help predict the interaction 1 It uses plastic material
(Barrios-Muriel et al., strain field and LoNEs. Foot of devices to the skin, thus could help 2 Manufactured using 3D printing
2018) 2 Propose a design criterion for the reduce friction between the skin and technique
wearable devices device interface, reducing skin problems 3 Rigid design with no additional sensor
or actuator for joint movement
2019 Rodríguez Jiménez Design and build a fully mechanical knee Knee- 1 Housing of self-locking Thermoforming polymer Able to control knee joint movement 1 Device is bulky and heavy
et al. (Jiménez et al., orthosis Ankle- system – plastic sheets efficiently without buckling during 2 Device are made of combination of
2019) Foot 2 Gears – steel stance phase metal and plastic
3 Rods – Duraluminium 3 Joint movement controlled by PGT
4 Foot support – plastic
2019 Kobayashi et al. Investigate the effects of changing AFO Ankle- Polypropylene (PP) Thermoforming polymer Gait movement of the patients improved 1 Device was fabricated from PP
(Hunt et al., 2018) ankle alignment on lower limb joint Foot sheets and alignment of AFO could be used as 2 Joints movement are controlled by
kinematics and kinetics with constant one of the possible parameters for AFO Becker Triple Action ankle joints
dorsiflexion and plantarflexion resistance optimization
in individuals' post-stroke
2018 Wach et al. (Wach Characterize the compressive stiffness Ankle- 4 AFOs: 1 Thermoforming polymer Strut deflection and rotation may be 1 AFO material were fabricated from
et al., 2018) and device deflection of loaded AFO-limb Foot - 2 thermoplastic sheets used for predicting the performance and either plastic or carbon composite
complexes. AFO 2 Pre-preg carbon fiber functional outcome of an AFO 2 Rigid AFO with no additional hinge
- 2 carbon fiber composite sheet layup structure
2018 Takhakh & Abbas 1 Manufacture KAFO using carbon fiber Knee- Carbon fiber composite Pre-preg carbon fiber sheet The mechanical properties of carbon 1 AFO material was made from carbon
(Takhakh A and reinforced composite Ankle- layup fiber AFO are better than Polypropylene composite
Abbas S, 2018) 2 Compare the mechanical properties Foot 2 Manufactured using vacuum method
between traditional Polypropylene 3 Knee and ankle joints were controlled
metal – plastic and carbon composite by basic joints structure made from

180
AFO stainless steel
2018 Rodriguez et al. Propose a novel AFO design with negative Ankle- 1 Shafts, roller, CAM - stainless Pre-preg carbon fiber sheet Ankle joint movement and gait pattern 1 AFO is quite bulky
(Rodriguez et al., stiffness (nAFO) produced by a spring- Foot steel layup could be improved. 2 Material made from metal and carbon
2018) loaded 2 Casing - aluminium composite
CAM follower mechanism to compensate 3 Footplate, shank shell - 3 Joint was controlled by spring loaded
for the passive stiffness caused by the calf Carbon fiber composite CAM follower mechanism
muscle.
2018 Ulkir et al. (Ulkir Present the mechanical design and Ankle- Carbon fiber composite Pre-preg carbon fiber sheet The device were able to assist and 1 The AFO is lightweight but bulkier
et al., 2018) analysis of pneumatic AFO device Foot layup compensate the weakness and than a Polypropylene AFO
impairments of the ankle joint. 2 Material made from carbon composite
3 Joint movement assisted by PAM
2017 Totah et al. (Totah Proposed a multi-objective optimization Ankle- 1 Polypropylene (PP) None The proposed optimization method Only a simulated case study
et al., 2017) approach for choosing the appropriate Foot 2 Polyethylene (PE) could predict the optimal manufacturing
process, material and thickness that 3 Carbon composite choices to produce AFO.
minimizes production cost and time, and
maximizes device performance.
2017 Banga et al. (Banga Explore the possibilities of generating Ankle- 3 AFOs: 3D printing Reduce excessive heating and sweating 1 Material using plastic
et al., 2018) modular AFO elements, namely, calf, Foot 1 Polypropylene during long term usage 2 Rigid AFO with no joint movement
shank and footplate, with the localized 2 Polyethylene (Nylon) system implemented
composite reinforcement that aids in the 3 Polyamide 3 AFO fabricated either using FDM or SLS
optimization of the device in terms of
functionality, aesthetics, rigidity and cost.
2017 Silva et al. (Silva Produce metal/plastic hybrid components Arm 1 Device core – metal 3D printing The prototype could reduce excessive 1 The device is lightweight
et al., 2017) for orthopaedics applications by using 2 Device coating – plastic sweating, comfortable, waterproof, and 2 It was made of metal and plastic
additive manufacturing hygienic. 3 Manufactured using 3D printing
technology
(continued on next page)
Journal of the Mechanical Behavior of Biomedical Materials 99 (2019) 169–185
Table 2 (continued)

Year Author Objective Body Material Fabrication Method Results Gap


part
F.S. Shahar, et al.

2017 Kobayashi et al. 1 Investigate the mechanical properties Ankle- Polypropylene Thermoforming polymer Articulated AFO appeared effective in 1 Material using plastic
(Kobayashi et al., of the novel articulated AFO that can Foot sheets influencing lower-limb joint kinematics 2 Joint movement was supported by
2017) independently adjust plantarflexion and kinetics of gait in the individual Triple Action ankle joint
resistance, dorsiflexion resistance and post-stroke.
alignment
2 Explore the effect of changing AFO
mechanical properties on ankle and
knee joint angle, moment and power
during gait in an individual post-
stroke.
2016 Amerinatanzi et al. Develop a new ankle foot orthosis that Ankle- 1 AFO shell – plastic (specific Thermoforming polymer Results of the motion analysis on a 1 Joint movement assisted by spring or
(Amerinatanzi et al., helps patients to have more normal ankle Foot plastic was not mentioned) sheets healthy subject during walking indicate hinge
2016) joint behaviour. 2 Hinge springs – NiTi alloy that the use of the super elastic NiTi
springs causes more normal walk
compare to the use of the conventional
stainless steel springs, especially during
swing
phase and heel strike.
2016 Gloger et al. (Gloger Development of lighter lower limbs Hip- 1 Mainframe and joint – Pre-preg carbon fiber sheet Gait cycle becomes smoother, energy 1 No sensory subsystem for joint
et al., 2016) orthosis which construction will decrease Knee- aluminium layup transfer from device to users was movement
battery consumption and increase users Ankle- 2 Fixtures or connectors - high improved
comfort during walking. Foot density PE and copolymer
3 Support at hip – Kydex
4 Joints and moving parts
-plastics

181
5 Foot and support - carbon
composite
2015 Stier et al. (Stier Present a 3D multi-scale structural Ankle- Carbon fiber composite Pre-preg carbon fiber sheet The proposed modelling strategy is in 1 Rigid AFO with no additional
et al., 2015) analysis methodology to speed up the Foot layup agreement with the experimental data components, sensors, or actuators for
design process of AFO showing that the numerical method can joints
be used to predict the structural
behaviour of a Carbon Fiber Reinforced
Orthosis
2015 Papi et al. (Papi Establish a method that would allow the Ankle- Polypropylene Thermoforming polymer The new method could be used to 1 AFO material was made from plastic
et al., 2015) quantification of the contribution of AFOs Foot sheets predict ankle moment contribution of
in the control of the ankle joint during the AFO and help in AFO optimization.
gait
2015 Rakib et al. (Rakib Develop a prefabricated Stance Control Knee- 1 Support/cuffs - Carbon fiber 1 Pre-preg carbon fiber Results revealed a better gait 1 Cuff of thigh and shank are adjustable
et al., 2015) Orthosis (SCO) with suitable material and Ankle- composite sheet layup for the cuffs 2 Device was prefabricated and made
design Foot 2 Footplate –Polypropylene 2 Thermoforming polymer from a combination of several
(PP) sheets for the footplate components made of carbon composite,
3 Basic structure/side bars aluminium support and joints, and PP
-Aluminium footplate
3 Knee and ankle joint movement
supported by stance-control-knee-joint
(SCKJ) and double-action-ankle-joint of
Becker Orthopaedics
2014 Zou et al. (Zou et al., Predict the mechanical behaviour of AFOs Ankle- 3 AFOs: 1 Pre-preg carbon fiber FEA model could predict the behaviour 1 2 AFO materials are using lamination
2014) using FEA models Foot 1 2 AFO made from Carbon sheet layup of AFO and has the potential in assisting of several Carbon fiber layers of
Fiber composite; 2 Thermoforming polymer in AFO optimization. different orientation to make a
2 1 AFO made from sheets composite
Polypropylene (PP) 2 The orthosis were rigid and
prefabricated
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Journal of the Mechanical Behavior of Biomedical Materials 99 (2019) 169–185
F.S. Shahar, et al. Journal of the Mechanical Behavior of Biomedical Materials 99 (2019) 169–185

2 Material using PLA + CF reinforcement


using additive manufacturing technique
research being conducted on natural fiber composite as AFO fabrication

3 Ankle joint movement supported by a


1 Material using hybrid design of plastic

and leather + AliPlast foam for the T


3 Ankle joint supported by basic hinge

1 Material using metal frame support


materials. Furthermore, although there are some researches conducted
on fabricating AFO using 3D printing, the materials used are mostly
polypropylene. Thus, there are no research conducted on using natural
fiber composite in 3D printing.

simple hinge structure


2 Traditionally moulded

6. Natural composites as material replacement

1 Modular device
and canvas

From the previous section, it was discussed that composites have the

structure
highest compatibility with AFO as a fabrication material. An AFO de-

strap
sign needed to be lightweight, comfortable, strong, and have a good
Gap

aesthetic design. Table 3 shows the mechanical properties of AFO de-


veloped using the most common material used recently.
ankle dorsiflexion during heel strike

Low cost production with better


1 Survey shows hybrid AFO is lighter

compared to hybrid AFO (meaning

Reduce skin shear which could reduce


difference between the hybrid and

of the conventional AFO is higher


2 Gait analysis shows no significant

However, current composites such as carbon fiber, and glass fiber


design optimization compared to
conventional AFO except for the

movement during heel strike)

are much more expensive compared to metals, plastics, and wood. It


hybrid AFO has better gait
than conventional PP AFO

should also be noted that a composite is a material which was made


from one or more materials with different properties in order to create a
conventional method

new material with completely different properties. Thus, turning a low


cost raw material such as natural fiber into a composite is definitely
possible and has been proven since ancient civilization. From the past
several years, researchers have a renewed interest towards natural fiber
composite and had taken notice of their significance in material pro-
blisters
Results

duction. Its raw material does not only show that it is cheaper than
synthetic fiber (Salman et al., 2016a, 2017), natural composite is also
2 3D printing for footplate

lightweight, eco-friendly, and has an abundance supply due to its re-


1 Pre-preg carbon fiber
sheet layup for main
Thermoforming polymer

newability (Md Shah et al., 2019; Salman et al., 2016b, 2016c;


strut and footplate

Zakikhani et al., 2016).


Fabrication Method

Natural composites could be mainly found in plants. Namely a few


of such raw plant materials that could be used as natural composites are
and calf

Kenaf, jute, bamboo, pineapple leaf, and much more (Nor et al., 2019).
These fibers can provide flexibility in design and can be moulded into
sheets

None

any kind of shapes in order to fulfil a certain requirement or criteria of a


design. In addition, depending on the plant species, fiber orientation,
leather + AliPlast foam T straps
Polypropylene + canvas fabric

and matrix used, these natural composites could have high strength and
Polyamide + Carbon fiber

stiffness while maintaining its lightweight properties. These properties


were provided by the plant's cellulose structure. Cellulose is a natural
Metal AFO frame with

polymer which builds long fibrous cells that could be found within the
plant's stem (bast), leaves, or seeds. The natural composites made from
plants are mostly lightweight, biocompatible, recyclable, cheap, and
reinforced
Material

easily available. Natural composites could fulfil all of these require-


ments. Out of all natural composites, Kenaf fiber stood out the most due
to its abundance of supply in Malaysia, cheap raw material, and better
mechanical properties compared to other natural fiber.
Ankle-

Ankle-

Ankle-
Body

Kenaf also known as Hibiscus cannabinus is a type of fast growing


Foot

Foot

Foot
part

plant where the stalks could grow up to 5.5 m in height with a woody
base (Ayadi et al., 2017). Thus, when it is used in a composite, its fast
functionality, aesthetics, rigidity and cost
1 Investigate the effect of a hybrid AFO

Develop an AFO to correct Coronal-Plane


in patients with chronic hemi paretic

conventional plastic AFO in terms of

modular AFO elements: calf, shank, and


Explores the possibilities of generating

optimization of the device in terms of

growing characteristics ensures that there is no problem in its avail-


ability and production cost. Kenaf fiber can be found in the bast or core
footplate with localized composite

pathologies and reduce skin shear


2 Compare hybrid AFO with a

of the plant. Due to its absorption characteristics, Kenaf fiber has been
reinforcement that aids in the

used as a material to absorb oil and liquids. In addition, the Kenaf fiber's
convenience and effect

ability to absorb liquids will ensure that when it is used as a material for
an orthosis, the material will absorb the sweat produced in the enclosed
area of the orthosis. Thus, theoretically it could help in reducing the
possibility of skin irritation.
stroke
Objective

Table 4 shows the researches that had been conducted over the past
several years to enhance the mechanical properties of kenaf composite.
By comparing Tables 3 and 4, it can be concluded that, natural com-
posite could fulfil the minimum requirement of mechanical properties
Kyle A. Sherk (Sherk,
Munguia & Dalgarno

needed for a functioning AFO. Furthermore, by using kenaf composite,


Dalgarno, 2013)

the cost of raw material and weight of AFO can be reduce while still
(Munguia and
Table 2 (continued)

Do et al.58

maintaining the strength and stiffness of the materials. Table 5 shows


Author

the comparison of mechanical properties and cost of materials between


2008)

several synthetic fiber and natural fiber. By comparing Tables 3 and 5,


it can be seen that the strength of natural fiber are insufficient to
2013

2008
2014
Year

withstand the minimum strength exerted on the orthosis. Thus, this is


where composites play a significant role in enhancing the strength of

182
F.S. Shahar, et al. Journal of the Mechanical Behavior of Biomedical Materials 99 (2019) 169–185

Table 3
Mechanical properties of AFO from several researches that uses Polypropylene (PP) or Carbon Fiber (CF) Composite.
Material PP PP PP CF CF

Thickness (mm) 5 6.1 6.4 3.6 –


Tensile Strength (MPa) 35.76 – 30 437 2735
Compressive Strength (MPa) – – – – 1309
Young's Modulus (GPa) 1.25 1.03 2.4 – 1.27
Poisson's Ratio – 0.43 0.43 0.50 0.20
Sources (Jweeg, Takhakh, Abbas) Chu and Reddy (1995) Zou et al. (2014) Zou et al. (2014) Krukonis et al. (2017)

Table 4
Enhanced mechanical properties of Kenaf Composite by several different methods.
Composite Enhancement method Tensile strength (MPa) Young's Modulus (GPa) Sources

Kenaf + Epoxy + NaOH Chemical treatment 53.33 3.89 Kumar et al. (2018)
Kenaf + Epoxy None 46.67 3.20 Kumar et al. (2018)
Kenaf + Kevlar + Epoxy Hybridising reinforcement 54.18 6.90 Muhamad Paudzi et al. (2018)
Kenaf + PP + NaOH Chemical treatment 44.00 1.80 Sosiati et al. (2019)
Kenaf + PP + PP-g-MA + MWCNT Hybridising reinforcement + Compatibilization 36.78 2.70 Yaghoobi and Fereidoon (2019)
Kenaf + PP + PP-g-MA Compatibilization 32.31 2.23 Yaghoobi and Fereidoon (2019)
Kenaf + Epoxy + MH Chemical treatment 39.36 4.76 Saba et al. (2019)

PP: Polypropylene.
NaOH: Sodium Hydroxide.
PP-g-MA: Polypropylene Graft Maleic Anhydride.
MWCNT: Multi-walled carbon nanotube.
MH: Magnesium Hydride.

the natural fiber, by combining a reinforcement material (fiber) and a It can be expected more applications will use natural fiber composite
matrix (resin). especially in the medical and rehabilitation field due to its low price,
biocompatibility and recyclability.
7. Conclusions and future prospective of this work
Some of the major findings from this review are:
It can be concluded that there is a wide opportunity that can be
discovered by using kenaf composites as the AFO material. Basically, 1) An ideal AFO needs to be lightweight, stiff, and also strong in order
this paper mainly reviews on the AFO material and possibility of re- to support the lower limb while walking, standing, climbing, run-
placing the current material used in the market. The overall conclusions ning and much more.
that can be derived from this paper is summarized as follows: 2) Material productions are highly dependent on the specific strength
and specific stiffness. However, these properties are highly affected
1) Orthosis has existed since ancient civilization which had gradually by strength/stiffness and density of the material. Thus, in order to
developed from a simple splint towards more complex designs with have a good ratio of specific strength/stiffness, the variables of
hinges, sensors, and form-fitting designs. Orthosis had been devel- strength/stiffness and weight needs to be manipulated.
oped from wood, leather, metal, plastic, and finally carbon fiber 3) Most modern AFOs were made from plastics or carbon composites
composite respectively throughout several eras. This paper mainly due to its high specific strength and specific stiffness. However,
discussed on Ankle-Foot Orthosis (AFO) which is an orthotic device plastics has the tendency to pollute the environment after its use
that supports the Ankle-Foot area for better gait movement. It is whereas carbon composites were too expensive for a short term
commonly indicated use for foot drop treatment. There are mainly usage.
three fabrication process used in manufacturing an AFO which are 4) Kenaf composite has the possibility to replace plastics and carbon
thermoforming plastics, pre-preg carbon fiber composite, and 3D composite due to its cheap raw material compared to carbon com-
printing. posite and similarity in specific strength and stiffness with plastics.
2) Currently in the market and researches, the existing materials of
AFO are wood, metal and leather, plastics, and carbon fiber com- Currently, additive manufacturing has becoming well known due to
posites. By comparing all these materials, it was found that carbon its flexible design and optimization, and also its long term cost-effec-
composites are the most suitable material for AFO due to its low tiveness. Therefore, the future prospective work may implement the use
weight, high strength, and high stiffness properties. However, its of natural fiber composite in additive manufacturing using 3D printing
raw material cost was too expensive which drives the researchers techniques to reduce the current production time and cost.
and industries to use plastics more.
3) By comparing the mechanical strength of several AFOs made from
plastics and carbon fiber composite with the existing research on Acknowledgement
Kenaf composite mechanical strength, it can be concluded that there
is a possibility of replacing plastics and carbon composites with This work is supported by UPM grant, GP-IPS 9647100. The authors
Kenaf composites. Kenaf composite does not only retains the low would like to express their gratitude and sincere appreciation to the
weight, high strength and stiffness properties, it also reduced the Department of Aerospace Engineering, Faculty of Engineering,
cost of raw materials, and recyclable. Universiti Putra Malaysia and Laboratory of Biocomposite Technology,
4) Finally, it can be concluded that by the current trend of natural fiber Institute of Tropical Forestry and Forest Products (INTROP), Universiti
composite research around the world, an AFO which are cheaper, Putra Malaysia for the close collaboration in this research.
stronger, eco-friendly, user-friendly, and lighter could be developed.

183
F.S. Shahar, et al. Journal of the Mechanical Behavior of Biomedical Materials 99 (2019) 169–185

Appendix A. Supplementary data

(Jariwala and Jain,


2019; Ismail et al.,
Supplementary data to this article can be found online at https://
doi.org/10.1016/j.jmbbm.2019.07.020.

1.30–1.50
0.39–0.80

10.0–55.0

3.34–3.76
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