TYPE Original Research

PUBLISHED 30 August 2024

DOI 10.3389/fbioe.2024.1439616

Design and evaluation of a

OPEN ACCESS wedge-shaped adaptive knee
EDITED BY
Malek Adouni,
Abdullah Al Salem University, Kuwait
orthosis for the human lower
REVIEWED BY
Solomon Seid Kebede,
limbs
Ethiopian Defence University, Ethiopia
Adel Younis,
Australian University, Kuwait
Xin Zhou 1,2, Xiaoli Liu 3*, Jiaxin Hao 1, Yu Liu 4 and Yunqi Tang 5
1
*CORRESPONDENCE School of Art and Design, Xi’an University of Technology, Xi’an, China, 2School of Mechanical and
Xiaoli Liu, Precision Instrument Engineering, Xi’an University of Technology, Xi’an, China, 3Xi’an Children’s Hospital,
[email protected] The Affiliated Children’s Hospital of Xi’an Jiaotong University, Xi’an, China, 4School of Mechanical
Engineering, Xi’an Aeronautical University, Xi’an, China, 5College of Art and Design, Shaanxi University of
RECEIVED 28 May 2024 Science and Technology, Xi’an, China
ACCEPTED 15 August 2024
PUBLISHED 30 August 2024

CITATION
Zhou X, Liu X, Hao J, Liu Y and Tang Y (2024)
Design and evaluation of a wedge-shaped Introduction: The incidence of knee osteoarthritis (KOA) is moderately
adaptive knee orthosis for the human lower correlated with age and body weight and increases with life span and weight
limbs .
gain, associated with tearing and wearing the knee joints. KOA can adjust the
Front. Bioeng. Biotechnol. 12:1439616.
doi: 10.3389/fbioe.2024.1439616 force through the human lower limbs, redistribute the load of the knee joint,
reduce the pain, and restore mobility when the arthritis changes are mild.
COPYRIGHT
© 2024 Zhou, Liu, Hao, Liu and Tang. This is an However, most of the existing knee orthosis cannot be adjusted adaptively
open-access article distributed under the terms according to the needs of patients.
of the Creative Commons Attribution License
(CC BY). The use, distribution or reproduction in Methodology: This study establishes a biomechanical model of the knee joint to
other forums is permitted, provided the original
analyze the medial and lateral forces acting on the joint. The new adjustable knee
author(s) and the copyright owner(s) are
credited and that the original publication in this orthosis is designed. It applies the principle of four-point bending to apply
journal is cited, in accordance with accepted pressure to both sides of the knee joint, thereby adjusting the varus angle and
academic practice. No use, distribution or
modifying the medial and lateral forces on the knee joint. Through structural
reproduction is permitted which does not
comply with these terms. optimization, the prototype of the knee orthosis weighs only 324 g. Utilizing
three-dimensional scanning technology, discrete point cloud data of the leg
surface is obtained, reconstructed, and processed to create a 3D model of the
human leg surface. The design ensures a close fit to the human leg surface,
offering comfortable wear. A pressure sensing film system is employed to build a
pressure sensing test system, where the knee orthosis is worn on a prosthesis for
pressure testing to evaluate its ability to adjust knee joint forces.
Results: The pressure test results demonstrate that the knee orthosis can stably
provide an adjustment angle of 0–7° and sustain a maximum force of 10N on both
sides of the knee joint over extended periods. A self-developed 8-channel plantar
pressure sensing insole is calibrated against commercial plantar pressure sensors.
Human wear tests on 15 subjects show that during the operation of the knee
orthosis, it significantly adjusts plantar pressures, reducing lateral foot pressures
by 22% overall, with more pronounced corrective effects observed in lighter
participants.

Discussion: In this study, a wedge-shaped adaptive knee orthosis was provided

for KOA patients. The four-point force principle was used to balance the force

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Zhou et al. 10.3389/fbioe.2024.1439616

between femurs and tibia and adjust the meniscus contact gap. The orthotic
appliance has the advantages of simple mechanical structure, adjustable
correction Angle and good wearing comfort.

KEYWORDS

KOA, knee joint, mechanical design, knee orthosis, pressure test

1 Introduction orthotic device consisting of inflatable knee pads and insole (Rezaei
et al., 2019). The valgus torque in the orthosis was adjusted by using
Knee osteoarthritis (KOA) is a chronic disease characterized by the change of the plantar pressure, but the system was complicated.
articular cartilage deformation, abrasion, and bone hyperplasia The objective of the present study was to achieve the following
(Heidari, 2011). Moreover, it is more common in middle-aged research goals: 1) enhancing the overall wearing experience for
and elderly people, and its main physiological manifestations are patients while simultaneously reducing the weight of the orthosis,
discomfort symptoms such as knee swelling, pain, and soreness 2) simplifying the mechanical structure to improve practicality, 3)
during standing and walking (Louise et al., 2008). In addition to age, incorporating a fast multi-level adjustment capability to address
lower limb force line deviation, obesity, and trauma were also the individual patient requirements. This study introduces a knee
main factors affecting the prevalence of KOA (Bliddal and orthosis that facilitates adjustments of the force line with the
Christensen, 2009). Due to the limitations of medication and lower limbs and the knee varus angle through fast multi-level
surgery, therapists are increasingly recommending the use of adjustments in the coronal plane of the knee joint. By modifying
accessories, including mechanical insoles and knee orthosis (Xin the load distribution within the internal and external compartments
et al., 2021a). of the knee joint, this orthosis aims to alleviate patient pain and
The orthosis can limit the abnormal movement of the limbs, restore mobility.
maintain joint stability, provide certain auxiliary power for the weak Structural optimization design is a critical research area in
parts of muscles, and also restore the movement ability (Folmar modern structural design, providing tools for achieving optimal
et al., 2020). It is an external device for the rehabilitation of motor new structural designs and becoming a significant component of
dysfunction, which can change the functional characteristics or contemporary design methodologies. It involves parameterizing
structure of the neuromuscular and skeletal system. It is an relevant variables according to design requirements to generate a
important means of orthopedic treatment for bone and joint domain of all potential structural design solutions. Mathematical
injury and limb deformity. techniques are then used within this domain to search for designs
For both the KOA patients at an early stage and patients that not only meet predefined criteria but are also feasible and
recovering from knee replacement, wearing knee orthosis is an optimal. With the rapid advancement of computer technology and
effective way to relieve pain and symptoms. Orthotics are the widespread application of numerical computation methods,
showing increasingly important value in the adjuvant treatment optimization capabilities, and computational speeds have
of patients with neuromuscular and skeletal diseases, as well as in the correspondingly improved.
rehabilitation and social reintegration of the disabled. In recent For novel knee orthotic structures, which often involve complex
years, the number of disabled people has increased and the demand and numerous continuum structures with significant shape-
for assistive devices in the aging population has increased sharply. dependent performance implications, structural analysis poses
Many research institutions have carried out a series of studies to certain challenges. Structural optimization design benefits from
form a variety of knee orthoses. strong convergence, high reliability, and stability in optimization
An inflatable three-point force orthosis was designed by Robert algorithms, which are continually undergoing development and
D.A. (Gaasbeek et al., 2007). The adjustment of the orthopedic angle refinement by researchers. Introducing theories and methods
was achieved by controlling the degree of inflation of the flexible air from various modern disciplines, particularly artificial
bladder. Meanwhile, Mokhtar A designed an inflatable four-point intelligence, neural networks, fuzzy mathematics, uncertainty
force orthosis (Arazpour et al., 2013). The surface of the human mathematics, genetic algorithms, and others, has opened new
body frequently rubs against the airbag, and the air bladder is easily avenues for advancing optimization algorithms. Examples include
worn and failed. Cynthia H used the knee joint ectropion orthosis genetic algorithms, neural network-based algorithms, ant colony
produced by Otto Bock to change the orthopedic angle by adjusting algorithms, simulated annealing, and others. In recent years, a
the adjustment screw of the hinge position. However, the adjustment plethora of new and excellent algorithms have emerged,
of knee orthosis auxiliary angle needs to rely on specific instruments, propelling the development of design disciplines. These include
and it is inconvenient to adjust the specific auxiliary angle (Cynthia global optimization algorithms (Younis and Dong, 2010a), novel
et al., 2009). According to this principle, a new modular self- sampling search methods (Safari et al., 2015), adaptive multi-
centering four-point force knee orthosis was designed by Karimi objective optimization methods based on surrogate models
MT (Esrafilian et al., 2012). A new four-point bending partial (AMOS) (Younis and Dong, 2024), computational methods using
unloading orthosis was designed by Hangalur et al. (2017), which weighted ensemble of surrogates (WESO) (Younis and ElBadawy,
increases the medial compartment clearance and reduces pain. It is 2022), Pareto finder MOO algorithm for automatic multi-objective
very comfortable to wear but increases cartilage and meniscus wear surrogate (AMSP) (Younis and Dong, 2022), new global
in the opposite knee joint. Razaei developed a dynamically adjusted optimization algorithms (MSMDSES) (Younis and Dong, 2012),

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FIGURE 1
Human lower limb force line. (A) Straight line connecting center of femoral head, knee and ankle joint. (B) The genu varum of knee joint. (C) The
neutral knee joint. (D) The genu valgus of knee joint. LBA is the lower limb mechanical load line, FM is the femoral axis, TM is the tibial axis.

spatial exploration and single-peak region elimination (SEUMRE) biomechanics of the knee joint before any mechanical structure
algorithm (Younis and Dong, 2010b), approximate single-peak design aiming to obtain the expected ideal effect.
region elimination method (AUREM) (Younis et al., 2009),
pursuit sampling optimization algorithm (TR-MPS) (Cheng et al.,
2012), and the Grey Wolf Optimizer (GWO) algorithm (Younis 2.1 Physiological structure of knee joint
et al., 2022). The theoretical framework of structural optimization
design has also rapidly evolved, progressing from size optimization The essence of medial compartment knee osteoarthritis lies in
to shape, topology, layout, and type optimization; from single- the alteration of lower limb alignment, commonly manifested as
objective to multi-objective optimization; from deterministic to tibial deviation towards the medial side relative to the femur. This
uncertainty-based optimization; and from static structural alteration results in excessive pressure on the medial compartment,
optimization to dynamic structural optimization, continually leading to pain and joint deformities. Therefore, in response to this
elevating the hierarchy of optimization design. cause, orthotic devices are frequently employed in clinical practice to
The rest of the paper was organized as follows: Section 2 presents correct the alignment of the joint, alleviate symptoms, and prevent
biomechanical properties of the knee joint. Including physiological joint deformities. There are three commonly utilized approaches:
structure of knee joint, KOA pathological characteristics, lateral wedge insoles, genu varus orthosis, and mechanical
prevention, and treatment. And also the mechanical model of the corrective footwear.
knee joint. Section 3 presents the mechanical structure design and The knee joint is the largest and most complex joint in the
working principle. Section 4 describes the mechanical and functional human body in daily activities, the contact force between the tibia
experiment. Section 5 summarizes the main research results of and femur is several times the body weight (Taylor et al., 2004). Due
this paper. to such a large load, the probability of knee injury is higher than
other joints. The hip-knee-ankle angle (HKAA) is a common
parameter measured using full-length lower limb radiographs,
2 Biomechanical properties of often used to indicate the degree of deformity in knee
knee joint osteoarthritis (KOA). It is defined as the angle formed at the
intersection of lines drawn from the center of the femoral head
The knee joint belongs to a synovial joint, which is composed to the center of the tibial plateau and from the center of the talus to
of the distal femur, proximal tibia, and patella. It can also be the center of the tibial plateau. As depicted in Figures 1A, in
divided into the patella joint and femoral tibia joint. The femoral individuals without deformity, HKAA is approximately 180° as
patella joint contains the femur and patella (Özkaya et al., 2012). shown in Figure 1C. An HKAA angle greater than 180° indicates
Through the joint surface matching and soft tissue constraint a varus deformity, while an HKAA angle less than 180° indicates a
balance, the knee extensor muscle strength plays a role in valgus deformity.
transmission and constraint (Masouros et al., 2010). Femoral- KOA patients are accompanied by a certain degree of genu
tibial joint, including femur and tibia, is the main joint that varus, also known as bow-leg or knock-knee. In patients with knee
determines the kinetics of the knee joint. It mainly relies on the varus as shown in Figures 1B, degenerative changes can occurr in the
meniscus and related ligament tissue to impose additional knee cartilage, and the mechanical axis of the lower limb shifts to the
constraints on the joint to maintain stability (Reeves Neil and medial side of the joint. The medial pressure of the joint increase,
Bowling, 2011). Therefore, it is necessary to analyze the which aggravates the degree of varus (Cooke et al., 2007). The lateral

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compartment space of the knee joint is larger than that of the medial higher incidence than the lateral (Thorp et al., 2006). The
compartment, which leads to the shift of the force line of the lower degenerative changes of the cartilage of the knee joint caused by
limb to the medial. The medial articular surface is more prone to the patient led to the deviation of the mechanical axis of the lower
stress concentration and accelerates the wear of the medial cartilage, limb to the inside, increasing of adduction moment (Shull
resulting in the medial compartment KOA. The mechanical axis of et al., 2011).
knee valgus patients shifted to the lateral joint as shown in
Figure 1D, and the lateral pressure of the joint increases, which 2.2.2 KOA prevention and treatment
aggravates the degree of valgus and the wear of lateral cartilage. The main treatment methods for KOA include surgical
Therefore, studying the biomechanical changes of knee cartilage and treatment and non-surgical treatment. Currently, surgical
meniscus is of great significance to the pathogenesis, prevention and treatment is generally used for patients with severe KOA, while
orthosis design of early KOA. The incidence rate is higher than that conservative treatment is generally used for patients with mild KOA
of the lateral compartment. (Hartofilakidis et al., 2014). With the development of medical
rehabilitation equipment, lower limb medical rehabilitation
exoskeleton technology is becoming more mature. For patients
2.2 Knee osteoarthritis (KOA) with early and middle-stage KOA, patients who prefer
conservative treatment can use knee orthosis for conservative
Knee osteoarthritis is a common clinical disease. Its pathological treatment. The basic purpose of conservative treatment of KOA
characteristics are primary or secondary lesions of articular cartilage. is to relieve pain, maintain joint stability, improve joint function,
It is a chronic knee joint disease characterized by chronic inhibit cartilage wear and delay joint degeneration.
degeneration, wear and bone hyperplasia of articular cartilage. It The use of orthotic insole or knee orthosis can adjust the line of
is often affected by middle-aged and elderly people. With the force and increase the space of the joint compartment. By adjusting
increase of age and the decrease of exercise activities, muscles, the angle of the knee joint, it can adjust and balance the force of the
tendons, ligaments and other soft tissues in human joints are articular cartilage and the damaged part of the meniscus, thereby
prone to degenerative diseases, resulting in poor coordination of relieving pain, assisting patients to exercise normally, and
movements, resulting in a high incidence of knee osteoarthritis in preventing the deterioration of KOA. As a result, there is a great
the elderly. demand for knee orthosis.

2.2.1 KOA pathological characteristics

Primary cartilage lesion of knee joint refers to naturally 2.3 Mechanical model of knee joint
occurring cartilage lesion without external stimulation; Secondary
cartilage lesions of knee joint refer to cartilage lesions caused by joint A simplified force model of the human lower limb is employed
injuries, such as ligament tear, meniscus tear, synovitis, and other to conduct an analysis of the forces acting upon a normal knee
diseases. It is caused by a variety of factors, including age, obesity, joint, as depicted in Figures 2A. In the context of flexion/extension
trauma, genetics, and so on (Losina et al., 2012). The result is an motion in the human knee joint, the axis of motion can be regarded
asymmetric load between the medial and lateral compartments of as the bilateral posterior superior condyles located at the distal
the knee, causing joint pain (Jackson et al., 2004). femur, with the rotational center designated at the intersection of
In a normal human gait cycle, knee joint pressure is closely the knee joint axis (Shelburne et al., 2008). The line of force within
related to KOA pathological process (Hunt et al., 2006). The the lower limb of an average individual passes through the center
lower limb load will show periodic changes with the movement of of the femoral head, the center of the knee joint, and the center of
the lower limb. In the moment of foot contact, the load borne by the ankle joint.
the knee joint can reach 2–3 times the weight force, including the During a state of rest, the foot encounters a forward reaction
muscle force generated by muscle contraction, self-weight, and force F2 exerted by the ground, as well as a horizontal force F1 .
the sum force formed by dynamic load (Pandy and Andriacchi, The distance from the knee joint center to the ground is denoted
2010). When the foot strikes the ground during the whole as LG . The medial compartment of the knee joint undergoes a
standing period, due to the ground reaction force, the knee positive pressure Fa , situated at a horizontal distance ra from
joint in the coronal plane will produce a small knee valgus the knee joint center, whereas the lateral compartment
moment. As the gait proceeds, the knee adduction moment experiences a positive pressure Fb at a horizontal distance rb
(KAM) of greater amplitude and longer duration endures, from the knee joint center. By taking moments at the knee joint
causing the tibia to rotate inwards to the femur on the coronal center, the equilibrium equation can be formulated as shown in
plane (Hunt et al., 2008). Equation 1:
When the knee joint is varus or valgus, the angle between the F2
Fa + Fb

(1)
femur and the tibia will change accordingly, and the lower limb force Fb · rb − Fa · ra + F1 · LG
0
line will deviate to the other side of the knee joint center. As the
space between the lateral ventricles of the knee is larger than that of The distance between the center of the knee joint and the center
the medial side, the force line of the lower limbs is shifted to the of action points in the medial and lateral compartments is
medial side, and the medial articular surface is more prone to stress approximately equal and is estimated to be one-fourth of the
concentration, which accelerates the wear of the medial cartilage, knee width W. The force in the medial and lateral compartments
leading to the majority of the medial ventricles in KOA, with a of the knee joint can be achieved as Equation 2:

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knee joint will experience tension from the lateral collateral ligament, as
shown in Figure 2B.
The tibial inclination Angle is defined as θ1 . In the coronal plane,
the ground reaction force F1 and F2 decomposed into the tibia are
Fx and Fy , respectively as shown in Equation 3:

Fx
F1 sin θ1 + F2 cos θ1

(3)
Fy
F2 sin θ1 − F1 cos θ1

At this point, the distance from the distal center of the tibia to the
point of force application on the sole is LG . The direction of the force on
the lateral and medial sides of the knee joint will vary with internal or
external rotation of the knee. It points towards the center of the hip joint
along the distal center of the femur. Once the knee joint undergoes
internal rotation, the lateral compartment will experience tension from
the lateral collateral ligament Fc . Taking the moment about the center
point attached to the lateral collateral ligament as shown in Equation 4:
Fy rc + Fx LG − Fb rb cos θ2 − Fa (ra + rc ) cos θ2
0 (4)

The distance from the lateral collateral ligament to the center of

FIGURE 2 the knee joint rc is approximately equal to half of the knee width W.
Force line model of human lower limb. (A) Normal force line of
The force in the medial and lateral compartments of the knee joint
human lower limb. (B) Human lower limb force line in patients
with varus. can be achieved as Equation 5:
⎪
⎧
⎪ Fy 4Fx LG Fx
⎪
⎪ F
+ −
⎨ a cos θ2 Wcos θ2 2 sin θ2
F2 2F1 · LG ⎪ (5)
⎪
⎧
⎪ ⎪
⎪ 3Fx Fy 4Fx LG
⎨ Fa
2 + W
⎪ ⎪
⎩ Fb
− −
(2) 2 sin θ2 cos θ2 Wcos θ2
⎪
⎪
⎩ Fb
F2 − 2F1 · LG
⎪
2 W When a patient uses an orthosis to correct knee genu varus, it is
equivalent to applying an external moment Mw of abduction at the
Through the above equation, it can be observed that in order to
knee joint. Taking the moment about the center point attached to
maintain an upright posture, the medial compartment of the knee joint
the lateral collateral ligament as shown in Equation 6.
experiences greater force compared to the lateral compartment, making
Fy rc + Fx LG − Fb rb cos θ2 − Fa (ra + rc ) cos θ2 − Mw
0 (6)
the medial meniscus more prone to wear and tear. For patients with
knee genu varus (inward rotation), the abnormal alignment of the lower So the force in the medial and lateral compartments of the knee
limb causes a change in the angle between the tibia and femur joint can be achieved as Equation 7:
centerlines, resulting in a shift in the direction of plantar pressure.
Taking the case of a patient with knee genu varus as an example, a lower ⎪
⎧
⎪ Fy 4Fx LG Fx Mw
⎪
⎪ F
+ − −
limb biomechanical model needs to be reconstructed, considering the ⎨ a cos θ2 Wcos θ2 2 sin θ2 Wcos θ2
⎪ (7)
⎪
⎪ 3Fx Fy 4Fx LG Mw
offset angle generated by internal and external rotation of the knee joint. ⎪
⎩ Fb
− − +
In order to achieve an overall balance of forces on the knee joint, the 2 sin θ2 cos θ2 Wcos θ2 Wcos θ2

FIGURE 3
The working principle of knee orthosis. (A) The principle of the three-point force formula. (B) The principle of the four-point force formula.

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FIGURE 4
The commercial knee orthotics. (A) Orthomen Hinged ROM Knee Brace. (B) Z1 K2 Comfortline Hinged Knee Brace. (C) Orthomen OA Unloader Knee
Brace. (D) Teyder functional Knee Brace (476RDR). (E) BraceAbility Osteoarthritis Unloader Knee Brace. (F) Game Changer Unloader Knee Brace. (G) ELITE
Knee Support Brace. (H) McDavid Heavy Duty Knee Brace.

TABLE 1 The empirical formula of the human body parameter.

Name Weight/kg Main structural Function Adjustability

material
Orthomen Hinged ROM Knee Brace 1.50 Aluminum Improve the postoperative knee Telescopic adjustable ROM hinge
stability/Control motion amplitude

Z1 K2 Comfortline Hinged Knee 0.59 Silicone neoprene/Stainless Prevent sports injury/Prevent joint Condoyles liner adjusts for tightness and
Brace steel degeneration in mild KOA patients comfort

Orthomen OA Unloader Knee Brace 0.84 Polymer plastic Delay the operating time/Reduce the Adjustable hinge/Adjustable straps
knee osteoarthritis pain

Teyder functional Knee Brace NA Aluminum Improve knee stability/Reduce Adjust and fix the knee flexion Angle
movement impact

BraceAbility Osteoarthritis Unloader 0.66 Polymer Delay the operating time/Reduce the Adjustable range of motion extension
Knee Brace knee osteoarthritis pain plug-in

Game Changer Unloader Knee Brace 0.54 Neoprene/plastic Improve knee stability/Reduce knee Knee flexion and extension Angle
osteoarthritis pain adjustment

ELITE Knee Support Brace 1.67 plastic Reduce knee osteoarthritis pain/Reduce Customized knee pads without
knee load adjustment

McDavid Heavy Duty Knee Brace 0.52 Aluminum Improve knee support and stability The strap provides adjustable range and
structural support

By comparing Equations 5, 7, it can be observed that when using force on the lateral compartment to some extent Fb . However,
a knee orthosis, the presence of the moment Mw can reduce the force considering factors such as the body’s tolerance and the comfort of
on the medial compartment of the knee joint Fa and increase the wearing the knee orthosis, the adjustment of the degree of knee genu

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FIGURE 5
The structure and working principle. (A) Diagram of mechanism. 1-upper connecting rod, 2-upper lever support rod, 3-knee joint stress adjustment
support brackets, 4-lower lever support rod, 5-lower connecting rod, 6-upper toothed wedge block, 7- upper lever arm, 8- lower lever arm, 9-lower
toothed wedge block. (B) Assembly view of the knee orthosis.

varus correction through the application of an external moment Mw reduce the effect of rehabilitation treatment. In the later stage of
is limited. It can only alleviate further joint wear and extend the rehabilitation, the body’s adaptive adjustment function will adapt to
lifespan of the meniscus while correcting the individual’s the effect of auxiliary adjustment structure on the human body,
walking gait. forming physiological dependence on the knee orthosis, resulting in
long-term wearing and affecting the normal life of patients. In view
of the current situation of most knee orthosis, it is particularly
3 Design and working principle important to design a knee orthosis that can adjust the effect of knee
varus according to the patient’s own condition.
The existing knee orthosis on the market generally fixes the
angle of the knee joint in the coronal plane, and cannot adaptively
follow the normal motion of the knee joint in the sagittal plane. It 3.1 Mechanical design
can reduce the wear of the joint and relieve the pain of the patient’s
knee after the knee joint is fixed with knee orthosis. However, long- The knee joint is in the reciprocating cycle of load-bearing and
term wear can lead to atrophy of the flexion and extension muscles non-load-bearing in the human gait cycle, and the traditional three-
in the knee joint, resulting in the imbalance of muscle strength in the point force and four-point force orthoses usually have good
later stage, which affects normal walking. adjustment effects. The principle of three-point force is that the
In order to enhance patients’ experience of wearing knee body generates a counterforce against the force exerted by the
orthosis, designers will customize the adjustment mechanism of orthosis, and the two maintain a relative balance to give the
orthoses independently. However, in the process of patients’ lower wearer continuous pressure (Aleksandra et al., 2020; Khosravi
limb function recovery and knee rehabilitation, the adjustment effect et al., 2019). A force is applied to the knee joint on the thigh and
cannot be adjusted adaptively. For example, at the initial stage of calf of the affected side, and a reverse force is applied to the
wearing, patients refuse to wear knee orthosis due to the high contralateral condyle as shown in Figure 3A. By applying the
intensity of correction and strong pressure on limbs, which overturning moment on the coronal plane of the knee joint, the

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FIGURE 6
The knee orthosis was worn on the human prosthetic leg model.

partial inward torque is offset, to correct the force line of has the characteristics of one-way transmission, which leads to
the lower limb. the locking of toothed wedge blocks and can’t reverse, so as to
The principle of the four-point force formula is the same as that ensure the stable correction effect of knee orthosis.
of the three-point force formula, which corrects the lower limb force The knee orthosis, designed based on the biomechanics of the
line through torques with opposite directions and different action human lower limb, exhibits the following characteristics. Firstly,
points. The difference is that the force point is applied to the upper employing the principles of mechanical leverage, enables adjustment
and lower two points of the opposite condyle as shown in Figure 3B. of the pressure on the knee joint in the coronal plane, thereby
Force was applied on both sides of the knee joint to form a rollover modifying the load distribution between the internal and external
torque to adjust the force line of the human lower limb. compartments. This adjustment relieves patients’ pain and restores
Through searching and researching the currently available knee their mobility. Secondly, the inclusion of a specifically designed
orthosis products in the market, it was found that this type of hinge allows for optimal alignment with the knee joint’s range of
product is diverse and varied in styles. Currently, most commercial motion, minimizing interference during natural knee movements.
knee orthoses employ passive designs, with an average retail price of Thirdly, the orthosis can be customized to meet the corrective needs
around USD 120. According to sales volume data, knee orthosis of patients at different stages of rehabilitation. Upon assembly, the
products demonstrate broad market demand. Several representative knee orthosis was fitted onto a human prosthetic leg model, as
products were selected based on the principles of three-point and depicted in Figure 6. Overall, the orthosis demonstrates a
four-point force application, as depicted in Figure 4. Specific product straightforward mechanical structure and provides an excellent fit
parameters were collected for comparative analysis, as shown with the human leg. Furthermore, it can be concealed beneath
in Table 1. clothing, resembling the appearance of a normal leg, alleviating
The new adjustable orthosis for reducing the medial psychological burdens for the patient. Simultaneously, the special
compartment load was designed based on the principle of the hinge design ensures the patient’s knee joint swings naturally,
four-point force formula (Xin et al., 2021b), as shown in without impeding regular bodily movements.
Figure 5A. In order to transfer the load of the affected knee to
the contralateral knee to reduce the pressure of the affected knee.
The toothed wedge blocks (6, 9) are moved to the center of the knee 3.2 Wearable structure design
joint by the screw thrust, and the lever arms (7, 8) are raised to the
outside of the leg during the movement. At the same time, the other From the perspective of product design, it is important to prioritize
end of the lever arm (2, 4) support rod squeezes inside the leg, so that functionality while aiming to achieve an optimal user experience and a
the knee joint adjusts the stress brackets (3) to exert sustained comfortable wearing experience. When designing wearable
pressure on the knee joint. mechanisms for the human body, two key factors should be
The main structure of the orthosis, as shown in Figure 5B is considered based on ergonomics: materials and structure. On one
composed of connecting rod, upper and lower tooth adjustment hand, for wearable products on the human body, there will be
toothed wedge blocks, joint flexion connecting rod, and thigh and interactive forces between the human body and the device during
calf fixed braces. The two ends of the upper and lower knee joint walking or movement. If rigid materials are used exclusively, it may
flexion link are incomplete gears, which ensure the flexion motion of cause secondary harm to the muscles and bones. On the other hand,
the knee joint through tooth meshing. A series of threaded holes are scientific and rational design is crucial because exoskeletons exert
reserved along the vertical direction of the upper and lower significant pressure and have a large contact area with the human
connecting rods of the orthosis, which are matched with the body surface. If the pressure distribution is uneven, it can hinder blood
upper and lower universal connecting blocks, and the patients circulation, leading to ischemia and necrosis of soft tissues. If the contact
can adjust to the appropriate position according to their own area is not properly designed, it can impede skin respiration and prevent
conditions. With the cooperation of ratchet and ratchet bar, it sweat from evaporating, eventually resulting in skin ulcers.

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FIGURE 7
Design and modeling process of wearable structure. (A) EinScanPro 2X professional handheld 3D scanner. (B) The surface of the human leg. (C) The
point cloud data. (D) The surface model and perform surface construction. (E) Surface optimization model. (F) The upper semi-enclosed wear structure.
(G) The lower semi-enclosed wear structure.

Drawing upon the structure and characteristics of the human Using the EinScanPro 2X professional handheld 3D scanner, as
lower limb, a compatible wearable structure is devised to tackle the shown in Figure 7A, three-dimensional data collection of the surface of
aforementioned concerns in line with the principles and force the human leg was conducted, as shown in Figure 7B. After the scanning
characteristics of orthotic devices. Initially, an extensive surface process, the built-in algorithm of the scanner automatically aligns and
area is embraced, employing a semi-enclosed wearable structure merges the point cloud data, as shown in Figure 7C. The scanned
to evenly disperse the applied pressure on the leg. Subsequently, the environmental objects and excess point clouds of the leg were manually
wearable structure encompasses multiple pores, facilitating efficient removed, and obtained STL data. The data was imported into the 3D
heat dissipation and sweat evaporation. Moreover, lightweight and modeling software Solidworks to create a surface model and perform
flexible materials are employed to lessen the weight of the surface construction, as shown in Figure 7D. The noise reduction and
components without compromising their durability. Lastly, the optimization techniques on the model were also employed. Furthermore,
design adopts a shape that impeccably conforms to the contours the data was imported into Geomagic Studio software to generate
of the human skin. surfaces and exported the reverse model in Step format for forward
The irregular shape of the human leg surface makes it design purposes, as shown in Figure 7E. Additional optimization was
challenging to directly obtain the surface curvature performed on the surface using Geomagic software. When designing the
measurements. However, by utilizing three-dimensional scanning structure for legwear, it is important to ensure that the human joints and
technology, it is possible to acquire spatial point cloud data of the areas of movement are not covered by fixtures. Therefore, the part from
measured leg surface. This data can undergo a series of the scanned model was removed, keeping only the middle part of the leg
reconstruction processes to generate a three-dimensional mesh for designing a semi-enclosed wear structure, as shown in Figures 7F, G.
model of the measured object. Subsequently, through 3D The wear structure model was then 3D printed and assembled with the
reconstruction, a 3D model of the human leg surface can orthosis structure, resulting in a complete prototype of the wearable
be obtained. orthosis as shown in Figure 8.

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FIGURE 8
3D view of the knee orthoses with wearing structures.

FIGURE 9
The workflow of new adjustable knee orthosis. (A) The adjusting screw drives the toothed wedge block to move towards the inside of the knee. (B)
The toothed wedge block push the lever arm up to the outside. (C) The adjusting force bracket moves to the inside of the leg.

3.3 Working principle sagittal motion of the knee joint but also take into account the
small range motion of the knee joint on the coronal plane. At the
Through screw transmission, the correction angle of the knee same time, it can compensate for the movement of the orthosis
orthosis is finally achieved, so as to provide different degrees of caused by joint movement.
external force to the knee joint and alleviate the pressure on the The specific working principle of new adjustable knee orthosis is
affected side of the knee joint. Ratchet teeth are distributed on the as follows: 1) Rotate the adjusting screw, which will drive the toothed
outside of the toothed wedge blocks, which can engage with the wedge block to move towards the inside of the knee, as shown in
ratchet bar on the lever arm to realize one-way transmission and Figure 9A; 2) The toothed wedge block will push the lever arm up to
reverse self-locking of the toothed wedge. Patients can adjust the the outside, while the other end of the lever arm will squeeze to the
effect according to their own needs. The knee joint buckling inside of the leg, and the lever arm support rod will also move
connecting rod with a special structure can not only meet the inward, as shown in Figure 9B; 3) Because the knee adjusting force

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FIGURE 10
The working principle of new adjustable knee orthosis. (A) Diagram of knee orthosis adjustment angle. (B) The relationship between the number of
screw rotation rings and the adjustment angle. H is the height of toothed wedge block. L is the length of upper connecting rod. ΔX = X1-X2,which is the
height difference between each two adjacent adjustment points.

TABLE 2 The empirical formula of the human body parameter.

Adjustment points H (mm) L (mm) Tan θ (ΔH/L) Number of cycles Adjustment angle
point1 1.32 53.77 0.025 16 1.5°

point2 3.00 53.49 0.056 21 3°

point3 4.68 53.19 0.087 26 5°

point4 6.36 52.71 0.121 31 7°

bracket is fixedly connected with the lever arm and the flexion pressure values in different regions of the foot, which reflect the
connecting rod when the lever arm squeezes to the inside of the leg, effects of wearing on the human body.
the adjusting force bracket moves to the inside of the leg, thus The experimental system consists of two parts, as shown in
transferring the pressure from the lever arm to the inside of the leg, Figure 11. The first part is the information acquisition module,
as shown in Figure 9C. which directly collects pressure values and gathers physical pressure
According to human biomechanics, the knee varus angle signals of the foot’s variations using thin film pressure sensors as
from 0° to 7°. Therefore, there are four adjustment points sensitive components. Since the thin film pressure sensor outputs
distributed on the toothed wedge, as shown in Figure 10A. millivolt-level analog voltage signals, amplification is required to
The wedge block has four serrations distributed on it, and the amplify the collected pressure signals. The second part is the
orthotic device also has four adjustment points. The pitch of the conditioning module for pressure information. The signal is
adjusting screw is 0.8 mm. When the adjusting screw rotates amplified by the decoder and transmitted to a microcontroller, in
1 circle, it advances 0.8 mm to the medial knee. The relationship this case, an Arduino microcontroller. The collected signal is
between the number of screw rotation rings and the adjustment conditioned into a computer-readable digital signal and
angle, as shown in Figure 10B can be calculated by trigonometric transmitted to a computer via a data cable for data storage and
function, as shown in Table 2. processing.
The experimental testing device is shown in Figure 12. Using a
leg model to replace the human lower limb for testing can effectively
4 Experiment and functional evaluation simulate the surface curvature of the human leg, enabling close
fitting between the orthosis and the lower limb, thus achieving the
4.1 Physical experiment with pressure test transmission of forces. However, the main difference between the
model and the human leg lies in the definition of materials. The
The knee orthosis generates an abduction torque by exerting human skeletal structure is enveloped by muscles, which are highly
corresponding pressure on the leg of patients with genu varus, elastic and can be approximated as elastic materials. Therefore,
thereby altering the distribution of forces in the medial and lateral during testing, spring units are clamped between the leg model and
compartments of the knee joint. This correction realigns the lower the force adjustment bracket of the orthosis. This setup cushions and
limb mechanical axis, reduces meniscal wear, and alleviates joint absorbs the deformations caused by the compression of the leg
pain. Physical prototype testing is essential to validate the structural model by the orthosis’s pressure adjustment module. Also, it
design and feasibility of the proposed solution before conducting effectively transfers the pressure value without any loss or
human-wearing experiments. Moreover, direct measurement of attenuation.
forces in the medial and lateral compartments of the knee joint It is used to study the pressure values exerted by the orthosis on
is challenging. Therefore, a portable plantar pressure testing system the human leg and to determine the range of corrective pressures.
is designed to objectively evaluate the orthosis by analyzing the Different adjustment levels of the orthosis result in different

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FIGURE 11
Pressure sensing test system composition diagram.

as possible, and try to maintain an equal duration between each

adjust level, ensuring that the time intervals for each experiment
measurement are equal. The test results were collected and plotted as
test curves, as shown in Figure 13.
In this study, four distinct springs characterized by different
stiffness coefficients were chosen for experimental evaluation.
Experimental data was meticulously collected, and subsequent
analysis involved organizing and graphing the resulting force
curves. To optimize the interface between the orthosis and the
human body, thereby enhancing the effective transmission of
corrective loads, a preloading procedure was implemented before
any contact-induced deformation. Notably, upon wearing the
orthosis and securely fastening the straps, the initial preload
forces inherently varied owing to the disparate stiffness
FIGURE 12 properties exhibited by the selected springs.
Experimental test with knee orthosis.
As the orthosis commenced its operation, accompanied by the
continuous adjustment of the gear position during the experimental
process, the pressure values correspondingly increased, resulting in
adjustment angles, and there are also significant differences in the an overall stepped curve pattern. Each gear level corresponded to a
muscle status of individuals. Therefore, during the experiment, four specific pressure value, aligning with the anticipated design. During
springs with different stiffness coefficients are selected for testing. the uniform rotational adjustment of the adjusting screw, the
The parameters of the springs are shown in Table 3. Three triangular block moved downward, and upon entering the
measurements are taken for each type of spring. corrective gear level, the teeth on the surface of the triangular
The experimental steps are as follows: 1) Wear the orthosis. 2) block engaged with the groove on one end of the lever arm,
Open the Arduino software for serial communication debugging. 3) thereby lifting the lever and causing it to rotate. This rotational
Calibrate the thin film pressure sensor with known mass weights movement of the lever arm transferred force through the lever,
before testing. 4) Place the thin film pressure sensor at the desired resulting in a stable corrective force at the knee joint. Consequently,
pressure point, ensuring a tight fit. 5) Position and secure the during this phase, the curve exhibited a horizontal segment. Due to
model’s leg vertically. 6) Open the computer again, run the the nearly uniform speed of the triangular block’s movement, there
software, and simultaneously adjust the orthosis to different were no significant sudden force changes or step-like transitions
levels. 7) Repeat step 6 three times, retaining three sets of valid between adjacent corrective gear levels. Instead, a relatively uniform
experimental data. After each experiment, calibrate the pressure ascending segment with approximately consistent slope
sensor with standard mass block. Adjust the orthosis level as evenly was observed.

TABLE 3 The parameters of the spring.

Type Wire diameter (mm) Mean diameter (mm) Coil number Spring stiffness (N/mm)
Spring I 1.3 10 6.5 0.395

Spring II 0.9 4 5 1.845

Spring III 1.7 8 3.5 4.195

Spring IV 2.3 15 2.5 2.985

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FIGURE 13
Spring pressure value data curve.

The small-scale fluctuations observed in the curve can be their foot soles and the sensor insole after wearing the experimental
attributed to two primary factors. Firstly, these fluctuations arise shoes. The human foot consists of a total of 26 bones. Based on the
as a consequence of system friction, encompassing the frictional anatomical structure of the human body this experiment selected
forces between the triangular block and the track, as well as the eight specific bones for the placement of pressure sensors. These
friction between the orthosis and the leg. Secondly, these bones include the first metatarsal bone, the second and third
fluctuations originate from vibrations, particularly those induced metatarsal bones, the fourth and fifth metatarsal bones, the
by the impact between the teeth of the triangular block and the lateral side above the foot, the lateral side below the foot, the
grooves during gear shifting. In terms of the four sets of springs used medial side of the heel, the middle of the heel, and the lateral
in the testing, the orthosis can exert a maximum corrective pressure side of the heel. These eight areas represent the regions of the foot
of 10N, which is employed to adjust the forces on the inner and outer that experience significant pressure during weight-bearing activities.
sides of the knee joint. Moreover, due to the gradient settings of the During the experiment, sensor insoles depicted in Figure 14 were
gear levels, the orthosis possesses a certain range of adjustment, utilized. These insoles were equipped with 8 pressure sensors
allowing it to better meet the correction and adjustment needs of positioned at various locations. These specific positions on the
patients with habitual arthritis. Additionally, it is possible to select plantar surface of the foot were accordingly matched with the
springs that match the individualized requirements of patients, 8 pressure sensors. The experiment involved a total of
thereby obtaining a broader range of corrective force. 15 subjects, there are 5 subjects for each group, categorized into
weight ranges of 60–65 kg, 70–75 kg, and 80–85 kg. Each participant
underwent three sets of foot pressure tests, consisting of one test
4.2 Functional evaluation with plantar without wearing the orthosis and two tests while wearing
pressure test the orthosis.
To validate the accuracy of the plantar pressure data collected by
The effectiveness of the orthosis was evaluated by analyzing the the self-made device, a commercially available experimental device
changes in pressure values at eight points on the plantar surface was used to obtain plantar pressure data as a control. The subjects
before and after subjects wore the orthosis. This experiment aimed did not wear orthotics, only wearing plantar pressure insoles for
to maintain subjects’ daily habits, ensure ease of wearing during testing. The left foot was tested using a pressure-testing insole from a
testing, and minimize any impact on flexibility. The shoe insole commercial device, while the right foot was tested using a self-made
pressure testing method was employed, wherein an insole with built- pressure-testing insole. The variation curve of the measurement
in sensors was placed inside the experimental shoes worn during values of each pressure sensor with the gait cycle was obtained, as
testing. Subjects were instructed to ensure proper contact between shown in Figure 15.

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FIGURE 14
Plantar pressure test experiment with knee orthosis. (A) Position of the plantar pressure sensor relative to foot bones. These bones include the first
metatarsal bone ①, the second and third metatarsal bones ②, the fourth and fifth metatarsal bones ③, the lateral upper side above the foot ④, the lateral
side below the foot ⑤, the outer side of the heel ⑥, the middle of the heel⑦, and the inside of the heel⑧. (B) The self-made plantar pressure sensor was
used for experimental testing. (C) The Novell Pedar insole plantar pressure tester. (D) The subject wore knee orthosis and plantar pressure sensor for
experimental test with test software.

During the walking state, the soles of both feet sequentially five times, with each subsequent measurement being conducted after a
impact the ground, as shown in Figure 15A. Each gait cycle consists time interval of 3 min. During these intervals, the subjects removed
of two phases: the stance phase and the swing phase. The stance their feet from the experimental shoes, allowing the insoles to return
phase accounts for approximately 60% of the gait cycle and includes to an unloaded state. Subsequently, the measurements were repeated
three stages: heel strike, foot support, and toe-off. The swing phase following the insertion of the orthotics. Finally, the data obtained from
accounts for approximately 40% of the gait cycle and includes two each sensor, depicted in Figure 16.
stages: leg lift and swing. Therefore, for the pressure curve of a single Data differences in the icons are represented by the mean ±
foot, the pressure between the foot and the ground only acts during standard error (SEM) for each group. Analysis of variance (one-
the first 60% of the gait cycle (Karimi et al., 2012). Pressure signals way analysis of variance) and t-test were used to detect whether
from the sensors were collected to plot the pressure curve within the difference between groups was significant. Unless otherwise
stance phase of right leg, as shown in Figure 15B. stated, all statistical analyses were performed using Origin
The subjects underwent individual experiments for body wearing (Originlab, United States). P < 0.05 was considered
tests while wearing orthotics. Firstly, the sensors were calibrated to statistically significant.
ensure accurate measurements. The sensors were arranged on the By comparing and calibrating the foot pressure data collected by
insoles and inserted into the designated experimental shoes. The the homemade device with the foot pressure values obtained from a
subjects wore these shoes, with the hardware’s connecting wires commercially available experimental apparatus, it was found that
securely fastened to their legs. During the test, subjects stood still, the pressure values collected by the sensors of the homemade
ensuring their feet were positioned shoulder-width apart. For optimal experimental device are consistent with the data collected by the
correction, the orthotic angle was adjusted to its maximum value. sensors of the commercial experimental device. Therefore, the data
Once the sensors received stable signals, measurements were recorded obtained from the foot pressure measurement system can be used for
continuously for a duration of 30 s. This entire process was repeated subsequent experimental analysis.

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FIGURE 15
Plantar pressure sensor test experiment. (A) Changes of plantar pressure during human walking. (B) The force curve within stance phase of right leg
depends on the sensors.

Figures 16A, B present graphical representations of the average during human activities. It is also one of the joints prone to injury.
data collected from static foot pressure tests conducted on subjects The incidence of knee osteoarthritis increases with age. Knee
in three different weight ranges. The gray shaded area represents the orthoses play a crucial role in mid-stage knee osteoarthritis and
foot pressure values collected without wearing orthotics, serving as post-operative recovery. Through the analysis of existing knee
the control group for each experiment. By analyzing the orthoses, it was found that the load-bearing structures of these
experimental results from the three groups of subjects, it can be orthoses primarily use lightweight Aluminum alloys or rigid plastics,
observed that after wearing orthotics, there is a significant decrease reducing overall weight while ensuring adequate support strength.
in pressure values at points 3, 4, 5, and 6 for patients with medial Inner linings commonly consist of rubber and nylon materials,
knee instability. Points 3, 4, 5, and 6 on the sensor insole correspond layered to contact the skin, utilizing flexible materials to enhance
to the fourth to fifth metatarsal heads, the lateral aspect above the surface conformity and employing curved designs to minimize
foot, the lateral aspect below the foot, and the lateral aspect of the contact area, thereby promoting skin breathability and
heel respectively. For patients with medial knee instability, due to the perspiration. The knee orthosis’ fastening mechanisms feature
deviation of the lower limb alignment, the pressure on the lateral non-slip rubber strips and highly elastic fabrics to prevent sliding
side of the foot is greater compared to that of normal individuals. and failure during daily use and physical activity. They incorporate
There is a noticeable increase in pressure values at points 1, 7, and 8, buckle devices for quick donning and doffing. The majority of
which can be attributed to the effect of the orthotics causing a shift in existing products rely on structural wearing to restrict knee joint
the body’s center of gravity and adjusting the forces acting on the flexion angles, enhance knee joint support, reduce meniscal load,
medial and lateral sides of the knee joint. These results are consistent and alleviate knee joint pain. However, there is a shortage of
with the expected outcomes. Comparing the effects of wearing corrective products for the knee joint coronal plane. Products
orthotics among the three groups of subjects, the first group offering precise graded force adjustment tailored to individual
exhibited better corrective effects, with a relatively larger decrease patient needs and rehabilitation course requirements are limited.
in pressure values in the measured area. This can be attributed to the Addressing issues such as poor human-machine coordination
relatively lighter body weight of the subjects in the first group, which and discomfort during the wear of existing orthoses, this paper
makes the corrective effects of the orthotics more pronounced. As conducts a force analysis of the knee joint. It proposes a four-point
body weight increases, the localized adjustment of the force line force correction scheme and designs an adaptive knee orthosis to
through the orthotics becomes weaker. Therefore, for patients with address existing product deficiencies and shortcomings. After the
medial knee instability, actively reducing body weight is structural design and prototype processing test, the expected
also necessary. experimental results were obtained. However, after analysis and
demonstration, there are still some problems, which need further
research and discussion in the future.
5 Discussion and conclusion In this paper, a simplified internal and external force model of
the knee joint is established, but the structure of the knee joint is
5.1 Discussion complex, and there are many muscles and ligaments related to the
movement of the knee joint. Subsequently, the corresponding
The knee joint, the largest and most complex joint in the human research can be carried out on the optimization of the
body, bears significant weight and undergoes frequent movement mechanical model of the knee joint. Besides, the force line of the

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FIGURE 16
Spring pressure value data curve. (A) Compare the test data of self-made equipment with commercial equipment for different group subjects. *
represents a significant difference from the No Knee Orthosis group (B) Test pressure values with knee orthosis for different group subjects.; # represents
a significant difference from the group 1; △ represents a significant difference from the group 2.

human lower limb and the force of orthosis are analyzed, but the the human body and the improvement of the wear effect. The
influence of coordinated motion between the human lower limb and corresponding research will be carried out in the future.
orthosis is not considered. The next step is to establish a human- The lower limbs of the human body are accurately scanned and
machine coupling analysis system, which will have far-reaching 3D printed for the structural design of orthotics. However, due to
significance for the analysis of the interaction between orthosis and individual differences, the universal design is lacking. Although the

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well-designed wearing structure ensures a good fit between the account for dynamic changes in force positions during prolonged
device and the human body, and the design method is worth wear and walking by patients. Subsequent optimization designs
popularizing, the traditional bandages and Velcro are still used can consider material reduction while maintaining structural
for binding and pasting, and the fixing methods of the device stability, incorporating scientifically reasoned heat dissipation
and the winding methods of the bandage lack depth design. Also, hollow structures to facilitate skin cooling and perspiration
the adjusting mechanism of orthosis is driven by a thread, which management.
realizes the fine adjustment of classification, but the rotation
operation of the thread is inconvenient. The later stage should be
equipped with a detachable thread torsion lever moment arm to 5.2 Conclusion
achieve labor-saving and convenient operation. The adjustment
range of orthosis should be expanded to the research population, Knee orthosis plays an important role in the mid-term and
and the limb parameters of special groups such as children should be postoperative rehabilitation of knee osteoarthritis. However, most of
considered for structural design. the existing orthoses have problems such as fixed adjustment angle,
Although this paper verifies that knee orthosis can achieve uncomfortably worn, and interference of walking movement of
correction function, human testing needs to recruit more patients lower limbs. In this paper, a theoretical model of knee
with knee varus for testing. Because KOA affects walking speed, biomechanics is established to determine the relationship
range of motion, rhythm, stride length, and increases the adduction between the force of the knee joint in the medial and lateral
moment during walking, these parameters should be fully utilized to compartments and the force line of the lower limb, which
measure the performance of orthotics in later clinical trials. The next provides a theoretical basis for the design of auxiliary structures.
step will focus on the study of different degrees of KOA patients’ In order to reduce the knee adduction torque, a knee orthosis was
acceptance of orthosis, especially after long-term wear, the impact designed based on the four-point force principle. The processing
on human lower limb bones and muscles. It is believed that with the principle was verified by a physical pressure test. The experimental
improvement of follow-up research work, knee orthosis will results show that the orthosis can realize step-by-step pressure
be developed. adjustment and meet the design requirements. The results of the
Optimization design is a valuable tool for constructing physical stress test show that the orthosis can achieve an angular
simplified mathematical models, with the typical objective of range adjustment of 0°–7° and can provide a corrective force of
minimizing the weight of orthotic structures while satisfying 0–10N to the knee joint.
specific constraints on wear and fixation, to achieve optimal
adjustment forces between the inner and outer compartments of
the knee joint. Within orthotic structures, the primary stress-bearing Data availability statement
components are the toothed wedges and lever arms. The lever arm,
serving as a force transmission mechanism, determines the overall The raw data supporting the conclusions of this article will be
adjustment pressure of the orthosis based on its length and angle. In made available by the authors, without undue reservation.
contrast, the geometric shape of the toothed wedge determines the
external pressure applied at each adjustment level. These
components interact structurally and influence each other Ethics statement
mechanically.
In traditional structural shape optimization design methods, The studies involving humans were approved by medical ethics
employing finite element techniques facilitates addressing these committee of Northwestern Polytechnic University. The studies
issues. Utilizing general finite element analysis software enhances were conducted in accordance with the local legislation and
design efficiency while meeting specific design requirements. institutional requirements. The participants provided their
Research focuses on optimizing design parameters of toothed written informed consent to participate in this study. Written
wedges and lever arms through finite element simulation and informed consent was obtained from the individual(s) for the
iterative refinement. Analyzing optimization results identifies publication of any potentially identifiable images or data included
structural weaknesses, and determining optimal values for lever in this article.
arm length and toothed wedge angles to achieve satisfactory
design solutions.
For orthotic structural design, the goal of structural Author contributions
optimization is to achieve a safe and economical structure,
encompassing the dimensions and shapes of the orthosis. XZ: Conceptualization, Formal Analysis, Funding acquisition,
Within allowable structural limits, optimization focuses on Investigation, Methodology, Visualization, Writing–original draft,
adjusting lever arm dimensions (length, width, thickness) and Writing–review and editing. XL: Conceptualization, Data curation,
geometric angles of the toothed wedges to ensure high strength Formal Analysis, Investigation, Methodology, Project
while accommodating additional adjustment pressures. administration, Resources, Writing–original draft, Writing–review
Regarding the design of orthotic wearing structures, despite and editing. JH: Data curation, Formal Analysis, Resources,
utilizing 3D scanning technology to obtain three-dimensional Software, Validation, Writing–original draft, Writing–review and
models of the leg surface, ensuring a snug fit with the body’s leg editing. YL: Investigation, Project administration, Resources,
surface for comfortable wear, the static nature of this fit does not Software, Supervision, Writing–original draft. YT: Data curation,

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Zhou et al. 10.3389/fbioe.2024.1439616

Funding acquisition, Resources, Software, Project administration, Conflict of interest

Writing–review and editing.
The authors declare that the research was conducted in the
absence of any commercial or financial relationships that could be
Funding construed as a potential conflict of interest.

The author(s) declare that financial support was received for the
research, authorship, and/or publication of this article. This research is Publisher’s note
supported by the Doctoral Research Fund of Xi’an University of
Technology (No: 106-451123001); Scientific·Research All claims expressed in this article are solely those of the authors
Program·Fund·of Shaanxi Provincial Education Department (No: and do not necessarily represent those of their affiliated
23JK0567); Natural Science Basic Research Program of Shaanxi organizations, or those of the publisher, the editors and the
Province (No: 2024JC-YBQN-0996); Humanities and Social Sciences reviewers. Any product that may be evaluated in this article, or
Foundation of Ministry of Education of China (No: 23YJAZH132); claim that may be made by its manufacturer, is not guaranteed or
Social Science Foundation of Shaanxi Province in China (No. 2023J014). endorsed by the publisher.

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