Introduction
Knee Osteoarthritis (OA) is a type of joint lesion in which the joint becomes inflamed with synovium. Over time, with daily activities, a large amount of cartilage covering the bone is destroyed [1]. This metabolically active disease is progressive and chronic loss of cartilage depends on genetic factors, damage, or overload on the joint [2, 3]. According to the World Health Organization, knee OA is the most common form of arthritis, one of the four debilitating diseases in women and eighth in men. Knee OA in approximately 25% of adults over 55 years of age, is the most common joint disease. It causes significant pain in the knee [4, 5]. Common protective and non-invasive interventions are orthosis treatments that try to correct the alignment with mechanical tools and reduce the load on the internal compartment of the knee [6, 7, 8]. Functional orthoses, knee braces, shoes, and insoles are among the orthosis treatments. Knee braces work by controlling the deflection of the knee in the frontal plane and changing its orientation by applying force through the straps [9]. The braces should also reduce the angle of flexion of the knee in the sagittal plane [10, 11]. However, patient adaptation to braces is the main problem in using it [12]. It seems that applying unnecessary valgus force on the knee in all gait stages is one reason for not using braces [13]. As we know, the deviation of the varus direction of the knee occurs only between the moment the heel hits the ground and up to 30% of the gait stance stage. After that, from the heel and toe lifting stage to the end of the knee swing and the heel hitting the ground again, the varus is reduced by the locking mechanism of the knee. So, it is unnecessary to apply a constant force on the knee with a brace at all stages of gait [14].
Another important point to note is that knee braces have joints with one or two degrees of freedom of movement, while the natural movements of the knee joint are in three plates with six degrees of freedom of movement [15, 16]. On the other hand, the piston forces created by the brace on the patient’s limb during gait and different places of the brace on the knee, during successive wearing and removal, which, for 5 mm of wrong placement of the brace joint on the limb, can cause major changes in limb mechanics [17]. Thus, it seems that the incompatibility of brace and knee joint motion, inconsistency between brace knee joint with the anterior-posterior movement of the femur over tibia during knee flexion, brace piston movement on the limb, and application of continuous corrective force by stretching on the knee in all gait stages are factors that braces are not accepted by patients [12, 18]. These tips led us to the design of the new knee joint.
The knee joint brace with its new joint includes a flexible steel wire interface, two small pieces of steel in the center of the joint, distal and proximal aluminum loads attached to the joint, and rails embedded in the distal joint aluminum load. The new joint is made of durable and quality 7075 aluminum and 316LVM / stainless steel. So, in addition to lightness, it has high strength. The total weight of the joint is 260 g (Figure 1). Thigh and leg braces were made by molding the patient’s limbs. The shells of this brace are made of acrylic resin [19].
The new joint mechanism converts the knee movement at the end of the swing stage into a corrective movement of the adductor deflection to the middle of the stance stage by pulling the wire embedded in a special chamber. The power to correct the adductor angle of the knee during normal gait is provided in proportion to the body’s weight-wire tension, with adjustable screws.
A special rail was installed in the distal part of the joint load to adopt the brace’s movement to the femur’s sliding motion on the tibia bone during knee flexion and longitudinal displacement of the knee. By providing a sliding motion on the brace load, the machine brace was found to accompany the knee with a transfer motion of 10 to 15 mm up and down in the locked and free position of the knee.
The new brace joint was made of three joints to simulate the knee lock mechanism and create rotational movements around the vertical axis inside the joint. In this way, the ability to move in three motion plates in accordance with knee movements is provided for the brace joint [19].
Participant and Method
One female volunteer (age 61, weight 69 kg, height 154 cm) participated in this study. The patient was brought to the orthosis and prosthesis clinic of the University of Rehabilitation Sciences and Social Health. The subject was selected according to the inclusion and exclusion criteria. Based on the Clarence Lawrence scale, the patient had pain in one knee for the past 6 months and grade 2 knee OA [20]. The patient had clinical signs of swelling, dryness and joint pain, muscle weakness, and loss of knee confidence. Radiography of the affected knee in a standing position in frontal view showed narrowing of the joint space and sharpening of the edge of the tibia. The patient’s physical activity was impaired due to pain. The patient was not a candidate for joint replacement surgery. He had no history of invasive treatment, including injection therapy for the knee. He was also diagnosed with obesity, osteoarthritis of the other knee, and hypersensitivity to pain.
On the other hand, she did not suffer from symptomatic neurological or spinal diseases such as disk herniation, osteoarthritis of the hip, wrist, or ankle, and skin problems or any illness that makes orthosis difficult to use [21]. The subject used braces only for the affected limb. The Ethics Committee of the University of Rehabilitation Sciences and Social Health approved this study with the code IR.USWRREC.1392.130, and the subject signed the informed consent form.
The subject’s gait was assessed in two modes with and without braces. Data recording began from the moment the heel of each foot strikes with the force plate device. The person had to take appropriate steps on two screens with her natural gait pattern. To record kinematic parameters including knee angles in the frontal, sagittal, and spatial-temporal planes gait, including speed, step time, phase percentage, affected limb step length, number of steps per minute, and standing time on two legs, we used advanced gait analysis devices. 
We quantified normal and pathological gait patterns and force plate to determine the beginning and end of the stance stage. The advanced gait analyzer, a Vaikan device (460 Oxford Metrics, UK), has five infrared cameras with 100 Hz Workstation software and a Kistler A9286 5-m power plate device. Fifteen infrared light-reflecting markers were applied to the patient’s lower extremities using a double-sided adhesive, according to the Stoltze et al. method [22]. 
To collect data in the laboratory, the patient walked for a while at her comfortable and normal speed in both conditions of with and without braces on the force plate device embedded in the ground between the cameras of the gait analyzer, which was finally recorded five times. To prevent the effects of shoes and braces on the patient’s gait, she walked barefoot. The reproducibility of the gait analyzer was measured in one day to evaluate the variables. To investigate the group changes of the parameters studied in the present study, the paired t test was used.
Results
When using the brace, the adductor angle of the knee on the frontal plate decreased, and the gait speed increased. The knee adduction angle in the stance phase dropped from 4.25° to 2.3°, and the patient’s gait speed while wearing the brace increased from 0.88 m/s to 0.93 m/s. In addition, an increase in knee range of motion and stride length was observed using braces. The knee flexion angle in the swing phase increased from 44.72° to 46.19° when using the brace. On the other hand, the stride length increased from 1.125 m to 1.451 m when using the brace, and the percentage of stance phases decreased from 63.53 to 62.68 when using the brace.
Discussion and Conclusion
Because of the normal movements of the knee and the motion mismatch of the existing brace joints with the knee joint, the problem of instability of the brace on the limb is raised [23, 24]. To create a proper suspension and eliminate the extra movements of the braces on the limb, the patient is forced to tighten it, which leads to excessive pressure on the soft tissue, while applying the corrective load of the braces on the limb is also provided only by strap pressure [7]. In the study of Gaasbeek et al. [31], it was observed that the range of motion of the knee with a brace on the sagittal plate decreases with strap pressure. Recent designs have focused on applying a static correction load through the brace joint or shells. As in the medullary brace of Esrafilian et al. [32], change the direction of the knee is provided by applying a constant and adjustable force on the brace joint, by screwing according to the adductor deviation of the knee and patient tolerance, on the outer upper shell and lower inner shell on the frontal plate. Also, in Laroche locked spacer joint, the knee joint encounters the locking of the brace joint while moving when varus deflection occurs in the knee [28].
On the other hand, in a light brace with a soft frame by Stamenović et al. [33], a three-point pressure leverage arm was made using the shells pneumatic lever, which by inflating the shells and activating the pneumatic system and inflating separate bags, apply the correction force of valgus on the knee. In braces with rigid and shell pneumatic frames of Arazpour et al. [35], the adductor torque correction in the frontal plate is done by adjusting the pneumatic correcting force embedded in the shells by the patient. In all of these designs, the patient can impair the function of the brace to avoid applying a double corrective load on the injured limb and prevent further pain, or the brace can damage the patient’s soft tissue and normal gait, especially in corsets that focus on the input of varus correction force shells, where pressure is observed in soft tissues, especially the arteries [31]. The new mechanical joint can correct the varus direction of the knee using a kinematic inhibitor built into the joint by converting the knee extension movement in the sagittal plane to the abduction movement in the frontal plate by pulling the wire. On the other hand, to prevent the brace from moving on the limb, a rail is inserted in the lower load of the joint. The new joint has maximum kinetic adaptation to the knee in all planes of motion, is light in weight, and can convert motion in the final stages of the swing phase to the middle of the stance phase so that it does not control the knee in the swing phase where adductor deflection is minimized. Thus, the corrective force is not applied to the injured knee in all stages of walking, which is in accordance with the main biomechanical mechanism and stages of knee movement [32, 33] and can lead to improved function and symmetrical gait pattern in the early and middle stages of the knee OA [34]. It was also observed that the brace with the new joint reduced the amount of knee flexion in the stance phase of gait and helped create complete knee flexion in the swing phase. These findings are precisely in line with the correction required for gait in patients referred to in the Silva study [35].
It should be noted that in people with OA, less extension occurs in the late stages of stance in the knee, which is associated with a delay in the peak angle of flexion in the swing phase [18, 36]. As in Sharma’s study [37], the change of knee flexion angle during gait has been introduced as a factor determining the severity of the disease. The present study results on the correction of knee angles on the sagittal plate show inconsistencies with the findings of Gaasbeek et al’s study, the valgus maker brace did not change the amount of knee flexion in the swing phase [31]. In Davidson’s study, braces were found to prevent full knee extension in the stance phase of gait due to the application of constant valgus-creating forces on the frontal plane. However, due to the motion adaptation to the knee joint and the rail providing the sliding movement of the brace joint near the knee, the new joint mechanism has the least dependence on the strap pressure to provide the brace suspension on the limb. These variables should be examined separately in the following steps and future studies. It is suggested that in a comprehensive and more extensive investigation, the effect of this brace on patients with severe degrees of OA on scales 3 and 4 of Clarence Lawrence be measured.
People with knee OA also show changes in gait pattern and stride characteristics such as the number of strides per minute and stride length or gait speed [39]. According to the Creaby study [43], slowing gait is a compensatory strategy to reduce pain in these patients, and improving speed, and other spatial-temporal variables of gait can confirm the functional abilities of the knee joint. Patients reduce the load on the knee joint by decreasing the gait speed [41, 42]. The use of braces with a new knee joint increased the patient’s gait speed. Although the value of this variable was higher compared to conditions without braces, this rate is still low compared to healthy people of the same age. Improving the patient’s gait speed in this study could be due to the increase in stride length by decreasing the knee flexion angle in the stance stage along with increasing the number of strides per minute, which should be measured in a more extensive study.  
On the other hand, it can be inferred that the speed integral, i.e., distance, also increases because of increasing the gait speed. Therefore, it was observed that the stride length was raised with this brace, which was also confirmed by the information obtained from the gait analysis device [31]. These results are consistent with the Trombini-Souza et al.'s study [46] on gait speed, the number of strides per minute, stride length, and step length recorded from the output of the gait analyzer, but differ from the Richards’ study [31]. Since the new joint is in motion adaptation to the knee joint, and the results of this study show control of the adductor angle in the stance phase and improvement of the flexural angle in the swing phase, braces can increase the speed by increasing the stride length and the number of strides per minute. However, the Richards study emphasized that patients should not increase the number of strides per minute and the gait speed of patients with braces. 
Because this study was designed to present the initial findings of a new knee brace, the results cannot be generalized to a large population. The main purpose of this study was to evaluate the performance of this brace on patients, so a person with OA of the internal compartment of the knee was included in this study. The immediate effects of gait with a brace were also investigated in this study. This is one of the main limitations of this study. In addition, the patient was analyzed as a control group, so this study lacks a control group. The sample size was small, and the inability to involve patients with grades 3 and 4 of the Clarence Lawrence scale was another limitation of this study. After a large-scale clinical examination and final confirmation of the initial results, this brace can be a suitable alternative to correct varus deviation in patients with invasive and time-consuming methods. 
Conclusion
It seems that the new joint uses the joint mechanism of accelerator and lock in the swing and stance phase and accompanying the knee in the transverse and sagittal plane with the transliteration piece and preventing longitudinal movement and sliding of the brace on the limb. Also, moving and avoiding disturbance to the knee during flexion movement can correct the direction of the knee in the frontal and sagittal planes.

Ethical Considerations
Compliance with ethical guidelines
The Ethics Committee of the University of Rehabilitation Sciences and Social Health, Confirmed the study (Code: IR.USWRREC.1392.130).

Funding
This research did not receive any grant from funding agencies in the public, commercial, or non-profit sectors. 

Authors' contributions
All authors equally contributed to preparing this article.

Conflict of interest
The authors declared no conflict of interest.


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