1. Introduction
The biomechanical analysis of footfall and the gait is research field that is attracting more attention nowadays. It is recognized as a very effective tool for dealing with various issues associated with the march. On the one hand, these tools can be found in sports for performance analysis and feature optimization [
1,
2,
3]. On the other hand, on the clinical side, it is used to diagnose pathologies and physical or behavioral abnormalities [
4,
5], as well as to monitor rehabilitation and rectification processes [
6,
7].
The lower limbs are the ones that suffer more during the movement of a person. Thus, they are prone to numerous diseases. With the increase in life expectancy and the ageing of the population, there are increasing numbers of cases of pain and pathologies that affect these parts of the musculoskeletal system [
8]. However, the appearance of these problems is not only concentrated in the elderly population. According to [
9], around 24% of people over 45 years report frequent foot pain. Many of these disorders arise as a result of having some physical abnormality not treated efficiently, such as flat feet, which gradually affects the rest of the musculoskeletal system. Another possible cause of the appearance of chronic pathologies of this nature is associated with daily bad walking habits [
10,
11,
12]. Some of these bad habits are moving with an unbalanced load with respect to the center of the spine, or having a very marked pronator or supinator gait, which deviates from safety margins, which can cause metatarsalgia [
13]. All of these anomalies and bad habits require analysis to identify them and the design of an action plan to solve them. Furthermore, the progress of this action plan has to be analyzed over time.
Gait abnormalities associated with specific clinical cases, such as the appearance of tumors, Parkinson’s disease, or cerebral palsy, are also common, according to [
14]. In order to prevent severe damage, each of these cases should be analyzed and monitored, over time, specifically. The tracking of each case separately is a complex task.
The methods to analyze the gait include visual observation. This has a limited precision and can change between individual medical professionals (clinician). Therefore, visual observation is often complemented by standardized tests [
15], which can be performed with different measurement equipment. The most frequent electronic measurement resources are located in specialized rooms, called Gait Labs [
16]. The measurement systems of these rooms include cameras and sensor platforms that capture the trajectory and distribution of pressure on the sole of the foot. The information collected is then analyzed to identify patterns and calculate important characteristics in the clinic. Although these types of instruments are generally accurate, they cause physical and cognitive conditioning in the patient during the collection of the data, as they focus on performing tests, for which there may be bias in the measurement [
17]. Furthermore, creating this type of room is economically expensive, and the information collected is limited to the time of the testing session [
18].
The latest alternatives to the previously described approach are focused on the integration of measurement sensors into wearable devices. These devices can record or transmit data while the user performs daily activities [
19]. This approach allows continuous analysis while distancing the user from the data-collection process. The method to collect the maximum amount of data of the footprint, static or while walking, is by recording the pressure distribution of the different regions of the foot. There are several studios and commercial solutions which have created specialized footwear for this purpose [
20]. Resistive sensors are widely used because of their low cost and ease of implementation. However, they have a very abrupt response when exposed to pressure, which makes it difficult to extract precise information from the different regions of the foot [
21]. Another alternative is the use of capacitive sensors. The effectiveness of this alternative depends largely on the type of materials used to fabricate the sensors. The materials must be plastic enough to allow an easy deformation but, at the same time, have the ability to return to their original decompressed state. Another requirement to address is a linear behavior between the deformation and reversion to the original shape. This is needed to achieve pressure measurements with higher resolution.
Another important feature in this kind of footwear is the distribution of the sensors in the insole. Simple solutions place sensors in the areas where most pressure is usually exerted, that is, in the area where metatarsals and phalanges join the foot, in the most distal area, and in the heel [
22,
23]. However, this may not be sufficient to analyze pathological cases. Adopting a contrasting perspective, some designs use a mesh of sensors which are evenly distributed throughout the insole [
24,
25]. These solutions achieve higher resolutions. However, the device is more complex, since it has to provide electronic resources and computational logic capable of managing the connection and reading the data from each sensor. This complexity affects the collection times, the energy autonomy time, and the device cost. A compromise solution may be the most advantageous: distributing a series of sensors in regions where pressure is usually exerted but also covering, to a lesser extent, regions of the sole of the foot where applying more pressure than appropriate reveals pathological cases or anomalies.
This paper presents the design and characterization of insoles to measure plantar pressure composed of 12 capacitive sensors for each foot. The novelties of the manuscript are: (1) The poly(dimethylsiloxane) (PDMS) material used as dielectric with an additional shock-absorbing role. The features of the material allow reversible deformation when subjected to pressure, providing high resolution in terms of data collection and continuous use without breaking or yielding the insole. (2) The smart distribution of the sensors. They are placed to identify the pressure exerted in regions where normal and abnormal patterns can be identified, such as in the case of flat feet, hypersupination, or hyperpronation. (3) The reading of the sensors is carried out by means of a single integrated circuit for each insole, simplifying and reducing the time for the acquisition of measurements. (4) A complete process of the elaboration of the capacitive plantar insole is outlined; this is an alternative design to other proposals which does not require complex or expensive laboratory tools for its development.
The rest of the manuscript is organized as follows.
Section 2 summarizes recent works that propose alternative capacitive insoles, as well as designs that use PDMS as a component in plantar insoles.
Section 3 describes the materials used and the design of the insole, as well as the design of the system as a whole and the methodology used to characterize and analyze the system. In
Section 3, the results and discussion are shown. Finally,
Section 4 presents the conclusions.
2. Related Works
In the current state-of-the-art, there are already proposals for wearable systems with capacitive insoles. Commercial solutions such as Motion SCIENCE [
26,
27,
28], for which manufacturing processes are not available for replication, are common. Other studies, less scarce, do propose their own insole design with capacitive sensors.
In the study of [
29], capacitive sensors composed of a glass epoxy PCB as a conductive layer and rubber as a dielectric are proposed. Four sensors were attached to a rubber sole in its lower part to make the system. The measurement system is completed with a simple CDC of its own design, an ATMEGA8 microcontroller, and an XBEE module to send the results. The load results show a response close to linear, although with a progressive decrease in response to loads greater than 40 kg over the entire area of the insole. The rubber material used to manufacture the sensor is not specified.
Similarly to the previous study, in [
30], sensors which include rubber as a dielectric layer are proposed; however, a conductive textile “W- 290-PCN” from the manufacturer A-Jin is used. The method of integrating the sensors in the plantar insole is more sophisticated: a rubber insole with grooves is made to house the conductive layer and the cables that allow the connection with the acquisition system. In this proposal, there are 10 sensors which are integrated into the insole and have to be placed in more peripheral areas because the central area is reserved for locating the connection cables for each sensor. A commercial CDC MPR121QR2, an STM32F103 microcontroller, and a bluetooth module are used as the main components of the collection and transmission system. Data on the response to different loads are not provided, but a comparison of the response to walking is made between the proposed system and another commercial F-Scan system, obtaining similar results. In this study, the composition of the gum used is also not provided.
In the work [
31], an insole is presented whose sensors use a double layer of copper and an EMFIT electroactive ferroelectric film as an intermediate layer. There are eight sensors located on the insole, in positions of greatest interest based on the pressure zones of the foot during walking and treading. In the version of the referenced study, the fragments of EMFIT are glued together with the copper inside two layers of copper that cover the foot area. In a later, more sophisticated version presented in [
32], EVA rubber is used to adhere the sensors. The second publication presents the hardware used, consisting of FDC1004 as CDC, an LPC824 microcontroller, and a bluetooth module SPBT3.0DP2; this system is integrated into the insole itself in the area of the plantar vault. The study shows that the response is linear from loads of 600 KPa.
The study presented in [
21] proposes the design of a low-cost insole, in which the sensors are made up of silver cloth as a conductor and four layers of cotton cloth. The insole consists of two layers of cotton that contain three circular-shaped sensors, which have a very high radius with which they cover the entire area of the foot. As elements of the acquisition system, there is a PCAP01 as CDC, a PIC18F25K80-I/MM microcontroller and a bluetooth module. Although it does not present a linear response of pressure with respect to capacitance, the study reveals that the derivative with respect to an initial capacitance is close to linear.
The study [
33] presents a sophisticated design composed of small triangular links, each of which has twelve capacitive sensors made of copper and a silicone rubber foam to which a spray of electrically conductive silicon rubber is applied. Each of the triangles records the measurements of an AD7147 CDC controller. The measurements are sent and processed by a single controller, and sent by I2C. The performance of the system is accurate given the number of pressure sensors, a total of 280; however, the complexity of the system requires special shoes that limit portability.
This work proposes the use of PDMS as a flexible dielectric material for the development of a capacitive insole. In previous work, the plantar insole proposals use PDMS as a cover for piezo-resistive sensors. In [
34], a simple design is presented that does not require complex tools for its elaboration or welding process, but no acquisition system is presented and the difficulty of connecting the outputs, which are distributed along one edge of the insole, is not resolved. In [
35], PDMS is also used, creating a composition with multiwalled carbon nanotube (MWCNT) to make a piezo-resistive sensor; the insole design in this case is complex, requiring sophisticated printing machines. In this study, no complete acquisition system is presented either. In work [
36], the authosr again use a composition of PDMS and MWCNT to cover the electrodes, creating piezoresistive sensors. A plantar insole of seven sensors is proposed, which is arranged on a layer of PET substrate, and a mold is used to create the layer of a PDMS-MWCNT composite in the place where the electrodes are located. The manufacturing process of the PET substrate layer with the electrodes is not detailed.
The proposal of this work consists of a complete system in which PDMS is used as a dielectric intermediate layer and copper is used as a conductor to develop capacitive sensors. PDMS is not only distributed in the location of the sensors but also covers the rest of the area of the plantar insole, so it has the same composition and thickness, improving ergonomics, and without conditioning the distribution of pressure during footsteps due to the presence of different materials on the surface of the insole. The way to manufacture this layer is from a mold, which can be customized without the need to alter the manufacturing process, providing the possibility of creating different plantar-insole sizes, and changing the size, shape, and distribution of the sensors.
Second, building on the insoles developed in this work, future work is intended to redirect the studies of footprint analysis begun by [
37,
38], in which machine learning is used to identify gait pathologies with resistive insoles. With current improvements in hardware performance and communication technologies, advances in the development of wearable IoT devices for health monitoring have been increasing. These include everything from the development of devices which monitor vital signs [
39] to the detection of stress [
40] or habits that put health at risk [
41]. With the use of capacitive insoles and the use of PDMS as a dielectric, given its mechanical qualities, it is hoped to achieve better resolution in the data than those obtained with resistive sensors, allowing one to take advantage of the potential of advanced machine-learning algorithms, which can identify subtle features and are tolerant to noise.
5. Conclusions
In this paper, a system equipped with capacitive insoles for recording anomalies in footprints was developed. To achieve the linear response of each sensor, a PDMS composition is used as the dielectric in the intermediate layer of the plantar insole. This paper shows the entire development process of the insole and the collection and delivery system. Thus, any researcher can replicate it. The proposed manufacturing process does not require the use of expensive tools. The most expensive material used is flexible PCB sheet, although this material can be replaced, for example, by using 3D printers to make flexible printed circuits.
The analysis performed reveals that capacitive sensors have advantages over resistive ones. Specifically, capacitive sensors are capable of reacting to small weights, which allows the analysis of anomalies and pathologies with more subtle characteristics. In addition, they offer a linear behavior for weights from 1Kg without saturation.
The presented design is an alternative to other capacitive insoles proposed in the literature, offering correct performance, behavior under footfall similar to studies that achieve a linear response, and totally homogeneous integration of the sensors in the plantar insole, which favors ergonomics.
The response offered by the recording system is appropriate in terms of time to identify the changes, phases, and events in the march. There is room for improvement in the transmission process and changes in decimation to perform more samples per second.
The main limitation identified in the prototype consists of the disturbance in the values due to the electric field exerted by the body. However, this disturbance can be partly removed in a simple way by performing multiplication operations. The results of the gait analysis reveal that the signal retains the gait information after the transformation. However, the search for different filtering methods could be relevant to retain information of interest for the identification of anomalies.
As a future work, the developed system will be used to record the gait of several users with pathologies or anomalies that influence gait. With the prepared data set, machine-learning models will be developed and evaluated to identify pathologies autonomously in order to develop a complete monitoring and diagnostic support system.