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<front>
<journal-meta>
<journal-id journal-id-type="publisher-id">Front. Bioeng. Biotechnol.</journal-id>
<journal-title>Frontiers in Bioengineering and Biotechnology</journal-title>
<abbrev-journal-title abbrev-type="pubmed">Front. Bioeng. Biotechnol.</abbrev-journal-title>
<issn pub-type="epub">2296-4185</issn>
<publisher>
<publisher-name>Frontiers Media S.A.</publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="publisher-id">1639630</article-id>
<article-id pub-id-type="doi">10.3389/fbioe.2025.1639630</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Bioengineering and Biotechnology</subject>
<subj-group>
<subject>Original Research</subject>
</subj-group>
</subj-group>
</article-categories>
<title-group>
<article-title>Application of artificial muscle e-rubber for healthcare sensing: verification of measurement properties as a smart insole</article-title>
<alt-title alt-title-type="left-running-head">Yoneda et al.</alt-title>
<alt-title alt-title-type="right-running-head">
<ext-link ext-link-type="uri" xlink:href="https://doi.org/10.3389/fbioe.2025.1639630">10.3389/fbioe.2025.1639630</ext-link>
</alt-title>
</title-group>
<contrib-group>
<contrib contrib-type="author" corresp="yes">
<name>
<surname>Yoneda</surname>
<given-names>Hidemasa</given-names>
</name>
<xref ref-type="aff" rid="aff1">
<sup>1</sup>
</xref>
<xref ref-type="aff" rid="aff2">
<sup>2</sup>
</xref>
<xref ref-type="corresp" rid="c001">&#x2a;</xref>
<uri xlink:href="https://loop.frontiersin.org/people/3001004/overview"/>
<role content-type="https://credit.niso.org/contributor-roles/conceptualization/"/>
<role content-type="https://credit.niso.org/contributor-roles/data-curation/"/>
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<role content-type="https://credit.niso.org/contributor-roles/funding-acquisition/"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Yamaga</surname>
<given-names>Takashi</given-names>
</name>
<xref ref-type="aff" rid="aff3">
<sup>3</sup>
</xref>
<role content-type="https://credit.niso.org/contributor-roles/conceptualization/"/>
<role content-type="https://credit.niso.org/contributor-roles/Writing - review &#x26; editing/"/>
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</contrib>
<contrib contrib-type="author">
<name>
<surname>Fujiwara</surname>
<given-names>Takeshi</given-names>
</name>
<xref ref-type="aff" rid="aff4">
<sup>4</sup>
</xref>
<role content-type="https://credit.niso.org/contributor-roles/Writing - review &#x26; editing/"/>
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</contrib>
<contrib contrib-type="author">
<name>
<surname>Komori</surname>
<given-names>Yoko</given-names>
</name>
<xref ref-type="aff" rid="aff4">
<sup>4</sup>
</xref>
<uri xlink:href="https://loop.frontiersin.org/people/3088211/overview"/>
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</contrib>
<contrib contrib-type="author">
<name>
<surname>Shimada</surname>
<given-names>Masatoshi</given-names>
</name>
<xref ref-type="aff" rid="aff4">
<sup>4</sup>
</xref>
<role content-type="https://credit.niso.org/contributor-roles/data-curation/"/>
<role content-type="https://credit.niso.org/contributor-roles/formal-analysis/"/>
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</contrib>
<contrib contrib-type="author">
<name>
<surname>Kato</surname>
<given-names>Yuki</given-names>
</name>
<xref ref-type="aff" rid="aff5">
<sup>5</sup>
</xref>
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</contrib>
<contrib contrib-type="author">
<name>
<surname>Oyama</surname>
<given-names>Shintaro</given-names>
</name>
<xref ref-type="aff" rid="aff6">
<sup>6</sup>
</xref>
<uri xlink:href="https://loop.frontiersin.org/people/362778/overview"/>
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<contrib contrib-type="author">
<name>
<surname>Shimoda</surname>
<given-names>Shingo</given-names>
</name>
<xref ref-type="aff" rid="aff6">
<sup>6</sup>
</xref>
<uri xlink:href="https://loop.frontiersin.org/people/810540/overview"/>
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</contrib>
<contrib contrib-type="author">
<name>
<surname>Yamamoto</surname>
<given-names>Michiro</given-names>
</name>
<xref ref-type="aff" rid="aff1">
<sup>1</sup>
</xref>
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<contrib contrib-type="author">
<name>
<surname>Hirata</surname>
<given-names>Hitoshi</given-names>
</name>
<xref ref-type="aff" rid="aff6">
<sup>6</sup>
</xref>
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<aff id="aff1">
<sup>1</sup>
<institution>Human Enhancement and Hand Surgery, Nagoya University</institution>, <addr-line>Nagoya</addr-line>, <country>Japan</country>
</aff>
<aff id="aff2">
<sup>2</sup>
<institution>Orthopedic Surgery, Aichi Medical University</institution>, <addr-line>Nagakute</addr-line>, <country>Japan</country>
</aff>
<aff id="aff3">
<sup>3</sup>
<institution>Orthopedic Surgery, Tsushima City Hospital</institution>, <addr-line>Tsushima</addr-line>, <country>Japan</country>
</aff>
<aff id="aff4">
<sup>4</sup>
<institution>New Value Business, Toyoda Gosei Co., Ltd.</institution>, <addr-line>Ama</addr-line>, <country>Japan</country>
</aff>
<aff id="aff5">
<sup>5</sup>
<institution>Orthopedic Surgery, Chunichi Hospital</institution>, <addr-line>Nagoya</addr-line>, <country>Japan</country>
</aff>
<aff id="aff6">
<sup>6</sup>
<institution>Graduate School of Medicine, Nagoya University</institution>, <addr-line>Nagoya</addr-line>, <country>Japan</country>
</aff>
<author-notes>
<fn fn-type="edited-by">
<p>
<bold>Edited by:</bold> <ext-link ext-link-type="uri" xlink:href="https://loop.frontiersin.org/people/1759758/overview">Pavel Zelenovskii</ext-link>, University of Aveiro, Portugal</p>
</fn>
<fn fn-type="edited-by">
<p>
<bold>Reviewed by:</bold> <ext-link ext-link-type="uri" xlink:href="https://loop.frontiersin.org/people/861462/overview">J&#xfc;rgen Maas</ext-link>, Technical University of Berlin, Germany</p>
<p>
<ext-link ext-link-type="uri" xlink:href="https://loop.frontiersin.org/people/3103106/overview">Aman Khurana</ext-link>, Indian Institute of Technology Indore, India</p>
</fn>
<corresp id="c001">&#x2a;Correspondence: Hidemasa Yoneda, <email>yoneda.hidemasa.s7@f.mail.nagoya-u.ac.jp</email>
</corresp>
</author-notes>
<pub-date pub-type="epub">
<day>21</day>
<month>08</month>
<year>2025</year>
</pub-date>
<pub-date pub-type="collection">
<year>2025</year>
</pub-date>
<volume>13</volume>
<elocation-id>1639630</elocation-id>
<history>
<date date-type="received">
<day>02</day>
<month>06</month>
<year>2025</year>
</date>
<date date-type="accepted">
<day>07</day>
<month>08</month>
<year>2025</year>
</date>
</history>
<permissions>
<copyright-statement>Copyright &#xa9; 2025 Yoneda, Yamaga, Fujiwara, Komori, Shimada, Kato, Oyama, Shimoda, Yamamoto and Hirata.</copyright-statement>
<copyright-year>2025</copyright-year>
<copyright-holder>Yoneda, Yamaga, Fujiwara, Komori, Shimada, Kato, Oyama, Shimoda, Yamamoto and Hirata</copyright-holder>
<license xlink:href="http://creativecommons.org/licenses/by/4.0/">
<p>This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.</p>
</license>
</permissions>
<abstract>
<p>Electroactive polymer (EAP) artificial muscles are gaining attention in robotic control technologies. Among them, the development of self-sensing actuators that integrate sensing mechanisms within artificial muscles is highly anticipated. This study aimed to evaluate the accuracy and precision of the sensing capabilities of the e-Rubber (eR), an artificial muscle developed by Toyoda Gosei Co., Ltd., and to investigate its potential for healthcare sensing applications such as smart insoles. The objective was to transform the eR into a thin capacitor and estimate the applied load by sensing minute changes in the capacitance. The changes in the EAP dielectric constant, electrode area, and inter-electrode distance, all of which define the capacitance, are non-linear functions. The relationship with the external force also exhibits nonlinearity. To address this issue, we experimentally plotted the load and capacitance changes and derived a regression equation. We evaluated the sensing characteristics of both a stand-alone sensor and a sensor embedded in a smart insole, followed by a precision verification of the load estimation using the derived regression equation. Load&#x2013;capacitance changes were measured up to 400&#xa0;N at three conditions: 23&#xa0;&#xb0;C and 50% humidity, 40&#xa0;&#xb0;C and 50% humidity, and 40&#xa0;&#xb0;C and 80% humidity. For the standalone sensor, the coefficient of variation was less than 1.25% and the confidence interval was 0.25%, indicating high precision. However, for the sensor embedded within the insole housing, the coefficient of variation increased to less than 8%, and the confidence interval was 1.5%, likely owing to the influence of gaps within the insole structure. Regarding the load estimation equation, a 5th-order polynomial approximation (R<sup>2</sup> &#x3e;0.999) demonstrated the best fit, indicating that it is sufficiently accurate for healthcare sensing applications. Although capacitance-based sensors are increasingly being used in biomedical monitoring for pressure and load measurements owing to their durability and high sensitivity, their primary challenge lies in the nonlinearity of the sensing results. Although this challenge also exists for capacitance sensors utilizing artificial muscles, our study shows that developing a regression equation based on the experimental relationship between the load and capacitance changes can yield sufficient precision for practical healthcare applications.</p>
</abstract>
<kwd-group>
<kwd>e-rubber</kwd>
<kwd>artificial muscle</kwd>
<kwd>capacitance sensor</kwd>
<kwd>dielectric elastomer</kwd>
<kwd>smart insole</kwd>
<kwd>sensing for healthcare</kwd>
</kwd-group>
<counts>
<page-count count="16"/>
</counts>
<custom-meta-wrap>
<custom-meta>
<meta-name>section-at-acceptance</meta-name>
<meta-value>Nanobiotechnology</meta-value>
</custom-meta>
</custom-meta-wrap>
</article-meta>
</front>
<body>
<sec id="s1">
<title>1 Introduction</title>
<p>Artificial muscles that exhibit expansion, contraction, and other movements, just like biological muscles, have attracted significant attention in robotics control (<xref ref-type="bibr" rid="B9">Jing et al., 2023</xref>). Typical artificial muscles driven by electrical energy utilize electroactive polymers (EAPs), which are polymeric materials capable of changing their shapes and dimensions, sandwiched between electrodes. EAPs include dielectric elastomers, piezoelectric polymers, and adsorption films. When a voltage is applied to the electrodes, the EAP deforms, resulting in actuation (<xref ref-type="bibr" rid="B14">Maksimkin et al., 2022</xref>).</p>
<p>The e-rubber (eR) developed by Toyoda Gosei Co., Ltd. is an EAP-type artificial muscle that employs a dielectric elastomer. The eR is composed of multiple layers, including the EAP and electrodes. When current flows, the dielectric elastomer layer deforms and is converted into an actuator movement (video). To maintain elasticity while ensuring lightness, a dielectric elastomer was initially developed using slide-ring materials (<xref ref-type="bibr" rid="B25">Sapsford and Michieletto, 2025</xref>).</p>
<p>In the healthcare field, early intervention is crucial for preventing the progression of many conditions to severe stages. For example, osteoarthritis (OA) of the knee can be definitively diagnosed with radiography, but there are no established biomarkers for its detection in the early stages, except magnetic resonance imaging (MRI) (<xref ref-type="bibr" rid="B12">Li et al., 2023</xref>; <xref ref-type="bibr" rid="B19">Piccolo et al., 2023</xref>). However, it is known that gait abnormalities are present in the early phases of the disease (<xref ref-type="bibr" rid="B4">Duffell et al., 2014</xref>). Consequently, gait analysis may enable the detection of early pathological changes even before they are visible on radiographs (<xref ref-type="bibr" rid="B32">Wipperman et al., 2024</xref>).</p>
<p>In this context, smart insoles equipped with soft sensors have been widely reported, and the technology itself is not novel. Our goal, however, is to develop a smart insole specifically capable of early detection of degenerative diseases such as OA. To contribute effectively to preventive medicine in healthcare, we set two primary objectives: achieving a consumer-friendly price point of under $250 for widespread adoption and enabling preventive interventions using the insole. This contrasts sharply with high-end, high-precision systems such as Moticon OpenGo (Munich, Germany), Novel Pedar (Munich, Germany), and Tekscan F-Scan (Norwood, MA, United States), which are priced over $2,000, with some exceeding $10,000, making them prohibitive for widespread preventive use.</p>
<p>In addition to their role as actuators, artificial muscles can be utilized as sensors capable of detecting minute forces. This is achieved by treating the artificial muscle as a capacitor and leveraging the change in its capacitance owing to external forces (<xref ref-type="bibr" rid="B10">Jung et al., 2008</xref>). A recent trend in artificial muscle research is the development of &#x201c;self-sensing actuators,&#x201d; which combine actuation functionality with the ability to sense their activity. This approach mimics the spindles found in human muscles, enabling self-sensing of shape changes in the artificial muscle to control the actuator. This is expected to be applied to robot control using artificial intelligence (<xref ref-type="bibr" rid="B5">Gonzalez-Vazquez et al., 2023</xref>). By integrating a thin sensing actuator into a smart insole, we envision the possibility of not only sensing but also delivering interventions based on the sensor data. For instance, it could alert users to a high risk of falling by sending signals from the sole or enhance plantar sensation for patients with diabetes or peripheral neuropathy (<xref ref-type="bibr" rid="B1">Ahmad et al., 2024</xref>). Such plantar actuation could potentially promote active rehabilitation.</p>
<p>Therefore, we chose eR for our smart insole development, and we modified the eR into a thin sensor to monitor dynamic plantar pressure (<xref ref-type="fig" rid="F1">Figure 1</xref>). The sensor was designed with a sandwich-like structure to mitigate capacitive noise from contact with the plantar skin or socks. Furthermore, a combination of two distinct materials was utilized to create a design that reduces hysteresis. To realize eR smart insole, several challenges must be addressed, including ensuring the accuracy and reliability of the sensing component, processing measurement data in real-time, and delivering appropriate actuation based on the results. As a first step, we must verify the accuracy and precision of the eR sensing capabilities. Because a thorough validation of eR for such precise healthcare applications has not been previously undertaken, this study aimed to perform this foundational evaluation. Consequently, this study aimed to evaluate the measurement accuracy of the sensor with the premise of its application as a plantar pressure sensor.</p>
<fig id="F1" position="float">
<label>FIGURE 1</label>
<caption>
<p>
<bold>(A)</bold> An eR sensor created by making artificial muscle thinner, and <bold>(B)</bold> its cross-sectional view.</p>
</caption>
<graphic xlink:href="fbioe-13-1639630-g001.tif">
<alt-text content-type="machine-generated">Image A shows a black, elongated device with a rounded top and two flat strips extending from the bottom, possibly a sensor or probe. Image B is a schematic cross-section diagram of layers within the device. It details components including an insulation layer, ground electrodes, base material layers, double-coated adhesive tape, dielectric layers, and a sensing electrode, each with specified thicknesses in micrometers.</alt-text>
</graphic>
</fig>
</sec>
<sec sec-type="materials|methods" id="s2">
<title>2 Materials and methods</title>
<sec id="s2-1">
<title>2.1 Structure of the eR sensor</title>
<p>The eR sensor is composed of two 0.5&#xa0;mm thick urethane foam dielectric layers and three silver paste electrodes, resulting in a total thickness of 1.47&#xa0;mm. The dielectric layers possess distinct densities and mechanical properties, a design that expands the measurable load range. Specifically, Dielectric Layer 1 has a density of 150&#xa0;kg/m<sup>3</sup>, a compressive stress of 0.006&#xa0;MPa at 25% strain, and a compression set of 1.0%, whereas Dielectric Layer 2 has a density of 240&#xa0;kg/m<sup>3</sup>, a compressive stress of 0.022&#xa0;MPa at 25% strain, and a compression set of 4.2%.</p>
<p>This configuration, utilizing dielectrics with different elastic moduli, facilitates stepwise deformation in the thickness direction. Consequently, compared to a single-dielectric sensor, the capacitance change does not saturate, enabling a detectable output over a wider input range (<xref ref-type="bibr" rid="B36">Zhu et al., 2022</xref>). Furthermore, the top and bottom electrodes are connected to 0V to serve as ground electrodes. These act as electrostatic shields to mitigate the influence of external noise.</p>
</sec>
<sec id="s2-2">
<title>2.2 eR sensing theory</title>
<p>The principle of the eR sensor is to estimate the external force by treating the eR as a parallel-plate capacitor and utilizing the change in capacitance. When the eR deforms owing to an external force, the electrode area A and the distance between the electrodes d change; consequently, the capacitance changes. The capacitance C stored in eR is defined by the following <xref ref-type="disp-formula" rid="e1">Equation 1</xref>:<disp-formula id="e1">
<mml:math id="m1">
<mml:mrow>
<mml:mi>C</mml:mi>
<mml:mo>&#x3d;</mml:mo>
<mml:mfrac>
<mml:mrow>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mi>r</mml:mi>
</mml:msub>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:mi>A</mml:mi>
</mml:mrow>
<mml:mi>d</mml:mi>
</mml:mfrac>
</mml:mrow>
</mml:math>
<label>(1)</label>
</disp-formula>
</p>
<p>Where &#x3f5;<sub>
<italic>r</italic>
</sub>: relative permittivity of the elastomer, &#x3f5;<sub>0</sub>: permittivity of vacuum, A: electrode area, d: distance between electrodes. &#x3f5;<sub>0</sub> &#x3d; 8.854 &#xd7; 10&#x2013;<sup>12</sup>&#xa0;F/m.</p>
<p>By measuring the change in capacitance (&#x394;C) before and after the application of an external force, the external force can be inversely calculated as <xref ref-type="disp-formula" rid="e2">Equation 2</xref>. C was defined by considering changes in each parameter.<disp-formula id="e2">
<mml:math id="m2">
<mml:mrow>
<mml:mo>&#x394;</mml:mo>
<mml:mi>C</mml:mi>
<mml:mo>&#x3d;</mml:mo>
<mml:mfrac>
<mml:mrow>
<mml:mrow>
<mml:mfenced open="(" close=")" separators="|">
<mml:mrow>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mrow>
<mml:mi>r</mml:mi>
<mml:mn>0</mml:mn>
</mml:mrow>
</mml:msub>
<mml:mo>&#x2b;</mml:mo>
<mml:mo>&#x394;</mml:mo>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mi>r</mml:mi>
</mml:msub>
</mml:mrow>
</mml:mfenced>
</mml:mrow>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:mrow>
<mml:mfenced open="(" close=")" separators="|">
<mml:mrow>
<mml:msub>
<mml:mi>A</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:mo>&#x2b;</mml:mo>
<mml:mo>&#x394;</mml:mo>
<mml:mi>A</mml:mi>
</mml:mrow>
</mml:mfenced>
</mml:mrow>
</mml:mrow>
<mml:mrow>
<mml:msub>
<mml:mi>d</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:mo>&#x2b;</mml:mo>
<mml:mo>&#x394;</mml:mo>
<mml:mi>d</mml:mi>
</mml:mrow>
</mml:mfrac>
<mml:mo>&#x2212;</mml:mo>
<mml:mfrac>
<mml:mrow>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mrow>
<mml:mi>r</mml:mi>
<mml:mn>0</mml:mn>
</mml:mrow>
</mml:msub>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:msub>
<mml:mi>A</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
</mml:mrow>
<mml:msub>
<mml:mi>d</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
</mml:mfrac>
</mml:mrow>
</mml:math>
<label>(2)</label>
</disp-formula>
</p>
<p>The relative permittivity of dielectric elastomers is generally unaffected by external forces or changes in shape, with negligible variations observed (<xref ref-type="bibr" rid="B35">Zhao and Suo, 2010</xref>). The dielectric layer of e-rubber uses urethane foam, which consists of a bulk material and air bubbles with different relative permittivity (<xref ref-type="fig" rid="F1">Figure 1</xref>). We hypothesize that while the relative permittivity of urethane foam remains largely unchanged at small strains, it changes under load as air bubbles collapse, causing the bulk material&#x2019;s properties to become dominant (<xref ref-type="bibr" rid="B16">O&#x27;Neill et al., 2022</xref>).</p>
<p>The change in capacitance is defined by the change in the elastomer permittivity, electrode area, and distance between the electrodes. However, since the changes in &#x394;d and A are not linear but rather non-linear functions, and because the elastomer&#x2019;s permittivity &#x3f5;<sub>
<italic>r</italic>
</sub> changes due to density variations caused by stress and strain, the capacitance becomes a non-linear function.</p>
<p>Next, we examined the relationship between &#x394;C and the external force F. Assuming that the electrode area of eR and the relative permittivity of the elastomer does not change, the initial capacitance C<sub>0</sub> and the capacitance C<sub>1</sub> after loading are given by <xref ref-type="disp-formula" rid="e1">Equation 1</xref> as <xref ref-type="disp-formula" rid="e3">Equations 3</xref>, <xref ref-type="disp-formula" rid="e4">4</xref>:<disp-formula id="e3">
<mml:math id="m3">
<mml:mrow>
<mml:msub>
<mml:mi>C</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:mo>&#x3d;</mml:mo>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mi>r</mml:mi>
</mml:msub>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:mfrac>
<mml:mrow>
<mml:mi>A</mml:mi>
</mml:mrow>
<mml:mrow>
<mml:msub>
<mml:mi>d</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
</mml:mrow>
</mml:mfrac>
</mml:mrow>
</mml:math>
<label>(3)</label>
</disp-formula>
<disp-formula id="e4">
<mml:math id="m4">
<mml:mrow>
<mml:msub>
<mml:mi>C</mml:mi>
<mml:mn>1</mml:mn>
</mml:msub>
<mml:mo>&#x3d;</mml:mo>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mi>r</mml:mi>
</mml:msub>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:mfrac>
<mml:mi>A</mml:mi>
<mml:mrow>
<mml:msub>
<mml:mi>d</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:mo>&#x2212;</mml:mo>
<mml:mo>&#x394;</mml:mo>
<mml:mi>d</mml:mi>
</mml:mrow>
</mml:mfrac>
</mml:mrow>
</mml:math>
<label>(4)</label>
</disp-formula>
</p>
<p>Thus, the change in capacitance &#x394;C is calculated by <xref ref-type="disp-formula" rid="e5">Equation 5</xref>:<disp-formula id="e5">
<mml:math id="m5">
<mml:mrow>
<mml:mo>&#x394;</mml:mo>
<mml:mi>C</mml:mi>
<mml:mo>&#x3d;</mml:mo>
<mml:msub>
<mml:mi>C</mml:mi>
<mml:mn>1</mml:mn>
</mml:msub>
<mml:mo>&#x2212;</mml:mo>
<mml:msub>
<mml:mi>C</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:mo>&#x3d;</mml:mo>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mi>r</mml:mi>
</mml:msub>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:mi>A</mml:mi>
<mml:mrow>
<mml:mfenced open="(" close=")" separators="|">
<mml:mrow>
<mml:mfrac>
<mml:mn>1</mml:mn>
<mml:mrow>
<mml:msub>
<mml:mi>d</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:mo>&#x2212;</mml:mo>
<mml:mo>&#x394;</mml:mo>
<mml:mi>d</mml:mi>
</mml:mrow>
</mml:mfrac>
<mml:mo>&#x2212;</mml:mo>
<mml:mfrac>
<mml:mrow>
<mml:mn>1</mml:mn>
</mml:mrow>
<mml:mrow>
<mml:msub>
<mml:mi>d</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
</mml:mrow>
</mml:mfrac>
</mml:mrow>
</mml:mfenced>
</mml:mrow>
</mml:mrow>
</mml:math>
<label>(5)</label>
</disp-formula>
</p>
<p>When a normal load F is applied to an elastic dielectric (thickness d<sub>0</sub>, area A, Young&#x2019;s modulus E), the change in thickness &#x394;d is calculated with <xref ref-type="disp-formula" rid="e6">Equation 6</xref>:<disp-formula id="e6">
<mml:math id="m6">
<mml:mrow>
<mml:mo>&#x394;</mml:mo>
<mml:mi>d</mml:mi>
<mml:mo>&#x3d;</mml:mo>
<mml:mfrac>
<mml:mrow>
<mml:mi>F</mml:mi>
<mml:msub>
<mml:mi>d</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
</mml:mrow>
<mml:mrow>
<mml:mi>E</mml:mi>
<mml:mi>A</mml:mi>
</mml:mrow>
</mml:mfrac>
</mml:mrow>
</mml:math>
<label>(6)</label>
</disp-formula>
</p>
<p>Substituting (6) into (5), &#x0394;C is calculated with <xref ref-type="disp-formula" rid="e7">Equation 7</xref>
<disp-formula id="e7">
<mml:math id="m7">
<mml:mrow>
<mml:mo>&#x394;</mml:mo>
<mml:mi>C</mml:mi>
<mml:mo>&#x3d;</mml:mo>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mi>r</mml:mi>
</mml:msub>
<mml:msub>
<mml:mi mathvariant="normal">&#x3b5;</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:mi>A</mml:mi>
<mml:mo>&#xb7;</mml:mo>
<mml:mfrac>
<mml:mrow>
<mml:mn>1</mml:mn>
</mml:mrow>
<mml:mrow>
<mml:msub>
<mml:mi>d</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
</mml:mrow>
</mml:mfrac>
<mml:mrow>
<mml:mfenced open="(" close=")" separators="|">
<mml:mrow>
<mml:mfrac>
<mml:mn>1</mml:mn>
<mml:mrow>
<mml:mn>1</mml:mn>
<mml:mo>&#x2212;</mml:mo>
<mml:mfrac>
<mml:mi>F</mml:mi>
<mml:mrow>
<mml:mi>E</mml:mi>
<mml:mi>A</mml:mi>
</mml:mrow>
</mml:mfrac>
</mml:mrow>
</mml:mfrac>
<mml:mo>&#x2212;</mml:mo>
<mml:mn>1</mml:mn>
</mml:mrow>
</mml:mfenced>
</mml:mrow>
<mml:mo>&#x3d;</mml:mo>
<mml:msub>
<mml:mi>C</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:mrow>
<mml:mfenced open="(" close=")" separators="|">
<mml:mrow>
<mml:mfrac>
<mml:mn>1</mml:mn>
<mml:mrow>
<mml:mn>1</mml:mn>
<mml:mo>&#x2212;</mml:mo>
<mml:mfrac>
<mml:mi>F</mml:mi>
<mml:mrow>
<mml:mi>E</mml:mi>
<mml:mi>A</mml:mi>
</mml:mrow>
</mml:mfrac>
</mml:mrow>
</mml:mfrac>
<mml:mo>&#x2212;</mml:mo>
<mml:mn>1</mml:mn>
</mml:mrow>
</mml:mfenced>
</mml:mrow>
</mml:mrow>
</mml:math>
<label>(7)</label>
</disp-formula>
</p>
<p>Therefore, the relationship between &#x394;C and F can be defined as a non-linear relationship. Furthermore, for small deformations where F&#x226a;EA, using the Maclaurin expansion, &#x0394;C is approximated by <xref ref-type="disp-formula" rid="e8">Equation 8</xref>:<disp-formula id="e8">
<mml:math id="m8">
<mml:mrow>
<mml:mo>&#x394;</mml:mo>
<mml:mi>C</mml:mi>
<mml:mo>&#x2248;</mml:mo>
<mml:msub>
<mml:mi>C</mml:mi>
<mml:mn>0</mml:mn>
</mml:msub>
<mml:mo>&#xb7;</mml:mo>
<mml:mrow>
<mml:mfenced open="(" close=")" separators="|">
<mml:mrow>
<mml:mfrac>
<mml:mi>F</mml:mi>
<mml:mrow>
<mml:mi>E</mml:mi>
<mml:mi>A</mml:mi>
</mml:mrow>
</mml:mfrac>
</mml:mrow>
</mml:mfenced>
</mml:mrow>
</mml:mrow>
</mml:math>
<label>(8)</label>
</disp-formula>
</p>
<p>This indicates that, in the small-deformation region, where the external force is considerably small, the relationship between the load and capacitance can be defined as linear. However, as the external force increases, the electrode area of the eR, the relative permittivity of the elastomer change, and the structural hysteresis of the elastomer also have an effect. Consequently, the relationship between the change in capacitance and external force applied to eR may deviate from the results obtained using this equation. Therefore, we decided to plot the external force and capacitance changes experimentally and perform regression using curve fitting.</p>
</sec>
<sec id="s2-3">
<title>2.3 Measurement of load and capacitance change, and evaluation of sensor measurement characteristics from obtained results</title>
<p>The measurements were conducted inside a TX411N constant-temperature chamber (Kusumoto Chemicals, Ltd., Tokyo, Japan) with a force gauge (EMX-1000N, Imada, Toyohashi, Japan) installed to ensure constant humidity and temperature (<xref ref-type="fig" rid="F2">Figure 2</xref>). A load was continuously applied to the sensor using a force gauge, and the change in capacitance was measured. Loads were applied from 0 to 400&#xa0;N at a rate of 0.5&#xa0;mm/s (<xref ref-type="fig" rid="F3">Figure 3</xref>). Capacitance was measured using an LCR meter (IM 3536, Hioki EE Corp., Ueda, Japan) and a custom-developed program.</p>
<fig id="F2" position="float">
<label>FIGURE 2</label>
<caption>
<p>Load application test of the eR sensor using a force gauge installed within a constant temperature chamber. Capacitance was measured using an LCR meter placed externally.</p>
</caption>
<graphic xlink:href="fbioe-13-1639630-g002.tif">
<alt-text content-type="machine-generated">A laboratory instrument with a digital display reading &#x22;0.0&#x22; is situated in a metal cabinet. The device features a clear casing for samples and wires attached to it. A stack of plastic trays is placed beside the machine, and a red emergency stop button is visible. The equipment has labels in both English and another language.</alt-text>
</graphic>
</fig>
<fig id="F3" position="float">
<label>FIGURE 3</label>
<caption>
<p>Durability test conducted using a pusher attached to an air cylinder, installed within a constant temperature chamber; &#x2a;: Pusher, &#x23;: eR sensor.</p>
</caption>
<graphic xlink:href="fbioe-13-1639630-g003.tif">
<alt-text content-type="machine-generated">A metallic setup features a circular metal component marked with an asterisk and a smaller, disc-shaped structure marked with a hashtag attached to a flat rectangular base. The assembly is part of a larger machine setup, with a perforated metal background and yellow tape securing the disc to the base.</alt-text>
</graphic>
</fig>
<p>We used 30 eR samples and performed three measurements on each sample. Since EAP properties vary with temperature and humidity, measurements were taken under three conditions: Condition A (room temperature assumed: 23&#xa0;&#xb0;C, 50% humidity), Condition B (close to biological monitoring conditions: 40&#xa0;&#xb0;C, 50% humidity), and Condition C (close to conditions for clothes and shoes in a sweating state: 40&#xa0;&#xb0;C, 80% humidity).</p>
<p>Polymeric materials such as EAPs exhibit the Mullins effect, where the elasticity changes after repeated loading. In applications such as measuring pressure with insoles during walking or pinching movements of the fingers, repeated loading operations can potentially alter the measurement values. Therefore, as a durability test, we performed frequent pressure operations and measured the changes before and after the operation. The durability test setup included a constant-temperature chamber (SH-642, Espec Corp., Osaka, Japan) equipped with a pusher attached to an air cylinder (COQ2B40-40DZ, SMC, Tokyo, Japan), which was monitored using a load cell (LUR-2KNSA1, KYOWA Electronic Instruments, Chofu, Japan) (<xref ref-type="fig" rid="F3">Figure 3</xref>). For the durability test, simulating actual walking, we applied 200,000 cycles of reciprocal loading from 0 to 100&#xa0;N per second within a constant-temperature chamber at 40&#xa0;&#xb0;C and 80% humidity.</p>
<p>To evaluate the measurement characteristics of the eR sensor, we assessed its reliability and validity based on the Consensus-based Standards for the selection of health status Measurement Instruments (COSMIN) guideline (<xref ref-type="bibr" rid="B15">Mokkink et al., 2010</xref>). Reliability refers to the dispersion of sample values and its magnitude represents precision. Conversely, the closeness of the sample mean indicates that the population mean was calculated with accuracy. Because the sample values increase with external force, and consequently, the standard deviation also increases, we calculated them as coefficients of variation. Accuracy is the difference between the sample and population means, calculated using a 95% confidence interval.</p>
<p>To measure the measurement characteristics, we calculated the coefficient of variation and confidence interval for six conditions (Conditions A, B, and C before and after durability testing) based on the measurement values from all samples at load points of 50, 100, 150, 200, 300, and 400&#xa0;N. We used t-distribution to calculate the 95% confidence interval, defining the confidence interval width as the ratio of the estimated population mean divided by the 95% confidence interval.</p>
</sec>
<sec id="s2-4">
<title>2.4 Hysteresis of dielectric layers</title>
<p>We investigated the hysteresis of the two dielectric layer materials used as Dielectric layers 1 and 2 (<xref ref-type="fig" rid="F1">Figure 1</xref>) in the eR sensor, using a force gauge according to the procedure described in <xref ref-type="sec" rid="s2-3">Section 2.3</xref>. The samples were 32&#xa0;mm in diameter before compression. The tests were conducted at 20&#xa0;&#xb0;C and 45% relative humidity. Each sample was compressed from 0&#xa0;N to 400&#xa0;N over 12.3&#xa0;s. We analyzed the relationships between nominal stress (load divided by sample area) and capacitance, and between nominal strain (deformation divided by initial thickness) and capacitance change, during both loading and unloading cycles.</p>
<p>To evaluate hysteresis, we calculated two metrics for each relationship: The first was the mean hysteresis error (%FS), defined as the average of the absolute differences in capacitance between the loading and unloading curves at a given input value, normalized by the full-scale output. The second was the normalized hysteresis loop area, obtained by integrating the area enclosed by the loading and unloading curves using the trapezoidal rule and dividing it by the product of the full-scale input and output ranges. These values provided quantitative measures of the reversibility and repeatability of the sensor response.</p>
</sec>
<sec id="s2-5">
<title>2.5 Insertion into insoles</title>
<p>We aimed to create a smart insole for measuring plantar pressure using eR and to verify the measurement accuracy of the sensor for this purpose. The planned smart insole consists of four sensors: one at the forefoot, one each on the medial and lateral sides of the midfoot, and one on the hindfoot (<xref ref-type="fig" rid="F4">Figure 4A</xref>). As shown in the figure, the insole cross-sectional feature sensors were sandwiched between the Ethylene Vinyl Acetate (EVA) foam and polyurethane foam (<xref ref-type="fig" rid="F4">Figure 4B</xref>). We created six smart insoles for measurement and performed three measurements for each insole.</p>
<fig id="F4" position="float">
<label>FIGURE 4</label>
<caption>
<p>Arrangement of eR sensors within the insole <bold>(A)</bold> and cross-sectional view <bold>(B)</bold>.</p>
</caption>
<graphic xlink:href="fbioe-13-1639630-g004.tif">
<alt-text content-type="machine-generated">Diagram labeled A and B. A: Illustration of an insole with eR sensors and a green component marked as a circuit board and battery. B: Cross-section showing an eR sensor placed between an upper cabinet and lower cabinet with a spacer.</alt-text>
</graphic>
</fig>
</sec>
<sec id="s2-6">
<title>2.6 Evaluation of load-capacitance change from insoles and measurement characteristics of insole-embedded sensors</title>
<p>The measurement characteristics of the sensors inserted into the insoles were evaluated, as described in <xref ref-type="sec" rid="s2-4">Section 2.4</xref>. The measurement and durability testing equipment were the same as those described in <xref ref-type="sec" rid="s2-3">section 2.3</xref>. The load application speed was 10&#xa0;mm/min, with loads ranging from 0 to 400&#xa0;N. To simulate the plantar pressure measurement, the force gauge indenter was made of POM resin and Si rubber, rather than the metal indenter used in the 2.2&#x2019;s mold (<xref ref-type="fig" rid="F5">Figure 5</xref>). The indenter was used to apply a load to the insole (<xref ref-type="fig" rid="F5">Figure 5</xref>). For the load test, we similarly changed the indenter and applied 200,000 cycles of reciprocal loading from 0 to 230&#xa0;N per second in a constant-temperature chamber at 40&#xa0;&#xb0;C and 80% humidity.</p>
<fig id="F5" position="float">
<label>FIGURE 5</label>
<caption>
<p>Load application test on the insole installed within a constant temperature chamber. Using a pusher (&#x23;), the sensor part is pressed to measure the amount of applied pressure and the change in capacitance.</p>
</caption>
<graphic xlink:href="fbioe-13-1639630-g005.tif">
<alt-text content-type="machine-generated">A close-up of a machine pressing a material with a black and yellow diamond pattern. A white roller with the symbol &#x22;#&#x22; is seen beneath the pressing mechanism. Yellow tape and handwritten red and black markings are visible on a metal surface.</alt-text>
</graphic>
</fig>
<p>The 30 eRs were tested under load conditions similar to those described for the sensor in <xref ref-type="sec" rid="s2-3">Section 2.3</xref>. For each sample, tests were conducted three times, both before and after load application, under Conditions A, B, and C.</p>
</sec>
<sec id="s2-7">
<title>2.7 Creation of regression equations for load-capacitance in insole-embedded sensors and verification of load estimation accuracy</title>
<p>We plotted the relationship between the obtained &#x394;C and the applied load, then calculated a polynomial to represent this relationship using curve fitting. The least squares method was used for the calculation, and Python&#x2019;s NumPy polyfit and poly1d libraries were used for the computation. The candidate equations for curve fitting included a 5th-order polynomial, natural exponential functions, and integer-based exponential functions. Machine learning methods can be used as an alternative to curve fitting. Nevertheless, they were not considered due to the substantial processing burden they would impose on the insole&#x2019;s circuitry. The accuracy of the curve fitting was evaluated using the coefficient of determination (R2) and the Root Mean Squared Error (RMSE).</p>
</sec>
<sec id="s2-8">
<title>2.8 Dynamic characteristics analysis of insole-embedded sensors</title>
<p>Using the system described in <xref ref-type="sec" rid="s2-4">section 2.4</xref>, a dynamic characteristics analysis was conducted by applying continuous loads to the insole sensors to simulate walking. The loading cycles were set to simulate different walking speeds: a 2-s cycle for a slow walk (S), a 1-s cycle for a normal walk (N), and a 0.6-s cycle for a quick walk (Q). A load of 0&#x2013;240&#xa0;N was repeatedly applied 50 times for each condition (<xref ref-type="fig" rid="F6">Figure 6</xref>). The initial 10 cycles of each loading session were excluded from the data, and the subsequent 40 cycles were used for the dynamic analysis. The capacitance of the insole was sampled every 20&#xa0;ms. This loading procedure was performed under the three environmental conditions A through C, detailed in <xref ref-type="sec" rid="s2-4">section 2.4</xref>. The same durability test as in <xref ref-type="sec" rid="s2-4">section 2.4</xref> was conducted to examine changes before and after the test. The investigated parameters were the difference between the loading interval and the detected waveform peak interval, and the signal drift rate. To assess whether the two groups were statistically equivalent, we conducted an equivalence test using the two one-sided test (TOST) procedure. The equivalence margin was pre-specified as 50% of the standard deviation. Equivalence was concluded if the 90% confidence interval of the mean difference fell entirely within the predefined margin, and both one-sided p-values were below 0.05. Analyses were performed using Python 3.12. The signal drift rate was calculated for all conditions from <xref ref-type="sec" rid="s2">section 2</xref>. By dividing the difference in estimated load (derived from capacitance) before and after the durability test by the pre-test estimated load.</p>
<fig id="F6" position="float">
<label>FIGURE 6</label>
<caption>
<p>Load application pattern in dynamic characteristics analysis. Initially, a single load is applied for 10 s, followed by a 3-min no-load period. Subsequently, to simulate a slow walk (Simulation S), a 2-s cycle (1-s load, 1-s no-load) is repeated 50 times. Next, to simulate a normal walk (Simulation N), a 1-s cycle (0.5-s load, 0.5-s no-load) is repeated 50 times. Finally, to simulate a quick walk (Simulation Q), a 0.6-s cycle (0.3-s load, 0.3-s no-load) is repeated 50 times. For the analysis of S, N, and Q, the last 40 of the 50 loading cycles are used.</p>
</caption>
<graphic xlink:href="fbioe-13-1639630-g006.tif">
<alt-text content-type="machine-generated">Graph showing three simulated load cycles over time. Registration has a 10-second load and 0.4-second unload. Simulation S: 1-second load and unload, repeated 50 times. Simulation N: 0.5-second load and unload, repeated 50 times. Simulation Q: 0.3-second load and unload, repeated 50 times. Each simulation spans 3 minutes, with a consistent 240N load.</alt-text>
</graphic>
</fig>
</sec>
</sec>
<sec sec-type="results" id="s3">
<title>3 Results</title>
<sec id="s3-1">
<title>3.1 Load-capacitance relationship and measurement characteristics of the sensor unit alone</title>
<p>The relationship between the load value from the continuous pressure applied by the force gauge and the change in capacitance of the sensor unit alone showed a linear increase in the small deformation region up to 20&#xa0;N under all conditions (A, B, and C). Beyond 20&#xa0;N, it exhibits a non-linear monotonic increase, closely resembling a logarithmic curve (<xref ref-type="fig" rid="F7">Figure 7</xref>). Although there were differences between individual samples, no variations were observed among the samples. After the durability test, a slight change in the capacitance output was observed; however, the shape of the curve remained consistent (<xref ref-type="fig" rid="F7">Figure 7</xref>).</p>
<fig id="F7" position="float">
<label>FIGURE 7</label>
<caption>
<p>Capacitance-load curves for the standalone sensor.</p>
</caption>
<graphic xlink:href="fbioe-13-1639630-g007.tif">
<alt-text content-type="machine-generated">Three graphs compare capacitance change (&#x394;C) in picofarads (pF) versus load in newtons (N) under different conditions. The graphs are labeled: 23&#xB0;C, 50% humidity; 40&#xB0;C, 50% humidity; and 40&#xB0;C, 80% humidity. Each graph shows curves for before and after durability tests, with the curves having a similar upward trend and converging at higher loads.</alt-text>
</graphic>
</fig>
<p>The coefficients of variation and confidence interval widths for all samples at the specified loads are listed in <xref ref-type="table" rid="T1">Tables 1</xref>&#x2013;<xref ref-type="table" rid="T3">3</xref>. The coefficient of variation was less than 1.25%, indicating that sample variability was within acceptable precision limits. Furthermore, the confidence interval width showed a slight increasing trend after durability testing, but was generally less than 0.25%, which was deemed acceptable in terms of accuracy.</p>
<table-wrap id="T1" position="float">
<label>TABLE 1</label>
<caption>
<p>Measurement Characteristics of the Standalone Sensor Unit (23&#xa0;&#xb0;C, 50% humidity).</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="left"/>
<th colspan="3" align="center">Before Durability Test</th>
<th colspan="3" align="center">After Durability Test</th>
</tr>
<tr>
<th align="center">Load(N)</th>
<th align="center">Capacitance<break/>Mean &#xb1; SD (pF)</th>
<th align="center">CV(%)</th>
<th align="center">Width of 95%CI (%)</th>
<th align="center">Capacitance<break/>Mean &#xb1; SD (pF)</th>
<th align="center">CV(%)</th>
<th align="center">Width of 95%CI (%)</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td align="center">50</td>
<td align="center">42.13 &#xb1; 0.45</td>
<td align="center">1.07</td>
<td align="center">0.19</td>
<td align="center">43.77 &#xb1; 0.5</td>
<td align="center">1.14</td>
<td align="center">0.18</td>
</tr>
<tr>
<td align="center">100</td>
<td align="center">48.74 &#xb1; 0.4</td>
<td align="center">0.82</td>
<td align="center">0.18</td>
<td align="center">50.5 &#xb1; 0.39</td>
<td align="center">0.77</td>
<td align="center">0.18</td>
</tr>
<tr>
<td align="center">150</td>
<td align="center">51.93 &#xb1; 0.34</td>
<td align="center">0.65</td>
<td align="center">0.19</td>
<td align="center">53.48 &#xb1; 0.36</td>
<td align="center">0.67</td>
<td align="center">0.17</td>
</tr>
<tr>
<td align="center">200</td>
<td align="center">53.92 &#xb1; 0.29</td>
<td align="center">0.54</td>
<td align="center">0.15</td>
<td align="center">55.25 &#xb1; 0.35</td>
<td align="center">0.63</td>
<td align="center">0.18</td>
</tr>
<tr>
<td align="center">300</td>
<td align="center">56.18 &#xb1; 0.35</td>
<td align="center">0.62</td>
<td align="center">0.21</td>
<td align="center">57.19 &#xb1; 0.43</td>
<td align="center">0.75</td>
<td align="center">0.23</td>
</tr>
<tr>
<td align="center">400</td>
<td align="center">57.4 &#xb1; 0.45</td>
<td align="center">0.78</td>
<td align="center">0.19</td>
<td align="center">58.22 &#xb1; 0.52</td>
<td align="center">0.89</td>
<td align="center">0.21</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn>
<p>SD, standard deviation; CV, coefficient of variation.</p>
</fn>
<fn>
<p>CI, confidence interval.</p>
</fn>
</table-wrap-foot>
</table-wrap>
<table-wrap id="T2" position="float">
<label>TABLE 2</label>
<caption>
<p>Measurement Characteristics of the Standalone Sensor Unit (40&#xa0;&#xb0;C, 50% humidity).</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="left"/>
<th colspan="3" align="center">Before Durability Test</th>
<th colspan="3" align="center">After Durability Test</th>
</tr>
<tr>
<th align="center">Load(N)</th>
<th align="center">Capacitance<break/>Mean &#xb1; SD (pF)</th>
<th align="center">CV(%)</th>
<th align="center">Width of 95%CI (%)</th>
<th align="center">Capacitance<break/>Mean &#xb1; SD (pF)</th>
<th align="center">CV(%)</th>
<th align="center">Width of 95%CI (%)</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td align="center">50</td>
<td align="center">45.63 &#xb1; 0.41</td>
<td align="center">0.90</td>
<td align="center">0.15</td>
<td align="center">47.53 &#xb1; 0.51</td>
<td align="center">1.07</td>
<td align="center">0.19</td>
</tr>
<tr>
<td align="center">100</td>
<td align="center">52.43 &#xb1; 0.33</td>
<td align="center">0.63</td>
<td align="center">0.15</td>
<td align="center">54.3 &#xb1; 0.36</td>
<td align="center">0.66</td>
<td align="center">0.13</td>
</tr>
<tr>
<td align="center">150</td>
<td align="center">55.67 &#xb1; 0.27</td>
<td align="center">0.49</td>
<td align="center">0.13</td>
<td align="center">57.24 &#xb1; 0.31</td>
<td align="center">0.54</td>
<td align="center">0.12</td>
</tr>
<tr>
<td align="center">200</td>
<td align="center">57.65 &#xb1; 0.23</td>
<td align="center">0.40</td>
<td align="center">0.12</td>
<td align="center">58.97 &#xb1; 0.3</td>
<td align="center">0.51</td>
<td align="center">0.15</td>
</tr>
<tr>
<td align="center">300</td>
<td align="center">59.86 &#xb1; 0.26</td>
<td align="center">0.43</td>
<td align="center">0.15</td>
<td align="center">60.79 &#xb1; 0.35</td>
<td align="center">0.58</td>
<td align="center">0.18</td>
</tr>
<tr>
<td align="center">400</td>
<td align="center">61.05 &#xb1; 0.33</td>
<td align="center">0.54</td>
<td align="center">0.11</td>
<td align="center">61.69 &#xb1; 0.41</td>
<td align="center">0.66</td>
<td align="center">0.15</td>
</tr>
</tbody>
</table>
</table-wrap>
<table-wrap id="T3" position="float">
<label>TABLE 3</label>
<caption>
<p>Measurement Characteristics of the Standalone Sensor Unit (40&#xa0;&#xb0;C, 80% humidity).</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="left"/>
<th colspan="3" align="center">Before Durability Test</th>
<th colspan="3" align="center">After Durability Test</th>
</tr>
<tr>
<th align="center">Load(N)</th>
<th align="center">Capacitance<break/>Mean &#xb1; SD (pF)</th>
<th align="center">CV(%)</th>
<th align="center">Width of 95%CI (%)</th>
<th align="center">Capacitance<break/>Mean &#xb1; SD (pF)</th>
<th align="center">CV(%)</th>
<th align="center">Width of 95%CI (%)</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td align="center">50</td>
<td align="center">48.03 &#xb1; 0.43</td>
<td align="center">0.90</td>
<td align="center">0.17</td>
<td align="center">50.15 &#xb1; 0.63</td>
<td align="center">1.26</td>
<td align="center">0.20</td>
</tr>
<tr>
<td align="center">100</td>
<td align="center">55 &#xb1; 0.35</td>
<td align="center">0.64</td>
<td align="center">0.15</td>
<td align="center">57.06 &#xb1; 0.48</td>
<td align="center">0.84</td>
<td align="center">0.18</td>
</tr>
<tr>
<td align="center">150</td>
<td align="center">58.28 &#xb1; 0.31</td>
<td align="center">0.53</td>
<td align="center">0.14</td>
<td align="center">60.02 &#xb1; 0.41</td>
<td align="center">0.68</td>
<td align="center">0.17</td>
</tr>
<tr>
<td align="center">200</td>
<td align="center">60.29 &#xb1; 0.32</td>
<td align="center">0.53</td>
<td align="center">0.15</td>
<td align="center">61.7 &#xb1; 0.41</td>
<td align="center">0.66</td>
<td align="center">0.18</td>
</tr>
<tr>
<td align="center">300</td>
<td align="center">62.48 &#xb1; 0.4</td>
<td align="center">0.64</td>
<td align="center">0.21</td>
<td align="center">63.47 &#xb1; 0.49</td>
<td align="center">0.77</td>
<td align="center">0.22</td>
</tr>
<tr>
<td align="center">400</td>
<td align="center">63.59 &#xb1; 0.52</td>
<td align="center">0.82</td>
<td align="center">0.19</td>
<td align="center">64.37 &#xb1; 0.55</td>
<td align="center">0.85</td>
<td align="center">0.17</td>
</tr>
</tbody>
</table>
</table-wrap>
</sec>
<sec id="s3-2">
<title>3.2 Evaluation of load-capacitance change and measurement characteristics of insole-embedded sensors</title>
<p>When comparing measurements from the sensor unit alone to those from sensors inserted into the insole casing, differences in the load-capacitance relationship were observed. Specifically, the sensors within the insole casing showed a gentler increase in the load-capacitance curve compared to the standalone sensor, which was influenced by the gaps within the insole casing (<xref ref-type="fig" rid="F8">Figure 8</xref>).</p>
<fig id="F8" position="float">
<label>FIGURE 8</label>
<caption>
<p>Capacitance-load curves for the sensor within the insole casing.</p>
</caption>
<graphic xlink:href="fbioe-13-1639630-g008.tif">
<alt-text content-type="machine-generated">Three graphs illustrate the change in capacitance (\( \Delta C \) in picofarads) versus load (N) under different conditions. Left graph: 23&#xB0;C, 50% humidity. Middle graph: 40&#xB0;C, 50% humidity. Right graph: 40&#xB0;C, 80% humidity. Each graph shows two lines, in pink for before and blue for after a durability test, both showing similar upward curves.</alt-text>
</graphic>
</fig>
<p>The coefficients of variation and confidence interval widths at the specified loads are listed in <xref ref-type="table" rid="T4">Tables 4</xref>&#x2013;<xref ref-type="table" rid="T6">6</xref>. The coefficient of variation was less than 8%, indicating that while the sample variability was greater than that of the standalone sensor, it was still considered within acceptable precision limits. The confidence interval width also showed a slight increasing trend after durability testing, but was generally less than 1.5%, which was deemed acceptable in terms of accuracy.</p>
<table-wrap id="T4" position="float">
<label>TABLE 4</label>
<caption>
<p>Measurement Characteristics of Insole-Embedded Sensors (23&#xa0;&#xb0;C, 50% humidity).</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="left"/>
<th colspan="3" align="center">Before Durability Test</th>
<th colspan="3" align="center">After Durability Test</th>
</tr>
<tr>
<th align="center">Load(N)</th>
<th align="center">Capacitance<break/>Mean &#xb1; SD (pF)</th>
<th align="center">CV(%)</th>
<th align="center">Width of 95%CI (%)</th>
<th align="center">Capacitance<break/>Mean &#xb1; SD (pF)</th>
<th align="center">CV(%)</th>
<th align="center">Width of 95%CI (%)</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td align="center">50</td>
<td align="center">45.75 &#xb1; 1.78</td>
<td align="center">3.89</td>
<td align="center">0.57</td>
<td align="center">48.37 &#xb1; 3.48</td>
<td align="center">7.19</td>
<td align="center">1.14</td>
</tr>
<tr>
<td align="center">100</td>
<td align="center">102.75 &#xb1; 1.22</td>
<td align="center">1.19</td>
<td align="center">0.21</td>
<td align="center">108.33 &#xb1; 4.87</td>
<td align="center">4.50</td>
<td align="center">0.83</td>
</tr>
<tr>
<td align="center">150</td>
<td align="center">148.52 &#xb1; 1.51</td>
<td align="center">1.02</td>
<td align="center">0.19</td>
<td align="center">158.85 &#xb1; 9.61</td>
<td align="center">6.05</td>
<td align="center">1.16</td>
</tr>
<tr>
<td align="center">200</td>
<td align="center">199.93 &#xb1; 1.64</td>
<td align="center">0.82</td>
<td align="center">0.16</td>
<td align="center">217.77 &#xb1; 16.34</td>
<td align="center">7.50</td>
<td align="center">1.42</td>
</tr>
<tr>
<td align="center">300</td>
<td align="center">304.33 &#xb1; 1.98</td>
<td align="center">0.65</td>
<td align="center">0.15</td>
<td align="center">334.32 &#xb1; 27.51</td>
<td align="center">8.23</td>
<td align="center">1.94</td>
</tr>
<tr>
<td align="center">400</td>
<td align="center">385.85 &#xb1; 2.49</td>
<td align="center">0.65</td>
<td align="center">0.17</td>
<td align="center">423.52 &#xb1; 32.45</td>
<td align="center">7.66</td>
<td align="center">2.08</td>
</tr>
</tbody>
</table>
</table-wrap>
<table-wrap id="T5" position="float">
<label>TABLE 5</label>
<caption>
<p>Measurement Characteristics of Insole-Embedded Sensors (40&#xa0;&#xb0;C, 50% humidity).</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="left"/>
<th colspan="3" align="center">Before Durability Test</th>
<th colspan="3" align="center">After Durability Test</th>
</tr>
<tr>
<th align="center">Load(N)</th>
<th align="center">Capacitance<break/>Mean &#xb1; SD (pF)</th>
<th align="center">CV(%)</th>
<th align="center">Width of 95%CI (%)</th>
<th align="center">Capacitance<break/>Mean &#xb1; SD (pF)</th>
<th align="center">CV(%)</th>
<th align="center">Width of 95%CI (%)</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td align="center">50</td>
<td align="center">39.62 &#xb1; 2.72</td>
<td align="center">6.87</td>
<td align="center">1.03</td>
<td align="center">42.57 &#xb1; 3.1</td>
<td align="center">7.28</td>
<td align="center">1.13</td>
</tr>
<tr>
<td align="center">100</td>
<td align="center">85.61 &#xb1; 3.83</td>
<td align="center">4.47</td>
<td align="center">0.77</td>
<td align="center">90.25 &#xb1; 4.58</td>
<td align="center">5.07</td>
<td align="center">0.90</td>
</tr>
<tr>
<td align="center">150</td>
<td align="center">129.87 &#xb1; 6.54</td>
<td align="center">5.04</td>
<td align="center">0.87</td>
<td align="center">141.32 &#xb1; 10.53</td>
<td align="center">7.45</td>
<td align="center">1.32</td>
</tr>
<tr>
<td align="center">200</td>
<td align="center">179.4 &#xb1; 8.97</td>
<td align="center">5.00</td>
<td align="center">0.89</td>
<td align="center">198.44 &#xb1; 15.46</td>
<td align="center">7.79</td>
<td align="center">1.39</td>
</tr>
<tr>
<td align="center">300</td>
<td align="center">277.68 &#xb1; 12.57</td>
<td align="center">4.53</td>
<td align="center">1.06</td>
<td align="center">308.47 &#xb1; 23.43</td>
<td align="center">7.60</td>
<td align="center">1.81</td>
</tr>
<tr>
<td align="center">400</td>
<td align="center">362.26 &#xb1; 13.74</td>
<td align="center">3.79</td>
<td align="center">0.00</td>
<td align="center">397.57 &#xb1; 28.13</td>
<td align="center">7.08</td>
<td align="center">1.97</td>
</tr>
</tbody>
</table>
</table-wrap>
<table-wrap id="T6" position="float">
<label>TABLE 6</label>
<caption>
<p>Measurement Characteristics of Insole-Embedded Sensors (40&#xa0;&#xb0;C, 80% humidity).</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="left"/>
<th colspan="3" align="center">Before Durability Test</th>
<th colspan="3" align="center">After Durability Test</th>
</tr>
<tr>
<th align="center">Load(N)</th>
<th align="center">Capacitance<break/>Mean &#xb1; SD (pF)</th>
<th align="center">CV(%)</th>
<th align="center">Width of 95%CI (%)</th>
<th align="center">Capacitance<break/>Mean &#xb1; SD (pF)</th>
<th align="center">CV(%)</th>
<th align="center">Width of 95%CI (%)</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td align="center">50</td>
<td align="center">43.79 &#xb1; 3.45</td>
<td align="center">7.88</td>
<td align="center">1.16</td>
<td align="center">45.84 &#xb1; 3.95</td>
<td align="center">8.62</td>
<td align="center">1.33</td>
</tr>
<tr>
<td align="center">100</td>
<td align="center">96.34 &#xb1; 5.49</td>
<td align="center">5.70</td>
<td align="center">0.94</td>
<td align="center">102.87 &#xb1; 4.87</td>
<td align="center">4.73</td>
<td align="center">0.83</td>
</tr>
<tr>
<td align="center">150</td>
<td align="center">158.6 &#xb1; 11.51</td>
<td align="center">7.26</td>
<td align="center">1.20</td>
<td align="center">178.19 &#xb1; 10.8</td>
<td align="center">6.06</td>
<td align="center">1.04</td>
</tr>
<tr>
<td align="center">200</td>
<td align="center">229.31 &#xb1; 16.32</td>
<td align="center">7.12</td>
<td align="center">1.23</td>
<td align="center">263.47 &#xb1; 15.74</td>
<td align="center">5.97</td>
<td align="center">1.06</td>
</tr>
<tr>
<td align="center">300</td>
<td align="center">374.45 &#xb1; 22.65</td>
<td align="center">6.05</td>
<td align="center">1.43</td>
<td align="center">430.41 &#xb1; 22.84</td>
<td align="center">5.31</td>
<td align="center">1.27</td>
</tr>
<tr>
<td align="center">400</td>
<td align="center">425.92 &#xb1; 26.68</td>
<td align="center">6.26</td>
<td align="center">1.48</td>
<td align="center">567.3 &#xb1; 28.84</td>
<td align="center">5.08</td>
<td align="center">1.42</td>
</tr>
</tbody>
</table>
</table-wrap>
</sec>
<sec id="s3-3">
<title>3.3 Hysteresis of dielectric layers</title>
<p>For both dielectric layers, hysteresis curves were generated by plotting capacitance against nominal stress and nominal strain. These plots revealed a disparity between the loading and unloading paths, indicating the presence of hysteresis (<xref ref-type="fig" rid="F9">Figure 9</xref>). The average hysteresis error with respect to both nominal stress and nominal strain was below 10% for both dielectric layer 1 and layer 2 (<xref ref-type="table" rid="T7">Table 7</xref>). Furthermore, the normalized hysteresis loop area for both layers was 0.1 or less. While this performance is not comparable to that of state-of-the-art sensors, it demonstrates a moderate level of precision.</p>
<fig id="F9" position="float">
<label>FIGURE 9</label>
<caption>
<p>Hysteresis of materials constituting two dielectric layers. <bold>(A)</bold> Material constituting Dielectric Layer-1, <bold>(B)</bold> Material constituting Dielectric Layer-2.</p>
</caption>
<graphic xlink:href="fbioe-13-1639630-g009.tif">
<alt-text content-type="machine-generated">Graph A shows nominal strain versus nominal stress in megapascals, and Graph B shows nominal strain and &#x394;Cs in picofarads. Both graphs display red loading curves and blue unloading curves, illustrating the difference in behavior during loading and unloading phases.</alt-text>
</graphic>
</fig>
<table-wrap id="T7" position="float">
<label>TABLE 7</label>
<caption>
<p>Differences between pressure intervals and peak capacitance intervals of force gauges before and after durability testing in slow walking simulation.</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="center"/>
<th align="left"/>
<th align="center">Mean hysteresis error (%FS)</th>
<th align="center">Normalized hysteresis loop area</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td rowspan="2" align="center">Dielectric Layer 1</td>
<td align="center">Nominal Stress</td>
<td align="center">9.98</td>
<td align="center">0.100</td>
</tr>
<tr>
<td align="center">Nominal Strain</td>
<td align="center">8.13</td>
<td align="center">0.075</td>
</tr>
<tr>
<td rowspan="2" align="center">Dielectric Layer 2</td>
<td align="center">Nominal Stress</td>
<td align="center">7.75</td>
<td align="center">0.058</td>
</tr>
<tr>
<td align="center">Nominal Strain</td>
<td align="center">6.28</td>
<td align="center">0.050</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn>
<p>%FS, percent of full scale.</p>
</fn>
</table-wrap-foot>
</table-wrap>
</sec>
<sec id="s3-4">
<title>3.4 Curve fitting of load-capacitance in insole-embedded sensors and verification of load estimation accuracy</title>
<p>The load-capacitance curve for the sensors embedded within the insole casing was regressed to a polynomial. A 5th-order polynomial, as shown <xref ref-type="disp-formula" rid="e9">Equation 9</xref>, was adopted:<disp-formula id="e9">
<mml:math id="m9">
<mml:mrow>
<mml:mi>L</mml:mi>
<mml:mi>o</mml:mi>
<mml:mi>a</mml:mi>
<mml:mi>d</mml:mi>
<mml:mrow>
<mml:mfenced open="[" close="]" separators="|">
<mml:mrow>
<mml:mi>N</mml:mi>
</mml:mrow>
</mml:mfenced>
</mml:mrow>
<mml:mo>&#x3d;</mml:mo>
<mml:mi>a</mml:mi>
<mml:mo>&#xb7;</mml:mo>
<mml:mo>&#x394;</mml:mo>
<mml:msup>
<mml:mi>C</mml:mi>
<mml:mn>5</mml:mn>
</mml:msup>
<mml:mo>&#x2b;</mml:mo>
<mml:mi>b</mml:mi>
<mml:mo>&#xb7;</mml:mo>
<mml:mo>&#x394;</mml:mo>
<mml:msup>
<mml:mi>C</mml:mi>
<mml:mn>4</mml:mn>
</mml:msup>
<mml:mo>&#x2b;</mml:mo>
<mml:mi>c</mml:mi>
<mml:mo>&#xb7;</mml:mo>
<mml:mo>&#x394;</mml:mo>
<mml:msup>
<mml:mi>C</mml:mi>
<mml:mn>3</mml:mn>
</mml:msup>
<mml:mo>&#x2b;</mml:mo>
<mml:mi>d</mml:mi>
<mml:mo>&#xb7;</mml:mo>
<mml:mo>&#x394;</mml:mo>
<mml:msup>
<mml:mi>C</mml:mi>
<mml:mn>2</mml:mn>
</mml:msup>
<mml:mo>&#x2b;</mml:mo>
<mml:mi>e</mml:mi>
<mml:mo>&#xb7;</mml:mo>
<mml:mo>&#x394;</mml:mo>
<mml:mi>C</mml:mi>
<mml:mo>&#x2b;</mml:mo>
<mml:mi>f</mml:mi>
</mml:mrow>
</mml:math>
<label>(9)</label>
</disp-formula>
</p>
<p>For example, the plot results obtained from a forefoot sensor in one casing are shown in <xref ref-type="fig" rid="F7">Figure 7</xref>. From this result, the curve fitting yielded: a &#x3d; 2.26 x 10<sup>&#x2212;3</sup>, b &#x3d; &#x2212;9.67 x 10<sup>&#x2212;2</sup>, c &#x3d; 1.53, d &#x3d; &#x2212;10.4, e &#x3d; 33.1, f &#x3d; 1.34. The accuracy of the curve fitting was calculated as R<sup>2</sup> &#x3d; 0.998839 and RMSE &#x3d; 3.687313 (N). We determined that the 5th-order polynomial provided a better fit for regression than a natural exponential approximation (R<sup>2</sup> &#x3d; 0.99856) or an integer-based exponential function (R<sup>2</sup> &#x3d; 0.99856), and thus adopted it.</p>
<p>The relationship between load and capacitance differs for each sensor. Therefore, we perform an individual calibration for each sensor embedded in the insole to determine the coefficients of <xref ref-type="disp-formula" rid="e9">Equation 9</xref>.</p>
</sec>
<sec id="s3-5">
<title>3.5 Results of dynamic characteristics analysis of insole-embedded sensors</title>
<p>The results for the detected pressure peak intervals are shown in <xref ref-type="table" rid="T8">Tables 8</xref>&#x2013;<xref ref-type="table" rid="T10">10</xref>. No significant differences were observed in any of the conditions (p &#x3c; 0.05). The signal drift rate ranged from 5% to 10%, varying with environmental and walking conditions, which suggests that correction may be necessary for long-term use (<xref ref-type="table" rid="T11">Table 11</xref>).</p>
<table-wrap id="T8" position="float">
<label>TABLE 8</label>
<caption>
<p>Differences between pressure intervals and peak capacitance intervals of force gauges before and after durability testing in slow walking simulation.</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="center"/>
<th align="center">Temperature and humidity</th>
<th align="center">Force gauge pressure interval<break/>Mean &#xb1; SD (ms)</th>
<th align="center">Peak capacitance interval <break/>Mean &#xb1; SD (ms)</th>
<th align="center">Difference<break/>Mean (95%CI)</th>
<th align="left"/>
</tr>
</thead>
<tbody valign="top">
<tr>
<td rowspan="3" align="center">Before the Durability Test</td>
<td align="center">23&#xa0;&#xb0;C, 50% humidity</td>
<td align="center">2000.28 &#xb1; 28.24</td>
<td align="center">1999.70 &#xb1; 15.49</td>
<td align="center">&#x2212;0.577&#x2a; (&#x2212;1.200, &#x2212;1.061)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td align="center">40&#xa0;&#xb0;C, 50% humidity</td>
<td align="center">2000.11 &#xb1; 31.29</td>
<td align="center">1999.70 &#xb1; 21.77</td>
<td align="center">&#x2212;0.406&#x2a; (&#x2212;0.879, &#x2212;0.712)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td align="center">40&#xa0;&#xb0;C, 80% humidity</td>
<td align="center">1999.74 &#xb1; 35.65</td>
<td align="center">1999.79 &#xb1; 21.28</td>
<td align="center">0.047&#x2a; (&#x2212;0.009, 0.191)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td rowspan="3" align="center">After the Durability Test</td>
<td align="center">23&#xa0;&#xb0;C, 50% humidity</td>
<td align="center">2000.10 &#xb1; 34.71</td>
<td align="center">1999.82 &#xb1; 12.35</td>
<td align="center">&#x2212;0.276&#x2a; (&#x2212;0.616, &#x2212;0.466)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td align="center">40&#xa0;&#xb0;C, 50% humidity</td>
<td align="center">2000.26 &#xb1; 34.22</td>
<td align="center">1999.73 &#xb1; 18.64</td>
<td align="center">&#x2212;0.531&#x2a; (&#x2212;1.113, &#x2212;0.969)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td align="center">40&#xa0;&#xb0;C, 80% humidity</td>
<td align="center">1999.80 &#xb1; 37.28</td>
<td align="center">1999.71 &#xb1; 18.69</td>
<td align="center">&#x2212;0.092&#x2a; (&#x2212;0.254, &#x2212;0.105)</td>
<td align="center">EQ</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn>
<p>EQ, equivalent, &#x2a; Indicates statistical equivalence, with both one-sided tests from the TOST, procedure reaching significance (p &#x3c; 0.05) and the confidence interval entirely within the equivalence bounds.</p>
</fn>
</table-wrap-foot>
</table-wrap>
<table-wrap id="T9" position="float">
<label>TABLE 9</label>
<caption>
<p>Differences between pressure intervals and peak capacitance intervals of force gauges before and after durability testing in normal walking simulation.</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="center"/>
<th align="center">Temperature and humidity</th>
<th align="center">Force gauge pressure interval<break/>Mean &#xb1; SD (ms)</th>
<th align="center">Peak capacitance interval <break/>Mean &#xb1; SD (ms)</th>
<th align="center">Difference<break/>Mean (95%CI)</th>
<th align="left"/>
</tr>
</thead>
<tbody valign="top">
<tr>
<td rowspan="3" align="center">Before the Durability Test</td>
<td align="center">23&#xa0;&#xb0;C, 50% humidity</td>
<td align="center">999.98 &#xb1; 10.08</td>
<td align="center">999.96 &#xb1; 3.6</td>
<td align="center">&#x2212;0.021&#x2a; (&#x2212;0.068, &#x2212;0.016)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td align="center">40&#xa0;&#xb0;C, 50% humidity</td>
<td align="center">999.98 &#xb1; 8.76</td>
<td align="center">999.91 &#xb1; 5.77</td>
<td align="center">&#x2212;0.064&#x2a; (&#x2212;0.151, &#x2212;0.1)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td align="center">40&#xa0;&#xb0;C, 80% humidity</td>
<td align="center">999.95 &#xb1; 11.18</td>
<td align="center">999.81 &#xb1; 4.18</td>
<td align="center">&#x2212;0.140&#x2a; (&#x2212;0.306, &#x2212;0.242)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td rowspan="3" align="center">After the Durability Test</td>
<td align="center">23&#xa0;&#xb0;C, 50% humidity</td>
<td align="center">999.86 &#xb1; 12.96</td>
<td align="center">999.94 &#xb1; 4.96</td>
<td align="center">0.079&#x2a; (0.125, 0.184)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td align="center">40&#xa0;&#xb0;C, 50% humidity</td>
<td align="center">1,000.04 &#xb1; 10.75</td>
<td align="center">999.98 &#xb1; 4.41</td>
<td align="center">&#x2212;0.055&#x2a; (&#x2212;0.131, &#x2212;0.084)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td align="center">40&#xa0;&#xb0;C, 80% humidity</td>
<td align="center">1,000.24 &#xb1; 10.33</td>
<td align="center">999.91 &#xb1; 2.89</td>
<td align="center">&#x2212;0.330&#x2a; (&#x2212;0.667, &#x2212;0.625)</td>
<td align="center">EQ</td>
</tr>
</tbody>
</table>
</table-wrap>
<table-wrap id="T10" position="float">
<label>TABLE 10</label>
<caption>
<p>Differences between pressure intervals and peak capacitance intervals of force gauges before and after durability testing in quick walking simulation.</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="center"/>
<th align="center">Temperature and humidity</th>
<th align="center">Force gauge pressure interval<break/>Mean &#xb1; SD (ms)</th>
<th align="center">Peak capacitance interval <break/>Mean &#xb1; SD (ms)</th>
<th align="center">Difference<break/>Mean (95%CI)</th>
<th align="left"/>
</tr>
</thead>
<tbody valign="top">
<tr>
<td rowspan="3" align="center">Before the Durability Test</td>
<td align="center">23&#xa0;&#xb0;C, 50% humidity</td>
<td align="center">599.94 &#xb1; 4.03</td>
<td align="center">599.96 &#xb1; 3.88</td>
<td align="center">0.021&#x2a; (0.026, 0.058)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td align="center">40&#xa0;&#xb0;C, 50% humidity</td>
<td align="center">599.85 &#xb1; 3.38</td>
<td align="center">599.98 &#xb1; 3.45</td>
<td align="center">0.128&#x2a; (0.233, 0.269)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td align="center">40&#xa0;&#xb0;C, 80% humidity</td>
<td align="center">600.02 &#xb1; 4.66</td>
<td align="center">599.95 &#xb1; 5.41</td>
<td align="center">&#x2212;0.070&#x2a; (&#x2212;0.159, &#x2212;0.116)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td rowspan="3" align="center">After the Durability Test</td>
<td align="center">23&#xa0;&#xb0;C, 50% humidity</td>
<td align="center">600.02 &#xb1; 4.04</td>
<td align="center">600.02 &#xb1; 3.97</td>
<td align="center">0.000&#x2a; (&#x2212;0.017, 0.017)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td align="center">40&#xa0;&#xb0;C, 50% humidity</td>
<td align="center">600.04 &#xb1; 1.78</td>
<td align="center">599.96 &#xb1; 4.75</td>
<td align="center">&#x2212;0.073&#x2a; (&#x2212;0.157, &#x2212;0.13)</td>
<td align="center">EQ</td>
</tr>
<tr>
<td align="center">40&#xa0;&#xb0;C, 80% humidity</td>
<td align="center">600.02 &#xb1; 4.74</td>
<td align="center">599.96 &#xb1; 4.94</td>
<td align="center">&#x2212;0.055&#x2a; (&#x2212;0.125, &#x2212;0.09)</td>
<td align="center">EQ</td>
</tr>
</tbody>
</table>
</table-wrap>
<table-wrap id="T11" position="float">
<label>TABLE 11</label>
<caption>
<p>Signal drift rate calculated by comparing before and after endurance testing under various temperature and humidity conditions.</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="center">Temperature and humidity environment</th>
<th align="center">Slow walk</th>
<th align="center">Normal walk</th>
<th align="center">Quick walk</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td align="center">23&#xa0;&#xb0;C, 50% humidity</td>
<td align="center">8.88%</td>
<td align="center">8.21%</td>
<td align="center">7.21%</td>
</tr>
<tr>
<td align="center">40&#xa0;&#xb0;C, 50% humidity</td>
<td align="center">8.63%</td>
<td align="center">6.95%</td>
<td align="center">5.81%</td>
</tr>
<tr>
<td align="center">40&#xa0;&#xb0;C, 80% humidity</td>
<td align="center">9.72%</td>
<td align="center">8.25%</td>
<td align="center">6.99%</td>
</tr>
</tbody>
</table>
</table-wrap>
</sec>
</sec>
<sec sec-type="discussion" id="s4">
<title>4 Discussion</title>
<p>Polymer actuators composed of EAP and metal composites have been developed as artificial muscles because they can deform and generate stress in response to external signals (<xref ref-type="bibr" rid="B23">Rus and Tolley, 2015</xref>). Compared with ion-driven EAPs, electric-field-driven EAPs, including eRs, require higher driving voltages but offer faster response times and capabilities for large deformations, making them highly suitable as actuators (<xref ref-type="bibr" rid="B3">Bar-Cohen, 2004</xref>). Moreover, if the eR is treated as a capacitor, leveraging the instantaneous nature of the capacitance changes within the EAP, it can be applied as a sensor to inversely calculate the applied external forces. Sensing is possible with a significantly smaller voltage application&#x2013;far less than the power required for actuator actuation&#x2013;if minute changes in capacitance can be detected (<xref ref-type="bibr" rid="B17">O&#x2019;Brien et al., 2010</xref>).</p>
<p>Integrating both sensing and actuation functionalities into an artificial muscle can not only lighten the overall system and simplify wiring but also enable the construction of real-time feedback control loops based on the state of the actuator. This mimics the reflex loops of biological proprioception, allowing adaptive movements that emulate the human body&#x2019;s reflex structures (<xref ref-type="bibr" rid="B2">Anderson et al., 2012</xref>; <xref ref-type="bibr" rid="B22">Rizzello, 2023</xref>; <xref ref-type="bibr" rid="B20">Prechtl et al., 2024</xref>). Intrinsic Self-Sensing, which utilizes the changes in the physical properties of EAP material&#x2019;s physical properties (<xref ref-type="bibr" rid="B20">Prechtl et al., 2024</xref>). Although this method eliminates the need for additional components, it requires the separation of the actuation signal from the sensing signal. Currently, this has not yet been achieved with the eR, posing a future challenge.</p>
<p>Realizing artificial muscles with self-sensing actuation capabilities is a highly challenging endeavor. In light of this, we prioritized an initial validation of their accuracy specifically as soft sensors. When using EAP-type artificial muscles solely for sensing, the most significant difference compared to conventional pressure sensors is the non-linear relationship between the external force and capacitance, primarily because of the inherent nonlinearity between stress and strain in elastomers (<xref ref-type="bibr" rid="B33">Wissler and Mazza, 2007</xref>). In this study, using eR, we observed an approximately linear change up to 10&#xa0;N, which corresponds to a strain region of less than 10% across all conditions. However, loads beyond this range exhibit a non-linear distribution. Therefore, we measured changes in &#x394;C with increasing external load to investigate the eR sensor&#x2019;s measurement characteristics. The coefficient of variation remained below 2% and the confidence interval width was within 3%, indicating acceptable precision and accuracy. Even when the sensor was integrated into an insole casing, although the precision slightly decreased, both the precision and accuracy were judged to be within acceptable limits. We also confirmed that a 5th-order polynomial provided the most accurate regression for the load estimation. Because the approximation formula changes with variations in the elastomer temperature, humidity, and repeated loading, we conducted measurements under multiple humidity and temperature conditions, as well as before and after 200,000 durability cycles. The results showed that while a specific relationship equation needs to be established for each sensor and temperature/humidity condition, it is entirely feasible to inversely calculate the load values based on these relationships.</p>
<p>Compared with the standalone eR sensor, the eR sensor placed within the insole casing showed a different rising profile in its load-capacitance curve owing to the gaps present within the insole casing (<xref ref-type="fig" rid="F7">Figures 7</xref>, <xref ref-type="fig" rid="F8">8</xref>). A fifth-order polynomial was found to be the best fit for the load estimation from the eR sensors embedded in the insole casing, a 5th-order polynomial was found to be the best fit. For the load-capacitance curve of the standalone sensor, while the initial increase was linear, the overall non-linear behavior remained unchanged. Similarly, when using a 5th-order polynomial for regression of the standalone sensor, oscillations were observed in the regression curve and actual values below 50&#xa0;N owing to the Runge phenomenon, making this regression unsuitable for that range (<xref ref-type="fig" rid="F10">Figure 10</xref>). Based on these characteristics of the regression curve, the minimum detectable load was set to 50&#xa0;N. When applying eR as a capacitance sensor for other purposes, where the capacitance change behavior might differ, it will be necessary to perform curve regression based on the load and capacitance changes and to determine which curve regression equation provides the best fit. Load estimation using 5th-order polynomial regression is advantageous, as it involves only a continuous process of additions and multiplications with just six parameters. This allows for real-time computation within the insole&#x2019;s circuitry. Compared to machine learning-based load estimation, this method is less prone to delays during the continuous processing required for walking analysis. Furthermore, the 5th-order polynomial regression approach has an extremely small memory footprint, contributing to reduced power consumption of the smart insole.</p>
<fig id="F10" position="float">
<label>FIGURE 10</label>
<caption>
<p>Differences in capacitance-load curve fitting between the standalone sensor and the insole-embedded sensor: The standalone sensor showed the Runge phenomenon during 5th-order polynomial regression <bold>(A,B)</bold>, leading to a discrepancy between actual and estimated load <bold>(C)</bold>.</p>
</caption>
<graphic xlink:href="fbioe-13-1639630-g010.tif">
<alt-text content-type="machine-generated">Panel A consists of two graphs. The first graph displays a standalone sensor&#x27;s capacitance-load curve, showing a steep increase initially and then leveling off, with a regression curve closely following. The second graph, for an embedded sensor, demonstrates a similar pattern. Panel B depicts a graph comparing estimated loads for a standalone sensor and an insole embedded sensor, showing closely aligned linear trends with slight variations.</alt-text>
</graphic>
</fig>
<p>A primary challenge in capacitive pressure sensors is managing the trade-off between high sensitivity and low hysteresis. Our design addresses this by employing a hybrid dielectric structure that pairs a soft elastomer for high sensitivity with a stiffer elastic layer to promote mechanical recovery and mitigate viscoelastic hysteresis. This multi-layer architecture not only reduces hysteresis but also extends the sensor&#x2019;s dynamic range by suppressing capacitance saturation, an approach whose efficacy in improving sensor metrics is supported by the literature (<xref ref-type="bibr" rid="B36">Zhu et al., 2022</xref>; <xref ref-type="bibr" rid="B11">Kumar et al., 2023</xref>). The fabricated sensor demonstrated a hysteresis error of approximately 10% FS. While this value is higher than the sub-1% FS achieved in state-of-the-art devices (<xref ref-type="bibr" rid="B8">Huang et al., 2023</xref>), it is comparable to levels reported for other flexible sensors, such as the 10.3%FS error observed by <xref ref-type="bibr" rid="B27">Shalabi et al. (2022)</xref>. Therefore, we contend that this performance represents an acceptable trade-off for applications that prioritize structural flexibility and a wide dynamic range over ultra-high precision, rendering the sensor well-suited for wearable systems aimed at the early detection of osteoarthritis by monitoring joint loading dynamics.</p>
<p>Over the past decade, several smart insoles have entered the market, spanning a wide price range from low to high (<xref ref-type="table" rid="T12">Table 12</xref>). This diversity is primarily due to differences in their sensor structures and intended applications. Lower-priced insoles are typically limited to specific applications, such as certain golf or running sports. Mid-to high-priced insoles, however, offer a wider range of applications, from gait analysis for research purposes to clinical use as medical devices. Common pressure sensors used in biological monitoring include piezoresistive, piezoelectric, and capacitive sensors (<xref ref-type="bibr" rid="B6">Hammock et al., 2013</xref>), and smart insoles utilizing the unique characteristics of each have been reported for plantar pressure measurement (<xref ref-type="bibr" rid="B24">Santos et al., 2024</xref>). For instance, F-Scan (Tekscan, US) uses piezoresistive sensors but is more suitable for short-term use owing to hysteresis issues (<xref ref-type="bibr" rid="B34">Zhang et al., 2023</xref>). In contrast, there is a growing trend towards smart insoles that adopt capacitive sensing, such as Moticon SCIENCE (Moticon ReGo, Germany) and Pedar (Novel, Germany) (<xref ref-type="bibr" rid="B34">Zhang et al., 2023</xref>). While capacitive sensors have drawbacks such as non-linear response and susceptibility to noise, they are suitable for long-term use owing to their low power consumption, high sensitivity, durability, and low susceptibility to hysteresis. Smart insoles using artificial muscles, such as eR, for capacitive sensing have not yet been reported. Because of the technical challenges, insoles using capacitive sensors are primarily found in the higher price range (<xref ref-type="table" rid="T12">Table 12</xref>). However, the eR Smart Insole is expected to be sold at a low to mid-price point thanks to the mass production of eR sensors and the efficiency improvements in its circuit structure.</p>
<table-wrap id="T12" position="float">
<label>TABLE 12</label>
<caption>
<p>Summary of commercially available smart insole sensors, applications, validation, accuracy, circuit placement, and battery type.</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="left"/>
<th align="center">Product name, manufacturer</th>
<th align="center">Sensors</th>
<th align="center">Applications</th>
<th align="center">Published accuracy/Validation</th>
<th align="center">Circuit placement</th>
<th align="center">Battery Type</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td rowspan="5" align="center">Low price (-$300)</td>
<td align="left">ORPHE TRACK<break/>ORPHE (Tokyo, Japan)</td>
<td align="left">Embedded 6-axis IMU module</td>
<td align="left">Running</td>
<td align="left">ICC &#x3e;0.9 was achieved for multiple items compared to motion capture analysis (<xref ref-type="bibr" rid="B30">Uno et al., 2022</xref>)</td>
<td align="center">External module</td>
<td align="center">Rechargeable (Built-in)</td>
</tr>
<tr>
<td align="left">SALTED Golf Smart Insole<break/>SALTED (Seoul, South Korea)</td>
<td align="left">4-point resistive pressure sensors</td>
<td align="left">Golf</td>
<td align="left">Not disclosed</td>
<td align="center">Integrated</td>
<td align="center">Rechargeable (Built-in)</td>
</tr>
<tr>
<td align="left">A-RROWG<break/>NEC FiNC Technologies (Tokyo, Japan)</td>
<td align="left">IMU</td>
<td align="left">Walking</td>
<td align="left">Not disclosed</td>
<td align="center">Integrated</td>
<td align="center">Rechargeable (Built-in)</td>
</tr>
<tr>
<td align="left">ARION Smart Insoles<break/>ATO-GEAR B.V. (Eindhoven, Netherlands)</td>
<td align="left">8-point resistive pressure sensors &#x2b; IMU</td>
<td align="left">Running</td>
<td align="left">Compared with motion capture analysis during treadmill walking, the average error of the measured items was 0.09%. (<xref ref-type="bibr" rid="B31">Van Hooren et al., 2023</xref>)</td>
<td align="center">External module</td>
<td align="center">Rechargeable (Built-in)</td>
</tr>
<tr>
<td align="left">NURVV Run<break/>NURVV Group (Twickenham, UK)</td>
<td align="left">16-point resistive pressure sensors &#x2b; IMU</td>
<td align="left">Running</td>
<td align="left">Not disclosed</td>
<td align="center">Integrated</td>
<td align="center">Rechargeable (Built-in)</td>
</tr>
<tr>
<td rowspan="3" align="center">Middle price ($500&#x2013;2000)</td>
<td align="left">Stridalyzer PRISM<break/>ReTiSense Technologies (Bangalore, India)</td>
<td align="left">100-point resistive pressure matrix &#x2b; IMU</td>
<td align="left">Gait pressure analysis (clinical and research)</td>
<td align="left">Not disclosed</td>
<td align="center">Integrated</td>
<td align="center">Rechargeable (Built-in)</td>
</tr>
<tr>
<td align="left">PRO-SPECS Smart Insole <break/>LS Networks (Seoul, South Korea)</td>
<td align="left">Dual-chip IMU &#x2b; pressure sensors</td>
<td align="left">Step counting, posture, running data logging</td>
<td align="left">Not disclosed</td>
<td align="center">Integrated</td>
<td align="center">Rechargeable (Built-in)</td>
</tr>
<tr>
<td align="left">Moticon ReGo/OpenGo<break/>Moticon ReGo AG (Munich, Germany)</td>
<td align="left">16-area capacitive textile pressure sensors &#x2b; IMU</td>
<td align="left">Rehabilitation, sports, and gait measurement</td>
<td align="left">Compared with force plate analysis, the correlation of the force-time curve was 0.8 or higher (<xref ref-type="bibr" rid="B28">St&#xf6;ggl and Martiner, 2017</xref>)</td>
<td align="center">Integrated</td>
<td align="center">Replaceable Battery</td>
</tr>
<tr>
<td rowspan="3" align="center">High price ($4,000-)</td>
<td align="left">Loadsol<break/>Novel (Munich, Germany)</td>
<td align="left">Full-surface capacitive force sensor</td>
<td align="left">GRF measurement, rehab, sports science</td>
<td align="left">The mean bias in several items, including ground contact time, impulse, peak force, and time to peak, was &#x3c;3.4%. (<xref ref-type="bibr" rid="B26">Seiberl et al., 2018</xref>)</td>
<td align="center">External module</td>
<td align="center">Replaceable Battery</td>
</tr>
<tr>
<td align="left">F-Scan<break/>Tekscan (Norwood,MA, United States)</td>
<td align="left">954 piezoresistive sensors</td>
<td align="left">Gait analysis, orthotic and footwear evaluation, and Sports biomechanics</td>
<td align="left">ICC&#xa0;0.83&#x2013;0.98, CV&#xa0;2.7%&#x2013;13.4% in test&#x2013;retest reliability during treadmill walking (<xref ref-type="bibr" rid="B18">Patrick and Donovan, 2018</xref>)</td>
<td align="center">Integrated</td>
<td align="center">Rechargeable (Built-in)</td>
</tr>
<tr>
<td align="left">Pedar novel (Munich, Germany)</td>
<td align="left">99&#x2013;183 Capacitive sensors</td>
<td align="left">Clinical and sports gait research, footwear R&#x26;D, diabetic-foot care, rehab load monitoring, and biomechanics teaching</td>
<td align="left">As a result of two measurements taken 1 week apart, 93% of the 160 parameters had a coefficient of variation of 25% or less (<xref ref-type="bibr" rid="B21">Ramanathan et al., 2010</xref>)</td>
<td align="center">Integrated</td>
<td align="center">Rechargeable (Built-in)</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn>
<p>IMU, inertial measurement unit; GRF, ground reaction force; ICC, intraclass correlation coefficients; CV, coefficient of variation.</p>
</fn>
</table-wrap-foot>
</table-wrap>
<p>Accuracy validation is rarely performed for low-priced insoles, leaving their measurement precision and accuracy questionable. While most mid-to high-priced insoles undergo accuracy validation, the methodologies vary among studies. Some compare multiple gait parameters with values obtained from motion capture or force plates using intraclass correlation coefficients, while others assess the reliability of obtained values using the coefficient of variation. This diversity in validation methods makes a straightforward comparison of accuracy between different smart insoles difficult. However, our findings indicate that the measurement characteristics of the eR as an insole sensor are not inferior to those of similar capacitive sensors, demonstrating its potential for application in healthcare devices (<xref ref-type="bibr" rid="B29">Tao et al., 2020</xref>; <xref ref-type="bibr" rid="B7">Ho et al., 2022</xref>; <xref ref-type="bibr" rid="B13">Luna-Perej&#xf3;n et al., 2023</xref>).</p>
<p>A limitation of this study is that the load values were not continuous. Furthermore, even if the stress applied to the elastomer is constant, the capacitance fluctuates over a period, making it impossible to completely exclude hysteresis effects, where slight capacitance changes occur depending on the measurement timing. In addition, because the sensing values changed after the durability test, periodic calibration was necessary. Another limitation of this study is that our investigation was restricted to only three temperature and humidity conditions. However, because the insole inside a shoe generally operates under conditions that approximate these, despite slight variations in temperature and humidity, we believe this does not pose a significant issue for measurement. An additional limitation of this sensing approach is the increased coefficient of variation in sensor readings caused by structural gaps within the insole. As a potential solution, we considered a simplified film-type structure in which foamed urethane is sandwiched between Polyethylene Terephthalate (PET) sheets to suppress such structural variability. However, this design poses concerns regarding long-term durability under external forces. This remains a structural issue that requires further investigation in future studies. Although the eR was developed as a sensing actuator, it currently cannot perform actuation and sensing simultaneously, which requires further improvement.</p>
<p>In conclusion, it has been demonstrated that the eR, originally developed as an actuator, can be effectively utilized as a sensor to inversely calculate the external forces applied to the body, particularly when used as a sensor within an insole casing, based on its characteristic capacitance change. Its accuracy and precision strongly support its potential for applications beyond smart insoles in healthcare fields that require dynamic monitoring, such as gait and finger movement analysis. Furthermore, eR has the potential to be integrated as a sensor in self-sensing artificial muscles.</p>
</sec>
</body>
<back>
<sec sec-type="data-availability" id="s5">
<title>Data availability statement</title>
<p>The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.</p>
</sec>
<sec sec-type="author-contributions" id="s6">
<title>Author contributions</title>
<p>HY: Conceptualization, Data curation, Methodology, Software, Visualization, Writing &#x2013; original draft, Writing &#x2013; review and editing, Funding acquisition. TY: Conceptualization, Writing &#x2013; review and editing, Funding acquisition, Investigation. TF: Writing &#x2013; review and editing, Data curation, Investigation, Methodology, Supervision. YoK: Data curation, Investigation, Methodology, Visualization, Writing &#x2013; original draft. MS: Data curation, Formal Analysis, Funding acquisition, Investigation, Methodology, Software, Supervision, Validation, Writing &#x2013; review and editing. YuK: Writing &#x2013; review and editing. SO: Writing &#x2013; review and editing. SS: Supervision, Writing &#x2013; review and editing. MY: Supervision, Writing &#x2013; review and editing. HH: Supervision, Writing &#x2013; review and editing.</p>
</sec>
<sec sec-type="funding-information" id="s7">
<title>Funding</title>
<p>The author(s) declare that financial support was received for the research and/or publication of this article. This work was supported by JSPS (Japan Society for the Promotion of Science) KAKENHI Grant Number 21H03288, 22K21205, and 24K14378.</p>
</sec>
<ack>
<p>The authors thank Daisuke Matsuda, Nozomu Uesugi, and Tomoyuki Tainaka for their technical assistance with the experiments. We also thank Koji Anada, Haruyasu Mizutani, and Katsuya Sugiyama for their expertise in the application of the e-rubber smart insoles.</p>
</ack>
<sec sec-type="COI-statement" id="s8">
<title>Conflict of interest</title>
<p>Authors TF, YK, and MS were employed by New Value Business, Toyoda Gosei Co., Ltd.</p>
<p>The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.</p>
</sec>
<sec sec-type="ai-statement" id="s9">
<title>Generative AI statement</title>
<p>The author(s) declare that no Generative AI was used in the creation of this manuscript.</p>
<p>Any alternative text (alt text) provided alongside figures in this article has been generated by Frontiers with the support of artificial intelligence and reasonable efforts have been made to ensure accuracy, including review by the authors wherever possible. If you identify any issues, please contact us.</p>
</sec>
<sec sec-type="disclaimer" id="s10">
<title>Publisher&#x2019;s note</title>
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</sec>
<sec sec-type="supplementary-material" id="s11">
<title>Supplementary material</title>
<p>The Supplementary Material for this article can be found online at: <ext-link ext-link-type="uri" xlink:href="https://www.frontiersin.org/articles/10.3389/fbioe.2025.1639630/full#supplementary-material">https://www.frontiersin.org/articles/10.3389/fbioe.2025.1639630/full&#x23;supplementary-material</ext-link>
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