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  <front>
    <journal-meta>
      <journal-title-group>
        <journal-title>Biomedical Signal
Processing: Advances in Theory, Algorithms and Applications</journal-title>
      </journal-title-group>
    </journal-meta>
    <article-meta>
      <title-group>
        <article-title>FPGA-based Hardware Classifier for Diabetic Sensorimotor Polyneuropathy Severity Assessment</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>Sandeep Kumar Pandey</string-name>
          <email>sandeep.avadh@gmail.com</email>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Geetika Srivastava</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Mamun Bin Ibne Reaz</string-name>
          <xref ref-type="aff" rid="aff2">2</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Sawal Hamid Md Ali</string-name>
          <xref ref-type="aff" rid="aff2">2</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Edi Kurniawan</string-name>
          <xref ref-type="aff" rid="aff1">1</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Rabindra Gandhi Thangarajoo</string-name>
          <xref ref-type="aff" rid="aff2">2</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Ganga Ram Mishra</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>SacchidaNand Shukla</string-name>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <aff id="aff0">
          <label>0</label>
          <institution>Dr. Rammanohar Lohia Avadh University</institution>
          ,
          <addr-line>Ayodhya</addr-line>
          ,
          <country country="IN">India</country>
        </aff>
        <aff id="aff1">
          <label>1</label>
          <institution>National Research and Innovation Agency (BRIN) of Indonesia, KST BJ Habibie</institution>
          ,
          <addr-line>South Tangerang</addr-line>
          ,
          <country country="ID">Indonesia</country>
        </aff>
        <aff id="aff2">
          <label>2</label>
          <institution>Universiti Kebangsaan Malaysia</institution>
          ,
          <addr-line>Bangi, Selangor</addr-line>
          ,
          <country country="MY">Malaysia</country>
        </aff>
      </contrib-group>
      <pub-date>
        <year>2020</year>
      </pub-date>
      <volume>3</volume>
      <issue>4</issue>
      <fpage>978</fpage>
      <lpage>981</lpage>
      <abstract>
        <p>At present Diabetic Sensorimotor Polyneuropathy (DSPN) is a fast growing condition among diabetic patients, with potentially severe consequences such as permanent disability and leaving to death in some cases. However, there is hope on the horizon as early detection can prevent the amputation and deaths. Present study proposes an innovative solution for early detection of DSPN severity by the application of Machine Learning (ML) techniques over Electromyography (EMG) signals obtained from various lower limb muscles during gait. These signals provide valuable information about the nerve function and enable us to identify the presence of DSPN at an early stage. To bring this technology to life, a sophisticated neural network is further implemented on a hardware platform Xilinx ZCU102 Field Programmable Gate Array (FPGA) device. The outcomes are promising, with the device accuracy rate of approximately 79% in detecting DSPN. This outcome may pave way for a brighter future in DSPN diagnosis. With continued advancements, this technology has the potential to transform the DSPN diagnosis process in near future, allowing for earlier intervention and better patient outcomes.</p>
      </abstract>
      <kwd-group>
        <kwd>eol&gt;DSPN</kwd>
        <kwd>EMG</kwd>
        <kwd>FPGA</kwd>
        <kwd>ML 1</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>1. Introduction</title>
      <p>
        Diabetes has emerged as a concerning and chronic disease, leading to permanent disabilities
and, unfortunately, even loss of life among patients. One of the disturbing actions of diabetes is
the rise of Diabetic Sensorimotor Polyneuropathy (DSPN) severity, a prevalent condition
affecting individuals worldwide [
        <xref ref-type="bibr" rid="ref1">1</xref>
        ]. DSPN serves as an early warning sign for diabetic foot
ulcers and non-healing wounds [
        <xref ref-type="bibr" rid="ref2 ref3">2, 3</xref>
        ]. Nearly, about half of diabetic patients suffer from DSPN,
and shockingly, half of them are unaware of the symptoms [
        <xref ref-type="bibr" rid="ref4 ref5">4, 5</xref>
        ]. Statistics reveal that 34% of
diabetic patients experience pain sensations, with type 2 diabetes patients exhibit a higher
incidence of painful neuropathic symptoms compared to type 1 diabetes patients. These painful
symptoms not only impact physical and psychological functioning but also contribute to anxiety
and depression.
      </p>
      <p>
        The diagnostic methods for DSPN, such as Vibration Perception Threshold (VPT), Nerve
Conduction Studies (NCS), Neuropathy Disability Score (NDS), Michigan Neuropathy Screening
Instrument, Achilles tendon reflexes, pinprick and temperature sensation, are expensive,
require expertise, and, in some cases, cause discomfort [
        <xref ref-type="bibr" rid="ref6">6</xref>
        ]. While there have been notable
advancements in treating symptomatic pain with the use of drugs, therapeutic options targeting
the underlying pathophysiology of DSPN remain limited. Early detection and prevention play
crucial roles in effectively managing DSPN [
        <xref ref-type="bibr" rid="ref7">7</xref>
        ].
      </p>
      <p>
        To address these challenges, authors proposed an approach: designing a DSPN severity
classifier using Machine Learning (ML) and its hardware implementation. Popularity of ML
techniques in biosignal processing making them ideal for DSPN diagnosis purpose [
        <xref ref-type="bibr" rid="ref8">8</xref>
        ]. Since
DSPN primarily affects lower limb muscles [
        <xref ref-type="bibr" rid="ref9">9</xref>
        ], therefore Electromyography (EMG) signals are
collected from various lower limb muscles during gait and processed using a ML algorithm. This
allows us to develop a DSPN severity classifier, which is then implemented in hardware using
the Xilinx ZCU102 FPGA board. Implemented hardware provided satisfactory accuracy during
testing. In our literature study we found that many studies reported approximately 99%
accuracy in software-based approaches, but as per research resources available no hardware
implemented algorithm has reported such high accuracy. Proposed work paves the way for the
development of a patient-friendly, portable device that can accurately classify patients as
normal or abnormal without the need for extensive expertise or complex procedures.
      </p>
      <p>The remaining part of the paper is organized as follows: discussion about EMG signal
preprocessing and processing using ML algorithms, proposed method, dataset preparation process,
design of the neural network, results and discussion and conclusion.</p>
    </sec>
    <sec id="sec-2">
      <title>2. EMG Signal Pre-Processing</title>
      <p>Electromyography (EMG) is a valuable technique used to study the electrical signals generated
by muscles in the body. By using electrodes, EMG pattern records and measures the electrical
activity produced by different muscles, providing information about their functions and
behavior [10]. In the recording process of EMG signals, two significant factors greatly impact
signal quality: the signal-to-noise ratio and distortion [10, 11, 12]. Addressing these factors is
important to ensure accurate and reliable results. For this, a meticulous approach towards
signal pre-processing is essential. Figure 1 show the key steps involved in the pre-processing of
EMG signals, which plays important role in improving the quality of the recorded EMG signal.</p>
      <sec id="sec-2-1">
        <title>Raw EMG Signal</title>
        <p>from Electrode
2.1.</p>
      </sec>
      <sec id="sec-2-2">
        <title>Amplification</title>
      </sec>
      <sec id="sec-2-3">
        <title>Stage</title>
      </sec>
      <sec id="sec-2-4">
        <title>Rectification</title>
        <p>and Filtration</p>
      </sec>
      <sec id="sec-2-5">
        <title>Segmentation</title>
        <p>The initial stage involves the collection of raw EMG signals using electrodes and their
amplification. Usually, a differential amplifier is used to amplify the signals properly. The raw
signal may be prone to various types of noise, such as low or high-frequency interferences, as
well as other artifacts. To overcome these unwanted disturbances, various processing
techniques are applied to minimize noise and artifacts. Since the amplitude of the EMG signal is
mostly used by researchers and clinicians, therefore further processing steps are used to extract
relevant information. The signal is rectified to change it into a unidirectional waveform,
allowing the analysis of the absolute magnitude of the EMG signal. Additionally, Averaging
techniques are used to obtain a representative measure of the EMG amplitude, providing
important information about muscle activity. In this way recorded EMG signal is preprocessed
to ensure good quality for interpretation and analysis.</p>
      </sec>
    </sec>
    <sec id="sec-3">
      <title>3. EMG Signal Processing Using Machine Learning</title>
      <p>EMG signal processing using ML algorithms involves several steps to extract meaningful
features from it and then classify the signals accurately. Figure 2 shows the stages of EMG
signal processing using ML [13, 14, 15].</p>
      <sec id="sec-3-1">
        <title>Training Dataset</title>
      </sec>
      <sec id="sec-3-2">
        <title>Testing Dataset</title>
      </sec>
      <sec id="sec-3-3">
        <title>Cross</title>
      </sec>
      <sec id="sec-3-4">
        <title>Validation ML Algorithm Output</title>
      </sec>
      <sec id="sec-3-5">
        <title>3.1. Feature Extraction</title>
        <p>Feature extraction is an important step in EMG signal processing, as it involves capturing the
relevant information that can be used for categorization. Various time-domains,
frequencydomain, or time-frequency domain features are extracted using feature extraction techniques
for processing.</p>
      </sec>
      <sec id="sec-3-6">
        <title>3.2. Feature Selection</title>
      </sec>
      <sec id="sec-3-7">
        <title>3.3. Data Augmentation</title>
        <p>The extracted features may contain redundant or irrelevant information. Feature selection
methods employed to identify the most discriminative features that contribute to classification
accuracy. This step helps reduce the dimensionality of data and thereby reduces the
computational complexity.</p>
        <p>It is a technique of artificially increasing the number of data in training set by generating
modified copies of dataset from existing data. It is important for AI applications, as accuracy
increases with the amount of training data.</p>
      </sec>
      <sec id="sec-3-8">
        <title>3.4. Training Data Preparation</title>
      </sec>
      <sec id="sec-3-9">
        <title>3.5. Machine Learning Algorithm Selection</title>
        <p>The pre-processed and normalized features are paired with corresponding labels (class
annotations) to create a labeled training dataset.</p>
        <p>Popular ML algorithms are used for EMG signal classification, such as Support Vector
Machines (SVM), K-Nearest Neighbours (KNN), Random Forests, or Deep Learning models like
Convolutional Neural Networks (CNN) [16]. In proposed work SVM is selected due to its ability
to handle complex decision boundaries and neural networks due to its power of computational
capabilities.</p>
      </sec>
      <sec id="sec-3-10">
        <title>3.6. Model Training</title>
      </sec>
      <sec id="sec-3-11">
        <title>3.7. Model Evaluation</title>
        <p>The ML algorithm is trained on the DSPN dataset to learn the patterns and relationships
between the features and the corresponding classes.</p>
        <p>After training, the performance of the trained model is evaluated using separate validation or
testing datasets. Cross-validation technique is used to obtain more reliable performance
estimates.</p>
      </sec>
      <sec id="sec-3-12">
        <title>3.8. Testing and Deployment</title>
        <p>The designed model is tested on new, unseen EMG signal data to assess its generalization
ability. Then final trained model deployed in real-world applications to classify EMG signals and
aid in the diagnosis or monitoring of conditions of DSPN.</p>
      </sec>
    </sec>
    <sec id="sec-4">
      <title>4. Proposed Method</title>
      <p>Inspired by the work of Muthuramalingam et al. [17], the presented study developed a novel
approach for DSPN diagnosis using a linear Support Vector Machine (SVM) based bi-layered
neural network. This architecture offers the advantage of efficient resource utilization while
achieving promising results with respect to accuracy. In proposed method, the first step
involved is training the SVM using MATLAB, freezing the model and then proceed for hardware
implementation. The SVM was trained on the DSPN training dataset, learning to classify EMG
signals associated with DSPN. SVM provided weighted outputs that captured the discriminative
characteristics of the input signals. To further enhance the accuracy of diagnostic system, the
weighted outputs from the SVM integrated into a bi-layered neural network. The bi-layered
neural network takes the weighted outputs of the SVM as inputs and processes them to
generate the final diagnostic output.</p>
    </sec>
    <sec id="sec-5">
      <title>5. Dataset Preparation</title>
      <p>During the gait cycle, lower limb muscles, namely the Vastus Lateralis (VL), Gastrocnemius
Lateralis (GL), and Tibialis Anterior (TA), are particularly affected [18]. To conduct the study on
Diabetic Sensorimotor Polyneuropathy (DSPN) diagnosis, the EMG data was obtained from the
research conducted by Watari et al. [19]. The dataset comprised 142 samples from 29 patients
without DSPN (considered as the normal condition) and 72 samples from 14 patients with
severe DSPN (considered as the abnormal condition) and did not include samples from patients
with mild or moderate DSPN. To ensure a balanced representation of normal and abnormal
cases, the Synthetic Minority Over-sampling Technique (SMOTE) data augmentation technique
[20, 21] was utilized. By applying SMOTE, the number of samples for the abnormal conditions
increases, bringing them to an equal proportion in the training dataset. By applying Relief
feature selection algorithm [22] on the EMG data obtained from the GL, VL, and TA muscles,
identify the most significant features from each dataset, highlighting the specific aspects of
muscle activity that are indicative of DSPN. Total 19 significant features identified from each
dataset, as illustrated in Figures 3, 4, and 5.</p>
      <p>The SVM classifier was trained using MATLAB 2021. For training total nine features selected
to represent the EMG data. These features were chosen using Relief feature selection
techniques. For the Gastrocnemius Lateralis (GL) data, the three most significant features
selected were GL Enhanced mean Absolute Value, GL Sigma (signal entropy) and GL Zero
crossing. Likewise, for the Vastus Lateralis (VL) data, the three most significant features chosen
were VL Sigma (signal entropy), VL Descriptor SE NCELL and VL Shape factor. Finally, for the
Tibialis Anterior (TA) data, the three most significant features included were TA Final/min, TA
Zero crossing and TA Descriptor SE NCELL. Using this set of nine features, trained a linear SVM
model in MATLAB, which exhibited an accuracy of 82% approximately. The trained SVM model
allowed us to classify the EMG data accurately based on the selected features and their
corresponding weights. This weighted output, which encapsulates the discriminative
information learned by the SVM, serves as valuable input to the neural network for further
analysis and classification.</p>
    </sec>
    <sec id="sec-6">
      <title>6. Neural Network Design</title>
      <p>Using the weighted output from the SVM a bi-layered neural network was designed in
MATLAB. This neural network played a crucial role in further refining the classification process
for DSPN diagnosis. In proposed work, this MATLAB-based neural network achieved an
accuracy of approximately 80%. To extend the applicability of this ML algorithm, it was
implemented in hardware using Vivado Design Suite (version 2022.2) provided by Xilinx. The
neural network's hardware implementation was realized using the Xilinx ZCU102 FPGA board.
This comprehensive hardware integration provided the full potential of the neural network's
computational capabilities in a practical and real-time manner. Figure 6 shows the architecture
of hardware-implemented neural network.</p>
      <p>Additionally, the device package is shown in Figure 7, which encapsulates the hardware
implementation of DSPN severity classifier.</p>
      <p>The proposed study bridges the gap between software and hardware by successfully
translating MATLAB-based neural network into a practical and tangible device. This model
brings us one step closer to a future where improved diagnostic device can assist in the early
detection and prevention of DSPN.</p>
    </sec>
    <sec id="sec-7">
      <title>7. Result and Discussion</title>
      <p>The hardware implementation of DSPN severity classifier on the ZCU102 FPGA board
resulted in an accuracy of approximately 79% while effectively utilizing the available resources.
The satisfactory performance across various metrics like power and latency signifies the
potential of proposed approach in diagnosing DSPN in patients. Although current
implementation focused on classifying patients into DSPN and non-DSPN categories, but there
are more categories in DSPN severity such as mild, moderate and sever. This opens up avenues
for future improvements and upgrades in hardware design. Table 1 presents a resource
utilization report, showing the efficient utilization of resources in presented hardware
implementation. Additionally, Figure 8 provides a graphical representation of the percentage
utilization of resources, showing optimal resource allocation.
16.12%</p>
    </sec>
    <sec id="sec-8">
      <title>8. Conclusion and Future Work</title>
      <p>Early diagnosis plays an effective role in preventing the severity of Diabetic Sensorimotor
Polyneuropathy (DSPN). To accomplish this, a machine learning-based model has been
successfully hardware implemented on the Xilinx ZCU102 FPGA board. Implemented model
achieved accuracy of 79% approximately in binary class classification, indicating its potential
for early diagnosis of DSPN. While design's accuracy is moderate, it should be more to ensure
good quality diagnosis and also the device should classify the severity level. Presented study
encourages to design a model in near future that can identify DSPN patients and also assess the
severity level of their disease. This will enable medical professionals to provide targeted
interventions and personalized treatment plans.</p>
    </sec>
    <sec id="sec-9">
      <title>Acknowledgements</title>
      <p>This research is supported by the ASEAN-India Collaborative Research Project, Department of
Science and Technology, Science and Engineering Research Board (DST-SERB), Govt. of India,
Grant no. CRD/2020/000220 and by Research and Development Scheme, Department of Higher
Education, Government of Uttar Pradesh, India, ref. no.
80/2021/1543(1)/70-4-20214(28)/2021.</p>
    </sec>
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