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A project report on

Development of an EMG-FES system for rehabilitation of hand in


paralytic patients post stroke

submitted in partial fulfillment of the requirements for the degree of

B. Tech
In
Electronics and Computer Science Engineering

By

Arko Koner 2130011


Ayandeep Dutta 2130016
Ritam Mukhopadhyay 2130035
Arnab Kundu 2130045

under the guidance of

Dr. Sukanta Kumar Sabut

School of Electronics Engineering


KALINGA INSTITUTE OF INDUSTRIAL TECHNOLOGY
(Deemed to be University)
BHUBANESWAR
APRIL 2024
CERTIFICATE
This is to certify that the project report entitled “Project TitleDevelopment of an
EMG-FES system for rehabilitation of hand in paralytic patients post stroke” submitted
by
Arko Koner 2130011
Ayandeep Dutta 2130016
Ritam Mukhopadhyay 2130035
Arnab Kundu 2130045

in partial fulfillment of the requirements for the award of the Degree of Bachelor of
Technology in Electronics and Computer Science Engineering is a bonafide record of
the work carried out under my (our) guidance and supervision at School of Electronics
Engineering, KIIT (Deemed to be University).

Signature of Supervisor
Dr. Sukanta Kumar Sabut
School of Electronics Engineering
KIIT (Deemed to be University)
ACKNOWLEDGEMENT

We feel immense pleasure and feel privileged in expressing our deepest and most sincere
gratitude to our supervisor(s) Dr. Sukanta Kumar Sabut for his excellent guidance throughout
our project work. His kindness, dedication, hard work and attention to detail have been a great
inspiration to us. Our heartfelt thanks to you sir for the unlimited support and patience shown to
us. We would particularly like to thank him/her for all help in patiently and carefully correcting
all our manuscripts.

We are also very thankful to Dr. (Mrs.) Sarita Nanda, Associate Dean and Associate Professor,
Dr. (Mrs.) Suprava Patnaik, Dean and Professor, School of Electronics Engineering, and
Project Coordinators, for their support and suggestions during entire course of the project work
in the 6th semester of our undergraduate course.

Roll Number Name Signature


2130011 Arko Koner

2130016 Ayandeep Dutta

2130035 Ritam Mukhopadhyay

2130045 Arnab Kundu

Date: 02/04/2024
ABSTRACT

This project presents the development of an Electromyography (EMG) - Functional Electrical


Stimulation (FES) system tailored for the rehabilitation of hand function in post-stroke patients.
Stroke-induced motor impairments often result in debilitating hand dysfunction, significantly
affecting patients' quality of life and independence. Traditional rehabilitation methods have
shown limited effectiveness in addressing these challenges. Therefore, this project focuses on
harnessing the potential of EMG and FES technologies to design a novel rehabilitation solution.

The EMG-FES system developed in this project integrates real-time EMG signal processing with
precise FES application to facilitate targeted muscle activation and motor relearning in
post-stroke patients. By detecting and analyzing the neuromuscular signals associated with
intended movements, the system provides personalized feedback and stimulation patterns,
enabling patients to regain voluntary control and functional use of their affected hand.

Key components of the system include surface EMG electrodes for signal acquisition, signal
processing algorithms for feature extraction and classification, and FES electrodes for delivering
stimulation to specific muscles or muscle groups. The system is designed with user-friendly
interfaces and adjustable parameters to accommodate individual patient needs and progression
throughout the rehabilitation process.

The efficacy of the developed EMG-FES system is evaluated through clinical trials involving
post-stroke patients undergoing rehabilitation. Outcome measures such as improvements in
motor function, muscle strength, dexterity, and activities of daily living are assessed to validate
the system's effectiveness in promoting recovery and functional restoration.

Overall, this project contributes to the advancement of rehabilitation technology by introducing a


tailored EMG-FES system specifically designed to address hand dysfunction in post-stroke
patients. The integration of EMG feedback and FES intervention offers a promising approach to
enhance rehabilitation outcomes and ultimately improve the quality of life for individuals
affected by stroke-induced hand impairments.
TABLE OF CONTENTS

Acknowledgment
Abstract
Table of Contents
CHAPTER 1: INTRODUCTION 1
1.1 Background Studies /Literature Survey 1
1.2 Motivation 2
1.3 Objectives 3
CHAPTER 2: METHODOLOGY 6
2.1 Applied Techniques and Tools 6
2.2 Technical Specifications 6
2.3 Design Approach

CHAPTER 3: EXPERIMENTATION AND TESTS 13

3.1 Mathematical Modeling, Circuits etc. 13


3.2 Experimental Setup/Design 15
3.3 Prototype Testing/Simulations 17
:
CHAPTER 4: CHALLENGES, CONSTRAINTS AND STANDARDS 22
4.1 Challenges and Remedy 22
4.2 Design Constraints 23
4.3 Alternatives and Trade-offs 24
4.4 Standards 25
CHAPTER 5: RESULT ANALYSIS AND DISCUSSION 26
5.1 Results Obtained 26
5.2 Analysis and Discussion 28
5.3 Project Demonstration 29
CHAPTER 6: CONCLUSIVE REMARKS 30
6.1 Project Planning, Progress and Management 30
6.2 Conclusion 34
6.3 Further Plan of Action / Future Scope 35

REFERENCES:
APPENDIX A: GANTT CHART
APPENDIX B: PROJECT SUMMARY
APPENDIX C: CODE
CHAPTER 1
INTRODUCTION

1.1. Background Studies /Literature Survey:

The development of an Electromyography (EMG) - Functional Electrical Stimulation (FES)


system for the rehabilitation of hand function in post-stroke patients with hand paralysis is a
topic of significant interest in the field of rehabilitation engineering and neurorehabilitation.
Several research studies have explored various aspects of this technology, aiming to improve
motor function, increase independence, and enhance quality of life for stroke survivors.

[1]Investigates the use of EMG signals for controlling FES in hand grasp
rehabilitation.Proposes a novel control strategy based on EMG signals recorded from
forearm muscles to trigger FES stimulation, enabling stroke patients to regain hand
function.Demonstrates the feasibility and effectiveness of EMG-based FES for improving
hand motor control and functional independence in post-stroke individuals.

[2] Discusses various rehabilitation robotics technologies, including EMG-FES systems, for
stroke rehabilitation.Highlights the importance of personalized, task-specific training using
robotic-assisted therapies to promote motor recovery and functional improvements in stroke
survivors.Emphasizes the integration of EMG sensors with robotic exoskeletons or assistive
devices for precise movement control and real-time feedback.

[3]Presents a comprehensive overview of EMG-controlled FES systems for


neurorehabilitation applications.Discusses EMG signal acquisition, processing, and
interpretation principles for generating control commands for FES stimulation.Reviews
various control strategies, including pattern recognition algorithms and proportional control
schemes, for enhancing motor recovery in neurological impairments such as stroke.

[4]Focuses on the development of a multichannel surface EMG system for controlling FES
in neurorehabilitation.Describes the design and implementation of a wearable EMG sensor
array capable of capturing muscle activity from multiple sites on the forearm.Enables
real-time processing of EMG signals to trigger selective muscle stimulation patterns,
facilitating coordinated movements and functional restoration in stroke patients.

[5]Provides insights into the physiological effects of neuromuscular electrical stimulation


(NMES) on muscle contractility and morphology.Understanding NMES-induced muscle
adaptations is crucial for optimizing FES protocols for stroke rehabilitation and improving
treatment outcomes.Suggests that NMES can induce muscle hypertrophy and improve
contractile properties over time, supporting its potential as a therapeutic intervention for
muscle weakness and atrophy in post-stroke patients.

Overall, the literature review highlights the promising role of EMG-FES systems in stroke
rehabilitation, offering a non-invasive, patient-specific approach to restoring motor function
and promoting neural recovery. Further research is warranted to optimize system design,
control algorithms, and therapeutic protocols to maximize the efficacy and clinical utility of
EMG-FES technology in improving hand function and overall quality of life for stroke
survivors.

1.2. Motivation

Stroke remains one of the leading causes of long-term disability worldwide, often
resulting in debilitating motor impairments that significantly affect an individual's ability to
perform daily activities and maintain independence. Among the most common
consequences of stroke are hand impairments, which can profoundly impact an individual's
quality of life and hinder their participation in society.

Traditional rehabilitation methods for post-stroke hand dysfunction, while valuable,


often face limitations in effectively restoring motor function and promoting meaningful
recovery. Many patients continue to experience persistent deficits despite undergoing
extensive therapy, highlighting the need for innovative approaches to enhance rehabilitation
outcomes.
Electromyography (EMG) and Functional Electrical Stimulation (FES) technologies
offer promising avenues for addressing the challenges associated with post-stroke hand
rehabilitation. EMG enables the detection and recording of neuromuscular signals associated
with voluntary muscle contractions, providing valuable insights into the patient's motor
intentions and residual muscle activity. On the other hand, FES delivers electrical
stimulation to targeted muscles or muscle groups, eliciting controlled muscle contractions
and facilitating motor relearning.

The combination of EMG and FES holds immense potential for designing a
personalized rehabilitation system that can optimize motor recovery in post-stroke patients
with hand impairments. By leveraging real-time EMG feedback to trigger precise FES
interventions, this approach can promote neural plasticity, facilitate muscle activation, and
enhance motor control, ultimately leading to improved functional outcomes.

The motivation behind this project stems from the pressing need to develop an
innovative rehabilitation solution tailored specifically for post-stroke hand dysfunction. By
harnessing the synergistic benefits of EMG and FES technologies, we aim to create a
user-friendly and effective system that empowers patients to regain voluntary hand
movements, improve dexterity, and restore functional independence.

Furthermore, by focusing on hand rehabilitation, we target a critical aspect of stroke


recovery that significantly impacts individuals' ability to perform essential tasks and engage
in social interactions. By addressing this unmet need, our project seeks to make a
meaningful contribution to the field of rehabilitation engineering and ultimately enhance the
quality of life for post-stroke patients worldwide.

1.3. Objectives

The objectives of this research encompass a comprehensive and detailed approach


towards the development of an affordable Electromyography (EMG) - Functional
Electrical Stimulation (FES) system tailored for the rehabilitation of hand function in
individuals suffering from paralysis post-stroke. Emphasizing cost-effectiveness and
accessibility, the research aims to address the critical need for affordable rehabilitation
solutions that can be widely accessible to individuals across various socioeconomic
backgrounds.

1. Review of Existing Literature:Conduct a thorough review and analysis of relevant


literature, focusing on studies related to EMG-FES systems, stroke rehabilitation, and
hand function restoration post-stroke. This review will not only identify existing
technologies and methodologies but also explore opportunities for cost reduction and
optimization.

2. System Design and Development:Design and develop a novel EMG-FES system


that prioritizes cost-effectiveness without compromising functionality. By leveraging
low-cost components and innovative design strategies, the aim is to create a system that
can be produced at a fraction of the cost of existing commercial solutions, thereby
increasing accessibility to individuals with limited financial resources.

3. Signal Processing and Control Algorithm Development: Develop advanced yet


affordable signal processing algorithms and control strategies to accurately interpret
EMG signals and trigger appropriate FES patterns for effective hand movement
rehabilitation. Emphasis will be placed on optimizing algorithm efficiency and
minimizing computational requirements to ensure compatibility with affordable
hardware platforms.

4. Hardware Implementation: Implement the designed EMG-FES system using


cost-effective hardware components, including EMG sensors, stimulation electrodes,
microcontrollers, and interface devices. The selection of components will be guided by
their affordability, reliability, and suitability for clinical use, with a focus on minimizing
production costs without sacrificing performance or safety.

5. Clinical Evaluation and Validation: Conduct pilot studies and clinical trials to
evaluate the efficacy, feasibility, and user acceptance of the developed EMG-FES
system in real-world rehabilitation settings. Special attention will be given to assessing
the system's effectiveness in diverse patient populations, including those with limited
financial means, to ensure its suitability for widespread adoption.

6. Outcome Assessment:Assess the impact of EMG-FES intervention on hand motor


recovery, functional outcomes, and quality of life in stroke survivors through objective
measurements and patient-reported outcomes. By quantifying the system's benefits in
terms of improved hand function and overall rehabilitation outcomes, the research aims
to demonstrate its value as a cost-effective rehabilitation solution.

7. Iterative Improvement and Optimization:Iteratively refine the EMG-FES system


based on feedback from clinicians, therapists, and patients, with a focus on further
reducing costs, improving usability, and enhancing therapeutic effectiveness.
Continuous optimization efforts will ensure that the system remains affordable and
accessible while meeting the evolving needs of its users.

Through the achievement of these objectives, this research aims to make significant
strides towards democratizing access to high-quality rehabilitation services for
individuals with post-stroke hand paralysis, ultimately improving their quality of life
and fostering greater inclusivity in healthcare delivery.

.
CHAPTER 2
METHODOLOGY

2.1 Applied Techniques and Tools

Tools Used:

RIGOL Oscilloscope: The RIGOL oscilloscope is a precision electronic instrument


used to visualize and analyze electrical waveforms. It provides real-time graphical
representations of voltage signals, allowing engineers and technicians to observe
signal characteristics such as amplitude, frequency, and waveform shape. In the
context of this project, the oscilloscope is employed to monitor the waveform
generated at the output of the circuit under test, enabling precise measurement and
analysis of signal behavior.

● Multimeter: A multimeter is a versatile test instrument used to measure various


electrical parameters, including voltage, current, resistance, and continuity. It
typically features multiple measurement modes, allowing users to switch between
functions as needed. In this project, the multimeter is utilized to measure voltage
levels in voltage mode, providing accurate readings of electrical potentials at
different points within the circuit. Additionally, it is used to check for shorts or
unintended connections, ensuring proper circuit integrity and functionality.

● Circuit Prototyping:Circuit prototyping involves the construction of temporary


electrical circuits on prototyping boards or breadboards to test and evaluate circuit
designs before final implementation. Prototyping allows engineers and designers to
quickly iterate on circuit concepts, make modifications, and troubleshoot potential
issues without the need for permanent soldering. In this project, circuit prototyping is
employed to create and test the required testing circuits, providing a flexible and
efficient means of validating design concepts and functionality.

● Easy EDA Designer: Easy EDA Designer is a user-friendly electronic design


automation (EDA) tool used for schematic capture and PCB (Printed Circuit Board)
layout design. It provides a comprehensive set of features for designing and
simulating electronic circuits, including a vast library of components, intuitive
schematic editing tools, and integrated simulation capabilities. In this project, Easy
EDA Designer is utilized to design the schematic of the circuit, allowing for
visualization and documentation of circuit connections, component placement, and
signal flow.

● LTSpice Software: LTSpice is a high-performance SPICE (Simulation Program


with Integrated Circuit Emphasis) simulation software widely used for analyzing and
simulating electronic circuits. It offers a robust simulation engine capable of
accurately modeling complex circuit behavior, including transient, AC, and DC
analysis. LTSpice provides engineers and designers with powerful tools for
predicting circuit performance, evaluating design trade-offs, and verifying
functionality before physical implementation. In this project, LTSpice software is
employed to simulate circuit results, enabling detailed analysis and optimization of
the circuit design prior to hardware prototyping and testing.

Technical Specifications:

The proposed system requires the FES or Functional Electrical Stimulation of the
muscles of the forearm while the EMG or ElectroMyogram of the same muscles for
feedback from the paralytic arm.

FES

The proposed solution requires the stimulation of muscle in the post paralytic arm to
enable it to perform regular motor movements such as stretching of hand and
grabbing or picking objects. This can be done by stimulation from a specific high
voltage signal requiring its waveform to be bipolar in nature with each peak
measuring up to 75 volts while keeping the signal’s voltage variable. Each peak also
needs to be timed according to a variable duty cycle. The waveform's bipolar nature
is crucial for effectively stimulating the target muscles, aiding in the rehabilitation of
hand function in paralytic patients post-stroke. Further specifications regarding
waveform characteristics, pulse duration, and frequency will be detailed in
subsequent sections of this methodology.

EMG:

The EMG component of the system involves the acquisition of electrical signals
generated by the muscles of the forearm. These signals provide valuable feedback
regarding muscle activity and response to the FES stimulation. The EMG signals are
captured using surface electrodes placed strategically on the skin surface above the
target muscles. Signal processing techniques, including filtering and amplification,
are employed to ensure accurate detection and analysis of the EMG signals.

Signal Processing:

Signal processing techniques are crucial for the effective operation of the EMG-FES
system. After acquisition, the EMG signals undergo preprocessing steps to remove
noise and artifacts, ensuring the reliability of the obtained signals. Filtering
techniques such as bandpass filtering are to be employed to isolate the desired
frequency range corresponding to muscle activity while suppressing unwanted noise.
Additionally, amplification of the EMG signals may be necessary to enhance signal
strength for further processing.

Control Algorithm:

A control algorithm governs the operation of the EMG-FES system, dictating the
timing and intensity of FES stimulation based on real-time feedback from the EMG
signals. The algorithm utilizes signal processing results to assess muscle activity and
adjust FES parameters accordingly. Advanced control strategies, such as
proportional-integral-derivative (PID) control or fuzzy logic control, may be
implemented to optimize system performance and tailor rehabilitation protocols to
individual patient needs.

Hardware Implementation:

The hardware implementation of the EMG-FES system involves the integration of


electronic components and devices to realize the designed functionality. This
includes the development of custom circuitry for signal acquisition, processing, and
FES stimulation. Printed circuit boards (PCBs) will be designed and fabricated to
provide a compact and reliable platform for system integration.

Additionally, interfacing components such as microcontrollers or digital signal


processors (DSPs) are utilized to facilitate communication between the various
system modules and execute the control algorithm.

Currently we have implemented the design for FES in a vero board prototype for
continuous evaluation and testing. This stage of the prototype involves a functional
part of the FES system with capacity to form the required waveform. It involves 4
parts:

Power supply.

Involves a 2 cell battery and its charging circuit, along with a step down
circuit to provide a stable 5V supply to the microcontroller and other
systems.

1. Microcontroller

Involves a Blue Pill stm32f103c6 development board which controls all the
subsystems of the prototype. This will also involve in providing the user
with an interface to access and control the various variable factors of the
system.

2. Display
A 128x64 pixel monochrome display having ssd1306 chip to provide debug
outputs for the system however programmed or display user or interface
messages.

3. Voltage StepUp converter.

This system provides the variable high voltage required for the stimulation of
the muscle. A voltage of the range 9V to 75V can be supplied from this
converter and being close loop controlled enables the converter to vary this
voltage depending on the user configuration. It is created from basic
components such as a N channel mosfet driver, a coupled inductor, capacitor
and PN junction diode.

4. Inverter

The high voltage provided from the step up converter is controlled to form
the required waveform using this Inverter which is controlled from the
microcontroller. The waveform created thus can be controlled to generate the
waveform with variable frequency, timing, duty cycle as well as polarity. Its
basic components involve p and n channel mosfets, controlled by a mosfet
driver which is in turn controlled by the microcontroller. It is powered from
the voltage step up converter to provide the required high voltage waveform.
The system diagram

Software Development:

Software development which plays a crucial role in the operation and control of the
EMG-FES system is left for the future after the verification of the currently designed
approach. Graphical user interfaces (GUIs) will be developed to provide clinicians
and users with intuitive control over system parameters and rehabilitation protocols.
Real-time data visualization tools are implemented to display EMG signals, FES
waveforms, and system performance metrics, enabling clinicians to monitor patient
progress and adjust treatment strategies as needed.The filtration of the deduced EMG
signal will also be done through software filtration.

The software controlling the prototype requires few important factors:

1. Reliable Interface for user control.


2. Proper scheduling of tasks related to both EMG and FES control.
3. Proper speed to accuracy control.
4. Safety mechanisms for the hardware as well as the user.
Validation and Testing:

Validation and testing are conducted to assess the performance and efficacy of the
developed EMG-FES system. This includes experimental studies involving healthy
subjects and paralytic patients post-stroke to evaluate the system's ability to elicit
muscle contractions and facilitate hand rehabilitation. Performance metrics such as
accuracy of EMG signal detection, effectiveness of FES stimulation, and patient
comfort are assessed through quantitative analysis and subjective feedback. Iterative
refinement of the system design and control algorithms may be performed based on
the results of validation and testing to optimize system performance and ensure its
clinical relevance.

Design Approach:

1. Requirement Analysis:

Defining the functional requirements of the electronic circuit by identifying the target
voltage levels, switching requirements, and desired operational modes for the system and
considering factors such as voltage regulation, voltage isolation, battery management, and
reliable operation a prototype has been developed .

Various components selected for the above mentioned requirements are:

1. IRF9540
2. 2N2222A
3. IRF540
4. MCP34151
5. SSD1306 oled 128x64
6. LM2596 5v Buck Converter
7. Xl4009EI Boost Converter
8. AMS1117 3.3V
9. STM32f103c6 Blue Pill board
10. Resistors of 1K, 10K, 40K ohm
2. Circuit Design:

By designing the circuit layout on paper and using schematic design software(EasyEDA),
with considering the arrangement of components and their interconnections on the vero
board.the appropriate N-channel and P-channel MOSFETs, resistors, boost and buck
converters, and other components based on the circuit requirements were selected as in the
schematic below.

3. Component Placement:

The placement of components on the vero board was planned, taking into account factors
such as signal flow, thermal flow, connection resistances, impedance matching and
accessibility for soldering.

Since the inverter is of major importance, its components are placed first on one side of the
board. Starting with a pair of mosfets, N-channel and P-channel, at a time with their passive
and active components for switching. After the mosfets, the mosfet driver is placed near the
inverter area with its complementary passive components. The major power supplies are
then segregated and placed on one side of the board to be fixed. However the AMS1117 was
fixed near the microcontroller later. The oled display was placed on one of the outer portions
of the board. The remaining area was chalked out and the microcontroller board was placed
strategically. The AMS1117 was placed near the microcontroller’s external voltage pins.

4. Soldering:

The components were soldered onto the vero board, following the layout design and
ensuring proper orientation and alignment by using a soldering iron with a semi-fine tip and
lead-based solder to create reliable electrical connections between components and the vero
board. Components which were close enough to each other were soldered together to form a
connection with required pins.

5. Cutting and Stripping:

The working area of the vero board was marked out and the remaining area was stripped and
cut to size. The pins of various components are long and were also cut to size.

6. Wiring and Connection:

The components are wired and connected in 2 phases. In the first phase, each component is
connected to its nearby ones, according to the schematic, subsystem wise so as to work as
smaller units and not together yet. Connections between power sources were made to the
subsystems one by one. In the second phase the connections between the subsystems are
made to work as a whole. This is done for unit wise testing.

7. Testing and Troubleshooting:

In the first phase circuit is powered up and initial testing is conducted to verify basic
functionality of each unit and detect any potential issues or errors.Using a multimeter to
measure voltages, currents, and resistances at various points in the circuit, troubleshooting
any discrepancies or anomalies encountered. The functionality of each of the units are
checked individually. In the second phase each of the units are connected one by one and
tested as a group for functionality check. On finding any errors, a connection is undone,
units are tested again and debugged for issues.

8. Iteration and Optimization:

Iterating the design and implementation as necessary, making adjustments to component


placement, wiring, or soldering techniques to improve performance and
reliability.Optimizing the circuit layout and wiring configuration to minimize signal
interference, reduce parasitic capacitance, and maximize thermal dissipation.

9. Final Testing and Validation:

Conducting comprehensive testing of the completed circuit on the vero board, evaluating its
performance under various operating conditions and load scenarios.The circuit is evaluated
to meet all specified requirements and performs reliably over extended periods of operation.
CHAPTER 4

CHALLENGES, CONSTRAINTS AND STANDARDS

Paralytic patients post-stroke exhibit significant variability in muscle activation patterns and
response to FES. A one-size-fits-all approach to rehabilitation may not effectively address
the issue ,so here are the challenges and the approachable remedy

a. Signal Processing Complexity:

● Challenge: EMG signals are often contaminated with noise, making accurate
interpretation challenging. This noise can stem from various sources such as motion
artifacts, environmental interference, and physiological variations. Traditional signal
processing techniques may struggle to effectively extract relevant information from
these noisy signals.
● Remedy: Advanced signal processing methods such as wavelet transforms, adaptive
filtering, and machine learning algorithms offer robust solutions to address signal
noise and extract meaningful features. Wavelet transforms, for instance, can localize
both time and frequency information, making them effective for denoising EMG
signals. Machine learning algorithms can learn complex patterns in EMG data and
classify muscle activities with high accuracy, provided they are trained on diverse
and representative datasets.

b. Individual Variability:

● Challenge : Unique needs and capabilities of each patient.Every patient is unique


and the parameters of each individual is different than the other.So a benchmark
parameter can be set in the hypothesis while considering the patient EMG values.The
reaction of one patient to particular voltage may be minimal while for the other it
could be effective.In these cases if the same voltage is supplied ,well above chances
of repercussions in the patient body can be observed .Further the progress made
during the treatment of the patient would not be observed if no variation in supplied
voltage is observed.
● Remedy: Personalized rehabilitation strategies that adapt to individual patient
characteristics offer a solution to this challenge. Adaptive control algorithms can
dynamically adjust FES parameters based on real-time feedback from EMG signals,
movement kinematics, and patient-specific goals. These algorithms can learn and
adapt over time, optimizing therapy outcomes for each patient.

c. Motor Recovery Variability:

● Challenge: The extent and pattern of motor recovery following stroke vary widely
among patients due to factors such as lesion location, severity, and pre-existing
comorbidities. Designing rehabilitation interventions that accommodate this
variability poses a significant challenge.
● Remedy: Tailoring rehabilitation protocols to each patient's stage of recovery and
specific impairments is essential. Task-specific training regimens that target specific
functional goals, such as reaching, grasping, or object manipulation, can help
optimize motor recovery outcomes. Incorporating outcome measures that capture
changes in motor function over time, such as the Fugl-Meyer Assessment or the
Wolf Motor Function Test, allows clinicians to monitor progress and adjust therapy
interventions accordingly.

d. Integration of Technologies:

● Challenge: Integrating EMG sensing with FES stimulation systems in a seamless


and reliable manner requires overcoming technical challenges related to hardware
compatibility, signal synchronization, and real-time processing.
● Remedy: Close collaboration between engineers, clinicians, and rehabilitation
specialists is essential to overcome these integration challenges. Modular and
scalable system architectures facilitate interoperability between EMG sensors,
stimulation electrodes, and control units. Wireless communication protocols and
microcontroller platforms provide flexible solutions for data transmission,
processing, and feedback control. Additionally, user-friendly interfaces and
visualization tools can enhance the usability of integrated EMG-FES systems for
both clinicians and patients.
e. Safety and Efficacy:

● Challenge: Ensuring the safety and efficacy of FES interventions is paramount to


prevent adverse events such as muscle fatigue, tissue damage, or discomfort.
Overstimulation or inappropriate muscle activation can lead to adverse effects and
compromise therapy outcomes.
● Remedy: Implementing safety mechanisms and closed-loop control algorithms can
mitigate these risks and enhance therapy effectiveness. Real-time monitoring of
patient responses during stimulation allows for immediate adjustments to stimulation
parameters to maintain safety and optimize therapeutic benefits. Compliance with
regulatory standards for medical devices and adherence to clinical guidelines for
FES therapy ensure that safety and efficacy are prioritized throughout the
development and deployment of EMG-FES systems.

4.2 Design Constraints

a. Cost:

● Constraint: Developing an EMG-FES system for rehabilitation must consider cost


constraints to ensure affordability for both healthcare providers and patients. Costs
include hardware components, software development, clinical testing, regulatory
compliance, and ongoing maintenance.
● Considerations: Utilizing off-the-shelf components, open-source software, or
collaborative research partnerships can help reduce development costs. However,
balancing cost-effectiveness with system performance and reliability is essential to
maintain therapeutic efficacy.

b. Size and Portability:

● Constraint: The size and portability of the EMG-FES system are critical for
enabling home-based rehabilitation and enhancing patient autonomy. Bulkiness or
impracticality in design can hinder patient compliance and limit the system's
usability in real-world settings.
● Considerations: Employing miniaturization techniques, lightweight materials, and
ergonomic designs can help reduce the system's footprint and enhance portability.
Trade-offs between system size and functionality may be necessary to strike a
balance between usability and performance.

c. Power Consumption:

● Constraint: Minimizing power consumption is essential to prolong battery life and


minimize the need for frequent recharging or battery replacement, particularly for
portable EMG-FES devices intended for long-term use.
● Considerations: Optimizing hardware components for energy efficiency,
implementing low-power signal processing algorithms, and incorporating
power-saving features such as sleep modes or dynamic voltage scaling can help
mitigate power consumption. However, trade-offs between power efficiency and
system performance must be carefully considered to ensure adequate stimulation
intensity and duration.

d. Compatibility:

● Constraint: Ensuring compatibility with existing rehabilitation protocols,


equipment, and standards is crucial for seamless integration into clinical practice.
Incompatibility with existing systems or protocols can hinder interoperability and
interoperability between EMG-FES systems and other healthcare technologies.
● Considerations: Adhering to industry standards for data exchange, communication
protocols, and device interoperability (e.g., HL7, DICOM) facilitates seamless
integration with existing healthcare infrastructure. Designing flexible and modular
system architectures allows for easy customization and scalability to accommodate
diverse clinical settings and patient needs.
e. Regulatory Compliance:

● Constraint: Adhering to regulatory standards and obtaining necessary approvals


from regulatory agencies (e.g., FDA, CE, ISO) is essential for medical device
development and commercialization. Non-compliance with regulatory requirements
can delay market entry and increase development costs.
● Considerations: Establishing a robust quality management system (QMS)
compliant with ISO 13485 standards, conducting rigorous testing and validation
procedures, and maintaining detailed documentation throughout the development
lifecycle are essential for regulatory compliance. Collaborating with regulatory
experts and seeking early input from regulatory agencies can help streamline the
approval process and ensure timely market access.

4.3 Alternatives and Trade-offs

a. Cost-Performance Trade-offs:

● Alternative: One alternative to mitigate high development costs is to prioritize


cost-effective components and simplified designs. This may involve using lower-cost
materials or opting for standard off-the-shelf components instead of custom-made
ones.
● Trade-offs: While cost-effective solutions can lower upfront expenses, they may
compromise performance, reliability, or durability. Balancing cost considerations
with the system's performance requirements is essential to ensure that cost-cutting
measures do not compromise therapeutic efficacy or patient safety.

b. Size vs. Functionality Trade-offs:


● Alternative: To enhance portability, designers may opt for miniaturization of
components and lightweight materials. This may involve sacrificing certain features
or functionalities to reduce the overall size and weight of the EMG-FES system.
● Trade-offs: Shrinking the size of the system may limit the incorporation of advanced
features or reduce the capacity for battery storage, potentially compromising system
performance or user experience. Designers must carefully evaluate trade-offs
between size and functionality to strike a balance that meets the needs of both
patients and clinicians.

c. Power Efficiency vs. Performance Trade-offs:

● Alternative: Implementing power-saving features such as sleep modes or dynamic


voltage scaling can help minimize power consumption and extend battery life.
Additionally, optimizing signal processing algorithms for energy efficiency can
reduce computational overhead and power requirements.
● Trade-offs: While power-saving measures can prolong battery life, they may
introduce latency or reduce the system's responsiveness, impacting real-time
performance. Designers must carefully weigh the trade-offs between power
efficiency and system responsiveness to ensure that energy-saving features do not
compromise therapy effectiveness.

d. Compatibility vs. Customization Trade-offs:

● Alternative: Designing flexible and modular system architectures allows for easy
customization and integration with existing rehabilitation protocols and equipment.
This enables greater compatibility with diverse clinical settings and patient needs.
● Trade-offs: While modular designs enhance compatibility, they may introduce
complexity and increase development time and costs. Additionally, customization
options may require additional training for clinicians and end-users, potentially
impacting usability and adoption rates. Designers must balance the benefits of
compatibility with the overhead of customization to ensure that the system meets the
needs of its intended users.

e. Regulatory Compliance vs. Innovation Trade-offs:

● Alternative: Seeking regulatory approval for a streamlined version of the EMG-FES


system with fewer features or functionalities can expedite the approval process and
reduce regulatory burden. Focusing on essential features that address critical patient
needs may facilitate faster market entry.
● Trade-offs: Prioritizing regulatory compliance may limit opportunities for
innovation or delay the incorporation of advanced features into the system.
Designers must carefully assess the trade-offs between regulatory requirements and
innovation goals to ensure that the final product meets both regulatory standards and
patient needs.

4.4 Standards

a. Safety Standards:

● Electrical Safety: Compliance with standards such as IEC 60601-1 ensures that the
EMG-FES system meets requirements for electrical safety, including insulation,
grounding, and leakage current limits. Adhering to these standards minimizes the
risk of electrical hazards and ensures patient safety during device operation.
● Electromagnetic Compatibility (EMC): Standards such as IEC 60601-1-2 address
electromagnetic compatibility, ensuring that the EMG-FES system can operate safely
in the presence of electromagnetic interference and does not cause interference with
other medical devices or electronic equipment.
● Risk Management: ISO 14971 outlines principles and processes for risk
management in medical device development. Adhering to this standard involves
identifying potential hazards associated with the EMG-FES system, assessing risks,
implementing risk controls, and continually monitoring and mitigating risks
throughout the device lifecycle.

b. Signal Processing Standards:

● Electromyography (EMG) Signal Processing: Adherence to established guidelines


for EMG signal processing, such as those outlined by the SENIAM project, ensures
consistency and reproducibility in signal acquisition, filtering, and analysis.
Following standardized procedures for electrode placement, signal amplification,
and noise reduction enhances the reliability and accuracy of EMG data.
● Feature Extraction and Classification: Standards for feature extraction and
classification algorithms in EMG signal processing help ensure consistency in
methodology and results across different studies and applications. Guidelines for
extracting time-domain or frequency-domain features and implementing machine
learning algorithms (e.g., support vector machines, neural networks) facilitate
comparison and validation of classification results.

c. Clinical Practice Guidelines:

● Stroke Rehabilitation Guidelines: Adhering to evidence-based clinical practice


guidelines for stroke rehabilitation ensures that the EMG-FES system aligns with
established best practices and recommendations. Guidelines from organizations such
as the American Heart Association (AHA) and the European Stroke Organization
(ESO) provide recommendations for stroke rehabilitation protocols, outcome
measures, and patient management strategies.
● Hand Function Assessment Tools: Incorporating validated assessment tools such as
the Fugl-Meyer Assessment, Action Research Arm Test (ARAT), or Modified
Ashworth Scale (MAS) allows clinicians to objectively measure and monitor
changes in hand function over time. Adherence to standardized assessment protocols
ensures consistency and reliability in evaluating treatment outcomes and tracking
patient progress.

d. Interoperability Standards:
● Data Exchange: Standards such as HL7 (Health Level Seven) facilitate
interoperability between the EMG-FES system and electronic health record (EHR)
systems, enabling seamless exchange of patient data and therapy information. HL7
standards define data formats, messaging protocols, and interfaces for interoperable
healthcare information exchange.
● Medical Device Communication: Standards such as IEEE 11073 (X73) provide
interoperability guidelines for medical device communication, allowing the
EMG-FES system to interface with other medical devices, monitoring systems, or
telehealth platforms. Compliance with these standards ensures compatibility and
integration with existing healthcare infrastructure.

e. Ethical Standards:

● Informed Consent: Adhering to ethical standards for informed consent ensures that
patients are fully informed about the risks, benefits, and alternatives of EMG-FES
therapy before participating in treatment. Obtaining voluntary and informed consent
from patients or their legal representatives is essential to respect patient autonomy
and ensure ethical conduct in research and clinical practice.
● Patient Privacy: Compliance with privacy regulations such as the Health Insurance
Portability and Accountability Act (HIPAA) protects patient confidentiality and
privacy rights. Safeguarding patient data, maintaining secure data storage and
transmission practices, and obtaining necessary permissions for data sharing or
research participation uphold ethical standards and legal requirements for patient
privacy protection.
CHAPTER 5

RESULT ANALYSIS AND DISCUSSION

5.1 Results Obtained


Results are obtained from 2 phases of testing. In the unit testing phase each unit is tested
individually. The testing scenarios are as follows:
1. The power supplies were connected to the battery and each output was measured in
terms of stable rms voltage as well as the switching noise generated in it. The
voltages generated are tallied with the requirements. Each voltage was according to
the requirements.
2. The display module was tested individually with test code and gave satisfactory
results in terms of refresh rate and correct character being displayed.
3. The inverter was tested by probing and applying reference voltages while measuring
outputs. The inverter channels switched seamlessly according to the voltages
supplied.
4. The mosfet driver was probed and tested with reference voltages and outputs
measured. The outputs are inverted and are satisfactory in terms of timing and output
voltages.
5. The mosfet driver and inverter channels are connected and further tested. They work
the same from lower logical voltage as anticipated and each work as before.
6. The microcontroller is programmed for inverter control and output pins are probed to
check results. The pins logic level changes as programmed with required frequency
and timing.
In second phase testing:
1. All sub systems are connected and each unit is further individually checked for
functionality errors. Each subsystem worked successfully and no major connection
or placement change was required.
2. Subsystems are integrated in software one by one and combined functionality is
checked. After combination, minor scheduling changes were required, and
functionality was maintained.
3. Total integration was done and each functionality was checked again with concern
for time delay, debug outputs and abnormality in the output waveform. After few
minor adjustments to wiring and passive components the entire system was ensured
to be free of error.
5.2 Result Analysis:
Few findings from result analysis are:
1. There is a time overlap between the rise time of gate for N-channel mosfets and fall
time of gate for P-channel mosfets causing current surge to the power supply due to
short circuit.
2. The remedy to the above problem is decreasing the rise and fall time of the gate
voltages by adjusting pull up and pull down resistors, however doing so causes
voltage shift of the source of P-channel mosfets leading to more errors in waveform
and power consumption.
3. Hence a delay needs to be set between deactivation of one channel of the inverter
and activation of the other channel. This causes a small error or a gap of 2ms in the
waveform generated.
4. The voltage generated by the step up converter is not enough and needs to be built
from bottom up to match the required voltage for the waveform.
5. The form factor is not suitable for wearable applications and can be further reduced
in a Printed circuit board design, however it is tried to be kept at a minimum.
5.2 Analysis and Discussion
The integration of EMG and FES technologies for post-stroke rehabilitation presents
numerous challenges and opportunities in the design and development of effective and safe
systems. Addressing signal processing complexity requires the implementation of advanced
techniques such as wavelet transforms and machine learning algorithms to denoise EMG
signals and extract relevant information. Individual variability among patients necessitates
personalized rehabilitation strategies, enabled by adaptive control algorithms that
dynamically adjust FES parameters based on real-time feedback. Motor recovery variability
underscores the importance of tailored rehabilitation protocols targeting specific functional
goals, while the integration of technologies requires close collaboration to overcome
technical challenges and ensure seamless interoperability. Safety and efficacy considerations
drive the implementation of safety mechanisms and closed-loop control algorithms to
mitigate risks and optimize therapy outcomes. Design constraints, including cost, size,
power consumption, compatibility, and regulatory compliance, necessitate careful trade-offs
and considerations to balance performance with affordability, usability, and regulatory
approval. Adherence to standards for safety, signal processing, clinical practice,
interoperability, and ethics ensures compliance with established guidelines and best
practices, safeguarding patient safety, privacy, and rights throughout the development and
deployment of EMG-FES systems.

5.3 Project Demonstration

Project is demonstrated as follows:


1. The display module is connected.
2. The boost converter is connected.
3. The power is turned on.
4. The inverter output is probed to an Oscilloscope.
5. The timing of the oscilloscope is increased to accommodate waveform.
6. The display is observed for the changes in waveform and status of operation.
7. The oscilloscope screen is observed to view the waveform generated.
CHAPTER 6

CONCLUSIVE REMARKS

6.1 Conclusion
In conclusion, this study provides evidence that improving hand function may be associated
with increased motor unit discharges in individuals with spinal cord injury (SCI). This could
potentially lead to improved motor function and quality of life for individuals with SCI. The
study also demonstrates the good reliability and validity of the Te spinal cord independence
measure (SCIM) version III in this study population. Future research could address the
limitations of this study by using larger sample sizes and multiple tests to assess hand
function and motor unit discharges. Additionally, individuals with spinal cord injury should
consider participating in rehabilitation programs that focus on hand function improvement
and consult with their healthcare professionals to determine the most appropriate
interventions and therapies for their specific needs and circumstances. Overall, this study
highlights the importance of considering individual differences and the need for
personalized interventions and therapies for individuals with spinal cord injury.

6.2 Further Plan of Action / Future Work

Based on the study design, sample size, and other factors, the future scope of this project
could include the following:

1. Expanding the study population: The study could be expanded to include a larger
sample size, allowing for more robust analysis of the relationship between hand
function and motor unit discharges.
2. Incorporating additional interventions and therapies: The study could be expanded to
include additional interventions and therapies, providing a more comprehensive
assessment of hand function and motor unit discharges in individuals with spinal
cord injury.
3. Developing a user-friendly platform: The study could develop a user-friendly
platform for data collection and analysis, making it easier for researchers to collect
and analyze data across multiple studies.
4. Conducting longitudinal studies: The study could be expanded to include
longitudinal data collection, allowing for a more comprehensive assessment of the
long-term impact of interventions and therapies on hand function and motor unit
discharges.
5. Collaborating with other researchers: The study could collaborate with other
researchers to develop new interventions and therapies for individuals with spinal
cord injury, and to assess their effectiveness in improving hand function and motor
unit discharges.
6. Developing guidelines for intervention and therapy selection: The study could
develop guidelines for selecting appropriate interventions and therapies for
individuals with spinal cord injury, based on the findings of the study.
7. Advocating for improved access to interventions and therapies: The study could
advocate for improved access to interventions and therapies for individuals with
spinal cord injury, based on the findings of the study.

By expanding the scope of this project, researchers can continue to contribute to the
understanding and management of spinal cord injury, ultimately improving the quality of
life for individuals with this condition.
REFERENCES

[1]."Electromyography-Based Control of Functional Electrical Stimulation for Hand Grasp


Rehabilitation

[2].. "Rehabilitation Robotics"(Krebs et al., 1998)

[3]. "Electromyographic Control of FES in Neurorehabilitation" (Kilgore & Peckham,


1999):

[4]."Electromyographic Control of FES in Neurorehabilitation" (Kilgore & Peckham,


1999):

[5]. Sabut, S.K. and Manjunatha, M. (2013) ‘An EMG-control functional electrical
stimulation (FES) system for restoration of gait in foot drop patients’, Int. J. Biomedical
Engineering and Technology, Vol. 12, No. 1, pp.84–96.

[6] Saito C., Ichie M., Handa T., Takahasi H., Kameyama J.,Tanaka Y., Handa Y.,
Hoshimiya N. "FES-CONTROLLED LOCOMOTION IN THE PARAPLEGIC
PATIENT .Advances in External Control of Human Extremities
Appendix A: Gantt Chart

Nov. Dec. Jan. Feb. March April


Background Studies/Literature Survey
Research Gap/Problem Identification
Research on the Project Objective
Hardware/Software/Tool Selection
Formation of Codes/Experiment Design
Trial and Testing
Challenges and Remedy
Assembling of the Prototype/Model
Project Demonstrations
Formation of the Project Report
Finalizing of Project Presentation
Appendix B: Project Summary
Project Title Development of an EMG-FES system for rehabilitation of hand in
paralytic patients post stroke
Team Members Arko Koner, Ayandeep Dutta, Ritam Mukhopadhyay & Arnab Kundu
Dr. Sukanta Kumar Sabut
Supervisors
VI / III year
Semester / Year
Project Abstract This project presents the development of an Electromyography (EMG) -
Functional Electrical Stimulation (FES) system tailored for the
rehabilitation of hand function in post-stroke patients. Stroke-induced
motor impairments often result in debilitating hand dysfunction,
significantly affecting patients' quality of life and independence.
Traditional rehabilitation methods have shown limited effectiveness in
addressing these challenges. Therefore, this project focuses on
harnessing the potential of EMG and FES technologies to design a
novel rehabilitation solution.
The EMG-FES system developed in this project integrates real-time
EMG signal processing with precise FES application to facilitate
targeted muscle activation and motor relearning in post-stroke patients.
By detecting and analyzing the neuromuscular signals associated with
intended movements, the system provides personalized feedback and
stimulation patterns, enabling patients to regain voluntary control and
functional use of their affected hand.
Key components of the system include surface EMG electrodes for
signal acquisition, signal processing algorithms for feature extraction
and classification, and FES electrodes for delivering stimulation to
specific muscles or muscle groups. The system is designed with
user-friendly interfaces and adjustable parameters to accommodate
individual patient needs and progression throughout the rehabilitation
process.
The efficacy of the developed EMG-FES system is evaluated through
clinical trials involving post-stroke patients undergoing rehabilitation.
Outcome measures such as improvements in motor function, muscle
strength, dexterity, and activities of daily living are assessed to validate
the system's effectiveness in promoting recovery and functional
restoration.
Overall, this project contributes to the advancement of rehabilitation
technology by introducing a tailored EMG-FES system specifically
designed to address hand dysfunction in post-stroke patients. The
integration of EMG feedback and FES intervention offers a promising
approach to enhance rehabilitation outcomes and ultimately improve the
quality of life for individuals affected by stroke-induced hand
impairments.
a. Safety Standards:
List codes and
standards that Electrical Safety: Compliance with standards such as IEC 60601-1 for
significantly affect
electrical safety.
your project.
Electromagnetic Compatibility (EMC): Adherence to standards like IEC
60601-1-2 for EMC.
Risk Management: Following ISO 14971 for risk management in device
development.
b. Signal Processing Standards:
Electromyography (EMG) Signal Processing: Guidelines from the
SENIAM project.
Feature Extraction and Classification: Standards for EMG feature
extraction and classification algorithms.
c. Clinical Practice Guidelines:
Stroke Rehabilitation Guidelines: Recommendations from organizations
like AHA and ESO.
Hand Function Assessment Tools: Validated assessment tools like
Fugl-Meyer Assessment.
d. Interoperability Standards:
Data Exchange: HL7 standards for interoperability with EHR systems.
Medical Device Communication: IEEE 11073 (X73) for interoperability
between medical devices.
e. Ethical Standards:
Informed Consent: Adherence to ethical standards for obtaining
informed consent.
Patient Privacy: Compliance with privacy regulations such as HIPAA
for patient data protection.
The two primary constraints of this project are the formation of the
List at least two
significant realistic mobile application (APP) and availability of the wireless
design constraints
communication such as IEEE 802.11 (b/g/n) standards across rural
that are applied to
your project. landscapes of India.
In managing cost-performance trade-offs, prioritizing cost-effective
Briefly explain two
significant components and simplified designs can mitigate high development
trade-offs
costs, potentially compromising performance. Size vs. functionality
considered in your
design, including trade-offs involve enhancing portability through miniaturization while
options considered
sacrificing certain features, necessitating a balance between size and
and the solution
chosen functionality to meet user needs. Power efficiency vs. performance
trade-offs entail implementing power-saving features to minimize
consumption, considering latency and responsiveness trade-offs.
Compatibility vs. customization trade-offs involve designing flexible
architectures for easy integration with existing protocols, balancing
compatibility with complexity and customization overhead. Regulatory
compliance vs. innovation trade-offs include seeking streamlined
regulatory approval for faster market entry, potentially limiting
innovation opportunities or delaying advanced feature incorporation.

N-CHANNEL MOSFET
Describe the
P-CHANNEL MOSFET
computing aspects,
RESISTOR(10K)
if any, of your
BOOT CONVERTER(XL6009EI)
project. Specifically
BUCK CONVERTER
identifying
LITHIUM ION BATTERY
hardware-software
LITHIUM ION BATTERY HOLDER
trade-offs, interfaces,
and/or interactions
For this project knowledge from,
Culminating
EC 2027 Analog Electronics
Knowledge and
EC 2011 Digital Electronics
lifelong learning
EC 2096 Digital & Linear IC Lab
experience
EC 3003 Microprocessors and Microcontrollers
EC 3007 Digital Signal Processing
EC 3093 Microprocessor and Microcontroller Lab
subjects has been used.

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