Balance, support, and propulsion are all dependent on the ankle joint complex. It is, however, particularly vulnerable to musculoskeletal and neurological injuries, particularly neurological ailments like drop foot after a stroke. Damage to the central nervous system is a significant component in ankle dysfunction (CNS). Consequently, the primary objective of rehabilitation training is to enhance CNS restructuring and compensation, as well as the recovery of motor perception function in the motor system. The tibia, fibula, talus, and calcaneus make up the ankle joint complex (AJC). To simplify AJC movements, the tibia and fibula are considered one unit, and the ankle joint is made up of the articulation between the tibia-fibula unit and the talus. The AJC is critical for maintaining balance, support, and propulsion. Damage to the central nervous system (CNS), which must be activated for reconstruction and compensation, as well as to support the recovery of the motor system's motor perception function, is a significant component in ankle dysfunction. In this situation, physiotherapy becomes critical for patients. This, however, involves a lengthy, repeated, and rigorous recovery procedure, putting a significant strain on standard ankle rehabilitation training. Due to a lack of time and resources, typical ankle rehabilitation therapy is unable to deliver enough training frequency and intensity.

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Figure 1: Skeletal structure of the ankle joint.

As a result, a growing number of ankle rehabilitation robots have been designed to provide long-term precise and uniform rehabilitation training of the AJC, the most studied of which is the parallel ankle rehabilitation robot (PARR). Over the previous two decades, PARRs have evolved rapidly in terms of mechanical designs, control tactics, and rehabilitation training approaches, as seen by the research chosen. However, each of the extant PARRs has its unique set of advantages and disadvantages, and only a handful of the produced devices have undergone clinical testing. In the mechanism design and optimization of PARRs, it is critical to build a PARR with three degrees of freedom (DOFs) and where the mechanism's rotation center corresponds with the AJC rotation center.

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Figure 2: PARR prototype

Furthermore, rehabilitation training plans are developed based on therapists' subjective clinical experience, which creates a problem in which therapists are unable to accurately control changes in complex forces, rehabilitation training forms, As a result, it's critical to develop ankle rehabilitation robots to replace traditional ankle rehabilitation training, which have the advantages of providing long-term accurate and uniform rehabilitation training as well as the ability to adaptively modify the difficulty of rehabilitation training based on real-time feedback from training. Furthermore, the use of robot-assisted ankle rehabilitation procedures allows for real-time data collecting during the training process, providing for a better understanding of the AJC's biomechanical characteristics and mobility, as well as customizing future treatments.

These strategies, in particular, can successfully minimize medical staff labor intensity, increase the efficacy of ankle rehabilitation training, and compensate for a lack of rehabilitation medical resources. And training parameters, making accurate training of the affected limbs difficult. The most studied technologies for ankle rehabilitation are parallel ankle rehabilitation robots (PARRs) and wearable devices. PARRs have a fixed platform and can be used for multiple degree of freedom (DOF) rehabilitation with a small size and high rigidity, whereas wearable devices are known as exoskeletons or powered orthoses and are frequently used for gait training. When opposed to a wearable device, a PARR has the benefit of preventing a further damage to the ankle joint by not allowing the lower leg to follow the swing during ankle rehabilitation therapy.

The parallel robot setup for ankle rehabilitation should have 3-DOF rotating motion and a suitable range of motion (ROM). The topological analysis and configuration optimization approach selects a configuration without duplicate branches. A two-ups/RRR parallel ankle rehabilitation robot (PARR) with three rotating degrees of freedom around a virtual stationary centre for the ankle joint was designed. As shown in Figure 3, it comprises of a confined branch and two drive branches. The constrained one with the RRR structure is made up of three rotating joints coupled in series, designated by R1, R2, and R3, correspondingly. R1 is a vertical active joint that is mounted vertically. Furthermore, the three axes are perpendicular to one another and intersect at the coordinate system's origin (0). To simplify the construction of the driven units, the configuration UPS is chosen as the drive branch and the joint P is chosen as the active joint.

Figure 3: Structure of PARR. Figure 4: Structure of the moving platform.

In our daily lives, technology is unavoidable. This is because, in today's dynamic environment, existence would be meaningless without technology. The basic goal of technology, which brings together instruments to encourage development, usage, and information sharing, is to make chores simpler and to solve many of humanity's issues. We must emphasize how helpful technology is to our lives as it advances and makes our lives even more convenient. Furthermore, robots assist firms in achieving automation by replacing tedious, labor-intensive operations, and their application in industries is growing across the world. Science, industry, medicine, and healthcare are among industries where robots may be found. Robots are employed to collect data in study. Furthermore, robots and gadgets can be used to evaluate the efficacy of robotics software or to evaluate newly developed technologies. Human contact and mobility are also used by researchers using study robots.

Automated applications have expanded in the realm of medicine and rehabilitation to include valuable solutions for physicians, patients, treatment centers, and other stakeholders. Cleaning, surgeries, aiding employees, and other jobs in the medical sector may be supported by robots, but rehabilitation is the most essential aspect of healthcare, and it will be the focus of this project. In this field, finding a contemporary treatment for individuals with strokes, spinal cord injuries, muscle loss, and ankle joint dysfunctions is a challenge. The purpose of this research idea is to create a robotic device that can tackle this challenge. With the support of physical therapy, the proposed technique would allow patients to have entire joint mobility and functioning and to move stroke survivors' ankle-foot to strengthen muscles, and to achieve motion therapy.

Requirement

This project's requirements would be examined, starting with its prototype size and on through its mass, material, safety, and intuitiveness. To begin, this project's goal is to create a gadget that will aid therapists in ankle rehabilitation and physiotherapy. As a result, 22cm would be a good starting point, with the possibility of expanding to a greater size later if necessary. Because the gadget would be utilized in treatment sessions, the ease with which it could be moved is a great benefit, therefore its weight would be no more than ten kilos. Moving on to the material, the prototype would be created using 3D printing in order to save money at the outset. As a result, ABS would be used (Acrylonitrile Butadiene Styrene). ABS is also mechanically strong, easily available, and comes in a broad range of colors. Titanium would be the material that would be utilized on the real gadget following the prototype stage. Although it is more expensive, it is preferable to choose a material that is renowned for its medical compatibility. The field chosen for this device is extremely delicate, and all medical robots must meet IEC 60601-1 criteria for fundamental safety and necessary performance, including the prevention of mechanical risks, extreme temperatures, fire, shock, electromagnetic emissions, and radiation exposure.

Design constraint

In terms of design constraints, we must identify a number of constraints when creating the 3 DOF spherical mechanism. First, the price varies depending on whether the system is a prototype or a genuine one. A prototype might cost between 15-30 KD, while a complete system could cost between 2500-4000 KD, depending on materials, production process, and transportation. The pieces should not be overly complicated in order to make them straightforward to produce. The actual mechanism is difficult to make out of aluminum or titanium since it requires students to be overseen by specialists. As a result, Computer Aided Design (CAD) and 3D printing, which uses layering to produce three-dimensional things, are two of the best and most straightforward ways for modeling and prototyping. The construction of this three-degree-of-freedom spherical robot is expected to take between two and three months. Also, keep in mind that the logistics of obtaining everything you'll need and putting it all together will take time.

ISO 14971:2019  

 Risk management is an important consideration in the use and advancement of robots in the medical industry, because patients are already in a vulnerable position, and any unforeseen flaw in the equipment could exacerbate the patient's condition. As a result, an international standard, BS EN ISO 14971, was created to protect both the patient and the employees that use the devices. Because it isn't always about humans, it might also be considered property or environmental destruction. The European Union accepted the following standard as a new edition of BS EN ISO 14971, with CEN ISO/TR 24971 serving as the guidance report. Similarly, all steps should be documented in the manufacturing organization's procedures. The risk management plan, as the first step, provides detailed documentation of the activities to be carried out across the device's lifetime. A review of the plan must be undertaken prior to the device's commercial distribution to confirm that it was carried out properly and that no important activities were overlooked. The second step is risk assessment, which entails both risk analysis and risk evaluation. Risk analysis begins with a clear explanation of the medical device's intended use, and anything beyond that is considered abuse. Following that, expected risks are appraised using the criteria outlined in top management's risk acceptability policy. Step three, risk control, can be accomplished in one of three ways: making the design safe, putting in place safety measures, or giving data with safety measures. Step four is to assess the overall residual hazards, which can be linked to the medical device's side effects or aftereffects during treatment. As a result, any remaining hazards must be communicated. Step five is to conduct a risk management review, and the results should be kept in the risk management file. Step six: If a new risk emerges after production, the maker should reevaluate the risk management approach' applicability.

Figure 9: ISO 14971:2019

  ISO 9000 family standards

  This set of family standards was created to assist enterprises in implementing effective quality management systems (ISO 9000, ISO 9001, ISO 9004, ISO 19011). ISO 9001 is the most generally known Quality Management System (QMS) standard in the world, and it helps companies better satisfy the needs of their customers and other stakeholders. This is accomplished by ensuring that the end goods are of constant quality. Starting with the customer, because the product is meant for consumers to use, the therapists and patients in the existing state. As a result, the device must meet their needs and specifications. Next, clear leadership is required for the internal environment to grow and progress in a systematic manner. Furthermore, the members' participation is critical for the project to go smoothly. Furthermore, the output would be more efficient if the resources and activities were approached as a process. Understanding, identifying, and managing connected actions in the manner of a system leads to a good outcome.

 The team's goal should be continuous improvement and striving for greater results. Decisions should be founded on data analysis, thus take a factual approach to making them. Moving forward, it is important to maintain mutually effective supplier relationships because they add value to both parties. To satisfy users, it is necessary to meet their needs and expectations, which are referred to as customer requirements. Furthermore, sticking to and executing quality management standards in order to boost consumer confidence in the product or equipment. A process is the action of employing input resources to produce output. The process approach to quality management is strongly supported by international standards.

The quality policy and quality objectives focus on adhering to the framework and guiding the project toward continual improvement. The achievement of the quality aim boosts the confidence of those who are interested.

Figure 10: Quality management system approach

  IEC 80601-2-78

 This standard, published in July 2019 by the International Electrotechnical Commission (IEC), aims to ensure specific safety and performance requirements for medical robots that physically and directly interact with patients with disabilities, either to perform or support rehabilitation, assessment, or compensation in regards to patient movement functions. IEC 80601-2-77 and IEC 80601-2-78, Medical Electrical Equipment standards, took many years to develop and were developed in collaboration between IEC and ISO bodies. The IEC 80601-2-78 standard includes a wide range of medical robots first launched as Rehabilitation Assessment Compensation Alleviation (RACA) robots in the medical profession. The robots assist the therapist or reduce the workload during procedures and sessions. They're also employed to help patients with body structure or bodily function replacement. RACA robots are programmed to complete specific tasks and operate with a degree of autonomy to move within a predetermined range in order to complete them. 

 COUNCIL DIRECTIVE 93/42/EEC  

The European Council is the highest level of standardization, defining directives and high-level certification standards for systems. Medical equipment must provide a high level of protection for patients, users, and third parties, as well as deliver the performance levels that the producers claim. As a result, one of the directive's key goals is to maintain or increase the current level of protection in the Member States. That is the primary rationale for including this standard in this article while keeping the consumers' best interests in mind.

The academic journey is nearing to a close as the semesters pass by naturally. Now, in the last semester, all of the parts are coming together, and all of the materials collected may be used in the graduation project. Transforming Ideas to Innovation II (ENGR 132) was one of the first courses in the freshman year, and it taught students how to analyze and solve issues like engineers. Basic Mechanics I (ME 270) was a static forces and free body diagrams (FBD) course in which the goal was to construct a truss beam bridge and attain equilibrium. Basic Mechanics II (ME 274) dealt with dynamic forces and moving bodies, with a concentration on motion laws. This course, Graphical Communication and Spatial Analysis (CGT 163), introduced a new program called Solid Works. This is a design program that converts ideas into graphic engineering and engineering drawings. As future engineers, we were able to identify how to standardize the engineering drawings that would be utilized in projects by learning how to do so. Furthermore, the lectures of Introduction to Mechanical Design, Innovation, and Entrepreneurship with Lab (ME 263) taught us the engineering design process, while the lab concentrated on conducting simulations on Solid Works and developing bill of materials. Machine Design I with Lab (ME 352) exposed students to the notion of degrees of freedom (DOF) and how to assess and deal with them. Because the topic of the project is Design and Simulation of a 3-DOF Spherical Robot, and sensors and perhaps motors will be employed, Mechatronics (ME 588) is a robotics related course that focuses on sensors and motors. Reading and writing codes were taught in Programming Applications for Engineers (CS 159), a course on an introduction to the programming world and its languages. This naturally aided the project's use of the math lab. This last course, Technology and Research Strategies (BUS 230), is unrelated to engineering, although it did teach the fundamentals and methods of conducting research in both AUM databases and professional journals.

This project began in the previous deliverable containing a literature review, problem statement, product benchmark, design requirements and constraints, related coursework and finally appendix. In the current deliverable, will focused on the design part and connecting the electrical part and coding the Arduino. The below is the coding for the Arduino to make the motor works, enables the motor to move in a particular direction, makes 200 pulses for making one full cycle rotation, changes the rotations direction and makes 400 pulses for making two full cycle rotation; by using Arduino program:

#include <Arduino.h>

// Stepper Motor X

const int stepPin = 5; // X.STEP

const int dirPin = 4; // X.DIR

void setup() {

// Sets the two pins as Outputs

pinMode(stepPin,OUTPUT);

pinMode(dirPin,OUTPUT);

}

void loop() {

// Makes 200 pulses for making one full cycle rotation

// Reduction ratio is 30 –> 6000

for(int x = 0; x < 400; x++) {

digitalWrite(stepPin,HIGH);

delayMicroseconds(2000);

digitalWrite(stepPin,LOW);

delayMicroseconds(2000);

}

delay(1000); // One second delay

// Makes 400 pulses for making two full cycle rotation

for(int x = 0; x < 400; x++) {

digitalWrite(stepPin,HIGH);

delayMicroseconds(2000);

digitalWrite(stepPin,LOW);

delayMicroseconds(2000);

}

delay(1000);

}

In addition, all group members worked in connecting the electrical part. So, for the wiring part we use some items like stepper motor, stepper motor driver, power supply, Arduino, bread board, and DuPont cable. First for the stepper we use NEMA17, stepper motors are a DC motors that can rotate in separate steps. These motors have various coils that are organized in groups called phases. When this coil works in each phase in sequences. The motor provides a rotation. Second, we need the stepper motor driver to make sure we have enough energy also it is very useful for hopping to drive small stepper motor. Third, the Arduino is an open-source electronics platform that is an important part to use simple hardware and software to make it easy to use. Fourth, bread board is one of the most fundamental pieces to build circuits to connect the components on the board. Fifth, we have the DuPont cable that is an electrical line that has pin or connector at each end, or a set of them in a cable. This cable is important to connect the components with each other like of a brad board. Finally, the power supply it is an electrical device that provide electric power to an electrical load. We use a power supply with 6A and 12V to moderate enough energy.

Figure 11:items need for the project

figure 12:Motor figure 13: power supply

figure 14:Arduino figure 15: breadboard

figure 16: DuPont cable

We start connecting the components by connecting the motor with the bread board in ( i 3456) then place the stepper motor driver in the middle of the bread board next, in (7 and 8 b) in the bread board to (7 and 6) in the Arduino after that (7 and 8i) to 5v and ground in the Arduino and we connect (5 and 6b) in the bread board and 1 and 2 i in the bread board to the power supply. After that we face a problem with connecting the power supply to the bread board because we use the power supply that has 6A and this kind of power supply don’t have place to connect the cable from the bread board so we solve our problem with the barrel jack. Finally, we connect the Arduino to the PC and apply the code to drive our motor.

Figure 17

figure 18: hand drawing for electrical connection

Finally, for the design part we use fusion 360 and then we use a 3d printer to print the part that we design. The part that we are designing is for connecting the three motors together. We begin with giving ideas and we end up with three ideas, as shown below:

Figure 19: first design figure 20: second design

Figure 21: third design(white) figure 22: third design(green)

All the ideas were good but we decide to go with the third one, because it is easy to make.

Figure 23: hand drawing for the third design

In the previous picture, it shows us there is one mechanical piece, which is a large circle in the middle and 4 small circles in the corners, connected to them by gears at the bottom, through them we can install the power supply to obtain degrees of freedom

Figure 24: hand drawing for some of the design that we make

In the previous picture, there are two mechanical pieces that are connected to each other via 4 screws. And the piece in the first drawing ( left side ) is the one that connects to the power supply and installs it in it. As for the piece in the second drawing ( right side ), it is a gear attached to the first piece with 4 screws to secure them together

Figure 25: Project work plan

In the deliverable 1, we did a work plan as shown in figure 9, we did this work plan to divide the work equally. First of all, we seat a meeting to talk and know each other and to discuss about the project, and before the meeting all of us reed the articles and the sample od deliverable one that the instructor provides it to us. In the meeting was the one who is making the work plan, and also, she helped with the product benchmark. also, worked in the product benchmark and related coursework. took care of the literature review and the problem statement. , was responsible of requirements and she helped with design constraint. Finally, all of us worked so hard and we were all cooperated and helped each other.

In deliverable 2, worked on the fusion 360 and design the part that connect the three motors together. worked on designing the part that were doing it put in paper as a hand drawing. were responsible od the electrical part and the wiring.