DESC:FORM 2
THE PATENTS ACT, 1970
(39 OF 1970)
&
THE PATENTS RULES, 2003
COMPLETESPECIFICATION
(See section 10 and rule 13)
1. Title of the invention:“QUADEASE: A WEARABLE REAL-TIME BIOFEEDBACK DEVICE FOR MEASURING QUADRICEPS LAG ”
2. Applicant:
NAME NATIONALITY ADDRESS
1. Marwadi University
Indian Marwadi University, Rajkot-Morbi Highway, at, Gauridad,Rajkot, Gujarat 360003, India
2. Kumari Sapna
3. Kakkad Ashish Dhirajlal Faculty of Physiotherapy, Marwadi
University, Rajkot – Morbi Highway Road,Gauridad, Rajkot, Gujarat 360003
3. Preamble to the description
COMPLETESPECIFICATION
The following specification particularly describes the invention and the manner in which it is to be performed:

Field of the Invention:
The present invention relates to the field of medical device. More specifically, the present invention is a wearable real-time biofeedback device for monitoring and improving the performance of the quadriceps muscle of legs by using sensors, microcontrollers, and wireless connectivity.
Background of the Invention:
Biofeedback therapy is an instrument-based learning process that uses "operant conditioning" techniques. It provides patients with augmented or extrinsic feedback to help them learn to recognize their own body signs and control them consciously. Biofeedback may help patients improve movement patterns, enhance accuracy during functional activities, promote patient participation in their rehabilitation, and lessen the need for regular interaction with healthcare personnel. The biofeedback parameters that are often employed in physical rehabilitation may be classified as physiological or biomechanical. Neuromuscular biofeedback methodologies are electromyography (EMG) biofeedback and real-time ultrasound imaging (RTUS) biofeedback. Biomechanical biofeedback includes inertial sensors, force plate systems, electrogoniometry, pressure biofeedback, and camera-based systems.
The anterior cruciate ligament (ACL) is the most crucial ligament to the knee’s stability, attaching from the front part of the tibia to the back part of the femur. Its purpose is to keep the tibia from sliding forward and rotating on the femur. ACL injury is a major cause of severe knee injuries, and approximately 100,000 ACL reconstructions are done each year. After ACL reconstruction surgery, a rehabilitation program is necessary to achieve the same functional capacity as the non-operated limb. Lack of full extension following ACL rupture may contribute to functional deficits and an increased risk of osteoarthritis. To restore the knee to near-normal function, rehabilitation should aim to minimize pain, regulate inflammation and healing, re-establish full range of motion, avoid muscular hypotrophy, enhance muscle strength, preserve proprioceptive function, and allow the return to work and sports activities. However, a large proportion of people never recover to their pre-injury level of function. Potential explanations for this include a loss of confidence and self-efficacy, as well as inadequate involvement with the rehabilitation process. Patient understanding and participation are critical for effective recovery.
Quadriceps lag, which refers to the inability of the quadriceps muscle to fully contract, is a common problem in patients undergoing knee rehabilitation, especially after ACLR surgery. This lag can lead to decreased knee stability, reduced functional performance, and a delay in return to normal activities. Therefore, monitoring quadriceps lag is an essential component of knee rehabilitation programs.
Biofeedback devices have been used to measure quadriceps lag in patients undergoing rehabilitation. These devices provide real-time feedback on muscle activation, allowing doctors and therapists to monitor the progress of rehabilitation and adjust treatment as needed. However, existing biofeedback devices require trained professionals to operate and assess, limiting their usefulness for home exercise programs.
To address this issue, there is a need for a user-friendly biofeedback device that patients can use at home to monitor their quadriceps lag. Such a device could improve patient compliance with rehabilitation programs, reduce the need for in-person visits, and ultimately lead to better rehabilitation outcomes.
All available devices functioning for measurement of rangeof motion, are to be operated and assessed by trained professionals only. There is no device availablethat can be operated and assessed by a patient himself/herself in real-time. The present invention solve this problem.
The present invention is a user-friendly biofeedback device for measuring quadriceps lag. The device is easy to use, does not require specialized training to operate, and provides real-time feedback on muscle activation. The patients can use the device at home, allowing for more frequent monitoring of their rehabilitation progress and increased compliance with treatment protocols. Overall, the present invention has the potential to improve the quality of knee rehabilitation programs and outcomes for patients.
Object of the Invention:
The main objective of the present invention is to develop a wearable real-time biofeedback device for the measurement of quadriceps lag.
Another objective of the present invention is to test and validate a wearable real-time biofeedback device for the measurement of quadriceps lag with a universal goniometer.
Yet another objectives of the present invention is to determine the effect of intervention including a real-time biofeedback device for quadriceps lag in subjects with post-Anterior cruciate ligament Reconstruction. (ACLR).
Yet another objectives of the present invention is to generate real-time data for Quadriceps lag using sensors attached to the knee and develop a smartphone application connected to the device through Wi-Fi for users to see real-time data from the module.
Yet another objectives of the present invention is to make the device easy to attach to the knee using sensors that capture data and transmit it to a mobile application via Wi-Fi, enabling patients to monitor their progress and rehabilitation.
Yet another objectives of the present invention is to design the device for home exercise programs to enhance patient compliance and aid doctors and therapists in understanding the progress of knee rehabilitation.
Summary of the Invention:
The present invention relates to QuadEase which is a wearable biofeedback device designed to measure quadriceps lag during knee rehabilitation. Unlike other devices that require trained professionals to operate and assess, QuadEase can be used by patients themselves in real-time. The device comprises four major components: Node microcontroller unit (Node MCU) Esp 8266 (microcontroller with integrated WiFi capabilities), Microprocessor unit (MPU) 6050 with a six-axis gyroscope and accelerometer which is an Inertial Measurement Unit (IMU), which is a device that measures and reports a body's specific force, angular rate, and orientation using a combination of accelerometers and gyroscope, a battery management system with a USB charging port, and a chargeable lithium-ion battery (B). The sensors attached to the knee capture data that is then transmitted to a mobile application via Wi-Fi (W). The app displays real-time data, enabling patients to monitor their progress and rehabilitation. The present device provides visual feedback when active knee extension is performed and records the end range extension achieved by the participant. The information can be easily downloaded into a computer or laptop.
QuadEase is designed to be used by patients themselves, making it more accessible and useful for home exercise programs. By encouraging and monitoring active range of motion exercises for quadriceps lag, it enhances patient compliance and aids doctors and therapists in understanding the progress of knee rehabilitation. The present device offers features such as personalized threshold setting, timely notifications, alarming alerts, and comprehensive data management capabilities. It ensures accurate measurement through a multiple attempt approach and aims to validate its accuracy and reliability through comparison with a universal goniometer, a device commonly used for measuring joint range of motion.
Overall, the present invention (QuadEase) provides a valuable solution for monitoring knee rehabilitation progress in real-time, empowering patients to actively participate in their recovery process and aiding healthcare professionals in optimizing rehabilitation strategies.
Brief Description of drawings:

Figure 1 shows Block diagram of the present invention
MCU Node microcontroller unit Esp8266
MPU Microprocessor unit 6050
B Chargeable lithium-ion battery
W Wi-Fi

Figure 2 shows Module with Wi-Fi Connectivity
Figure 3 shows Wearable device and real-time biofeedback application
Figure 4 shows Mobile application
A Saved data
B Real time graph
C Real time quadriceps lag (active knee extension range of motion in degrees)
D Start and Stop indicator
E Target limit for Active knee extension in degrees
F Result

Figure 5 shows a Front View of the present invention (Real-time biofeedback device for quadriceps lag)
Figure 6 shows Rear View of the present invention
Figure 7 shows Top View of the present invention
Figure 8 shows Bottom View of the present invention
Figure 9 shows Side View of the present invention
Figure 10 shows the Prospective View of the present invention
Detailed Description of the Invention:
Existing devices for measuring range of motion typically require specialized training for operation and assessment, limiting their accessibility to trained professionals. Moreover, there is a distinct lack of devices that enable patients to independently assess their range of motion in real-time. Addressing this gap, the present invention introduces a groundbreaking wearable real-time biofeedback device designed specifically to monitor and enhance the performance of the quadriceps muscle in the legs. By integrating sensors, microcontrollers, and wireless connectivity, this device offers a user-friendly solution that empowers patients to actively participate in their rehabilitation process, thus bridging the existing gap in musculoskeletal rehabilitation tools.
The present invention relates to QuadEase which is a wearable, real-time biofeedback device designed to measure quadriceps lag during knee rehabilitation. The present device comprises of four major components, Node microcontroller unit (Node MCU) Esp8266, Microprocessor unit (MPU) 6050 which consists of a six-axis gyroscope and accelerometer, a Battery management system with a USB charging port, chargeable lithium-ion battery (B). The Wi-Fi (W) signal from the device captured by a mobile application through Wi-Fi (W) connectivity and the data graphically and numerically represented for the real-time biofeedback.
The real-time biofeedback device provides visual feedback whenever active knee extension is done, mainly it records the end range extension of knee achieved by the participant. The present device monitors and log every knee extension range performed by the participant. The recorded information can be easily downloaded into a computer or laptop. The real-time data for Quadriceps lag generated using sensors attached to the knee. A smartphone application made which is connected to the device throughWi-Fi (User can see real-time data from the module).
The device is attached to the knee using sensors that capture data and transmit it to a mobile application via Wi-Fi (W). The application displays real-time data in graphical and numerical formats, enabling patients to monitor their progress and rehabilitation. The device provides visual feedback when active knee extension is performed and records the end range extension achieved by the participant.
The Node MCU Esp8266 is a microcontroller unit (MCU) which processes the data from the sensors attached to the knee. The MPU 6050 is a motion sensor that detects the movement of the knee joint. The battery management system ensures that the device operates efficiently and effectively, and the chargeable lithium-ion battery (B) provides power to the device.This comprehensive setup, detailed in the QuadEase User Manual, forms the backbone of standard operating procedures, ensuring consistent and effective usage of the system.
The present invention comprises of:
a) Wearable Hardware Device:
The hardware integrates a 3-Axis Gyro/Accelerometer MPU 6050 for precise quadriceps lag measurement, Node MCU ESP8266 with Wi-Fi (W) for communication, a Lithium Ion Battery (B) for portability, and a Battery Management System (BMS) for safety.
b) Communication With Mobile Application:
Users pair the device with their Android phone via Wi-Fi (W). The Node MCU ESP8266 facilitates secure wireless communication, transmitting real-time data from the wearable device to the QuadEase application. This design ensures mobility and user-friendly lag measurements.
User Manual for QuadEase: Standard Operating Procedures (SOP)
Installation:
1. Download and Install QuadEase Application:
• Access the designated source to download the QuadEase application.
• Follow the installation instructions to set up the application on your Android device.

2. Pair Wearable Hardware with Android Phone via Wi-Fi:
• Enable Wi-Fi on Android phone.
• Pair the wearable hardware device with Android phone to establish a stable connection using Wi-Fi.

3. User Registration:
• Creating a Personalized User Profile.
• Begin by registering within the QuadEase application.
• Create a unique user name to facilitate accurate record-keeping and personalized user experience.

Real-time Lag Measurement:
1. Preparing Wearable Hardware Device:
• Ensure the wearable hardware device is securely strapped onto your leg for precise measurements.

2. Initiating Real-time Lag Measurement:
• Launch the QuadEase application on your Android device.
• Navigate to the measurement section.
• Set the lag limit as advised by your healthcare provider.
• Start the measurement process and gently move your leg upward.

Limit Setting:
1. Alert Configuration:
• Customize the app to generate alerts when the specified limit is reached, enabling timely intervention and monitoring.
Data Management (Data recording and storage):
1. Secure Patient Information Storage:
• Safely store patient information within the QuadEase application to ensure confidentiality and data integrity.

2. Daily Lag Measurement Tracking:
• Monitor daily lag measurements to track progress and assess rehabilitation effectiveness.

3. Historical Data Access:
• Access historical data to review past measurements and analyze progress over time.

Multiple Attempts and Final Lag Calculation:
1. Conducting Multiple Measurement Attempts:
• Perform three consecutive measurement attempts to ensure accuracy and reliability.

2. Automated Final Lag Calculation:
• QuadEase automatically calculates and displays the final lag measurement for the day based on the recorded attempts.

Reviewing Results:
1. Accessing Results Section:
• Navigate to the results section within the QuadEase application to review recorded measurement attempts and final lag values.

2. Analyzing Improvement Trends:
• Utilize graphical representations provided by QuadEase to identify trends and make informed decisions regarding rehabilitation strategies and progress tracking.
The main embodiment of the present invention, a wearable real-time biofeedback device for measuring quadriceps lag during knee rehabilitation comprising of:
a) Node microcontroller unit (MCU) Esp8266 for processing data from attached sensors;
b) Microprocessor unit (MPU) 6050 equipped with a six-axis gyroscope and accelerometerfor detecting knee joint movement;
c) Battery management system featuring a USB charging port for efficient operation;
d) Chargeable lithium-ion battery (B) providing power to the device; and
e) Wi-Fi (W);
wherein said device facilitates wireless connectivity to a mobile application for graphical and numerical representation of real-time biofeedback and visual feedback.
Another embodiment of the present invention, the said sensors attached to the knee capture data and transmit it to mobile application via Wi-Fi (W).
Another embodiment of the present invention, a method for knee rehabilitation by using a wearable real-time biofeedback device comprising of step:
a. Securely attaching said device to the leg;
b. Initiating real-time lag measurement through the smartphone application;
c. Monitoring progress through graphical and numerical representations;
d. Setting personalized thresholds for quadriceps lag degrees;
e. Receiving notifications when pre-defined limits are reached;
f. Ceasing leg movements upon alarming alerts;
g. Conducting multiple measurement attempts for accuracy;
h. Automatically calculating the final lag based on recorded attempts; and
i. Reviewing results within the application to analyze trends and make informed decisions regarding rehabilitation strategies.
The QuadEase User Manual offers comprehensive instructions for effectively utilizing the system. It covers installation, where users download and install the QuadEase app, then pair the wearable hardware with an Android phone via Wi-Fi (W). User registration involves creating a personalized profile for accurate record-keeping. Real-time lag measurement is achieved by securely attaching the device to the leg and using the app to track and display lag data graphically. Customizable alerts notify users when predefined limits are reached, allowing for timely intervention. Data management features include secure storage of patient information, tracking daily lag measurements, and accessing historical data for progress evaluation. Multiple measurement attempts ensure accuracy, with the app automatically calculating the final lag based on recorded attempts. Results can be reviewed in the app, enabling users to analyze trends and make informed decisions regarding rehabilitation strategies.
QuadEase is designed to be used by patients themselves, making it more acceptable and useful for home exercise programs. The device encourages and monitors active range of motion exercises for quadriceps lag, enhancing patient compliance and aiding doctors and therapists in understanding the progress of knee rehabilitation.
The QuadEase application offers a range of features designed to facilitate efficient and effective quadriceps lag measurement and management. Through seamless Wi-Fi connectivity, users can connect the app to the hardware device, enabling real-time monitoring of leg movements directly on their mobile devices. This real-time tracking is complemented by dynamic graphical representations, allowing users to visualize leg movement data for immediate analysis and assessment.
Setting personalized thresholds for initial quadriceps lag degrees is made simple with QuadEase, ensuring that individualized monitoring aligns with medical recommendations. Furthermore, the app provides timely notifications when pre-defined limits are reached, enabling prompt intervention when necessary. Additionally, alarming alerts are integrated to prompt users to cease leg movements once specified degrees are exceeded, promoting safe and effective rehabilitation practices.
In terms of data management, QuadEase facilitates comprehensive record-keeping by allowing users to save patient names alongside quadriceps lag data. This data is organized by date, facilitating easy retrieval and reference for ongoing progress tracking. Moreover, the application empowers users with analytical capabilities through the generation of downloadable PDF reports. These reports offer detailed analysis and study of quadriceps lag data, aiding in informed decision-making processes regarding patient management and rehabilitation strategies.
When it comes to measurement accuracy, QuadEase implements a multiple attempt approach. Users conduct three measurement attempts to ensure accurate quadriceps lag assessment. The final quadriceps lag value is automatically determined based on the minimum value recorded among the three attempts, providing a precise evaluation of the patient's condition and progress.
Testing and validating QuadEase with a universal goniometer is one of the objectives of the present invention. The universal goniometer is a device that measures the range of motion of a joint. Validation of QuadEase with a universal goniometer will provide evidence of the accuracy and reliability of the device.
The QuadEase device offers a wearable, real-time biofeedback solution for measuring quadriceps lag during knee rehabilitation. With its four major components, including the Node MCU Esp8266, MPU 6050, battery management system, and chargeable lithium-ion battery (B), the device provides accurate and reliable data on knee joint movement. The patients can use the device at home and receive visual feedback on their progress through a smartphone app, while doctors and therapists can monitor patient compliance and understand the effectiveness of knee rehabilitation. The validation of QuadEase with a universal goniometer will provide further evidence of the device's accuracy and reliability, making it a valuable tool for improving knee rehabilitation outcomes. ,CLAIMS:We claim:

1. A wearable real-time biofeedback device for measuring quadriceps lag during knee rehabilitation comprising of:
a) Node microcontroller unit (MCU) Esp8266 for processing data from attached sensors;
b) Microprocessor unit (MPU) 6050 equipped with a six-axis gyroscope and accelerometerfor detecting knee joint movement;
c) Battery management system featuring a USB charging port for efficient operation;
d) Chargeable lithium-ion battery (B) providing power to the device; and
e) Wi-Fi (W);

wherein said device facilitates wireless connectivity to a mobile application for graphical and numerical representation of real-time biofeedback and visual feedback.

2. The wearable real-time biofeedback device as claimed in claim 1, wherein the said sensors attached to the knee capture data and transmit it to mobile application via Wi-Fi (W).

3. The method for knee rehabilitation by using a wearable real-time biofeedback device as claimed in claim 1, wherein said method comprising of step:
a. Securely attaching said device to the leg;
b. Initiating real-time lag measurement through the smartphone application;
c. Monitoring progress through graphical and numerical representations;
d. Setting personalized thresholds for quadriceps lag degrees;
e. Receiving notifications when pre-defined limits are reached;
f. Ceasing leg movements upon alarming alerts;
g. Conducting multiple measurement attempts for accuracy;
h. Automatically calculating the final lag based on recorded attempts; and
i. Reviewing results within the application to analyze trends and make informed decisions regarding rehabilitation strategies.

Dated 15th Apr, 2024

Chothani Pritibahen Bipinbhai
Reg. No.: IN/PA-3148
For and on behalf of the applicant