BESPOKE – Innovation for health

BESPOKE Joint and Spine

Με την πρόοδο της τεχνολογίας αλλά και της επιστημονικής έρευνας η μέθοδος έχει βοηθήσει χιλιάδες ασθενείς με μυοσκελετικό πόνο σε όλο τον κόσμο. Από το 2007 έχει βοηθήσει ασθενείς και στην Ελλάδα ακόμη και μετά από χειρουργείο. Η θεραπεία βασίζεται στην διόρθωση των μηχανικών δυσλειτουργιών του μυοσκελετικού συστήματος και είναι ανώδυνη και χωρίς παρενέργειες.

BESPOKE is a wearable medical device for continuous monitoring of movement knee disorders and injuries their gamification rehabilitation and pain control . A sophisticated expert system for patients with orthopedic joint problems.The BESPOKE® consists of:

ONE monitoring device/wearable attached to a knee brace. This lightweight and unobtrusive device are worn by the patient on knee joint with a brace or low back with a belt . Each device collects kinematic data for all three dimensions,rehab progression data and objective pain and symptoms information. The patient wears the device, as often as required, in accordance with the physician’s suggestion. Apart from wearing the devices, the BESPOKE® requires no further user intervention for the information to reach the treating physician.

MOBILE APP. A mobile app for patients or caregivers to interact with the device and provide important diary information.

THE CLOUD. The back end of the BESPOKE® system where patient data is securely stored according to GDPR protocol.

The SaMD Tool. A web-based application to view and download patient reports with a comprehensive and objective assessment of the disease symptoms.

Telehealth systems like ours saves time and solve the distance problem between patient and doctor or COVID 19 restrictions issues. Our team has developed an innovative, non-invasive, continuous monitoring medical device and a sophisticated expert system. The BESPOKE ® is built to support doctors and physio in monitoring and treating knee injury patients and patients with post surgery knee conditions and pain like OA and ACL injury. The system has accumulated research and development activities of more than 3 years with doctors,physios,engineers and developers.

The BESPOKE® is a medical device for monitoring orthopedic disease post surgery(meniscus injury,ACL injury,PCL injury ,OA of the knee and many more pathologies), which could revolutionize patient treatment by: tracing, recording and processing a variety of symptoms, frequently presented in the disease, through the continuous use of
wearable monitoring device. Α mobile app/platform is used to facilitate patient doctor interaction and the overall patient experience.

The analysis of these symptoms is complemented with information on lifestyle and rehab program – from the BESPOKE ® patient mobile app/cloud. As a result, physician can obtain a comprehensive view of the patient’s unique disease rehab progression and symptoms and can modify the treatment and the exercises(rehabilitation)given accordingly. By continuously monitoring and analyzing symptoms and rehab progression, BESPOKE® could be beneficial in clinical decision-making and personalized condition treatment. It can also promote better patient-physician interaction and enhance the overall patient experience.

Muscle activation :The analysis of these symptoms is complemented with information on lifestyle and rehab program – from the BESPOKE® patient mobile app. As a result, physician can obtain a comprehensive view of the patient’s unique disease rehab progression and can modify the therapy and the exercises given accordingly. By continuously monitoring and analysing symptoms and rehab progression, BESPOKE® could be beneficial in clinical decision-making and personalized condition treatment. It can also promote better patientphysician interaction and enhance the overall patient experience.

• CONTINUOUS MONITORING OF PATIENT
• STATUS REPORTING MADE EASILY
• PRACTICAL SELF-ASSESSMENT OF PATIENT STATUS
• COMMUNICATION WITH DOCTOR & STATUS REPORTING THOUGH MOBILE APP
• EASY TO OPERATE
• VIDEO CONSULTATION

THE BESPOKE Platform

The web Platform enables physicians to deliver and modify their patients’ treatment plan in a dynamic and personalized way. Specific customized algorithms analyze the collected information and notify the medical team for various critical events.

User Friendly Mobile Application motivates the patients to adopt a more responsible behaviour and facilitates them to capture and deliver to their medical team essential data for improving their own treatment outcome.

Health professionals can review remotely submitted health information, in real time, while patients follow their treatment plan and unlock superior data insights regarding patient behavior and adherence and moreover the efficacy of the treatment.Accurate and reliable data collection in a hybrid (Questionnaires & Wearables) and patient friendly way.

Customers

HEALTHCARE PROFESSIONALS

A wearable medical device for continuous monitoring of low back and spinal disorders. A sophisticated expert system for patients with KNEE PAIN disease.
Intended Use
It is intended to trace record, process and store a variety of motor and non-motor symptoms frequently presented in KNEE pathologies , by the long-term use of wearable monitoring device.
The system can be used at any stage of the disease or after surgery after its initial diagnosis and when the patients are under medical treatment. Using the device and mobile application throughout the year, the patient will be able to follow his or her progress, perform simple tasks and exercises through the specific section of the application and interact with the physician and the caregiver in a simple, coherent and value adding manner.

• Practical Self-Assessment of Patient Status
• Communication With the Doctor & Status Reporting Through
• Mobile App
• Easy to Operate

Monitoring REHAB Progress

Movement information derived from the recordings and disease symptoms with their intensities, after appropriate data processing, are presented to the treating healthcare professional in a comprehensive way. The reports will be at the disposal and judgment of the attending healthcare professional and could allow for a better and objective assessment and understanding of the patient’s symptom condition related to the OA disease through the Physician Tool.
The motor symptom information is accompanied by other data, collected through the smartphone of the patient/caregiver related to the patient lifestyle, cognitive condition, diet, activity, etc. The system can provide a picture of the patient health status to the healthcare professional, along with detailed information in various time periods and a friendly environment for the healthcare professional to make a change in the patient’s therapeutic plan, which can be communicated through the BESPOKE ® system to the patient/caregiver.
Three actors compose the BESPOKE® ecosystem: (a) patients being at any stage of the disease, (b) caregivers – formal (nurses,physios, volunteers) or informal (relatives, family, volunteers) – optionally appointed for the patients, (c) healthcare professionals (medical doctors – experts in JOINT disorders rehab or Orthopedists, or General Practitioners.

CERTIFICATION AND EDUCATION

The system provides a closed loop of interaction among the patient, the caregiver and the medical doctor and at the same time provide a repository of most of the patient health status related data.
The patient can acquire the system from BESPOKE UK Ltd and he or she could be paired to a healthcare professional who provides the follow-up in the monitoring data and the communication with the patient / caregiver through the system. The patient could use the system only after consulting a healthcare professional who is obliged to be trained,
and registered to BESPOKE Ltd in the use of the BESPOKE® system (certified by BESPOKE Ltd. as BESPOKE® Healthcare Professional). Both, the patient and the healthcare professional are registered users of the BESPOKE® System.

PATIENTS

The BESPOKE® is a wearable medical device for continuous monitoring of orthopedic disease symptoms, designed for home use by patients and their caregivers. BESPOKE® derived information can assist your physician fine-tune disease treatment rehabilitation to better handle your motor symptoms and pain and reduce any unwanted exercise -related complications.
The expected benefits for patients are:
1.Objective view of the rehab progression
2.Ability to seek advice and hold discussions with the physician, based on actual data and not hypotheses.
3.Self-report; they can easily share data with physician and other caregivers
4.Physician constantly monitors and assesses their condition and symptoms

Visits organized when significant treatment changes are required through the continuous, objective flow of information about the disease symptoms, the physician can make better informed decisions about the treatment of the condition and any complications.
BESPOKE® aims to improve patient-physician interaction and clinical decision making, and enhance overall patient experience.
Any patient suffering from LBP disease, who is treated or was operated by a healthcare professional could have access to the system.

PROMs combined with the wearable

Patient-Reported Outcome Measures (PROMs) are scientifically validated questionnaires completed by individuals that measure what matters to patients – their quality of life, feelings, daily functioning, and the impact of their symptoms. PROMs gather, measure and provide feedback to the practitioner about treatment efficacy from a patientcentred perspective. Scientific researchers and medical professionals developed PROMs to help identify and assess the subjective experience of individual patients in clinical trials. Recognising its value, the broader medical community has widely adopted PROMs to assist clinical care decisions, evaluate healthcare objectives, and provide valuable information which may be used in the decision-making process.
At the patient-clinic level, PROMs provide direct patient reporting using standardized, scientifically validated questionnaires to measure and quantify their personal experiences. PROMs allows patients the opportunity to engage with their clinician in planning their own healthcare, which tends to lead to better quality care.
PROMs enable clinicians, practitioners, and other healthcare professionals the means to assess and track a patient’s experience over time, collecting data and information that would be used to provide better overall health outcomes at both the individual and the group level.
PROMs gather data from various patients to help inform practice or group management decisions. This can lead to greater efficiency and effectiveness for the medical service provider as the feedback helps practitioners assess whether a health service is working to improve patient outcomes or whether a change is needed.

PROMs List

1.Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ-10)

Description
A psychosocial screening questionnaire to identify ‘yellow flags’ that may increase risk of delayed recovery.

When to use
All MSK conditions – great for back pain, anterior knee pain, other persistent pain states/compensable injury/screening yellow flags

Number of questions
10

Time it takes to answer
4 minutes

2.Numeric Pain Scale (NPS)

Description
A simple pain scale out of 10.

When to use
Any pain state / After interventions

Number of questions
1

Time it takes to answer
>1 minute

Run an Online Consultation

BESPOKE Hub includes an online consultation function with video or text .
When initiating an online consultation in BESPOKE Hub your selected profile will receive an invitation to join the consultation via email.
From this email, your client can click on a link to access the video consultation.

Overview of the product

1.FORCE SENSORS

Information about the position or movement of a user’s limb can be used to monitor physical activities or for human-machine-interface applications.The force-generating capacity of skeletal muscle is an important metric in the evaluation and diagnosis of musculoskeletal health. Measuring changes in muscle force exertion is essential for
tracking the progress of athletes during training, for evaluating patients’ recovery after muscle injury, and also for assisting the diagnosis of conditions such as muscular atrophy after injury or surgery. Although the soft sensors can detect small muscle deformations during a contraction, their sensitivity also induces high variability to placement during donning. This is due in large part to complex muscular anatomy within, and anatomical variability across, individuals.FFS is a non-invasive technique to decipher the position or movement of a limb based on changes in the stiffness of the corresponding musculotendinous complex (MC) against a default state. The changes in stiffness of the targeted MC is often monitored by placing a force transducer on the targeted location with a preload force. This preload force corresponds to the default state, which is usually chosen as a state where the limb is in a relaxed position. However, depending on the application, the default state can be arbitrarily chosen.

2.IMU

An IMU measures and reports a body’s specific force (accelerometer), angular rate (gyroscope), and sometimes the magnetic field surrounding the body (magnetometer). IMUs provide the leading technology used in wearable devices and are employed in this thesis as they meet the main design constraints of this framework, maximizing portability and minimizing cost. Previous work indicates that when multiple IMUs are employed, satisfactory rehabilitation exercise classification accuracy results are achieved based on three, two and one IMUs. Such results drive the further investigation of the challenging classification problem using just a single IMU in this thesis, enhancing maximum portability compared to multiple IMU systems, in conjunction with sufficiently high success rates of movement detection.

Our goal is to reduce the need for the physical presence of a physiotherapist by aiding the efficient performance of exercise sessions at any location and increase patient engagement during physiotherapy by motivating the user to participate in a game using the current ultraportable framework of just a single IMU sensor and an Android device.
The proposed sensor node attached on the lower limb provides input to the gamified experience displayed on an Android mobile device, offering feedback to the patient in relation to whether the performed exercises were accurately conducted. A classification algorithm is proposed that automatically classifies an exercise in real-time as correct
or incorrect, according to physiotherapists’ set criteria. This application engages the patient to accurately perform the recovery exercises through a gamified 3D experience, ultimately minimizing physiotherapist supervision, at most locations. The goal is to understand in a qualitative manner the feedback collected from the patients. In this iteration, quantitative measures that include ROM and classification feedback were provided. The collected data provide qualitative feedback towards understanding the user’s and physiotherapist expectations in relation to the proposed rehabilitation system. A relationship between quantitative measures (ROM) and quality of physiotherapy and knee
recovery is investigated.

Laser beam for motor control

Motor learning is a term that corresponds to the relatively permanent acquisition and refinement of motor skills of different joints The principles underlying motor learning incorporate fundamentals of neuroscience, psychology, and rehabilitation science to explain how motor development and re-learning
occurs after injury. The use of motor learning principles can improve rehabilitation outcomes and be implemented with a variety of clinical populations such as stroke, amputee and motor speech disorders. Traditional musculoskeletal rehabilitation approaches tend not to integrate motor learning principles explicitly or with a goal to induce neuroplasticity, or sensory re weighting, or virtual reality technologies that support optimized functional performance and recovery. Incorporation of these new technologies(lasers) and herapies may provide a means to reduce the high re injury rate after ACLR,
as the ACL injury event is essentially a coordination error in sensory, visual or motor processing .

Gamefication rehab

With the advance of technology and increase in processing power, the development of more complex games became a reality. At first rendering engines emerged that focused on projecting 3D models on the screen. The use of a graphics processing unit (GPU) enabled very efficient manipulation of computer graphics. Modern GPUs highly parallel structure make them more effective than general-purpose CPUs for algorithms where processing of large locks of data is done in parallel. Besides graphic engines a game nowadays needs more functional components such as sound engine, physics engine, etc.
Game engines are used primarily for developing next generation games by allowing the developers to focus on higher level aspects of a game (interaction between objects) instead of building a game from scratch as in earlier eras (the game had to be designed from the bottom up to make optimal use of
the display hardware). As game engine technology matures and becomes more user-friendly, the application of game engines has broadened in scope.
They are now being used for serious games: visualization, training, medical, and simulation applications. To facilitate this accessibility, new hardware platforms are now being targeted by game engines, including mobile phones and web browsers.

Gamification Feedback

The main goal of the application is to improve compliance to the physiotherapy protocol, increase patient engagement, monitor physiological conditions and provide feedback using a reward process via a gamified experience, using the following methods: Real-time IMU feedback. Raw data from the IMU are
filtered and limb orientation is determined. By collecting this data, the proposed framework visualizes in real-time an approximation of the user’s motion in a 3D scene. In this context, a user engages in a serious game of a specific objective, for instance, the patient is instructed to try and fly an airplane while moving the knee in the vertical axis in order to collect coins. In this specific context the user engages to the Knee Extension/Knee flexion/Hip abduction exercise that requires the user to perform extension of the knee while moving it up / down along with the movement of the airplane.

Classification feedback

The raw data of the IMU are inserted in the classification algorithm. The algorithm decides whether the exercise has been accurately performed. If by the end of a single repetition, the exercise was classified as accurately performed, the player is rewarded, e.g. by increasing a coin score attribute and by providing animated information related to the success of movement. If the exercise was classified as inaccurately performed, in which case the movement violates angle or acceleration constraints, the application informs the user of the correct movement, e.g. by providing a limb movement animation and encourages the patient to try again. Along with the classification result, the algorithm also outputs the maximum ROM percentage of the achieved movement for this repetition. A 100% percentage means that the patient achieved maximum rotation of the knee. The maximum rotation of the knee differs in each designated exercise. For instance, in relation to the Knee Extension, it is 90° degrees. When a patient achieves a maximum ROM percentage of 50% in a single repetition then this corresponds to 45° degrees orientation.

Rehab with Gaming

Each Game Level is available for each user and each exercise type. If a user would like to change game level or exercise type this should be easily achievable from the main menu. More info on this functionality is provided in the UI Implementation Section.
There is one GameObject that has a Custom Component derived from MyExercise class. This component handles the real-time visualization eedback of the IMU. This GameObject is attached to one or more 3D
model that interacts / moves analogically to the ROM achieved. This is done by appropriately handling MyExercise events as described in the Scene Hierarchy & Persistent Game section.
There is a common award system for all game scenes. This consists of Coin Score. Users gather coins if a repetition is successful. Depending on the ROM achieved they gain the highest value coins. Detailed description of the award system is provided furthermore.
There is gameplay specific functionality and game assets in every scene. Some examples of these specific scenes are described below.
The award system of each game is kept the same for consistency of observed results. This shouldn’t be an absolute constraint in future development, as different kind of awards can provide a sense of personalization to the framework. On the current implementation though, each case is handled in a similar manner. This simplifies the experimental and result generation processes.
The basic gameplay functionality is the core of the game process. When players raise their knee in order to perform Knee Extension,Knee flexion or Hip abduction then they can see an airplane going upwards along with their Knee movement. In the same manner the airplane goes downwards when patients lower their knee to the neutral position. Above the plane there are some ordered coins that the plane gathers when collision is detected. Collision is detected when the airplane model bounding box touches the coin bounding box. In that event the coin score is increased depending on the Coin value (Bronze, Gold, Silver coins give 1, 2, 3 points respectively). The goal here is to maximize award on higher ROM but also provide award for lower ROM achieved. This happens in order to engage even the patients with weaker knee recovery to put more effort to gain higher reward.
The award system described was implemented with the help of physiotherapists and postoperative patients to make sure it can engage the patients to perform an exercise. As discussed further this is achieved mostly with the visual Coin motivation than the Coin Score itself. The advanced gameplay functionality is an extension of the basic functionality. It provides additional gameplay features. The advanced feature in this game constitutes of the ability of a player to buy more airplanes and gather more coins faster . The player can control multiple airplanes with the same knee movement and collect
coins and points faster. The user cannot buy more planes if there are no more coins available. When a user performs some incorrec