Community Research and Development Information Service - CORDIS

H2020

RETRAINER Report Summary

Project ID: 644721
Funded under: H2020-EU.2.1.1.5.

Periodic Reporting for period 1 - RETRAINER (REaching and grasping Training based on Robotic hybrid AssIstance for Neurological patients: End users Real life evaluation)

Reporting period: 2015-01-01 to 2016-06-30

Summary of the context and overall objectives of the project

The overall aim of the RETRAINER project is to tune and validate advanced, robot-based technologies to facilitate recovery of arm and hand function in stroke survivors and to extensively verify the use of the system by end-users (patients and clinicians). RETRAINER allows end-users to use their own arm and hand as much and as soon as possible after the trauma so to achieve the best outcomes in rehabilitation.

Stroke is a costly disease from the perspective of the person, his/her family, and the society as a whole. Starting from human costs, stroke is a leading cause of death and disability. Every year, about 16 millions firstever strokes occur in the world, causing 5.7 millions deaths. As a consequence, stroke ranks as the second cause of death in the world population after ischaemic heart disease (the third if neoplastic diseases are considered as a group). In the 28 EU countries, total annual cost of stroke is estimated €27 billion: €18.5 billion (68.5%) for direct costs and €8.5 billion (31.5%) for indirect costs. A further sum of €11.1 billion is calculated for the value of informal care. Including informal care in the total amount, percentages would change to 48.6% for direct costs, 22.3% for indirect costs, and 29.1% for informal care costs. About half of stroke survivors are left with some degree of physical or cognitive impairment. The need of support in common daily activities directly impacts on quality of life of the patients and their relatives; these latters frequently become their caregivers. Although often neglected, informal care is of paramount relevance to maintain stroke survivors in the community, and a valuable economic resource for the national health care systems. Available facts and figures may easily explain why the economic burden of stroke is requiring increasing attention for more effective health care planning and resources allocation.

Costs per patient in the first year after a single stroke amount to €18,517 in Germany. Of this, 37% is spent on rehabilitation, while outpatient treatment accounts for 49% in the subsequent four years, thus becoming the main cost factor. Lifelong direct treatment costs on average €43,129 per patient for ischemic stroke. Of this, around 40% is spent on outpatient treatment, 22% on inpatient treatment, 21% on rehabilitation, and 17% on nursing care. The total medical costs for stroke treatment in Germany in 2004 amounted in excess of 7.1 billion €. In a multinational study of 16 industrial nations, the lifelong costs of a stroke patient range from 11,787 US dollars for “not further specified” strokes in Australia, and to 3,035,671 US dollars for a stroke patient with untreated non-rheumatic atrial fibrillation. The average lifelong costs for a patient with ischemic stroke lie between 41,257 US dollars in Australia and 104,629 US dollars in Great Britain. The costs are determined mainly by the severity of the stroke (extended hospitalisation), the patient age (higher costs for younger patients) and gender (higher direct costs for women, higher indirect costs for men). These costs for the care of stroke patients underline the high economic significance of this illness for the health systems of developed countries.

The RETRAINER project is targeting mainly two categories of potential users:
1) Rehabilitation centers’ professionals: since they are responsible of the patients’ rehabilitation process, prevention of complication, and re-integration in the community;
2) Stroke patients and their families: since they can profit of this technology for increasing their independence in daily life and preventing complications.

RETRAINER, as an innovation action, implements a full technology transfer from the results of a previous FP7 project, MUNDUS, aimed at setting up an assistive device for severely disabled people in daily life activities; namely, RETRAINER makes available two systems for stroke rehabilitation, both derived from a subset of the MUNDUS project: S1, which aims at training the arm movements, and S2, which aims at training the hand movements.

RETRAINER S1 provides the end-user with a robot that does not completely take over the user’s tasks and doea not substitute the body’s functionality, but specifically supports the user only wherever he/she really needs support. Residual functionality is trained and improved rather than replaced by the robotic device. Arm movements are supported by a combined action of a passive exoskeleton for weight relief and NMES delivered to arm muscles in a controlled manner. The lightweight exoskeleton provides the user with an adjustable amount of weight support to reduce necessary muscular effort for movements and, at the same time, NMES increases muscle activation and strengthen the muscles. Stimulation amplitudes control is based on the residual EMG activities of the same stimulated muscles since the combination of NMES with the voluntary effort of the patients seems to maximize the therapeutic effects of NMES, thus having the highest potential to increase the rehabilitative outcomes.

RETRAINER S2 takes care of the training of hand functions thanks to a wearable NMES system with multiple electrode arrays, which is a modular tool usable as a platform for grasp rehabilitation, potentially improving the clinical applicability of NMES. The device is designed for providing electrical stimulation on extrinsic and intrinsic grasp muscles. It is composed of two independent electrode arrays, which can be donned on the user forearm and hand, and can deliver NMES provided by an external stimulator with demultiplexers. The stimulation patterns can be manually tuned to elicit functional grasp, to obtain whole muscle conditioning, and to produce open-loop or closed-loop grasp control.

Both systems benefit from the use of interactive objects that are daily life objects able to supply the robotic system with some information on themselves (e.g. physical characteristics, expected sequence of use) to drive their usage. The objects are equipped with RFID tags and a reader embedded in the robotic system processing the associated information to run predefined sequences of actions. A devoted processing of RSSI from the tags and environmental constraints allows the recognition of the selected objects among several ones. Within RETRAINER, this concept is exploited to drive rehabilitation exercises to get deeper knowledge on the recovery of the patient.

The complete systems will undergo a thorough randomized control clinical trial with end users to assess their efficacy in rehabilitation.
Certification and qualification of the system will be pursued, given the adequate quality of experimental results.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The project started on January 2015 and it is planned to last 48 months. The transfer of technology and the manufacturing of the prototype was planned to take place in the early 18 months of the project's life. Indeed, 8 prototypes of S1 and S2 systems are under delivery to the two clinical centers involved in the field trials. Trials will start in September 2016 for S1 and October 2016 for S2.

In this early phase of the project's running, most of activities were devoted to:
1) the finalization and tuning of the RETRAINER system specifications by clinicians and its acceptance by patients. These activities were accomplished in the early months of the project and led to a full set of functional specifications to drive the development phase;
2) the partial re-design and development of the S1 and S2 systems as defined above. As explained, the project aimed to build on the results of a previous project, MUNDUS. However, MUNDUS was ended in 2013 and the RETRAINER developers had to cope with the obsolescence of some of the MUNDUS technologies.

The following components were revised, developed, and manufactured as working prototypes for the next clinical trials:
- the RETRAINER exoskeleton: it is a 3 degrees of freedom lightweight exoskeleton able to compensate the weight of the end-user both at the arm and forearm level and to lock individually each of the three degrees of freedom.
- the RETRAINER stimulator: it is a portable device able to both induce muscles contractions and simultaneously measure the electromyographic signals of the stimulated muscles. The stimulator can be connected both to standard electrodes and electrode arrays by using a demultiplexer.
- the RETRAINER embedded control architecture: it is an embedded platform controlling the exoskeleton and the stimulator in real time and collecting EMG signals, angle data from the exoskeleton, and force and position data from the hand in order to let the end-user perform different movements of the upper limb.
- the RETRAINER graphical user interface: it drives the therapist during the donning and calibration of the S1 and S2 systems and the end-user during the training session, providing relevant feedback to the therapist about the performance of the patient in the execution of the exercises and producing simple reports at the end of the training session.
- the RETRAINER interactive objects: they are based on radio frequency technologies and inform the system about environmental conditions driving the exercise execution such as the proximity of the hand to the objects and the characteristics of the objects themselves (weight, dimension).

At present, both S1 and S2 are under refinement and technical testing to assure their full functionality for the planned clinical trials.

On the clinical trials side, the first 18 months of the project’s life were dedicated to the definition of:
a. the identification of potential end-users characteristics
b. the definition of a set of exercises both system should allow to perform
c. the investigation of potential end-users needs and cautions that have to be taken into account to optimize the design and production of both S1 and S2.
d. the design and implementation of the pilot tests
e. the design of the usability trial in a clinical setting

The planning of all the activities with patients was approved by all the involved ethical boards at different decisional levels, i.e the ethical board of the project, the local ethical committees in Germany and Italy and the Italian Ministry of Health.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

RETRAINER addresses pressing technological challenges and, after 18 months from the Project’s inception, the envisaged societal impacts are worth reconfirmation.

Indeed, OBHP – one of the leading companies in the area of prosthetics and orthotics - is currently investigating possible ways to exploit the results gained in RETRAINER.

The two SMEs involved in the project are interested in specific parts of the systems. In particular NMES is of interest to HASOMED and interactive objects are of interest to ABACUS.

Most importantly, the technology readiness level for the complete system is increased from TRL5 to a TRL 7, thus bringing the system into clinical practice for the first time. This capability will be used in a widespread clinical trial on two rehabilitation centers in Italy and Germany, with a third possible site in Austria. The clinical study, which is going to start after the first patient testing later, this year will demonstrate the usability of such a system in daily clinical practice and the effectiveness of such therapy in the rehabilitation process. Usability and effectiveness are of great interest to all partners involved. Based on the results of the clinical trial, it will then be possible to fully estimate the commercial potential of such a system.

The already existing exploitation plan will form an important stepping stone in the development of a full business model. Exploitation of single components and technologies developed in the project (as demonstrated above) is also likely and to be expected. Moreover, algorithms for EMG triggering and analysis even during electrical stimulation, as well as array electrodes for electrical stimulation, seem interesting and could either be marketed as part of a complete system (as demonstrated in RETRAINER) or stand-alone technologies.

The technological development completed within the 18 months of the project was performed in close adherence and under consideration of current regulations. A measured approach was taken to, on the one hand allow quick transfer of knowledge into products, while at the same time not restricting operational freedom of all partners involved. This approach should ensure a relatively quick transition towards qualification and regulatory approval of the system.

As an important aspect of the project, the participating industrial partners have developed personnel investigating key aspects of the project. Working on these key aspects has widened knowledge and expertise in the interesting field of rehabilitation following stroke. During the clinical trial we expect to gather even more knowledge, especially in the clinical domain. This will allow partners involved to better understand the needs of the clinical partners involved. Most importantly the intense participation of patients in the clinical trial will allow the consortium to better understand their needs. This improved understanding and knowledge will have a twofold effect. On the one hand, it will deepen understanding between academic partners at universities, clinical partners and physiotherapists and the industrial partners. One the other hand, it will educate a number of people and ensure that a sufficient number of well-trained professionals are available that will be required by future growth of the medical device industry.

The stimulator, which was developed for S1 and S2, is also usable as a stand-alone device for other NMES applications. As a first step, HASOMED is going to capitalize the stimulator as a medical device for scientific NMES applications. The stimulator offers many options for configuration and parametrisation, therefore it is attractive for lots of scientific applications. HASOMED also pursues the plan to capitalize the stimulator in different other ways. The device was developed with several open interfaces in hardware and firmware. The developed communication protocol allows a usage for different applications, e.g. in combination with other medical devices. The aim of HASOMED is to develop further functionalities and to create different product versions out.

The interactive objects are usable as rehabilitation tools even independently by the use of NMES and the support of the exoskeleton. ABACUS is capitalizing on the RETRAINER results to setup a standalone rehabilitation system able to be exploited in occupational therapy environments both in the clinics as well as at home. Indeed, interactive object may be any daily usage object (e.g. cups, glasses, etc.) appropriately equipped with smart tags.

Related information

Record Number: 194920 / Last updated on: 2017-02-17
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