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European advanced exoskeleton for rehabilitation of Acquired Brain Damage (ABD) and/or spinal cord injury's patients.

Periodic Reporting for period 2 - HANK (European advanced exoskeleton for rehabilitation of Acquired Brain Damage (ABD) and/or spinal cord injury's patients.)

Reporting period: 2017-03-01 to 2018-02-28

Stroke (and in general, any kind of Acquired Brain Damage – ABD –) and spinal cord injuries significantly affect thousands of individuals annually, leading to considerable physical impairment and functional disability. Gait is one of the most important activities of daily living affected in stroke survivors. Recent technological developments in powered robotics exoskeletons can create powerful adjunctive tools for rehabilitation and potentially accelerate functional recovery. A novel lower limb robotic exoskeleton, namely HANK, will represent a significant advance over the state-of-the-art for gait rehabilitation in stroke survivors. Its unique value proposition is based on:
• It incorporates all the existing technologies to control the movement of the exoskeleton, plus the use of EEG signals, facilitating the neuronal rehabilitation of the ABD patients and restoring the neuronal connections.
• It gives to the rehabilitation doctors and physiotherapist the opportunity to use the best movement strategy for each patient, thanks to its independent control system for each articulation (hip, knee and ankle).
• It allows the patients’ movements by controlled directly by the EEG signals (the exoskeleton can be managed directly by the mental orders of the patients), allowing the possibility to walk again for full paraplegic and quadriplegic patients, as these ones affected by spinal cord injuries.
• None of the competitors has implemented the ankle control system. Having the ankle joint control, HANK allows to the patients a smoother movement.
• And, last but no least, it will be have a very competitive price compared with the existing competence
Due to these differential advantages over the existing competitors, HANK will be a first-in-class product on the market. Thus, this proposal is clearly business-oriented, aiming to covers the required steps to pass from the current stage of the technology (TRL 7 – system prototype demonstrated in operational environment -) until TRL9, and to pilots the successful launching of this new product to the market. Specific project objectives include:
1. To make an aesthetic redesign of the exoskeleton (industrial design) and the whole definition of its industrialization, evaluating the manufacturing processes and adjusting costs and quality of the final devices.
2. To manufacture the first prototypes and pre-series, industrially produced.
3. To perform the clinical validation of this equipment, and to obtain the clinical certification, as well as the CE compliance and FDA compliance (USA market).
4. To prepare the pre-commercialization phase, disseminating the project results towards potential customers and assuring a wide diffusion in the media of the benefits of HANK.
5. To update the preliminary business model and business plan, contrasting the initial estimation with potential customers and users.
Main achievements during the first year of the project have been:

• At managerial level:
o Project progress monitored effectively.
o All project deliverables in this period (D1.1 D1.2 D2.1 D2.2 D3.1 D6.1 D6.2 D6.3-M3 D6.3-M12 D6.4 and D7.1) submitted on time.
o Coordinated the technological and scientific orientation of the project.
o Risks and contingencies managed effectively.
o Appropriate relationships and communication between all the partners, as well as with the European Commission (EC).
o Made project visible.

• At technical level:
o Transferred the technology of the exoskeleton from the CSIC towards GOGOA (mechanical components, assembly and set-up & tuning) and FAAR (electronics).
o Designed the first prototype exoskeleton, improving the aesthetical appearance and adapting it for industrial production.
o Produced the first industrial prototype of HANK.
o Tested the first prototype in real working conditions with Ataxia of Friedrich patients. Some improvements are required to increase usability and robustness of the prototype.
o New redesign of some components to increase usability and robustness. A second prototype is produced and functionally tested successfully.
o Fully defined the industrial production processes for industrial production of the exoskeleton.
o Performed first EMC tests for the CE mark in a certified laboratory. A new redesign of the electronic boards is required.
o Redesign of the electronic boards. New EMC tests are scheduled for the beginning of the 2nd project year.
o Started the industrial production of a pre-series of HANK exoskeletons.
o Updated the patent search
o Preliminary definition of the business and exploitation plans.
o Performed many dissemination activities towards users, potential customers and stakeholders. Required dissemination materials produced.
o Defined the preliminary ethics requirements.
o Prepared the risks management analysis, according to ISO 14971:2007-03 (Medical devices - Application of risk management to medical devices). Approval of these risks analysis by the Ethics Committee of FSL.
It is estimated that there are approximately 80 million people who need a wheelchair every day around the world. With the aging population this number increases immeasurably. This means that about 3 million Americans, 5 million Europeans, a total of 10 million citizens of developed countries and approximately 60 million people around the world depend on wheelchairs. Even if wheelchairs have improved in quality in recent decades, the options for people with mobility problems are limited. All that is about to change. Robotic technology opens up great prospects for the future, because it can help those people with mobility limitations to fend for themselves again. Exoskeletons offer, finally, a choice of alternative mobility for wheelchair users. Thanks to this new product these people return to stand, walk, turn around and sit by themselves. It is also possible to smooth lateral movement, climbing stairs and walking on hard, flat surfaces including ascending and descending slopes.

On the other hand, strokes are the leading cause of disability worldwide. Currently worldwide, 15 million persons suffer a stroke each year and forecast that this figure could double by 2020 (World Health Organization). In the case of people with brain damage, studies indicate that more than a year having passed since even trauma or stroke, limitations can be counteracted by appropriate therapy strengths. It can promote greater autonomy in the chronic phase recovering motor skills through active muscle activation with the use of appropriate technology. In future years, disability is a cause for even greater concern because its prevalence is increasing. This is because the population is aging and the risk of disability is higher among older adults, and also to the global rise of chronic diseases such as diabetes, cardiovascular disease, cancer and mental health disorders. These trends are creating an overwhelming demand for health and rehabilitation services. The aim of robotically assisted rehabilitation (RAR) is to increase the efficiency in the delivery of rehabilitation care for stroke patients while simultaneously improving the quality of that care. For chronic patients, studies have shown that even 1-year post-stroke sensory-motor impairment can be reduced with sufficient therapy.
Final design of HANK exoskeleton
First prototype of HANK exoskeleton