The work program will be implemented in 36 months and is divided into the WorkPackages (WP) detailed below.
WP1 - Preliminary analysis and definition of requirements and specifications [M1-M5]
The specific objective of this WP is to (a) carry out an accurate analysis of the control and sensorisation solutions for hand prostheses present in the literature, both in the research and commercial fields; (b) carry out an analysis of the end users' needs in addition to a critical analysis of the previous experiences of UCBM and recent works in the literature on human neural implants for prosthesis control; (c) define the requirements and specifications that the final prosthetic system must have in order to meet clinical and market needs.
WP2 - Prosthetic hand control subsystem [M1-M24]
WP2 has the objective of developing a control system for the prosthetic hand which, receiving information on the type of task to be performed from the EMG classifier, defines the motor commands to be sent to the prosthesis actuators to perform the desired gripping task with the right level of strength. To this end, preliminary studies will be carried out on humans to define movement patterns and force levels to be replicated on the prosthesis. We will therefore move on to the development of a controller distributed on two levels (high level and low level) dedicated, respectively, to the planning of the gripping task with patterns similar to the natural ones and to the control of the position of the fingers and of the force to be applied in the interaction with the object. In the low-level control system it is therefore envisaged to introduce a force/position control loop that finely regulates the closing force, based on the information coming from the tactile sensor subsystem.
WP3 - Tactile sensor subsystem [M6-M28]
The objective is the design (after a careful analysis and evaluation of the connected risks) and the realization of the sensory system. In particular, commercial and custom components will be integrated using standard technologies of microfabrication and rapid prototyping.
WP4 - SNP interfacing subsystem [M6-M28]
In this WP the interfacing system between the biomechatronic hand prosthesis and the patient's SNP will be developed. The efferent signal on the subject's motion intention will be extracted by EMG, while the afferent signal will be transmitted through intraneural interfaces.
WP5 - System Integration [M29-M31]
Work Package 5 aims to obtain a prototype of the prosthesis by integrating the hardware and software components developed in the previous WPs on an already existing prosthesis identified in WP1. The choice of the prosthesis will fall on a polyarticulated hand with open control architecture: an essential requirement to be able to proceed with the modification of the prosthesis control software, integrating the tactile sensory feedback and enabling the direct command of the actuators.
To achieve this objective we will proceed with the integration of the hardware components developed in the previous WPs (WP2, WP3 and WP4) and with the integration, in a single development environment, of the software components.
WP6 - Experimental validation and clinical evaluation [M13-M34]
The objective of this WP is: (a) To define and perform the clinical procedures for the implantation of intraneural electrodes in the peripheral nerves of a suitably recruited amputee; (b) Experimentally validate (in synergy with other active projects) the prosthetic system developed in WP5, following the definition and approval of the experimental protocol by the competent bodies.
WP7 - Translational research for exploitation of results and follow-up plans [M1-M36]
WP7 has the following objectives:
- evaluate the application impact of all the intermediate and final results of the project, so as to facilitate the transfer of these results to clinical application. To this end, each result will be evaluated in terms of cost/benefit ratio, bioethical aspects, clinical/psychological aspects related to the acceptability of the technological solutions by users, analysis of the risks and reliability of the proposed technologies, etc.;
- develop project roadmaps for the development andingengineering of innovative solutions and devices directly deriving from the project. To this end, the needs of patients will be assessed in relation to the solutions directly deriving from the results of the project and any changes to be made to them will be identified in order to make them safe and reliable, as well as more usable and acceptable, compared to the state of the art. commercial;
- elaborate the follow-up plans of the project, in particular through the definition of scientific and technological road maps for the further development of research activities in the field of prosthetics, also through the exploitation of the opportunities offered by the HORIZON2020 programmes, by the National Research and other potential sources of research funding.
WP8 - Dissemination of results [M1-M36]
This WP aims to promote dissemination activities towards (i) the national and international scientific community and the wider public on information regarding the project, including the objectives achieved, the data obtained and the technologies developed; (ii) all the members of the teams involved in the project and the INAIL medical and technical personnel in general, on the progress of the project and updates on the most recent developments in the prosthetic field.
WP9 - Project coordination and management [M1-M36]
The project will require a careful and timely setting, planning and management of the activities in order to achieve the objectives mentioned, in compliance with the times, costs and expected quality. To this end, moreover, a fluid management of information towards all partners and stakeholders of the collaboration must be guaranteed, both inside and outside the two entities.