Upper Limb Amputation at the Wrist Clinical Trial
Official title:
Interventional Pilot Study on the Evaluation of the Functionality, the Safety, and the Reliability of an Implantable Bi-directional Myokinetic Interface for the Natural Control of Artificial Limbs
This is a European project that it will develop an innovative robotic hand prosthesis, whose movements can be controlled in a natural and intuitive way. The project will be financed with 1.5 million euros by the European Research Council (ERC), through the "ERC Starting Grant 2015" program, one of the most competitive globally. According to current approaches (even the most technologically advanced or still under development) the control of the movements of the prosthetic hand occurs on the decoding of the electrical potentials, transmitted by the brain and captured by the peripheral neuromuscular system, through electrodes. The project has the ambition of wanting to overcome the limits of these techniques, through the development of an interface based on magnetic markers implantable in the muscles, capable of monitoring the elongation (lengthening) of the residual muscles, as happens naturally when performing a task motor (action), for example grabbing a bottle. With this information MYKI wants to control the movements of a robotic hand in a natural and intuitive way. In terms of potential, magnetic markers could also be used to provide a sensory feedback to the person wearing the robotic prosthesis, when it interacts with the environment, just as happens in the natural hand.
The 'MYKI- Studio Clinico' is a no-profit clinical study which aims at verifying the benefits and safety of an innovative upper limb interface, the Myokinetic interface, specifically conceived for patients with upper limb amputation. The study will verify whether the new interface, based on the use of implanted magnets, guarantees a natural and multi-degree of freedom control of robotic hands. Besides, the 'MYKI - Studio Clinico' will investigate if it is possible to convey physiologically appropriate proprioceptive information (i.e., movement and position information) of a missing finger or degrees of freedom through vibrations induced by implanted magnets. This idea is supported by the neuroscientific literature (Goodwin et al. 1972; Roll et al. 1989) and by studies conducted in the last years by the Sponsor's research group (see Clinical Investigator's Brochure ). Potential changes in the neurophysiological system will also be addressed. Finally, the controllability offered by the Myokinetic interface (i.e. the ability of the system to interpret the patient's voluntary motor commands, and to implement them on the robotic hand) will be experimentally compared with that offered by conventional surface electromyography (myoelectric prostheses). The Myokinetic interface will produce a natural control and perception of robotic hands. The handbook "Manuale D'Uso" describes the instructions for the correct use of the device. ;
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