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Smart and intuitive osseointegrated transfemoral prostheses embodying advanced dynamic behaviors

Periodic Reporting for period 2 - MyLeg (Smart and intuitive osseointegrated transfemoral prostheses embodying advanced dynamic behaviors)

Reporting period: 2019-01-01 to 2020-06-30

The MyLeg project aims at developing both a solid theoretical understanding and the enabling technologies for the realization of a new generation of transfemoral prostheses that can be intuitively operated, sensed, and trusted as the healthy counterpart. MyLeg introduces the concept of smart and intuitive osseointegrated transfemoral prostheses that embody advanced dynamic behaviors.
The MyLeg prosthetic system will be directly anchored to the amputee’s bone by means of osseointegrated implant to enhance the human-prosthesis interaction, perception, and motion capabilities; it will include implantable myoelectric sensors on targeted reinnervated muscles to realize an intuitive EMG control and to provide a high-level of cognition abilities; it will implement variable stiffness actuators realized with stress-stiffening nanostructured materials that guarantee high adaptability with respect to different tasks, dependability, and decisional autonomy; it will exploit light-weighted nanofibrous materials for sensing and energy harvesting.

Expected impacts:
- MyLeg will have a societal impact. Transfemoral amputees will better accept the prosthesis, their quality of life will improve, they will reach a higher degree of self-reliance, their social contacts will be enlarged, their (re-)integration in the society and in the labour-market will be facilitated.
- MyLeg will have an economic impact. Transfemoral amputees will need less support by formal/informal caregivers, which will reduce the burden on these groups and on society as a whole.
- MyLeg will impact the leadership role of Europe in the prosthetic market and, more in general, in the robotic world.

Objectives:
MyLeg will develop a new generation of powered transfemoral prosthetic legs that can be intuitively operated, sensed, and trusted as the healthy and reliable counterpart for a variety of tasks. The main objectives of the project are:
- To enhance human-prosthesis interaction, perception, and motion capabilities by exploiting osseointegration.
- To provide an intuitive control and to extend the user’s cognitive capabilities by using implantable myoelectric sensors on targeted reinnervated muscles.
- To achieve energy efficiency, dependability, and adaptability to different tasks by designing novel variable stiffness actuators and composite materials.
Work performed:
- The amputees’ needs have been deeply investigated (WP2).
- The benchmarks for the MyLeg system have been defined together with their measurable performance indexes (WP2).
- The requirements on the MyLeg systems have been listed (WP2).
- The technical/ethical documents, compulsory to perform clinical tests, have been prepared and submitted the the Dutch Ethics Committee. They have been approved in February 2020. The tests of the first MyLeg prototype have been performed in March 2020, suspended because of the COVID-19 pandemic, and re-started/finalized in August 2020 (WP2).
- The design of the first fully-passive MyLeg prototype (with composite materials) has been completed and the prototype tested with three osseointegrated amputess subjects (WP3, WP4, and WP6).
- The overall control architecture has been designed and implemented (WP3).
- The design of the second MyLeg prototype (with composite materials) has been completed but not fully fabricated yet. The low-level control has been developed and implemented (WP3 and WP4).
- Osseintegrated transfermoral amputee models have been developed and validated with amputee data (WP3).
- Composite materials have been developed for sensing (WP4).
- A first prototype for HD-EMG recording has been developed (WP5).
- High-level control strategies (based on sEMG) have been developed (WP5).
- First tests on fine-wire electrodes on TMR patients have been performed (WP5 and WP6).
- Clinical tests on osseointegrated patients have been performed (WP6).
- Clinical tests on target muscle reinnervation have been performed (WP6).
- The project website (www.myleg.eu) have been updated (WP7).
- Contributions to international conferences, journals, and general-public magazines have been published (WP7).
- The project MyLeg and its underlying ideas have been presented at several venues (WP7).
Progress beyond the state of the art:
- The design of the first fully-passive MyLeg prototype contains potential patents in terms of mechanism design and novel materials (WP3 and WP4).
- The overall control architecture has been designed to accomodate for a variety of activities of daily living (WP3).
- The medical procedure for target muscle reinnervation on transferal amputees have been studied and designed by the orthopedic surgeons (WP6).

Expected results:
The expected results are still in line with the project proposal.

Expected impacts:
- MyLeg will have a societal impact. Transfemoral amputees will better accept the prosthesis, their quality of life will improve, they will reach a higher degree of self-reliance, their social contacts will be enlarged, their (re-)integration in the society and in the labour-market will be facilitated.
- MyLeg will have an economic impact. Transfemoral amputees will need less support by formal/informal caregivers, which will reduce the burden on these groups and on society as a whole.
- MyLeg will impact the leadership role of Europe in the prosthetic market and, more in general, in the robotic world.