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The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus

Periodic Reporting for period 3 - CYBERLEGs Plus Plus (The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus)

Reporting period: 2019-07-01 to 2021-04-30

Lower-limb loss is a disabling condition affecting health and quality of life, particularly in older persons. Universal to all developed countries the main factors influencing the number of lower-limb amputations are the high prevalence of atherosclerosis and dysvascular diseases and the overall increase of life span. Over the past century, the growth of the older population has resulted mostly from a general increase in the overall population and from major declines in the leading causes of mortality all around the world. About European Countries, improved survival at older ages and low birth rate have resulted in Europe having the oldest populations in the world, with almost one European citizen out of four projected to be aged 65 years or older by 2030. Therefore, prevalence and incidence rates of age-related diseases are expected to increase in the years to come.
A person with a dysvascular transfemoral amputation usually walks more slowly than before but expends much more energy because it takes a much greater effort to walk after amputation. Moreover, we know that energetic, cognitive and stability challenges are not fully overcome by any artificial passive or active transfemoral prosthesis in the current state of the art. These factors and the lack of confidence in the prosthetic devices lead most of the amputees to prefer wheelchair to prostheses, with a deep impact on the health status, on the social inclusion and on the independence of the amputee in daily living activities.
The global goal of the CYBERLEGs Plus Plus (CLs++) project was to further develop and assess the technical and economic viability of the powered robotic ortho-prosthesis developed within the framework of the FP7-ICT-CYBERLEGs project to enhance/restore the mobility of transfemoral amputees. Restored mobility will allow amputees to perform physical activity thus counteracting physical decline and improving their overall health status and quality of life.
During the lifespan of the project, the CLs++ consortium achieved relevant results from three different perspectives, namely: (i) scientific and technological, (ii) economic viability assessment of the developed technologies, and (iii) dissemination and exploitation of the project results.
About the scientific and technological achievements, CLs++ team designed and developed two new generations (namely 1st- and 2nd-generation) of the following devices/technologies:
- active, modular transfemoral prosthesis (ATP; the 2nd generation was also called X-Leg),
- Active Pelvis Orthosis (APO), an exoskeleton for assisting hip flexion-extension,
- Active Knee Orthosis (AKO): the 1st generation was developed to operate as an optional additive module of the APO; the 2nd generation is battery-operated and fully portable, and usable as a standing alone device,
- Wearable Sensory Apparatus (WSA) that comprises a pair of instrumented shoes endowed with pressure-sensitive insoles and a set of Inertial Measurement Units that can be attached to body segments to monitor users’ movements and allow the decoding of their intended movement,
- Bidirectional Interface (BI), which is a non-invasive, portable augmenting feedback device embedding vibrotactile stimulation units to promote a more physiological gait pattern,
- Intention Detection (ID) algorithms for the APO and the X-LEG,
- Fall Risk Mitigation control strategy, mediated by the APO, meant to assist users when multidirectional slippages or tripping are detected,
- a bio-inspired control framework for governing the behaviour of the different hardware modules, reproducing key mechanisms of human locomotion, such as: motor primitives, muscle-like impedance, central pattern generation, and iterative learning.
The consortium also developed a truly new unilateral battery-operated, fully portable hip exoskeleton (called Single Hip Active Joint Aide, SHAJA), extremely light-weighted (about <3.5 kg including batteries and electronics), for hip flexion-extension assistance.
In addition to the activities of design and development, a thorough experimentation of the developed prototypes was carried out through a two-stage two-centre clinical investigation. The first stage targeted the 1st-generation of CLs++ technology. The second stage targeted the 2nd-genearation of CLs++ technology. Both experimentations were: (i) held in two sites, namely at Fondazione Don Gnocchi, and at Vrije Universiteit Brussel, (ii) organized in two main protocols, which focused on CLs++ APO and X-Leg, and different ancillary protocols, devoted to specific modules, such as the AKO, the sensory feedback module, the algorithm for fall-risk mitigation, and bioinspired control strategies. Overall, about 40 (including healthy subjects and patients) volunteers were involved in the experimentations.
During the lifespan of the project, a significant attention has been paid by the consortium to the assessment of the economic viability of the developed technologies. By leveraging on collected clinical data and a deep analysis of the state of the art, the consortium has elaborated a multifaceted business model for the cost-effectiveness analysis of the developed technologies, from the perspective of all stakeholders involved in their future adoption.
The CLs++ consortium has been quite active in promoting the work done in the project; hereafter some relevant figures:
- 26 journals papers,
- 37 conference papers,
- 9 chapters of book,
- organization of 6 international workshops,
- attendance with/without contribution of 38 workshops/conferences/events
- co-promotion of 3 special issues in ISI indexed journals,
- 10 press mentions,
- 1 blog post,
- 8 events attended with a promotional stand / live demonstration.
Throughout the duration of the project, the CLs++ consortium has devoted attention to foster exploitation of project results. During the first half, most of the attention was focused on promoting the exploitation of the APO technology: a detailed strategy to exploit the hip exoskeleton technology has been elaborated, and two product development projects promptly started with objectives and funds defined outside the scope of the CLs++ project. During the second part, the consortium elaborated the exploitation strategy of all remaining technologies.
The CYBERLEGs Plus Plus project has contributed to progress the state of the art of wearable robotics along four main directives:
- development/validation (DV) with end users of highly efficient and light-weighted powered prosthesis and orthoses,
- DV of a wearable sensory apparatus which –in combination with bio-inspired control strategies– enables the development of accurate and intuitive algorithms to intercept the users’ intended locomotion tasks,
- DV of fall-risk mitigation strategies in the control of the CLs++ ortho-prosthesis modules,
- DV of an augmenting feedback system based on vibrotactile stimulators used to improve the gait pattern of patients with motor impairments.
CLs++ technologies will be the starting point for a future generation of products aiming at improving mobility of transfemoral amputees, or other end users with gait impairment such as stroke survivors or Parkinson Disease patients, and therefore improve their quality of life.
Mosaic of CLs technologies