Periodic Reporting for period 1 - BELK (Wearable exoskeleton for knee rehabilitation with Functional Electrical Stimulation)
Período documentado: 2018-12-01 hasta 2019-11-30
The solution: The company GOGOA (www.gogoa.eu) specialized in design, manufacturing and commercialization of Robotic Assisted Rehabilitation (RAR) systems, has developed a functional prototype of the BELK system, a wearable robotic device that can be used for knee rehabilitation, in the sub-acute phase of knee injuries. It incorporates “assisted-as-needed” control and Functional Electrical Stimulation (FES) features, helping to speed-up and to improve the rehabilitation process.
Project aim and objectives: BELK project aims to cover the gap between the current TRL6 stage of the product and the full commercial deployment of this solution. Main objectives are (i) to improve technically the existing prototype, preparing it for industrialization (ii) to produce industrially a pre-series of BELK devices (iii) to perform clinical trials and achieve the CE certification (iv) to update the preliminary business and exploitation plans, and (v) to prepare the commercialization, disseminating the project results towards potential customers and the society in general.
o Developed hardware and firmware for real time coordination between the BELK and FES controllers.
o Designed the first prototype exoskeleton, improving the aesthetical appearance and adapting it for industrial production. New redesign of some components to increase usability and robustness.
o Produced a first version of the BELK prototype, for Electro-Magnetic Compatibility (EMC) and Electrostatic Discharges Immunity (EDI) tests.
o Performed first EMC and EDI tests for the CE mark in a certified laboratory with the BELK robotic device without the FES integration. Tests successfully passed.
o Submitted all the required documentation for the CE certification of the robotic rehabilitation device (without FES) to an official certification body (AEMPS).
o Functional validation of the robotic device integrated with the FES system.
o Fully defined the industrial production processes, including production sheets and Bill Of Materials, for industrial production of the exoskeleton.
o Validated the industrial production of the final prototype of the BELK system and started the industrial production of a pre-series of BELK exoskeletons.
o Updated the patent search and submitted the claim for two new patents, protecting the developed technology.
o Preliminary definition of the exploitation plan.
o Performed many dissemination activities towards users, potential customers and stakeholders. Required dissemination materials produced.
o Launching of a public Call for Tenders for the execution of the clinical trials. Two prestigious clinical institutions selected: the Public Basque Health Service (Osakidetza), to perform clinical trials with knee traumatic injured patients, and Casa di Cura Policlinica (CCP) with stroke patients.
o Prepared and submitted all required documentation to be approved by the Ethics Committees of Osakidetza and CCP, and by the Official Certification bodies in Spain and Italy.
o Defined Inclusion / exclusion criteria and clinical protocols for the clinical trials.
o Fulfilled all the Ethics Requirements. All project deliverables submitted on time. First milestone successfully achieved.
• First, there is a powered and wearable solution allowing users to perform knee rehabilitation during normal walking, unlike CPM devices. It is a one-joint-exoskeleton with an innovative transmission system (cable transmission – patented) that make possible to produce it at a reduced cost, which implies a final price similar to this one of CPM devices, but offering very advanced functionalities over them.
• Second, it is about providing the patient with ""only when you need it"" assistance, when currently the existing powered KAFO devices offer assistance based on all or nothing assistance. Current CPM systems are dedicated exclusively to repeat the movements that a physiotherapist would perform in a session, while KAFO devices reproduce a “robotic” movement, with very rigid pattern of movement, due to the lack of real-time adjustment between the force that patient can do and the force applied by the driver. BELK system only helps the movement in the stretch where the patient cannot. This implies intentionality by the patient that allows accelerating the rehabilitation since the effort realized is superior.
• Third, GOGOA has developed an algorithm to integrate Functional Electric Stimulation (FES) capabilities with the BELK robotic device. This intelligent and adaptable control algorithm allows to modulate the mechanical impedance that the exoskeleton exerts on the leg, combining the individual pattern of motion of the patient, the position of the leg and the force of the interaction between the patient and the device. Therefore, inducing variable muscle activation in the leg, which is indicated for optimal rehabilitation. None of the commercial knee rehabilitation devices (CPM, KAFO or exoskeletons) have this possibility.
In addition, the system is designed to be used at home, with no need to go to the rehabilitation centre, saving money and time, as well as the patient's mood. Technologically, this is possible through an optimal sensoring of the new device and the development of novel assistance control techniques that allow this assistance level based on ""only when you need it"".
The users needs addressed with this project are these ones related with a fast and effective rehabilitation of the knee and a fast and safe recovering of a natural pattern of gait. The rehabilitation process is a laborious work involving many physical therapy sessions over an extended period of time. These sessions mostly comprise repetitions of physical movements under the supervision of a physiotherapist. Because of this, a robotic system that allows these movements to be executed without the need of a therapist (even at the patient's home) greatly simplifies the process and dramatically reduces costs. Unlike existing CPM systems for knee rehabilitation, BELK may be used in the post-acute and functional training phases of the rehabilitation process as a wearable (non-static) system to accompany and assist the patient during the natural walking function."