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Simulation-based design and development of a novel 3D printed ankle-foot orthosis

Periodic Reporting for period 1 - SPRINTAFO (Simulation-based design and development of a novel 3D printed ankle-foot orthosis)

Periodo di rendicontazione: 2021-06-01 al 2023-05-31

Ankle sprains are one of the most common injuries among athletes, as well as other young and active adults, and account for 15% to 45% of all sports injuries. Furthermore, 10% to 30% of individuals with ankle sprains have developed chronic ankle instability. If not promptly treated, chronic ankle instability after ankle sprain can cause impaired mobility and quality of life reduction. This has afflicted approximately 200 million people across Europe, resulting in spending of over EUR 300M per annum to treat these patients with lower limb supports. Ankle foot orthosis (AFO) are externally-worn medical devices applied around the ankle joint to treat diverse walking disorders (including those caused by stroke and multiple sclerosis) by restoring a healthier gait pattern or preventing further injury. Traditional AFOs often rely on labour-intensive manufacturing techniques, which are slow, costly and can only produce a limited range of structures. In particular, these AFOs, either soft or semi-rigid, would uncomfortably restrict most or all of the degrees of freedom of the ankle, which limits their use by patients, can cause muscle to atrophy leading to increased susceptibility to future injury, and also negatively affects sports performance and quality of life.
The aims of the project are to develop a simulation-based platform for the personalised design and development of 3D printed orthoses, and apply the platform to the design and optimization of a novel 3D printed AFO. The overall objectives of the project are:
(1) Develop a musculoskeletal MBD model for the body consisting of head, torso and lower limb with a detailed foot model and the 3D printed AFO using OpenSim. Develop a Python code to run the MBD model automatically and use the code to perform MBD simulation for three different activities: ankle inversion-inducing dropping, walking and running activities;
(2) Determine the design variables of the AFO. Perform a batch simulation for the three activities using the simulation platform and develop a gradient descent optimization algorithm to optimize the AFO design through Python;
(3) Test the performance of the AFO in terms of protecting the ankle from injury in high ankle injury risk scenarios through inversion-inducing dropping activity simulation;
(4) Manufacture the AFO based on the optimized design parameters obtained from Objective 2 via 3D printing.
The following works were performed during the Fellowship:
(1) Two musculoskeletal models were developed and adopted to simulate three activities: one model was developed based on Rajagopal model, which was used to simulate walking and running activities; the other one was based on Delp model, which was used to simulate an inversion-inducing dropping activity. A python code was developed to run the two musculoskeletal models and simulation of the three activities automatically;
(2) The design variables for the AFO were determined. Based on the variables, a representation of AFO was created in the musculoskeletal model. An advanced gradient descent (GD) optimization algorithm was developed and integrated with the python code developed in Objective (1). The GD algorithm was then adopted to optimize the design variables of AFO;
(3) Collaborating with a postdoctoral researcher and a PhD student, the proposed AFO was 3D printed and assembled;
(4) The musculoskeletal model was used to test the perform of the AFO in terms of protecting the ankle from injury in high-risk scenarios through inversion-inducing dropping activity simulation.

The main results:
(1) The project developed a simulation-based medical device development platform, for the first time integrating an advanced musculoskeletal simulation model, an advanced GD optimization method and a state-of-the-art 3D printing technology, with aim of developing a novel AFO. This platform will provide a leap forward in the design, optimization, development and manufacturing of cost-effective, highly personalised and functional tailored orthoses.
(2) The project designed and developed a novel AFO that could feature unprecedented combinations of properties and functionality by controlling geometry, material composition and structure through 3D printing. Unlike previous soft or semi-rigid AFOs, the novel AFO demonstrated a tailored nonlinearity, which exhibits very low stiffness at natural movements of the ankle but significantly increased stiffness when the ankle is over inversed or extended. In this way the AFO will allow natural movements but impede excessive movements that lead to (re)injury.

Exploitation:
The simulation platform developed in the project will provide a research pipeline of how to develop a musculoskeletal model and apply the model to simulate the function of lower limb orthoses and prosthetics, which will be beneficial to the biomedical and biomechanical simulation communities, as well as orthoses and prosthetics industries;
The integration of a musculoskeletal simulation model and 3D printing technology will provide a state-of-the-art technology to produce cost-effective, highly personalized and function tailored orthoses and prosthetics, which will benefit the orthoses and prosthetic manufacturers and industries.

Dissemination:
(1) The results of the project will published in a top journal – Nature Biomedical Engineering;
(2) The developed simulation-based design, optimization and development platform for the medical device was presented in the University of Leeds and DePuy company in the UK;
(3) The developed musculoskeletal modelling and simulation were presented to the researchers and publics at “IfM Festival of Teaching, Research and Practice” in the University of Cambridge.
Progress beyond the state of the art:
This research developed a simulation-based platform for the personalised design and development of 3D printed orthoses, and apply the platform to the design and optimization of a novel 3D printed AFO. The project will lead to a pipeline for functional customisation of metamaterial orthoses through the integration of a personalised musculoskeletal biomechanical simulation model and 3D printing technologies. In the future, the platform will be used to analyse the musculoskeletal and joint functions, to predict and diagnose the musculoskeletal disorders and joint diseases, to design, optimize, manufacture and pre-clinically test new biomaterials and novel rehabilitation devices, including ankle-foot orthotics and exoskeletons.

Potential impacts:
Research advancement: The proposed research will pioneer the integration of an advanced musculoskeletal simulation model with a state-of-the-art 3D printing technology, with aim of developing a novel AFO, which when successful, will provide a leap forward in the development and manufacturing of cost-effective, highly personalised and functional tailored orthoses and medical devices.
Medical device: The proposed project targets to design and manufacture a novel AFO that could feature unprecedented combinations of properties and functionality by controlling geometry, material composition and structure through 3D printing. Unlike previous soft or semi-rigid AFOs, the proposed AFO will behaviour a tailored nonlinearity, which exhibits very low stiffness at natural movements of the ankle but significantly increased stiffness when the ankle is over inversed or extended. In this way the AFO will allow natural movements but impede excessive movements that lead to (re)injury.
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