An issue of great concern for amputees continues to be lack of proper fit and comfort in their sockets. This lack can often be attributed to changes in the shape of the residual limb that cannot be compensated for by existing prosthetic socket technology. In regions where cost is a prohibitive factor in the replacement of ill-fitting prosthetic sockets, the need for a volume adjustable, and potentially longer lasting, socket design is abundant. This research focuses on designing a volume adjustable lower limb prosthetic socket that accommodates the needs of amputees in underdeveloped countries using collaborative design techniques. Though advocated as a means of accurately identifying and satisfying their needs, including end-users in the design process often adds an additional layer of complexity because of differences in culture, language, or geography among the participants. This research therefore includes a study in which product design techniques were applied to the same volume adjustable socket design problem with a variety of users – typical users, lead users, and new Empathic Lead Users - from different countries, one developed and one developing. To overcome differences among participants, this research includes an alternative strategy to create Empathic Lead Users (ELU) from non-user product design engineers through the use of simulated lead user experiences. As a result of this study, customer needs analysis with ELU helps to identify 95% of traditional and lead user customer needs and 100% more latent needs, and possibly more avenues for product innovations, than interviewing lead or traditional users alone. The concepts generated by all users were also compared. Based on the resulting concepts’ novelty, variety, quality, and quantity, all users were able to satisfactorily complete the concept generation exercises and produced competitive design solutions. Using the concepts generated during this co-design study, a volume adjustable socket was developed. The final socket design, based on the analogous rotational movement of a camera aperture, is pursued through mechanical and subject testing. Early users of the socket liked the design and it has been demonstrated to provide the necessary volume adjustments, but future design iterations to improve its comfort are necessary. / text

In this paper, I will cover the step by step process of making my thesis film, Dantalion. These steps include writing, directing, production design, makeup, cinematography, editing, and sound. I will primarily focus on the pre-production work done for each one of these departments and how it affected the outcome of the finished film. I will then evaluate the outcome to determine the success of the project.

Submitted by Filipe dos Santos (fsantos@pucsp.br) on 2018-12-05T11:48:18Z No. of bitstreams: 1 Raissa Gonçalves Caselas.pdf: 4140601 bytes, checksum: 39e478f743f8ad192024eec9ac3c9304 (MD5) / Made available in DSpace on 2018-12-05T11:48:18Z (GMT). No. of bitstreams: 1 Raissa Gonçalves Caselas.pdf: 4140601 bytes, checksum: 39e478f743f8ad192024eec9ac3c9304 (MD5) Previous issue date: 2018-09-27 / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES / With the increasing insertion of 3D printing technologies in the industry, it becomes possible to develop new approaches for objects of different uses, allowing the creation of products highly adaptable to users, as well as the possibility of overcoming design barriers. Being aware of the limits of production and mechanical strength of materials as for lower limb prostheses when related to 3D printing, this research focused on the development of upper limb prostheses. Aiming to analyze the aesthetic and functional ways that the production of these prostheses has covered, were proposed case studies that sharpened the user's imagination and allowed them to be brought from the intangible to the palpable. Projects that were once considered to be impractical, with the technological advance are shown to be feasible, since CAD modeling with 3D printing opens new possibilities. Basing on the information sharing and using open source prosthesis designs, it was possible to attest to its reproducibility as well as the recurring aesthetic attributes, thus, two prostheses were printed and constructed with the use of additive manufacturing technology. Based on several authors from different areas, such as Lucia Santaella, Masahiro Mori, Vilem Flusser, João Teixeira, Chris Anderson and Kathryn Allan, as well as product development concepts, it was finally noticed that the aesthetics resulting from this union permeates the cyberpunk universe, introducing people who have physical disabilities not as "imperfect," but through technology, they can be like superhumans. Contrary to what was believed, prostheses showed a certain tendency towards robotization, admitting their inorganic nature and providing other means of personalization / Com a crescente inserção das tecnologias de impressão 3D na indústria, torna-se possível o desenvolvimento de novas abordagens para objetos de usos diversos, permitindo a criação de produtos altamente adaptáveis aos usuários, bem como a possibilidade de vencer barreiras projetuais. Tendo conhecimento dos limites de produção e de resistência mecânica dos materiais quanto as próteses de membro inferior quando relacionados à impressão 3D, esta pesquisa focou no desenvolvimento de próteses de membro superior. Buscando analisar os caminhos estéticos e funcionais que a produção dessas próteses tem cursado, foram propostos estudos de caso que aguçavam o imaginário do usuário e que permitiam trazê-los do intangível ao palpável. Projetos que outrora viam-se como sendo impraticáveis, com o avanço tecnológico se mostram realizáveis, pois a modelagem CAD junto a impressão 3D abrem novas possibilidades. Apoiando-se também no compartilhamento de informações e utilizando projetos de próteses open source, foi possível atestar sua reprodutibilidade, bem como os atributos estéticos recorrentes, assim, foram impressas e construídas duas próteses com a utilização de tecnologia de manufatura aditiva. Nos embasando em diversos autores de áreas distintas como, Lucia Santaella, Masahiro Mori, Vilem Flusser, João Teixeira, Chris Anderson e Kathryn Allan, além de conceitos de desenvolvimento de produtos, percebeu-se, por fim, que a estética que resulta dessa união permeia o universo do cyberpunk, apresentando as pessoas que possuem deficiências físicas não como “imperfeitas”, mas por meio da tecnologia, podem ser como super-humanos. Diferentemente do que se acreditava, as próteses apresentaram certa tendência à robotização, admitindo sua natureza inorgânica e propiciando outros meios de personalização

Students who graduate from a practitioner program in prosthetics & orthotics must achieve certification in order to obtain licensure and practice independently in 16 states. In states where licensure is not mandatory, graduates may choose to pursue certification in order assure patients that they are practicing at the highest level as well as to differentiate themselves from competitors. While studies have been carried out extensively regarding predictors of success on the certification exams in other professions, no such study has been carried out to date in prosthetics. The American Board for Certification in Prosthetics, Orthotics, & Pedorthics (ABC), established in 1948, historically has been the organization whose standards states adopt when wishing to implement licensure law. Therefore, the purpose of this study is to determine if statistically significant relations exist the ABC prosthetics certification pass or fail rates as well as the 3 exams which comprise certification based on specific predictor variables: gender, Carnegie ranking of the institution from where the candidate received the degree, and whether the candidate is extending credential. As it specifically relates to this study, credential extension refers to adding the certified prosthetist (CP) credential after already possessing the certified orthotist (CO) credential. A quantitative, retrospective, secondary data analysis of de-identified prosthetic resident data provided by the American Board for Certification in Prosthetics, Orthotics, & Pedorthics (ABC) and the National Commission on Orthotic & Prosthetic Education (NCOPE) was used to test the following research questions: Is there a relationship between gender, institution type, and/or credential extension and (1) success in achieving ABC prosthetics practitioner certification, (2) performance on the ABC prosthetics Written Multiple Choice exam, (3) performance on the ABC prosthetics Written Simulation exam, and (4) performance on the ABC Clinical Patient Management practical exam? Chi-square analysis, independent t-tests and logistic regression were used for data analysis in question 1. In research questions 2, 3, and 4 independent t-tests were used for analysis with two-level categorical independent variables and ANOVA was used for the three-level categorical independent variable, institution type. Linear regression was used for the models in research questions 2, 3, and 4. Statistically significant relations were found in each research question between the credential extension predictor variable and the dependent variables, with candidates who were extending credential performing better on each of the three examinations and, thus, greater success obtaining certification. This study was the first of its kind conducted regarding predictors of success in prosthetics certification, conducted with the variables of interest currently available. It served as a first step in filling the existing gap regarding this topic in the prosthetics literature. It informed the profession of the relationship between available predictors and variables of interest related to the ABC prosthetics certification exam. Further, it informed the profession of its status concerning collecting additional variables of interest that would permit analysis of more robust information, including grades on specific courses of interest, various GPAs and time between residency completion and exam date. Additionally, it informed the profession of its status concerning such research compared to other health professions with which it seeks to keep pace. Repeating this study with additional variables and an expanded sample size could potentially produce significant results, as has occurred in other professions. Further, additional analysis following stabilization of the new Master's degree and accreditation standards is warranted. This line of research has the potential to inform practice and policy in prosthetics education and certification. Finally, it will help the prosthetics profession keep pace with the other health professions and become a leader in best educational and clinical practices in managing patients who utilize prosthetic technologies.

Human gait is a complex process that involves the coordination of the central nervous and muscular systems. A disruption to the either system results in the impairment of a person’s ability to walk. Impairments can be caused by neurological disorders such as stroke and physical conditions like amputation. There is not a standardized method to quantitatively assess the gait asymmetry of affected subjects. The purpose of this research is to understand the fundamental aspects of asymmetrical effects on the human body and improve rehabilitation techniques and devices. This research takes an interdisciplinary approach to address the limitations with current rehabilitation methodologies. The goal of my Doctoral research is to understand the fundamental effects of asymmetry caused by physical and neurological impairments. The methods discussed in this document help in developing better solutions to rehabilitate impaired individuals’ gait. I studied four major hypothesis in regards to gait asymmetry. The first hypothesis is the potential of asymmetric systems to have symmetric output. The second hypothesis is that a method that incorporates a wider range of gait parameter asymmetries can be used as a measure for gait rehabilitation. The third hypothesis is that individuals can visually identify subtle gait asymmetries. Final hypothesis is to establish the relationship between gait quality and function. Current approaches to rehabilitate impaired gait typically focus on achieving the same symmetric gait as an able-body person. This cannot work because an impaired person is inherently asymmetric and forcing them to walk symmetrically causes them to adopt patterns that are not beneficial long term. Instead, it is more prudent to embrace the asymmetry of the condition and work to minimize in specific gait parameters that may cause more harm over the long run. Combined gait asymmetry metric (CGAM) provides the necessary means to study the effect of the gait parameters and it is weighted to balance each parameter’s effect equally by normalizing the data. CGAM provides the necessary means to study the effect of the gait parameters and is weighted towards parameters that are more asymmetric. The metric is also designed to combine spatial, temporal, kinematic, and kinetic gait parameter asymmetries. It can also combine subsets of the different gait parameters to provide a more thorough analysis. CGAM will help define quantitative thresholds for achievable balanced overall gait asymmetry. The studies in this dissertation conducted on able-body and impaired subjects provides better understanding of some fundamental aspects of asymmetry in human gait. Able body subjects test devices that aim to make an individual’s gait more asymmetric. These perturbations include a prosthetic and stroke simulator, addition of distal mass, and leg length alterations. Six able-body subjects and one amputee participated in the experiment that studied the effect of asymmetric knee height. The results which consisted of analyses of individual gait parameters and CGAM scores revealed that there is evidence of overall reduction of asymmetry in gait for both able-body subject on prosthetic simulators and transfemoral amputee. The transfemoral amputee also walked with a combination of distal mass with lowered knee height. Although this configuration showed better symmetry, the configuration is detrimental in terms of energy costs. Analyzing the data of gait with the stroke simulator showed that the subject’s gait does undergo alterations in terms of overall gait asymmetry. The distal mass and leg length alteration study has revealed some significant findings that are also reflected in the prosthetic study with distal mass. A leg length discrepancy (LLD) or the change of limb mass can result in asymmetric gait patterns. Although adding mass and LLD have been studied separately, this research studies how gait patterns change as a result of asymmetrically altering both leg length and mass at a leg’s distal end. Spatio-temporal and kinetic gait measures are used to study the combined asymmetric effects of placing LLD and mass on the opposite and same side. There were statistically significant differences for the amount of mass and leg length added for all five parameters. When LLD is added to longer leg, the temporal and kinetic gait parameters of the shorter limb and the altered limb’s spatial parameter become more asymmetric. Contrary to the hypothesis, there was no significant interaction between the amount of mass and leg length added. There were cases in all perturbations where a combination of mass and LLD make a gait parameter more symmetric than a single effect. These cases exhibit the potential for configurations with lower overall asymmetries even though each parameter has a slight asymmetry as opposed to driving one parameter to symmetry and other parameters to a larger asymmetry. CGAM analysis of the results revealed that the addition of distal mass contributes more towards overall asymmetry than LLD. Analyzing 11 gait parameters for LLD and mass on the same side showed that the overall asymmetry decreased for the combination of small LLD and mass. This is consistent with the findings from analyzing five individual gait parameters. Impaired subjects include individuals with stroke and amputees. The clinical trials for individuals with stroke involve training with the Gait Enhancing Mobile Shoe (GEMS) that pro- vides an asymmetric effect on the subject’s step length and time. Training with the GEMS showed improvement in clinical measures such as timed up and go (TUG), six minute walk test (6MWT), and gait velocity. The subjects also showed lower step length symmetry as intended by the GEMS. The ground reaction force asymmetries became more asymmetric as the spatial and temporal parameters became more symmetric. This phenomenon shows evidence that when an individual with stroke is corrected, for spatial and temporal symmetry is at the expense of kinetic symmetry. The CGAM scores also reflected similar trends to that of spatial and temporal symmetry and the r2 correlation with the gait parameters proved that double limb support asymmetry has no correlation with CGAM while ground reaction force asymmetry has a weak correlation. Step length, step, and swing time showed high correlation to CGAM. I also found the r2 correlation between the clinical measures and the CGAM scores. The CGAM scores were moderately correlated to 6MWT and gait velocity but had a weak correlation with TUG. CGAM has positive correlation with TUG and has negative correlation with 6MWT and gait velocity. This gives some validation to CGAM as a potential metric that can be used to evaluate gait patterns based on their asymmetries. Transfemoral amputees were tested for their gait with varied prosthetic knee heights to study the asymmetrical effects and trained split-belt treadmill. Asymmetric knee heights showed improvement in multiple gait parameters such as step length, vertical, propulsive, and braking force asymmetry. It also decreased hip and ankle angle asymmetries. However, these improvements did lead other parameters to become more asymmetric. The CGAM scores reflect this and they show overall improvement. Although the lowest knee height showed improvement, the input from the amputee suggested that the quality of gait decreased with the lowest knee height. These exploratory results did show that a slightly lower knee height may not affect the quality of gait but may provide better overall symmetry. Another exploratory study with split-belt treadmill training, similar to the protocol followed for individuals with stroke, showed definitive improvement in double limb support, swing time, step length and time symmetry. This was also reflected in the improvements seem post training in the CGAM scores as well. I found the r2 correlation of the CGAM and the gait parameters including gait velocity. Step length and swing time show consistent correlation for individual subjects and all the data combined to CGAM. Gait velocity shows a moderate correlation to CGAM for one subject and a high correlation to the other one. However, the combined data of gait velocities does not have any correlation with CGAM. These results show that CGAM can successfully represent the overall gait parameter asymmetry. The trends seen in the gait parameters is closely reflected in the CGAM scores. This research combines the study of asymmetry with people’s perception of human gait asymmetry, which will help in estimating the thresholds for perceivable asymmetrical changes to gait. Sixteen videos were generated using motion capture data and Unity game engine. The videos were chosen to represent the largest variation of gait asymmetries. Some videos were also chosen based on CGAM values that were similar but had large variation in underlying gait parameters. The dataset consisted of results of perturbation experiments on able-body subjects and asymmetric knee height prosthesis on transfemoral amputee. These videos were rated on a seven point Likert scale by subjects from 7 being normal to 1 being abnormal. Thirty one subjects took part in the experiment, out of which only 22 subject’s data was used because they rated at least 3 videos. The results show that the subjects were able to differentiate asymmetric gait with perturbations to able-body gait without perturbation at a self-selected speed. r2 correlation analysis showed that hip angle had mild correlation to the Likert scale rating of the 16 different gait patterns. Multivariate linear regression analysis with a linear model showed significant contribution of ankle and hip angles, vertical, propulsive, and braking forces. It is interesting that the majority of parameters that showed significance are not perceivable visually. Ankle and hip angles are visually perceivable and this significance revealed that subjects seemed to perceive asymmetric ankle and hip angles as abnormal. However, the subjects do not perceive asymmetric knee angles as completely abnormal with evidence of no significance, no correlation, and neutral Likert rating for gait patterns that perturbed knee angles.

Amputation is a life-changing event that results in a drastic reduction in quality of life including extreme loss of function and severe mental, emotional and physical pain. In order to mitigate these negative outcomes, there is great interest in the design of ‘advanced/robotic’ prosthetics that cosmetically and functionally mimic the lost limb. While the robotics side of advanced prosthetics has seen many advances recently, they still provide only a fraction of the natural limbs’ functionality. At the heart of the issue is the interface between the robotic limb and the individual that needs significant development. Amputees retain significant function in their nerves post-amputation, which offers a unique opportunity to interface with the peripheral nerve. Here we evaluate a relatively new approach to peripheral nerve interfacing by using microchannels, which hold the intrinsic ability to record larger neural signals from nerves than previously developed peripheral nerve interfaces. We first demonstrate that microchannel scaffolds are well suited for chronic integration with amputated nerves and promote highly organized nerve regeneration. We then demonstrate the ability to record neural signals, specifically action potentials, using microchannels permanently integrated with electrodes after chronic implantation in a terminal study. Together these studies suggest that microchannels are well suited for chronic implantation and stable peripheral nerve interfacing. As a next step toward clinical translation, we developed fully-integrated high electrode count microchannel interfacing technology capable of functioning while implanted in awake and freely moving animal models as needed for pre-clinical evaluation. Importantly, fabrication techniques were developed that apply to a broad range of flexible devices/sensors benefiting from flexible interconnects, surface mount device (SMD) integration, and/or operation in aqueous environments. Examples include diabetic glucose sensors, flexible skin based health monitors, and the burgeoning flexible wearable technology industry. Finally, we successfully utilized the fully integrated microchannel interfaces to record action potentials in the challenging awake and freely moving animal model validating the microchannel approach for peripheral nerve interfacing. In the end, the findings of these studies help direct and give significant credence to future technology development enabling eventual clinical application of microchannels for peripheral nerve interfacing.

Seven above-knee amputees were fitted with a low-cost prosthetic knee and different low-cost swing-phase setups were clinically assessed. Clinical testing included the 20-meter walk tests utilizing a mobile computer setup connected to a potentiometer and accelerometer mounted on the prosthetic limb. As hypothesized, incorporating friction and a spring system resulted in improved gait function. Of the two spring systems evaluated, the dual spring system performed better than the single spring system resulting in increased walking velocity with decreased maximum flexion and terminal impact. The dual spring system resulted in lower terminal impact because the deactivation of the stiff spring and activation of the less stiff spring during the last 25 degrees of swing-phase before extension allows the shank to decelerate and hit the bumper at a lower velocity. The swing-phase control mechanisms evaluated have the potential to improve prosthetic function and are ideal for use in low-cost and peadiatric prostheses.

Seven above-knee amputees were fitted with a low-cost prosthetic knee and different low-cost swing-phase setups were clinically assessed. Clinical testing included the 20-meter walk tests utilizing a mobile computer setup connected to a potentiometer and accelerometer mounted on the prosthetic limb. As hypothesized, incorporating friction and a spring system resulted in improved gait function. Of the two spring systems evaluated, the dual spring system performed better than the single spring system resulting in increased walking velocity with decreased maximum flexion and terminal impact. The dual spring system resulted in lower terminal impact because the deactivation of the stiff spring and activation of the less stiff spring during the last 25 degrees of swing-phase before extension allows the shank to decelerate and hit the bumper at a lower velocity. The swing-phase control mechanisms evaluated have the potential to improve prosthetic function and are ideal for use in low-cost and peadiatric prostheses.

Access to and subsequent control of spinal cord function are critical considerations for design of optimal therapeutic strategies for SCI patients. Electrical stimulation of the spinal cord is capable of activating behaviorally-relevant populations of neurons for recovery of function, and is therefore an attractive target for potential devices. A promising method for accessing these spinal circuits is through their axons, which are organized as longitudinal columns of white matter funiculi along the cord exterior. For this thesis, I hypothesized that these funiculi can be selectively recruited via electrodes appropriately placed on the surface of the spinal cord, for functional activation of relevant motor circuitry in a chronically-transected spinal cord. My tandem design goal was to fabricate and implement a conformable multi-electrode array (MEA) that would enable this selective stimulation. To accomplish this design goal, I participated in the design, fabrication, and electromechanical testing of a conformable MEA for surface stimulation of spinal tracts. I then assessed the fundamental capability of this MEA technology to stimulate white matter tracts in a precise, controlled, and functionally-relevant manner. This was accomplished via in vitro experiments that explored the ability of this MEA to locally activate axons via single- and dual-site surface stimulation. The results from these evaluation studies suggest that spinal-cord surface stimulation with this novel MEA technology can provide discrete, minimally-damaging activation of spinal systems via their white matter tracts. To test my hypothesis that surface stimulation can be used to recruit distinct populations in the spinal cord, I performed studies that stimulated lateral funiculi in both chronically-transected and intact in vitro spinal cords. Results from these studies reveal that selective surface stimulation of white matter tracts in the ventrolateral funiculus (VLF) elicit motor outputs not elicited in intact cords. In addition, I was able to demonstrate that the spinal systems activated by this surface stimulation involve synaptic components and are responsive to spatial, temporal, and pharmacologic facilitation. Corresponding labeling of the axonal tracts projecting through the T12 VLF indicate that, after chronic transection, the remaining spinal neurons whose axons travel through the VLF include those with cell bodies in both the intermediate region and dorsal horn. These electrophysiological results show that surface-stimulating technologies used to control motor function after injury should include focal activation of interneuronal systems with axons in the ventrolateral funiculus. As a whole, these studies provide essential starting points for further use of conformable MEAs to effectively activate and control spinal cord function from the surface of the spinal cord.

For many years, the biggest issue that causes discomfort and hygiene issues for patients with lower limb amputations have been the interface between body and prosthetic, the socket. Often made of an inflexible, solid polymer that does not allow the residual limb to breathe or perspire and with no consideration for the changes in size and shape of the human body caused by changes in temperature or environment, inflammation, irritation and discomfort often cause reduced usage or outright rejection of the prosthetic by the patient in their day to day lives. To address these issues and move towards a future of improved quality of life for patients who suffer amputations, Loughborough University formed the Next Generation Prosthetics research cluster. This work is one of four multidisciplinary research studies conducted by members of this research cluster, focusing on the area of Computer Aided Design (CAD) for improving the interface with Additive Manufacture (AM) to solve some of the challenges presented with improving prosthetic socket design, with an aim to improve and streamline the process to enable the involvement of clinicians and patients in the design process. The research presented in this thesis is based on three primary studies. The first study involved the conception of a CAD criteria, deciding what features are needed to represent the various properties the future socket outlined by the research cluster needs. These criteria were then used for testing three CAD systems, one each from the Parametric, Non Uniform Rational Basis Spline (NURBS) and Polygon archetypes respectively. The result of these tests led to the creation of a hybrid control workflow, used as the basis for finding improvements. The second study explored emerging CAD solutions, various new systems or plug-ins that had opportunities to improve the control model. These solutions were tested individually in areas where they could improve the workflow, and the successful solutions were added to the hybrid workflow to improve and reduce the workflow further. The final study involved taking the knowledge gained from the literature and the first two studies in order to theorise how an ideal CAD system for producing future prosthetic sockets would work, with considerations for user interface issues as well as background CAD applications. The third study was then used to inform the final deliverable of this research, a software design specification that defines how the system would work. This specification was written as a challenge to the CAD community, hoping to inform and aid future advancements in CAD software. As a final stage of research validation, a number of members of the CAD community were contacted and interviewed about their feelings of the work produced and their feedback was taken in order to inform future research in this area.