Abstract
Diabetic foot complications are commonly recognized as the most common cause of “non-traumatic” Lower Limb Amputation (LLA) internationally. In Singapore, diabetes is the leading cause of amputation. Following an amputation, the provision of a prosthesis aims to facilitate the return to a pre-morbid condition. For a prosthesis to achieve this, it must not only fit well against the residuum but be comfortable to wear and add value to the user’s quality of life (QOL). Despite the improvements in technology, the prosthesis remains uncomfortable and disused, or worse, abandoned. The focus of the thesis is to develop a comfort-driven prostheses design methodology (CPDM) to address the clinical gap in the provision of lower limb prostheses. This thesis aims to 1) understand what comfort means for LLA prosthesis users, and 2) develop a methodology for designing prostheses for comfort. In response, research was undertaken to investigate the phenomenon of comfort. Through a literature review, interviews, questionnaires, and experiments, an understanding of ‘comfort’ was developed. Further experiments and surveys were conducted to understand how the potential use of sensors and other potential digital technologies could improve the design process. In response to these findings several solutions were developed with prosthesis users to address various comfort factors. This involved the design and development of a sweat reducing liner to improve thermal comfort, and the design and development of a method to capture Lines of Non-Extension which can result in designs to mitigate discomfort pressures and other discomfort factors, and a case study describes the use a human-centered design methodology combined with a digital technology process to provide further insights into the design and development the CPDM. The CPDM was designed and developed for providing guidance to the design of comfortable prostheses. The CPDM consists of six design phases and necessary tasks to complete in each phase. Several tools and measures were developed to aid in understanding comfort and its influence on the QOL for the prosthesis user including the AEIOU framework, Requirements Checklist, and the Prosthetic Comfort Assessment Metric (PCAM). These tools and measures were incorporated into the CPDM which was evaluated by experienced prosthetists who were involved in the generation of prostheses. Following the positive feedback of CPDM, the methodology is now being used in a new research study to design and develop an integrated prosthetic liner and socket.