The BioRobotics Institute, Scuola Superiore Sant'Anna (Pisa), Viale Rinaldo Piaggio 34, 56025, Pontedera, Pisa, Italy.
Dept. of Excellence in Robotics and AI, Scuola Superiore Sant'Anna (Pisa), Piazza Martiri della Libertà, 33, 56127, Pisa, Italy.
J Neuroeng Rehabil. 2021 Dec 4;18(1):168. doi: 10.1186/s12984-021-00944-x.
Transfemoral amputees experience a complex host of physical, psychological, and social challenges, compounded by the functional limitations of current transfemoral prostheses. However, the specific relationships between human factors and prosthesis design and performance characteristics have not yet been adequately investigated. The present study aims to address this knowledge gap.
A comprehensive single-cohort survey of 114 unilateral transfemoral amputees addressed a broad range of demographic and clinical characteristics, functional autonomy, satisfaction and attitudes towards their current prostheses, and design priorities for an ideal transfemoral prosthesis, including the possibility of active assistance from a robotic knee unit. The survey was custom-developed based on several standard questionnaires used to assess motor abilities and autonomy in activities of daily living, prosthesis satisfaction, and quality of life in lower-limb amputees. Survey data were analyzed to compare the experience (including autonomy and satisfaction) and design priorities of users of transfemoral prostheses with versus without microprocessor-controlled knee units (MPKs and NMPKs, respectively), with a subsequent analyses of cross-category correlation, principal component analysis (PCA), cost-sensitivity segmentation, and unsupervised K-means clustering applied within the most cost-sensitive participants, to identify functional groupings of users with respect to their design priorities.
The cohort featured predominantly younger (< 50 years) traumatic male amputees with respect to the general transfemoral amputee population, with pronounced differences in age distribution and amputation etiology (traumatic vs. non-traumatic) between MPK and NMPK groups. These differences were further reflected in user experience, with MPK users reporting significantly greater overall functional autonomy, satisfaction, and sense of prosthesis ownership than those with NMPKs, in conjunction with a decreased incidence of instability and falls. Across all participants, the leading functional priorities for an ideal transfemoral prosthesis were overall stability, adaptability to variable walking velocity, and lifestyle-related functionality, while the highest-prioritized general characteristics were reliability, comfort, and weight, with highly variable prioritization of cost according to reimbursement status. PCA and user clustering analyses revealed the possibility for functionally relevant groupings of prosthesis features and users, based on their differential prioritization of these features-with implications towards prosthesis design tradeoffs.
This study's findings support the understanding that when appropriately prescribed according to patient characteristics and needs in the context of a proactive rehabilitation program, advanced transfemoral prostheses promote patient mobility, autonomy, and overall health. Survey data indicate overall stability, modularity, and versatility as key design priorities for the continued development of transfemoral prosthesis technology. Finally, observed associations between prosthesis type, user experience, and attitudes concerning prosthesis ownership suggest both that prosthesis characteristics influence device acceptance and functional outcomes, and that psychosocial factors should be specifically and proactively addressed during the rehabilitation process.
股骨截肢者经历了一系列复杂的身体、心理和社会挑战，加上当前股骨假肢的功能限制，情况更加复杂。然而，人类因素与假肢设计和性能特征之间的具体关系尚未得到充分研究。本研究旨在填补这一知识空白。
对 114 名单侧股骨截肢者进行了全面的单队列调查，调查内容包括广泛的人口统计学和临床特征、功能自主性、对当前假肢的满意度和态度，以及对理想股骨假肢的设计重点，包括是否有可能从机器人膝关节单元获得主动辅助。该调查是根据几个用于评估下肢截肢者运动能力和日常生活活动自主性的标准问卷定制的，包括对假肢满意度和生活质量的评估。对调查数据进行了分析，以比较使用和不使用微处理器控制膝关节单元（MPK 和 NMPK）的股骨假肢使用者的体验（包括自主性和满意度）和设计重点，随后进行了交叉类别相关性分析、主成分分析（PCA）、成本敏感性细分和无监督 K-均值聚类分析，应用于最敏感的参与者，以确定用户在设计重点方面的功能分组。
与一般股骨截肢者相比，队列中的患者主要是年龄较小（<50 岁）的创伤性男性截肢者，在年龄分布和截肢病因（创伤性与非创伤性）方面，MPK 和 NMPK 组之间存在显著差异。这些差异进一步反映在用户体验中，MPK 用户报告的整体功能自主性、满意度和对假肢的归属感明显高于 NMPK 用户，同时不稳定和跌倒的发生率也有所降低。在所有参与者中，理想股骨假肢的首要功能重点是整体稳定性、适应不同步行速度的能力和与生活方式相关的功能，而最高优先级的一般特征是可靠性、舒适性和重量，根据报销情况，成本的优先级高度可变。主成分分析和用户聚类分析显示，根据患者特征和积极康复计划的需求进行适当处方，先进的股骨假肢可以促进患者的移动性、自主性和整体健康。调查数据表明，整体稳定性、模块化和多功能性是股骨假肢技术继续发展的关键设计重点。最后，观察到假体类型、用户体验和对假体所有权的态度之间的关联表明，假体特征既影响设备的接受程度和功能结果，又表明在康复过程中应特别和积极地解决心理社会因素。
