Improving prosthetic provision in rural communities: limb scanning with caregiver assistance

改善农村社区的假肢供应：在护理人员协助下进行肢体扫描

• 批准号: 10753426
• 负责人: Glenn Klute
• 金额: --
• 依托单位: VA PUGET SOUND HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-10-01 至 2026-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10753426
• 关键词: Amputation; Body Weight; Caregivers; Clinic; Clinical; Data; Distal; Feedback; Goals; Hand; Health Services Accessibility; Improve Access; Individual; Injury; Knee; Limb structure; Location; Lower Extremity; Measurement; Measures; Medical center; Methods; Operative Surgical Procedures; Participant; Patient Outcomes Assessments; Patients; Persons; Play; Procedures; Process; Prosthesis; Randomized; Reporting; Research; Role; Rural; Rural Community; Scanning; Services; Shapes; Stress; Surveys; Techniques; Technology; Time; Tissues; Travel; Veterans; Visit; Walking; clinical practice; digital; digital technology; evidence base; experience; experimental study; fabrication; human subject; improved; instrument; limb amputation; novel; pandemic potential; pressure; pressure sensor; prosthesis fitting; prosthetic socket; reactive hyperemia; recruit; remote visit; repaired; residual limb; sensor; service delivery; service providers; standard of care

PROJECT SUMMARY (PUBLIC ABSTRACT) When the prosthetic socket of a Veteran with a lower limb amputation no longer fits or is damaged beyond repair, a new prosthetic socket is warranted. The provision of a new socket requires multiple clinical visits which can place a high travel burden and potential pandemic exposure stress on Veterans who live in rural communities far from VA Medical Centers or alternative prosthetic clinics. This research seeks to determine if one of the in- person visits traditionally needed to obtain a well-fitting prosthesis can be performed remotely with the assistance of a helper. We seek to discover if an untrained individual (a helper) can wield inexpensive, easy to use, digital technology to capture the shape of a residual limb to see if it can be used to fabricate a prosthetic socket that fits at least as well as one fabricated by a prosthetist using traditional, hand casting methods in the clinic. The expected result of this research is an evidence-based prosthetic fabrication process that reduces Veteran travel burden while providing a prosthesis that fits at least as well as the current standard-of-care. The upshot is a clear improvement in prosthetic provision for Veterans, particularly for those who live in rural communities. To make this determination, we propose to perform a between-subject experiment with two specific aims. To determine differences in goodness of fit between the two study sockets, we will use both patient reported outcomes, and the pressure applied to the distal end of the residual limb. Specific Aim 1: Determine if patient reported outcomes, by subjects wearing a prosthetic socket whose shape was captured with study helper assistance, are at least as good as those reported by subjects wearing a socket whose shape was captured by a prosthetist. We propose to recruit Veterans with a below knee amputation and their study helpers to participate in a human subject experiment. Participants will be randomly assigned and fit with either a prosthesis made with study helper assistance and digital methods, or one made wholly by a prosthetist using traditional methods. Patient reported outcome metrics will be collected while the subject is still wearing their as-prescribed socket at the beginning of the study (baseline), and again after wearing the study prosthesis for two weeks. Specific Aim 2: Determine if distal end residual limb pressure, measured from a group of individuals fit with a prosthetic socket whose shape was captured with study helper assistance using digital methods, are no worse than those measured from a group of individuals fit with a prosthetic socket whose shape was captured by a prosthetist using traditional methods. Concurrent with the human subject procedures briefly described above, we propose to fabricate duplicates (copies) of the two prosthetic sockets used by each subject in Specific Aim 1. A novel sensor will be embedded in these duplicate sockets which can measure the pressure applied to the distal end of the residual limb. Measurements of distal end residual limb pressure while standing and walking for both the as-prescribed and study sockets will be collected at the beginning of the study (baseline), and again after two weeks. The data from our experiments will be used to determine if residual limb shape capture by a helper using digital technologies can be used to make prosthetic sockets that fit at least as well as those made by a prosthetist using traditional, hand casting techniques. One third of all Veterans live in rural communities far from VA Medical Centers. When Veterans with a lower limb amputation need a new prosthetic socket, attending in-person clinical visits can be a challenge. If our hypotheses are supported, this research will provide evidence to support the use of digital technology as part of clinical practice, enabling a remote, study helper enabled alternative to one of the in-person clinical visits needed to fabricate a well-fitting prosthesis.

项目摘要（公共摘要） 当下肢截肢的退伍军人的假肢接受腔不再适合或损坏无法修复时， 需要使用新的假肢接受腔。提供新的插座需要多次临床就诊，这可以 给居住在农村社区的退伍军人带来沉重的旅行负担和潜在的流行病暴露压力 远离 VA 医疗中心或替代假肢诊所。这项研究旨在确定是否其中一个因素 传统上为获得合适的假肢所需的人员访问可以在协助下远程进行 一个帮手的。我们试图发现未经训练的个人（助手）是否可以使用廉价、易于使用的数字化工具 捕捉残肢形状的技术，看看它是否可以用来制造假肢接受腔 至少与假肢师在诊所使用传统的手工铸造方法制作的假肢一样合适。 这项研究的预期结果是基于证据的假肢制造过程，可减少退伍军人 旅行负担，同时提供至少符合当前护理标准的假肢。结果是 为退伍军人，特别是那些生活在农村社区的退伍军人提供假肢的情况明显改善。 为了做出这一决定，我们建议进行一项具有两个特定目标的受试者间实验。到 确定两个研究插座之间拟合优度的差异，我们将使用两个患者报告的 结果，以及施加到残肢远端的压力。 具体目标 1：确定佩戴假肢接受腔的受试者是否报告了结果，其形状 在研究助手的帮助下捕获的，至少与佩戴插座的受试者报告的一样好 假肢师捕捉到了它的形状。我们建议招募膝盖以下截肢的退伍军人 他们的学习帮助者参加了人体实验。参与者将被随机分配并适合 要么是用学习助手的帮助和数字方法制作的假肢，要么是完全由专家制作的假肢 假肢师使用传统方法。当受试者仍处于静止状态时，将收集患者报告的结果指标 在研究开始时（基线）佩戴规定的插座，并在佩戴研究后再次佩戴 假肢两周。 具体目标 2：确定一组个体测量的远端残肢压力是否符合标准 假肢接受腔的形状是在学习助手的帮助下使用数字方法捕获的，也没有更差 与一组装有假肢接受腔的个体测量的结果相比，假肢接受腔的形状是由 假肢师使用传统方法。与上面简要描述的人类受试者程序同时， 我们建议在特定目标中制作每个受试者使用的两个假肢接受腔的副本（副本） 1. 一个新颖的传感器将嵌入这些重复的插座中，可以测量施加在 残肢远端。站立和行走时远端残肢压力的测量 对于规定和研究插座，将在研究开始时（基线）收集，并再次收集 两周后。 我们的实验数据将用于确定助手是否使用数字技术捕获残肢形状 技术可用于制造假肢接受腔，其贴合度至少与假肢师使用 传统的手工铸造技术。 三分之一的退伍军人居住在远离退伍军人管理局医疗中心的农村社区。当退伍军人有下肢时 截肢需要新的假肢接受腔，亲自参加临床就诊可能是一项挑战。如果我们的假设 得到支持，这项研究将为支持数字技术作为临床治疗的一部分提供证据 实践，使远程研究助手能够替代所需的面对面临床访问之一 制作一个合适的假肢。