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(公开摘要) 当接受下肢截肢的退伍军人的假肢窝不再适合或损坏无法修复时， 需要一个新的假肢插座。提供新插座需要多次临床就诊，这可能 给居住在农村社区的退伍军人带来高旅行负担和潜在的大流行暴露压力 远离退伍军人医学中心或替代假肢诊所。这项研究试图确定是否有一个在- 传统上为了获得合适的假体而需要的人员探视可以在辅助下远程执行 一个帮手。我们试图发现一个未经培训的个人(助手)是否可以使用廉价、易于使用的数字 捕捉残肢形状的技术，看看它是否可以用来制造假肢插座， 至少与临床上修复师使用传统手工铸造方法制作的假体一样合适。 这项研究的预期结果是一种基于证据的假体制造过程，减少了退伍军人 在提供至少符合当前护理标准的假体的同时，还增加了旅行负担。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方面的明显改善。 为了确定这一点，我们建议进行一项有两个特定目标的受试者之间的实验。至 确定两个研究插座之间的适合度差异，我们将使用两个患者报告的 结果，以及施加在残肢远端的压力。 具体目标1：确定患者是否报告了结果，通过受试者佩戴形状为 在学习助手的帮助下捕捉到的，至少和戴着插座的受试者报告的一样好 它的形状被一位修复师捕捉到了。我们建议招募膝盖以下截肢的退伍军人 他们的研究帮助他们参与了一项人体实验。参与者将被随机分配并适合 使用由学习助手辅助和数字方法制作的假体，或者完全由 使用传统方法的修复师。患者报告的结果指标将在受试者仍处于 在研究开始时(基线)戴上规定的插座，并在戴上研究后再次戴上 做了两周的义肢。 具体目标2：确定远端残肢压力，从一组适合于 在学习助手的帮助下，使用数字方法捕捉到假肢插座的形状并没有变差 而不是从一群戴着假肢插座的人那里测量出来的，假肢插座的形状是由一个 使用传统方法的修复师。与上面简要描述的人类主体程序同时， 我们建议制作两个假体插座的复制品(复制品)，供每个受试者在特定目标下使用 1.在这些重复的插座中将嵌入一种新型传感器，它可以测量施加到 残肢远端。站立和行走时肢体远端残余压力的测量 对于规定的和研究，将在研究开始时收集套接字(基线)，然后再次收集 两周后。 我们的实验数据将被用来确定帮助者是否使用数字捕获残留的肢体形状 技术可以用来制造至少与修复师使用的假肢插座一样适合的假肢插座 传统的手工铸造技术。 三分之一的退伍军人生活在远离退伍军人医疗中心的农村社区。当有小腿的退伍军人 截肢需要一个新的假肢插座，亲自去看临床可能是一个挑战。如果我们的假设 ，这项研究将提供证据支持使用数字技术作为临床的一部分 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 制作一个合适的假体。