Brasthesis Prototype for Women Veterans with Upper Limb Amputations

目前传统的假肢胸带佩戴的妇女退伍军人与肢体损失）是小于 最适合女性的生理结构我们从运动[1]和安全带/安全气囊[2]文献中得知， 组织损伤会破坏流向乳房的血流，导致肿胀，大量失血， 血肿、脂肪坏死和油囊血肿。乳腺导管损伤可能会影响未来或 母乳的流动[3]。更常见的是，较小的浅动脉沿着静脉， 受伤，导致更多的局部损伤和不太严重的出血和瘀伤。虽然没有已知的 研究是否假体背带会导致乳房组织损伤，我们知道，频繁的 穿紧身衣服[4]会导致瘀伤、肿胀和血栓性静脉炎。我们设计了一款文胸 与纳入假肢背带原型的妇女退伍军人与中短transshumeral， 肩或肩胛间胸截肢，我们称之为Brasthesis截肢（专利申请中）。的 本计画的目的是以一系列的设计案例来验证Brasthesis的概念 样机本研究的具体目的是：（1）比较满意度和功能， 和舒适性;（2）使用压力映射进行比较 Brasthesis假体与传统假体的界面压力。5名女性近端上部 肢体损失将适合Brasthesis使用类似的程序，我们用来构建我们的 样机入选标准为：（1）单侧中短经肱骨、肩关节或肩胛间- 胸部单侧截肢和（2）现有的肌电或混合假肢，他们使用 或被拒绝/抛弃。培训没有假肢的参与者所需的额外资源 经验判断超出了SPIRE资源/本研究范围。排除标准为：（1）开放性 上躯干或四肢的伤口，以及（2）由于动态 线束的要求。我们将继续使用Brasthesis假肢与身体动力假肢， 后续研究。一旦患者提供了书面知情同意书，将订购两个布拉斯。一 患者将佩戴的胸罩。第二个胸罩将被解构和重构， 悬吊式安全带在Brasthesis拟合时，将收集基线， 人口统计学和临床数据以及满意度、功能和舒适度结果 措施试穿后，参与者将穿着Brasthesis紧身衣四周。参与者 将每周联系一次，以每周天数和每天小时数跟踪佩戴时间（目标1）。我们还将 使用Jawbone Up 24活动跟踪器作为假体佩戴时间的定量指标。 佩戴时间、满意度、功能和舒适度结果的前后顺序变化将 使用定量描述性分析进行分析。在佩戴期结束时，PI Winkler将进行 半结构化的电话采访参与者和假肢。采访将被转录 并运用描述现象学理论指导下的主题分析法进行分析。半- 结构化访谈将有三个总体讨论要点：（1）描述障碍 在安装Brasthesis护套时遇到的问题，（2）您如何根据 残肢的存在和长度以及可用的皮肤表面积 可用于与假体传感器接触，以及（3）Brasthesis传感器与 你的传统假肢目标2将使用压力映射技术来比较 Brasthesis患者和参与者的残肢和完好肢体手臂压力分布数据 传统的假肢我们将创建颜色编码的“热图”， 每个参与者的三维解剖结构的价值。

Current traditional prosthetic chest harnessing worn by women Veterans with limb loss) is less than optimal due to female anatomy. We know from the sports [1] and seat belt/airbag [2] literature that breast tissue injuries can disrupt the blood flow to the breast resulting in swelling, significant blood loss, hematoma, fat necrosis, and oil cyst hematoma. Injury to the mammary ducts can affect the future or current flow of breast milk [3]. More commonly, smaller superficial arteries along with veins become injured, leading to more localized injury and less serious bleeding and bruising. While there is no known research on whether a prosthetic harness can cause injury to breast tissue, we know that frequent wearing of tight clothing [4] can cause bruising, swelling, and thrombophlebitis. We have designed a bra with incorporated prosthetic harness prototype for women Veterans with mid to short transhumeral, shoulder, or interscapulothoracic amputation(s) that we have named Brasthesis (patent pending). The purpose of the proposed project is to use a case series design to prove the concept of Brasthesis prototype. The specific aims of this project are to: (1) Compare the satisfaction and function with and comfort of Brasthesis with the traditional harness and (2) Use pressure mapping to compare the interface pressure of Brasthesis with the traditional prosthesis. Five women with proximal upper limb loss will be fit with Brasthesis using a procedure similar to the one we used for constructing our prototype. The inclusion criteria are: (1) unilateral mid to short trans-humeral, shoulder, or interscapular- thoracic unilateral amputation and (2) have an existing myoelectric or hybrid prosthetic limb that they used or rejected/abandoned. The additional resources required to train a participant with no prosthetic experience is judged beyond SPIRE resources/scope of this study. The exclusion criteria are: (1) open wounds in the upper torso or extremities and (2) body-powered prosthetic users due to the dynamic requirements of the harness. We will pursue Using Brasthesis with body powered prosthetics in a subsequent study. Once the patient has provided written informed consent, two bras will be ordered. One bra the patient will wear. The second bra will be deconstructed and reconstructed for individualized suspensory harness strapping. At the time of Brasthesis fitting, baseline will be collected, demographic and clinical data and satisfaction, function, and comfort outcomes measures. After fitting, the participant will wear Brasthesis for four weeks. Participants will be contacted weekly to track wearing time in days per week and hours per day (Aim 1). We will also employ a Jawbone Up 24 activity tracker as a quantitative proxy of prosthesis wear time. Pre to post ordinal change in wearing time, satisfaction, function, and comfort outcomes will be analyzed using quantitative descriptive analyses. At the end of the wearing period, PI Winkler will conduct semi-structured phone interviews with participants and the prosthetist. Interviews will be transcribed and analyzed using thematic analysis guided by descriptive phenomenology theory. The semi- structured interview will have three overall discussion points: (1) Describe the barriers encountered while fitting Brasthesis , (2) How did you manage strap placement based on the presence and length of the residual limb and the available skin surface area available for contact with the prosthetic sensor, and (3) How does Brasthesis compare with your traditional prosthesis? Aim 2 will use pressure mapping technology to compare the residual limb and intact limb under arm pressure distribution data for Brasthesis and participants’ traditional prostheses. We will create color-coded ‘heat maps’ that directly link pressure values to the three-dimensional anatomy of each participant.