Brasthesis Prototype for Women Veterans with Upper Limb Amputations

上肢截肢女性退伍军人的支架原型

• 批准号: 10597162
• 负责人: Jeffrey T. Heckman
• 金额: --
• 依托单位: JAMES A. HALEY VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10597162
• 关键词: 3-Dimensional; Accelerometer; Affect; Air Bags; Amputation; Anatomy; Area; Arteries; Axilla; Blood flow; Breast; Case Series; Chest; Clinical Data; Clothing; Code; Color; Contusions; Custom; Cyst; Data; Exclusion Criteria; Fat necrosis; Feedback; Feeling; Female; Future; Gender; Genetic Transcription; Goals; Hematoma; Hemorrhage; Hour; Human Milk; Hybrids; Industry; Informed Consent; Injury; Interview; Legal patent; Length; Limb Prosthesis; Limb structure; Link; Literature; Mammary Duct; Mammary Gland Parenchyma; Manufactured football; Maps; Names; Oils; Outcome; Outcome Measure; Participant; Patients; Positioning Attribute; Procedures; Process; Prosthesis; Prosthesis Design; Proxy; Reporting; Research; Resources; Seat Belts; Shoulder; Side; Skin; Sports; Structure; Surface; Swelling; Technology; Technology Transfer; Telephone; Testing; Thrombophlebitis; Time; Training; Trauma; Upper Extremity; Veins; Veterans; Voice; Woman; Writing; arm; design; experience; improved; inclusion criteria; injured; interest; limb amputation; limb loss; neuromuscular; novel; open wound; phenomenological models; powered prosthesis; pressure; prosthesis fitting; prosthesis wearer; prosthetic alignment; prototype; residual limb; satisfaction; sensor; theories; tissue injury

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.

目前传统的肢体丧失退伍军人佩戴的假体胸带少于 由于女性的解剖结构，这是最理想的。我们从运动[1]和安全带/安全气囊[2]文献中知道乳房 组织损伤会扰乱流向乳房的血液，导致肿胀，大量失血， 血肿、脂肪坏死、油囊血肿。乳腺导管的损伤可能会影响未来或 目前的母乳流量[3]。更常见的是，较小的浅表动脉和静脉变得 受伤，导致局部损伤较多，出血和瘀伤较轻。虽然目前尚不清楚 关于假体马具是否会对乳房组织造成伤害的研究，我们知道经常 穿紧身衣[4]会导致瘀伤、肿胀和血栓性静脉炎。我们设计了一款胸罩 为具有中短臂的退伍军人提供了一体化假体马具原型， 肩部截肢(S)，我们已将其命名为(正在申请专利)。这个 拟议项目的目的是使用案例系列设计来证明胸骨的概念 原型。本项目的具体目标是：(1)将满意度和功能与 (2)使用压力标测比较与传统线束的舒适性 假体与传统假体的界面压力。五名患有上颌近端的女性 肢体缺失将适用于胸骨，使用与我们用于构建我们的 原型。入选标准为：(1)单侧中至短经肩、肩或肩间- 胸部单侧截肢和(2)他们使用的现有肌电假肢或混合假肢 或被拒绝/放弃。培训没有假肢的参与者所需的额外资源 经验的判断超出了本研究的范围。排除标准是：(1)开放 上半身或四肢的创伤和(2)身体动力假肢使用者由于动力 对马具的要求。我们将继续将胸骨与身体动力假体结合使用 后续研究。一旦患者提供了书面知情同意，就会订购两件胸罩。一 患者将穿的胸罩。第二个胸罩将被解构和重建，以实现个性化 吊带背带。在进行胸椎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，参与者将佩戴胸罩，为期四周。参与者 将每周联系以跟踪磨损时间，以每周天数和每天小时数为单位(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替代。 在佩戴时间、满意度、功能和舒适性结果的前后顺序变化 使用定量描述性分析进行分析。在佩戴期结束时，皮温克勒将进行 对参与者和修复师进行半结构化电话采访。采访将被转录成文字 并以描述现象学理论为指导，运用主题分析方法进行分析。半个月- 结构化面试将有三个总体讨论要点：(1)描述障碍 在安装支架时遇到，(2)您是如何管理背带放置的 关于残肢的存在、长度和可利用的皮肤表面积 可与假体传感器接触，以及(3)胸骨与假体传感器相比如何 用你的传统假肢？目标2将使用压力映射技术来比较 患者和受试者残肢和完整肢体在手臂压力下的分布数据 传统的假肢。我们将创建直接将压力联系在一起的彩色编码‘热图’ 每个参与者的三维解剖结构的价值。