Home Study of an Advanced Upper Limb Prosthesis

描述（由申请人提供）： 背景：迄今为止，DEKA组的VA研究是在实验室内监督条件下进行的。因此，尚未检查关键结局，包括手臂在家中活动的使用或采用程度以及高级假体器械对受试者生活质量的影响。确定这种先进假体装置的有用性和可接受性的下一步是对其家庭使用进行研究。目的：拟议研究的总体目标是检查先进上肢假肢装置在家中使用的可行性、可接受性和受益，以及在家中使用3个月期间使用的后勤支持要求。这项准实验性时间序列研究的具体目标是：1）识别并描述适合家庭使用这种先进假体的上肢截肢者以及不适合的上肢截肢者，2）比较现有假体与DEKA机械臂的使用程度，3）量化DEKA机械臂家庭使用对器械满意度的影响，功能活动的表现和用户的生活质量;以及4）量化研究期间所需的技术支持和维修的数量和类型，并估计因服务/维修而损失的家庭研究天数。研究方法：设计图：我们将使用时间序列设计来检查整个过程中器械满意度、功能活动表现和生活质量的变化 书房数据收集将在2个VA医疗中心和1个DoD研究中心进行。概述：研究的A部分将包括假肢装配和安装，然后是密集的、有监督的i-实验室培训和社区郊游。B部分将包括家庭评价和3个月的器械家庭使用，每两周进行一次重新评估。样本：我们将招募最多75名上肢截肢者，以获得最多40名受试者的完整A部分数据。最多36名完成A部分的参加者将被邀请参加B部分。数据收集：A部分受试者将保留每日日志，详细记录当前假体使用情况，并在实验室培训前佩戴活动监测器数周。培训完成后，研究工作人员将使用为本研究制定的一组标准将每例受试者分类为适合或不适合家庭使用。对于B部分，我们将收集关于家庭安全性、假体使用和家庭试验期间所需技术支持的数据。数据分析：我们将计算确定符合家庭使用适当性初步标准的参与研究A部分的受试者百分比。然后，我们将描述每组中的受试者，并检查那些不被认为适合家庭使用的受试者的特征，以确定哪些因素（如果有）具有预测性。现有假体活动的测量将 与家庭使用DEKA机械臂进行比较，以确定采用程度。我们将使用受试者干预前后的指标，检查整个研究期间器械满意度、功能活动表现和生活质量的变化。我们将汇总有关技术支持使用情况的描述性数据。重要性：从本研究中收集的信息对于使DEKA臂更接近商业化以及在VA医疗保健系统中成功传播和部署至关重要。这项研究的一个重要成果是制定DEKA手臂处方的临床指南。目前，VA假肢和感觉辅助器具很少有（如果有的话）临床指南，以告知先进技术的处方，确定合适的候选人或准备在家中使用假肢装置。

DESCRIPTION (provided by applicant): Background: VA studies of the DEKA Arm to date have been conducted in-lab, under supervised conditions. Thus, key outcomes including the extent of use or adoption of the arm for activities at home and the impact of the advanced prosthetic device on subjects' quality of life have not been examined. The next step in determining the usefulness and acceptability of this advanced prosthetic device is to conduct studies of its home usage. Objectives: The overall objective of the proposed study is to examine the feasibility, acceptance and benefits of home use of an advanced upper limb prosthetic device as well as the logistical support requirements utilized during 3 months of home usage. The specific objectives of this quasi-experimental, time series study are to: 1) identify and describe upper limb amputees who would be appropriate candidates for home use of this advanced prosthesis as well as those who would not be appropriate, 2) compare the extent of use of the existing prosthesis to that of the DEKA Arm, 3) quantify the impact of home use of the DEKA Arm on device satisfaction, performance of functional activities and the user's quality of life; and 4) quantify the amount and type of technical support and repairs needed during the study, and estimate the number of home study days lost due to service/repair. Methods: Design: We will use a time series design to examine changes in device satisfaction, performance of functional activities and quality of life throughout the study. Data collection will take place at 2 VA Medical Centers and 1 DoD site. Overview: Part A of the study will involve prosthetic fitting and set-up followed by intensive, supervised, i-laboratory training and community outings. Part B will consist of a home evaluation and 3 months of device home usage, with biweekly re-assessment. Sample: We will enroll up to 75 upper limb amputees to yield complete Part A data on up to 40 subjects. Up to 36 participants who have completed Part A will be invited to Part B. Data Collection: Part A subjects will maintain daily logs detailing current prosthesis use and will wear an activity monitor for several weeks prior to in-lab training. After training is complete, the study staff will classify each participant as appropriate or not appropriate for home usage using a set of criteria developed for this study. For Part B, we will gather data on home safety, prosthetic use and technical support required during the home trial. Data Analysis: We will calculate the percentage of subjects who participate in Part A of the study who are determined to have met the preliminary criteria for home use appropriateness. We will then describe the subjects in each group and examine characteristics of those subjects who were not considered appropriate candidates for home use to identify which, if any factors were predictive. Measures of existing prosthetic activity will be compared with those of home use of DEKA Arm to determine the extent of adoption. We will examine changes in device satisfaction, performance of functional activities and quality of life throughout the study using within subject pre and post intervention measures. We will summarize descriptive data on technical support usage. Significance: Information gleaned from this study will be critically important in moving the DEKA Arm closer to commercialization and successful dissemination and deployment within the VA system of healthcare. An important outcome of this study will be the development of clinical guidelines for prescription of the DEKA Arm. Currently, VA Prosthetics and Sensory Aids has few, if any, clinical guidelines to inform prescription of advanced technologies, determine appropriate candidates or readiness for home use of prosthetic devices.