Home Study of an Advanced Upper Limb Prosthesis

 描述(由申请人提供)： 背景：这是一份由RR&D资助的题为《高级上肢假体的家庭研究》(Home Study)的续展申请。DEKA ARM的设计目的是使用脚上佩戴的惯性测量单元(IMU)，结合传统的肌电控制和开关，根据需要控制多个自由度。到目前为止，需要一个或多个IMU来操作该设备。使用这种控制方法进行预先规划和顺序控制多个关节/执行器的复杂任务需要大量的认知负荷。最近发布的一种肌电模式识别系统有望通过消除IMU来减轻认知负担。用更直观的模式识别控制代替脚部控制，可能会使DEKA手臂更容易被接受，功能也更好。目的：总体目标是检查家庭使用DEKA ARM的可行性、接受性和益处，以及在家庭使用3个月期间使用的后勤支持要求。我们的具体目标是：1)确定和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上肢截肢的人；2)比较现有假体和DEKA手臂的使用程度，量化家庭使用DEKA手臂对装置满意度、功能活动表现和用户生活质量的影响；3)比较模式识别用户的结果和没有使用模式识别的患者的结果；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/维修而损失的家庭学习天数。方法：设计。本研究采用准实验、时间序列设计。这项研究包括两个部分：A部分包括使用DEKA ARM的实验室内培训和有监督的社区郊游；B部分包括为期3个月的家庭使用试验。样本。此次更新将招募最多12名接受经桡或经胸截肢的受试者。程序。A部分受试者将在培训前保持假体使用的每日记录。受试者将安装假肢插座，配置肌电模式识别控制，然后接受使用DEKA手臂的培训。培训结束后，研究人员将对每个参与者进行适当或不适合家庭使用的分类。对于B部分，我们将收集家庭试验期间所需的家庭安全、假肢使用和技术支持方面的数据。我们将使用A部分和B部分收集的标准化结果测量来检查疼痛、灵活性、功能活动、假体满意度和生活质量的结果，并从家庭安全评估、视频日志、调查、访谈和假体使用杂志中收集定性数据。数据分析。我们将计算参与研究A部分的受试者被确定为符合住宅用途适宜性的初步标准的百分比。我们将描述每一组的受试者，并检查那些被认为不适合家庭使用的受试者的特征，以确定哪些因素是可预测的。现有假体活动度的测量将与DEKA ARM的家用测量进行比较，以确定采用的程度。我们将在受试者干预前和干预后的措施下，在整个研究过程中检查设备满意度、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。我们将使用非参数Wilcoxon-Mann-Whitney检验将使用模式识别控制的受试者的结果与使用非参数Wilcoxon-Mann-Whitney检验的未使用模式识别的受试者的结果进行比较。重要：结果将为模式识别控制的采用提供信息，并有助于将DEKA臂更接近成功部署。结果将提供重要的信息，以帮助确定哪些截肢者是DEKA ARM的合适候选者，以及提供关于家庭环境中的有用性和可接受性的数据。这些发现将有助于制定先进的上肢假体技术和对照处方的临床指南。

 DESCRIPTION (provided by applicant): Background: This is a renewal application for the RR&D funded Merit Review titled, Home Study of an Advanced Upper Limb Prosthesis (Home Study). The DEKA Arm is designed to use inertial measurement units (IMUs) worn on the feet in combination with traditional EMG controls and switches, as needed to control multiple degrees of freedom. To date, one or more IMUs were required to operate the device. There is substantial cognitive load required for the complex task of pre-planning and sequentially controlling multiple joints/actuators using this control method. Recent commercial release of an EMG pattern recognition system holds promise for decreasing cognitive burden by eliminating the IMUs. Substituting foot control with more intuitive pattern recognition control may lead to greater acceptance of and better function with the DEKA Arm. Purpose: The overall objective is to examine the feasibility, acceptance and benefits of home use of the DEKA Arm, as well as the logistical support requirements utilized during 3 months of home usage. Specifically we aim 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 and quantify the impact of home use of the DEKA Arm on device satisfaction, performance of functional activities and the user's quality of life; 3) Compare the outcomes of users of pattern recognition to the outcomes of users without; 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. The study uses a quasi-experimental, time series design. This study has 2 parts: Part A involves in-laboratory training and supervised community outings using the DEKA Arm; Part B involves a 3 month trial of home use. Sample. This renewal will recruit up to 12 additional subjects with transradial or transhumeral amputation. Procedures. Part A subjects will maintain daily logs of prosthesis use prior to training. Subjects will be fit with a prosthetic socket, have EMG pattern recognition controls configured, and then be trained to use the DEKA Arm. After training, the study staff will classify each participant as appropriate or not appropriate for home usage. For Part B, we will gather data on home safety, prosthetic use and technical support required during the home trial. We will use standardized outcome measures collected in Part A and B to examine outcomes of pain, dexterity, functional activities, prosthetic satisfaction and quality of life and collect qualitative data from home safety assessments, video logs, surveys, interviews and prosthetic usage journals. 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 describe 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 the 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. We will compare outcomes for subjects using pattern recognition control to outcomes for subjects at similar configuration levels who did not use pattern recognition using nonparametric Wilcoxon- Mann-Whitney tests. Importance: Results will inform the adoption of pattern recognition controls and help to move the DEKA Arm closer to successful deployment. Results will provide important information to help determine which amputees are appropriate candidates for the DEKA Arm, as well as provide data on usefulness and acceptability in a home environment. Findings will help inform the development of clinical guidelines for prescription of advanced upper limb prosthetic technology and controls.