Home Study of an Advanced Upper Limb Prosthesis

先进上肢假肢的家庭研究

• 批准号: 9685044
• 负责人: LINDA J. RESNIK
• 金额: --
• 依托单位: PROVIDENCE VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9685044
• 关键词: Adoption; Amputation; Amputees; Characteristics; Clinical; Communities; Complex; Data; Data Analyses; Devices; FDA approved; Feedback; Freedom; Funding; Glean; Government; Guidelines; Healthcare Systems; Home environment; Intervention; Interview; Intuition; Joints; Journals; Lead; Limb Prosthesis; Logistics; Marketing; Measurement; Measures; Methods; Movement; Outcome; Outcome Measure; Participant; Pattern; Pattern Recognition; Pattern Recognition Systems; Performance; Pressure Transducers; Procedures; Prosthesis; Quality of life; Readiness; Reporting; Safety; Sampling; Scheme; Sensory Aids; Series; Services; Standardization; Supervision; Surveys; System; Technology; Testing; Time; Training; Upper Extremity; Work; arm; clinical development; cognitive load; design; dexterity; foot; innovation; laboratory experience; pain outcome; post intervention; prosthetic socket; public health relevance; recruit; repaired; satisfaction; success

 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.

 描述（由申请人提供）： 背景：这是对RR＆D资助的评论的续签申请，标题为“ And Vanced上肢假体”（家庭研究），ARM旨在与传统的EMG控件和开关结合使用脚步上的使用eSeasurement单元（IMU）（IMUS） ，需要使用此控制方法来控制多个自由度的自由度。通过Theka Arm的功能更大。成为tosesis的适当候选人，因为谁将不适合2）DEKA部门的候选人，并量化Deka Arm的家园对设备满意度的影响，功能性能和生命模式的尖顶没有; 4）在研究过程中量化的数量和报告的数量和维修，并估计了由于服务而丢失的培训和监督的郊游，B部分涉及3个月的房屋使用。 . Socket, Have Pattern Recognition Configured, and THENED TO USE The DEKA ARM. Pant as Apropriate 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将使用标准化的成果措施集体，部分痛苦，脱毛，功能活动，假肢和生活质量，并收集定性数据，视频日志，调查，访谈和假肢期刊。确定的研究已经遇到了这些受试者的特征设备满意度我们将总结有关技术支持使用的描述性数据。帮助Deka部门更接近成功的部署。

项目成果

Perceptions of satisfaction, usability and desirability of the DEKA Arm before and after a trial of home use.

• DOI: 10.1371/journal.pone.0178640
• 发表时间: 2017
• 期刊: PloS one
• 影响因子: 3.7
• 作者: Resnik LJ;Borgia ML;Acluche F
• 通讯作者: Acluche F

Use of the DEKA Arm for amputees with brachial plexus injury: A case series.

• DOI: 10.1371/journal.pone.0178642
• 发表时间: 2017
• 期刊: PloS one
• 影响因子: 3.7
• 作者: Resnik L;Fantini C;Latlief G;Phillips S;Sasson N;Sepulveda E
• 通讯作者: Sepulveda E

Does the DEKA Arm substitute for or supplement conventional prostheses.

DEKA Arm 是否替代或补充传统假肢？

• DOI: 10.1177/0309364617729924
• 发表时间: 2018
• 期刊: Prosthetics and orthotics international
• 影响因子: 1.5
• 作者: Resnik,Linda;Acluche,Frantzy;LiebermanKlinger,Shana;Borgia,Matthew
• 通讯作者: Borgia,Matthew

Responsiveness of outcome measures for upper limb prosthetic rehabilitation.

上肢假肢康复结果测量的反应性。

• DOI: 10.1177/0309364614554032
• 发表时间: 2016
• 期刊: Prosthetics and orthotics international
• 影响因子: 1.5
• 作者: Resnik,Linda;Borgia,Matthew
• 通讯作者: Borgia,Matthew

Appropriateness of advanced upper limb prosthesis prescription for a patient with cognitive impairment: a case report.

认知障碍患者高级上肢假肢处方的适当性：病例报告。

• DOI: 10.1080/17483107.2016.1201155
• 发表时间: 2017
• 期刊: Disability and rehabilitation. Assistive technology
• 作者: Barredo,Jennifer;Acluche,Frantzy;Disla,Roxanne;Fantini,Christopher;Fishelis,Leah;Sasson,Nicole;Resnik,Linda
• 通讯作者: Resnik,Linda