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.
The US Government has invested millions of dollars to develop advanced upper limb prosthetic technology. Since 2008 the VA has conducted studies of one of these technologies, the DEKA Arm. All VA studies have been conducted in-lab, under supervised conditions. Because of this, the VA has not been able to assess important outcomes such as adoption of the prosthesis at home, or the impact of using the device on quality of life. In order to determine the usefulness and acceptability of the device, a study of its home usage is needed. Results of the proposed study will inform the dissemination and deployment within the VA system of amputee care. Study results will be used to develop clinical guidelines for prescription of the DEKA Arm.
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