Research updates: VA study to optimize DEKA Arm

Abstract

Linda Resnik, PT, PhD In 2005, the Defense Advanced Res earch Projects Agency (DARP A) announced its Revolutionizing Prosthet ics program and funded the develop ment of the DEKA prosthetic arm. The DEKA Arm System incorporates major technological advances such as flexible socket desi gn, innovative control fea tures, software, and hardware that together enable e nhanced functionality that promises to surpass any currently available prosth etic device. In 2008, the Department of Veterans Affairs (VA) entered into an agreement with DARPA to conduct clinical evaluations of th e prototype DEKA Arm System, a pros thetic device system still under deve lopment and not yet available commer cially. Studies of the DEKA Arm System have been underway at VA sites since late 2008, with the first subject fitted with a DEKA Arm in early 2009. The primary objective of the VA study is to provide user and clinician feedback to support optimizati on of the DEKA Arm System to best suit patient needs. Specifically the study aims to (1) evaluate the person with amputation’s experience of using the DE KA Arm; (2) eva luate the clinicia ns’ (prosthetists and therapists) experience of fitting, se tting up, and training subjects with the DEKA Arm; and (3) evaluate improve ments in the DEKA Arm and its soft ware as it is optimized by DEKA throughout the study. The VA study involves five sites. The Providence V A Medical Center , Providence, Rhode Island, is the study c oordinating site. There are four data collection sites. The Manha ttan campus of the V A New York Harbor Health care System in New York City, New York, and the James A. Haley V eterans Hospital, Tampa, Florida, have been collecting data since 2009, and the V A Long Beach Healthcare System, Long B each, California, and Center for the Intrepid at Brooke Army Medical Center, San Antonio, T exas, became active study sites in early 2010. At its completion, the VA study sample will consist of up to 40 subjects with upper -limb am putation, the majority of which will be veterans. Subjects include persons with amputations at any of four levels (transradial, transhumeral, shoulder disa rticulation, and forequarter) who have lost one or both upper limbs. The VA study uses a multiple-case study design with a mixed-methodology approach. We collect data from three s ources: subjects, prosthetists, and thera pists. Our data collection tool kit includes several standardized outcome measures used to assess function, daily activities, and prosthetic satisfaction. We also collect qualitative data de rived from interviews, vi deo observations, and sur veys. This multiplicity of data sources enables us to better understand subjects’ experiences using the DEKA Arm and th eir perspectives on its usability , as well as recommendations for improvement. We synthesize data from each of our VA subjects into a case study report and share our findings with DEKA shor tly after the subject completes study activities. The case studies th at we develop summarize th e information from