Preliminary Evaluation of a Diagnostic Tool for Prosthetics

Abstract

The objective of the proposed application is to make prosthetic limbs more comfortable for Service members, Veterans, and civilians who have experienced limb amputation. The rationale is that often a prosthesis will not fit well because the amputee s residual limb changes volume within the prosthetic socket. A reduction in volume can cause the prosthesis to become loose on the residual limb while the person walks or runs. A loose socket can injure soft tissues and cause the user to be unstable and fall down. An increase in volume restricts blood flow to the limb and makes the socket feel tight and painful, possibly injuring limb tissues. The proposed effort addresses the problem of changing limb volume by bringing a new diagnostic system to amputee patient care. We use a small portable instrument to measure where, when, and by how much limb volume changes. We developed this technology under prior Congressionally Directed Medical Research Programs support. The focus in this application is use of the system for clinical diagnosis and treatment of volume problems common in people with limb loss. This application represents an important advancement from our previous effort and is necessary to ensure the developed technology can be effectively integrated into clinical care. In this study, we will first conduct testing with prosthesis users to establish how well different volume management solutions work and how they relate to data measured from the system. That insight will help us determine how best to use the technology in clinical care. We will then ask practitioners to test the system in their clinics to determine if it is a useful clinical tool for prosthetic fitting and if it reduces the total time required to achieve a successful prosthetic fit. Results of these studies will provide us valuable information about what clinical interventions work best and which prosthesis users are likely to benefit from each. The patients this diagnostic tool will help the most are people who use prosthetic limbs and change limb volume. These people may change limb volume because they recently had their leg amputation, because they live or work in a hot or humid environment that causes them to sweat and lose a lot of body water, or because they are very active. The system we have developed should work well on all of these individuals and help their prosthetists to identify and reduce prosthetic fit problems associated with limb volume fluctuation. The potential clinical benefit of this diagnostic system is fewer injuries associated with limb volume changes, improved prosthetic fit and suspension, and improved performance and endurance for Service members, Veterans, and civilians using prosthetic limbs. The risks are that future large-scale clinical studies (approximately 1 year in duration) will be required to validate the device as a commercial product and diagnostic procedure. The proposed diagnostic system, if proven successful in this application, should accomplish beneficial patient-related outcomes in relatively short order. A short development time between successful completion of the proposed research and commercialization is expected because there is minimal additional hardware development. Further, we are committed to developing this diagnostic system to work alongside the practitioner s usual practices and techniques, augmenting patient care as opposed to replacing expertise. We believe that providing practitioners with information about each individual prosthesis user s limb volume changes will help them provide improved, patient-centered care. The projected timeline to obtain a clinically relevant outcome is approximately 1 year after the completion of the proposed research. The proposed technology will benefit military personnel using prosthetic limbs by reducing pain and enhancing performance under strenuous activity and harsh environmental conditions. Service members will spend less time ad

Document Details

Document Type
DoD Grant Award
Publication Date
Jan 31, 2017
Source ID
W81XWH1610585

Entities

People

  • Joan E Sanders

Organizations

  • United States Army
  • University of Washington

Tags

Fields of Study

  • Medicine

Readers

  • Gulf War Illness and Chronic Multisymptom Illness in Veterans.
  • Rehabilitation and Prosthetic Care for Military Service Members and Veterans with Limb Loss or Disability.
  • Systems Analysis and Design