Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees
Trial Parameters
Brief Summary
The study will test a new approach to the design and implementation of socket and liner technology in individuals who lost a lower limb secondary to diabetes mellitus type II (herein referred to as dysvascular amputees). The technology-based intervention will be combined with an exercise program designed to improve the health status of dysvascular amputees.
Eligibility Criteria
Inclusion Criteria: * Unilateral transtibial amputation within the past 4-16 months * Etiology secondary to complications of Diabetes Mellitus (DM) type II * Current use of a prosthesis, with at least 2 months prior use * K2 or K3 level (as determined using the Amputee Mobility Predictor assessment tool) * Own a smartphone Exclusion Criteria: * Amputation due to cancer or macrotrauma or acute hemorrhage * Bilateral amputation * Medically or surgically unstable contralateral lower extremity as determined by medical criteria (e.g., critical limb ischemia) * Severe residual limb pain that limits function preventing participation in an exercise-based program * Medical conditions that would interfere with subject's participation in regular sustained exercise * Anthropometric characteristics that are not compatible with the technology used to scan the residuum and manufacture the liner and socket (e.g., a residuum circumference greater than 32 inches would not be compatible with the device u