Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

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

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 used to scan the residuum)
* Current pregnancy

Conditions3

Locations1 site

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