Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees
Diabete Type 2, Amputation
About this trial
This is an interventional treatment trial for Diabete Type 2
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 used to scan the residuum) Current pregnancy
Sites / Locations
- Spaulding Rehabilitation Hospital Boston
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
digital prosthetic interface technology group
traditional socket and liner technology group
Study participants randomized to this group will use the digital prosthetic interface technology developed by Bionic Skins.
Study participants randomized to this group will use a traditional socket-liner technology (i.e., study participants will use their own liner and socket system).