Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

Launched by SPAULDING REHABILITATION HOSPITAL · Dec 8, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people who have had a lower limb amputation due to complications from diabetes (Type 2) by using advanced technology for prosthetic sockets and liners. Along with this new technology, participants will also take part in an exercise program aimed at improving their overall health and mobility. The trial is currently recruiting individuals aged between 18 and 75 who have had a single leg amputation within the last 4 to 16 months and who are already using a prosthesis.

To be eligible for the study, participants must have a specific type of amputation due to diabetes and should be able to walk with a prosthesis at a certain level of mobility. They also need to own a smartphone, as this may be used as part of the study. Those who are pregnant, have had amputations for other reasons, or have certain medical issues that could interfere with exercise will not be able to participate. If you join the trial, you can expect to receive support and guidance as you try out the new prosthetic technology and participate in the exercise program designed for your needs.

Gender

ALL

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

Trial Officials