Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

Description

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.

Conditions

Diabete Type 2, Amputation

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Study Overview

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Study Details

Study overview

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.

Improving the Health Status of Dysvascular Amputees by Deploying Digital Prosthetic Interface Technology in Combination With an Exercise Intervention

Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

Condition
Diabete Type 2
Intervention / Treatment

-

Contacts and Locations

Boston

Spaulding Rehabilitation Hospital Boston, Boston, Massachusetts, United States, 02129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Spaulding Rehabilitation Hospital,

Paolo Bonato, PhD, PRINCIPAL_INVESTIGATOR, Spaulding Rehabilitation Hospital

Study Record Dates

2025-12-31