Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees
Improving the Health Status of Dysvascular Amputees by Deploying Digital Prosthetic Interface Technology in Combination With an Exercise Intervention
Spaulding Rehabilitation Hospital
38 participants
Dec 20, 2023
INTERVENTIONAL
Conditions
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 Criteria5
- 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 Criteria7
- 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
Interventions
Individuals randomized to this group will receive a socket and liner that are manufactured using a novel technique meant to achieve a better distribution of pressure on the residuum. The study is based on the hypothesis that an improvement in pressure distribution on the residuum will enable high adherence to an exercise program meant to improve health status in dysvascular amputees.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05656924