RecruitingPhase 2NCT05656924

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


Sponsor

Spaulding Rehabilitation Hospital

Enrollment

38 participants

Start Date

Dec 20, 2023

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a digital health program combined with an exercise plan for people who have had a below-the-knee amputation due to diabetes, to help improve mobility, physical fitness, and quality of life. **You may be eligible if...** - You had a below-the-knee amputation (one leg only) in the past 4–16 months, caused by type 2 diabetes complications - You currently use a prosthetic limb and have been doing so for at least 2 months - You are able to walk with some independence (K2 or K3 mobility level) - You own a smartphone **You may NOT be eligible if...** - Your amputation was due to cancer, severe injury, or sudden bleeding - You have had both legs amputated - Your other leg has serious medical complications preventing activity - You have severe pain in your residual limb that prevents exercise - You have other medical conditions that make regular exercise unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEdigital prosthetic interface technology

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)

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05656924


Related Trials