Prosthetic Smart Socket Technology to Improve Patient Interaction, Usability, Comfort, Fit, and Function.

Status unconfirmed · Not applicable

Conditions studied: Complications of the Amputated Limb

In brief

A common problem for the intermediate preparatory stage of prosthetic rehabilitation is distal pressure, due to commonly compromised sensation and lack of understanding how to address it in a newly fitted prosthesis. Excessive pressure can lead to severe skin breakdown, infection, surgical revision, re-hospitalization and delayed rehab. To prevent this common problem among rehabilitating amputees, smart socket technology has been developed to better identify problems that may occur. The Smart Socket Technology including Prompting (SST+P) in this pre-clinical project proposal provides a step activity monitor and senses distal pressure, which is novel to the technology. When excessive pressure is sensed on the residual limb, it will send a signal to the user's smart phone to make an adjustment. This prompting improves patient interaction and may prevent problems as a result of common volume fluctuation and compromised sensation. The purpose of this clinical trial is to determine if the ALPS iForce smart socket technology with prompting (SST+P) will improve patient interaction, usability, comfort, fit, function and health economy outcomes compared with the standard of care (SOC) clinical practice protocols of fitting prosthetic socket interfaces

Key facts

Study ID

NCT03199222

Run by

University of South Florida

People needed

60

Starts

2018-03-29

Expected to finish

2019-07-01

Last updated by the study team

2019-03-20

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unilateral transtibial amputation
• Unilateral revision or reconstruction of transtibial amputation
• Candidate for intermediate stage (i.e. preparatory) socket fitting
• Male or female, of any ethnicity
• 18-60 yrs of age (i.e. active military age)
• 100-275 lbs.

You may not qualify if…

• Body weight <100 or >275 lbs
• Does not speak English or Spanish
• Any other level of amputation than unilateral TTA

Where it is running

• University of South Florida — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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