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临床试验/NCT03199222
NCT03199222Unknown不适用

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

University of South Florida1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年3月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Intermediate stage prosthetic complications (clinical documentation)

研究概览

简要总结

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

详细描述

Limb loss requires prosthetic use. Prostheses usually consist of 2 components: 1) a soft interface to protect the skin and underlying musculoskeletal tissue and 2) a structural interface to enable attachment of prosthetic components to the human body. The interface connects the patient's body to the prosthetic components and thus ground during gait. The interface has 2 purposes: 1) to distribute weight-bearing forces throughout the entire residual limb (RL) and 2) to suspend the prosthesis during swing phase and unweighting. The interface assists in distributing vertical loads during weight bearing to minimize focal loading on pressure intolerant tissues. The interface also suspends prosthetic components to the RL in swing phase and other periods of unweighting.

Many amputees experience RL complications and decreased mobility resulting from the inability to detect excess pressure or a lack of distal contact with newly fit and poorly fit interfaces. A smart socket technology interface could benefit every new prosthetic patient by prompting the user of a compromised socket fit prior to inhibiting functional use and safety. Further, the smart socket technology interface may ultimately prevent other health complications and improve patient interaction, usability, comfort, fit and function. The ALPS iForce most economically measures these variables more comprehensively than any other known single device. Therefore the smart socket interface technology chosen for this proposal is the ALPs iForce. The iForce tracks pressure over time and indicates to the user when positive or negative distal pressure exists by providing volume management suggestions (i.e. sock-ply adjustments). The user interacts with data measured sent wirelessly to an application on a smart phone (Android/iOS/Windows), handheld device, or PC. Suggestions may include removal or application of prosthetic socks over the RL, or other appropriate volume management strategies, to improve fit and comfort. Early warning to possible skin irritation and breakdown may lead to a healthier limb.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

Arm 1: Smart socket technology w/patient prompting

Experimental

The prosthetic user WILL receive prompting by the smart socket technology regarding improper fit and suggestions for how to a restore a proper fit (i.e socks). Investigators will have access to the Smart Socket Technology database.

干预措施: Prosthetic smart socket technology with patient prompting (Device)

Arm 2: Clinical protocol. No patient prompting

No Intervention

The prosthetic user WILL NOT receive prompting by the smart socket technology regarding improper fit and suggestions for how to a restore a proper fit (i.e socks). However, investigators will have access to the Smart Socket Technology database.

结局指标

主要结局

Intermediate stage prosthetic complications (clinical documentation)

时间窗: Will be tracked for 120 days

Re-hospitalization rate

Intermediate stage prosthetic complications

时间窗: Will be tracked for 120 days.

Clinical documentation will track incidence of dermatologic issues, skin breakdown, sock ply, circumference, infection and wound severity.

Limb volume activity of the residual limb

时间窗: Will be tracked for 120 days

Limb volume will be tracked through clinical documentation including residual limb volumetrics (circumferential measurements), sock-ply changes (journal), and required interface changes will be used to record volume activity and corresponding consequence and management strategies.

次要结局

  • Step Activity(120 days)
  • Mobility(30 days post-amputation and at end of trial (120 days))
  • Balance and Stability(30 days post-amputation and at end of trial (120 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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