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临床试验/NCT05537792
NCT05537792已完成不适用

User-Independent Intent Recognition on a Powered Transfemoral Prosthesis

Georgia Institute of Technology2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Overground Self-selected Walking Speed

研究概览

简要总结

This work will focus on new algorithms for powered prostheses and testing these in human subject tests. Individuals with above knee amputation will walk with a robotic prosthesis and ambulate over terrain that simulates community ambulation. The investigators will compare the performance of the advanced algorithm with the robotic system that does not use an advanced algorithm.

详细描述

The focus of this work is a proposed novel AI system to self-adapt an intent recognition system in powered prostheses to aid deployment of intent recognition systems that personalize to individual patient gait. The investigators hypothesize that the prosthesis using our self-adaptive intent recognition system will improve walking speed. Independent community ambulation is known to be more challenging for individuals with TFA, and so the investigators will measure self-selected walking speed (SSWS) which is a correlate with overall health and is a predictor of functional dependence, mobility disability and falls; furthermore, slow SSWS are correlated to lower quality of life (QOL), decreased participation and symptoms of depression. Self-adapting intent recognition has great potential to restore gait in community settings and improve embodiment, which has been associated with improved QOL and increased device usage in patients who use advanced upper limb prostheses. In this experiment, patients with TFA will be fit with our robotic knee/ankle prosthesis and proceed to walk over a treadmill and overground at varying speeds, while the investigators capture 3D biomechanics in both the self-adaptive and static user-independent system (control condition). The investigators expect the self-adaptive system to learn the best prediction of the patient's unique gait, leading to advantages in functional and patient reported outcomes over the control and baseline conditions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A unilateral amputation of the lower limb
  • Aged between 18 to 75 years, inclusive
  • K3 or K4 level ambulators who can perform all locomotor tasks of interest (based on assessment of the physiatrist and/or prosthetist)
  • If a prosthesis is used, the participant must use a prosthetic knee and foot in their clinically prescribed prosthesis.

排除标准

  • Individuals with history of neurological injury, gait pathology, or cardiovascular condition that would limit ability to ambulate for multiple hours
  • Individuals who are currently pregnant (based on patient self-report) due to slight risk of falling during experiments

结局指标

主要结局

Overground Self-selected Walking Speed

时间窗: 1 day

This measures the individuals preferred overground walking speed which indicates their physical capability with a device.

次要结局

  • Overground Walking Speed Mean Absolute Error (MAE)(1 day)
  • Treadmill Walking Speed Mean Absolute Error (MAE)(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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