跳至主要内容
临床试验/NCT04599530
NCT04599530Unknown不适用

A Comprehensive Evaluation of a New Generation Bionic Foot

Vrije Universiteit Brussel0 个研究点目标入组 10 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
主要终点
Biomechanical: cadence

研究概览

简要总结

The Talaris Demonstrator is developed in continuation of previous prototypes called the AMPfoot 2.0, 3.0 and 4.0. The main goal of the experiment is to evaluate the effectiveness of TD during daily activities.

详细描述

A within study design will be conducted in order to evaluate four different prosthetic devices (current, non-propulsive TDF, propulsive TDF and Cyberlegs) with ten participants.

Prior to the baseline test, a familiarization trial aimed to accustom participants to the experimental protocol, to get used to the measurements and interface of the measurement devices. The baseline experimental trial is implemented to evaluate the current prosthesis during the different tests. The same tests will be performed during the evaluation of the other devices. Participants are asked to perform the following consecutive tasks with ten minutes of rest in between each task. The first task is a stair climbing test where participants' will be asked to ascend and descend a staircase. Participants start in front of the staircase and are asked to ascend and descend as fast as possible. Bilateral handrails are required to allow support when needed. The ascending phase is initiated with the prosthetic side, while the first step of the descending phase is performed with the non-involved leg. The second task is the L-test, where participants are asked to rise from a chair, walk through an office door, turn 90 degrees, walk down a hallway, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter will be covered. The slope walking test assesses the participants' ability to ascend and descend an inclined ramp as fast as possible. For safety reasons bilateral handrails are warranted. Participants start the test in an upright position in front of the ramp and are asked to ascend the ramp, turn around on the platform, descend the ramp and return to the starting position. During a two-minute walk test, participants are asked to respond as fast as possible to a stimulus visualized on a computer screen one meter in front of the treadmill. Finally, a hallway six-minute walk test will be performed on a hallway at a self-selected walking speed, which closely relates to the most efficient walking speed.

In between each test with a novel device, participants need accustom to the novel device to ensure a good alignment and fitting. Participants will be fitted and aligned to the novel device by a physiotherapist and prosthetist.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

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

入选标准

  • Age: 25 - 75 years
  • Gender: men and women
  • Level of amputation: unilateral transfemoral
  • Vascular, traumatic, congenital or other cause of amputation
  • Completed the rehabilitation program, meaning that participants possess their final prosthesis
  • Medicare Functional Classification Level: K2-4
  • Participants wear their prosthesis for at least 8 hours/day

排除标准

  • Any neurological disease
  • No upper limb or bilateral amputation
  • Stump pain or bad fit of the socket

结局指标

主要结局

Biomechanical: cadence

时间窗: 1 year

Cadence steps/min

Biomechanical: step width

时间窗: 1 year

Step width in cm

Performance: duration

时间窗: 1 year

secondfs

Psychological: Visual Analogue Scale

时间窗: 1 year

For Fatigue and Comfort on a scale from 0 to 10

Performance: walking speed

时间窗: 1 year

In meter per second

Biomechanical: step length

时间窗: 1 year

Step Length in cm

Biomechanical: swing phases

时间窗: 1 year

in % of gait cycle

Biomechanical: stance phases

时间窗: 1 year

in % of gait cycle

Physiological: oxygen consumption

时间窗: 1 year

in ml/min/kg

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jo Ghillebert

Doctorandus

Vrije Universiteit Brussel

相似试验