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临床试验/NCT05407545
NCT05407545已完成不适用

Evaluation of a Motorised Prosthetic Knee

Vrije Universiteit Brussel2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2023年6月2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
7
试验地点
2
主要终点
Performance

研究概览

简要总结

The study will investigate the effect over time of the Power Knee (Össur) on performance during daily activities in people with a unilateral transfemoral amputation, will determine subjective feelings and gait kinematics over time during daily activities and will investigate the association between subjective feelings and objective outcomes of performing daily activities.

详细描述

Participants will visit the lab 6 times over a period of 5 weeks. The study includes a familiarisation phase (3 measuring moments) followed by the experimental phase (3 measuring moments). During the measuring sessions, participants will perform four tasks with their current prosthesis and with the Power Knee (Össur). The order in which the devices will be tested, will be reversed on each measuring moment to control for possible order effects and fatigue.

The experimental protocol will entail an L-test and slope walking test that will each be performed 3 times, followed by a 6 minutes of hallway walking (6MWT), 10 min rest and a dual-task 6MWT.

The slope walking test assesses the participants' ability to ascend and descend a 6 m long ramp of 10% inclination 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.

The L-test, requires higher physical activity of the user. During the L-test, participants are asked to rise from a chair, walk 7 meters, turn 90 degrees, walk 3 meters, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter is covered.

The 6MWT will be performed on a hallway at a self-selected walking speed, which closely relates to the most efficient walking speed.

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

  • Unilateral transfemoral (above knee) amputation
  • Healthy subject
  • Medicare Functional Classification Level: K3-4

排除标准

  • Any neurological disease
  • Upper limb or bilateral amputation
  • Stump pain or bad fit of the socket

结局指标

主要结局

Performance

时间窗: 144 minutes

Distance covered during the 6MWT and dual-6MWT

次要结局

  • Psychological(200 minutes)
  • Physiological(286 minutes)

研究者

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

Kevin De Pauw

Prof. Dr.

Vrije Universiteit Brussel

研究点 (2)

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