Multicentre Interventional Pilot Study on the Evaluation of the Functionality, Safety and Reliability of a New Robotic Prosthesis for the Lower Limb At the Transfemoral Level
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- ad hoc check-list Adverse Event
研究概览
简要总结
The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-femoral amputees.
The main question it aims to answer are:
- Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device.
- Provide an indication of the functional effectiveness of the device and its satisfaction by patients.
Participants will perform:
- walking tests inside parallel bars on flat and/or inclined terrain;
- walking tests on treadmill;
- stair climbing/descent tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 否
入选标准
- •trans femoural amputation
- •Medicare Functional Classification Levels k3-k4
- •expert prosthesis wearer (more than one year)
- •electronic knee prostheses user
- •energy-release prosthetic foot user
排除标准
- •Relevant medical comorbidities
- •heart device wearers (PMK or AICD)
- •cognitive impairment
- •anxious or depressed illness
研究组 & 干预措施
prosthetic group
prosthetic group performs the entire protocol with the prosthesis prototype.
干预措施: WRL ATP (Device)
结局指标
主要结局
ad hoc check-list Adverse Event
时间窗: day 5
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
时间窗: baseline
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
时间窗: day 2
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
时间窗: day 3
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
时间窗: day 4
questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.
次要结局
未报告次要终点
研究者
Claudio Macchi
Full Professor
Fondazione Don Carlo Gnocchi Onlus