Interventional Pilot Study on the Evaluation of Functionality, Degree of Safety and Reliability of a New Robotic Prosthesis for Treatment of Transtibial Lower Limb Amputations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 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-tibial 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-tibial lower limb amputation;
- •Medicare functional classification: Level K3-K4;
- •Subjects who have worn prostheses for at least 1 year (experienced wearers);
- •Use of prosthesis with energy-returning prosthetic foot.
排除标准
- •Relevant medical comorbidities (serious neurological pathologies, cardiovascular pathologies, diabetes/hypertension not stabilized, severe sensory deficits);
- •Wearers of implantable cardiac medical devices (PMK or AICD);
- •Cognitive impairment (MMSE corrected for age and education <24);
- •Inability or unavailability to provide informed consent;
- •Severe depressive and/or anxious symptoms.
研究组 & 干预措施
prosthetic group
prosthetic group performs the entire protocol with the prosthesis prototype.
干预措施: WRL TTP (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 feasability of the prosthesis and description of any adverse events.
ad hoc check-list Adverse Event
时间窗: baseline
questionnaire that evaluate the device feasability 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 feasability 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 feasability 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 feasability of the prosthesis and description of any adverse events.
次要结局
- SCT - stair climb test(day 3)
- TUG - Timed Up and GO(day 3)
- CR-10 Borg Scale(day 5)
- System usability scale(day 5)
- 10mwt - 10 meters walking test(day 3)
- 6mwt - 6 minute walking test on the treadmill(day 5)
- Gait analisys(day 5)
- System usability scale(baseline)
- 10mwt - 10 meters walking test(day 2)
- SCT - stair climb test(day 2)
- TUG - Timed Up and GO(day 2)
- 6mwt - 6 minute walking test on the treadmill(day 4)
研究者
Claudio Macchi
Full Professor
Fondazione Don Carlo Gnocchi Onlus