NCT04157608撤回不适用
Evaluation of an Energy-Harvesting Mesofluidic Impulse Prosthesis (e-MIP) in Transtibial Prosthesis Users
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Energy returned
研究概览
简要总结
The purpose of this research is to validate the e-MIP design and function by testing the ability of e-MIP to harvest energy and return a sufficient amount of energy to assist the user during gait. The investigators will also evaluate whether prosthetic users are able to wear and use the e-MIP device long-term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral transtibial amputation
- •At least twelve months post-amputation
- •Currently walking on a prosthesis for at least one year
- •Uses modular endoskeletal prosthetic components
- •Has bilateral normal range of motion
- •Ability to walk independently and for an extended length of time (walking ability of each individual will be assessed by the principal investigator or study prosthetist during the recruitment period)
- •Ability to communicate individual perceptions
- •Ability to provide informed consent
排除标准
- •Confounding injury or musculoskeletal problem
- •Pregnancy
- •Lower limb peripheral neuropathy
- •Symptomatic cardiovascular disease or chronic obstructive pulmonary disease
- •Not able to read and understand English
结局指标
主要结局
Energy returned
时间窗: After four weeks with e-MIP (system ON and system OFF)
The amount of energy returned at the ankle joint, calculated from ankle torque and angle sensors with respect to time.
次要结局
- Prosthesis Evaluation Questionnaire(After four weeks with e-MIP (system ON and system OFF))
- Kinematics during Gait(After four weeks with e-MIP (system ON and system OFF))
- Kinetics during Gait(After four weeks with e-MIP (system ON and system OFF))
- Step Rate(After four weeks with e-MIP (system ON and system OFF))
- Step Activity(After four weeks with e-MIP (system ON and system OFF))
- Spatio-Temporal Gait Parameters(After four weeks with e-MIP (system ON and system OFF))
- Total Steps(After four weeks with e-MIP (system ON and system OFF))
研究者
研究点 (2)
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