The Efficacy of the Cyberlegs Xleg During Daily Activities in People With a Unilateral Lower Limb Amputation
试验速览
- 阶段
- 不适用
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Psychological outcome measure
研究概览
简要总结
The aim of the project is to evaluate the efficacy of the Cyberlegs X-leg in people with a unilateral transfemoral (above the knee joint) and transtibial (under the knee joint) amputation. De Cyberlegs X-leg is in continuation of the development of the Cyberlegs gamma-prototype (B.U.N. 143201732970; FAMHP reference number: 80M0725). The Cyberlegs X-leg is a motorized prosthesis which replaces the amputated part of the leg. Our hypothesis is that people with a lower limb amputation perform daily activities (e.g. walking, stair climbing, sit to stand, et cetera) easier, more comfortable and more efficient with the X-leg compared to their current prosthesis. Assessments will be based on a holistic approach in which biomechanical, physiological and psychological parameters are determined.
详细描述
Study design A crossover study and a case study design.
Subjects Number of subjects 14 participants will be recruited for this study.
Inclusion criteria Age:18 - 80 year Gender: men and women Level of amputation: unilateral transfemoral or transtibial Completed the rehabilitation program Functional Medicare Classification K-level 2-4
Exclusion criteria Comorbidity (hemiplegia or neurological diseases) Stump pain or bad fit of the socket
Procedures Recruitment process Experiments will take place at the research group Human Physiology and Sports Physiotherapy of campus Etterbeek from the Vrije Universiteit Brussel (Belgium). Participants will be recruited via clinical rehabilitation centers, such as V!GO (Wetteren or Pellenberg, Belgium), Jessa hospital (Hasselt, Belgium) or via advertisement and flyers. All participants will be providing written and oral information about the experimental protocol, potential risks and benefits before giving informed consent to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Level of amputation: unilateral transfemoral or transtibial
- •Completed the rehabilitation program
- •Functional Medicare Classification K-level 2-4
排除标准
- •Comorbidity (hemiplegia or neurological diseases)
- •Stump pain or bad fit of the socket
结局指标
主要结局
Psychological outcome measure
时间窗: 1 year
rating of perceived exertion (arbitrary valu between 0 and 10)
Physical performance determinant
时间窗: 1 year
duration of the different tests (sec) measured with a chronometer.
Biomechanical outcome measure
时间窗: 1 year
joint angels (degrees) of flexion and extension of the knee and ankle joint.
Electrohysiological outcome measure
时间窗: 1 year
heart rate (bpm)
Physiological outcome measure
时间窗: 1 year
oxygen uptake (ml/min)
次要结局
未报告次要终点
研究者
Jo Ghillebert
PhD candidate
Vrije Universiteit Brussel