Efficacy and Usability of the Cyberlegs++ (CLs++) Ortho-prosthesis Modules in Enabling and Enhancing Mobility in Trans-femoral Amputees
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 主要终点
- Energy expenditure
研究概览
简要总结
The aim of the study is to assess the efficacy and the usability of the cyberlegs ++ ortho prosthesis to improve the mobility and the quality of life in transfemoral amputees . This research focusses on the physical and mental effort needed in locomotion-related tasks and human robot interaction in transfemoral amputees using a novel active prosthesis. This is an international project and foresees 2 clinical studies aimed at assessing the efficacy of the CLs++ modules in different settings.
In this first clinical study, 16 patients with unilateral trans-femoral amputation, 8 at the Vrije Universiteit Brussel Department Human Physiology Research group (VUB-MFYS) and 8 at the Don Gnocchi Foundation, center of Florence.
详细描述
The aim of the study is to assess the efficacy and the usability of the cyberlegs ++ ortho-prosthesis to improve the mobility and the quality of life in transfemoral amputees. This research focusses on the physical and mental effort needed in locomotion-related tasks and human robot interaction in transfemoral amputees using the CLs++ ortho-prosthesis modules. Unilateral transfemoral amputees will be recruited by a multidisciplinary team (physicians, physiotherapists and psychologists) and a list of inclusion- and exclusions criteria as reported in the 'Eligibility' will be fulfilled to enrol the experiment. If the participant fulfils the requirements to be enrolled, the responsible for the study will provide him/her with the information sheet and will answer all possible questions. Once the participant agrees to participate in the study, he/she will sign the informed consent form and an appointment will also be arranged with the orthopedic workshop to make a spare socket to be used during the clinical testings. In this first clinical study, a set of modules of the three hardware (HW) modules of the CLs++ ortho-prosthesis will be tested, namely the Active Trans-femoral Prosthesis (ATP), the Active Pelvis Orthosis (APO) and the Knee Ankle Foot Orthosis (KAFO).
Each subject will be testing the different combinations of CLs++ modules along with the Wearable Sensory Apparatus (WSA) and the control software (SW):
1)APO+WSA, 2) ATP+WSA, 3) APO+ATP+WSA, 4) APO+KAFO+WSA.
The protocol of the CLs++ first clinical study will be constituted by two main phases:
The initial Phase/familiarization phase:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unilateral trans-femoral amputees both sex age: 30 - 80 yrs Functional K-level 1-4
排除标准
- •Severe comorbidity (hemiplegia, degenerative nervous system diseases, severe hip or knee arthrosis,chronic heart failure, chronic obstructive pulmonary, hip or knee replacement, severe sensory deficit
- •Pain of the stump/socket poor fitting
- •Inability to walk (safely) on a treadmill
结局指标
主要结局
Energy expenditure
时间窗: through 6 minutes
oxygen uptake (ml.kg)/carbondioxide production (ml.kg)
次要结局
- Prosthesis Evaluation Questionnaire(up to 24 weeks)
- Timed Up & Go test(through 14 seconds)
- EEG(through 6 minutes)
- Sit to stand test(through 5 minutes)
- Borg scale-ratings of perceived exertion(minute 6)
- Short Form 36 questionnaire(minute 1)
- Stair Climbing test(through 5 minutes)
- 6-Minute Walk Test (6MWT)(through 6 minutes)
- Slope walking(through 5 minutes)
- National Aeronautics & Space Administration Task Load Index(minute 6)
- System Usability Scale(up to 24 weeks)
研究者
Romain Meeusen
prof
Vrije Universiteit Brussel