The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus, 1st Clinical Study: Validation of the Efficacy of the CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus Modules in a Clinical Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in the physical effort needed for walking with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules.
研究概览
简要总结
The global goal of the CYBERnetic LowEr-limb coGnitive ortho-prosthesis Plus Plus (CLs++) project is to validate the technical and economic viability of the powered robotic ortho-prosthesis developed within the 7th Framework Program - Information and Communication Technology - CYBERnetic LowEr-limb coGnitive ortho-prosthesis project, as a means to enhance/ restore the mobility of transfemoral amputees and to enable them to perform locomotion tasks such as ground-level walking, climbing/descending stairs, standing up, sitting down and turning in scenarios of real life. Restored mobility will allow amputees to perform physical activity thus counteracting physical and cognitive decline which occurs with advancing age and improving the overall health status and quality of life.
This project involves players from academia, research institutions, end users, as well as robotics and healthcare industry, and has been funded by the European Commission (call identifier H2020 - Information and Communication Technology 24-2015, scope c, namely Technology Transfer - Robotics use cases, Grant Agreement 731931).
The CLs++ project is an Innovation Action (IA) and foresees 2 clinical studies aimed at assessing the efficacy of the CLs++ modules in different settings.
In this 1st clinical study, 16 patients with unilateral trans-femoral amputation, 8 @ the Don Gnocchi Foundation, Center of Florence, and 8 @ the Free University of Brussels, Dept. of Human Physiology, will participate in the assessment of the efficacy of the CLs++ ortho-prosthesis modules in a clinical setting.
详细描述
In the first clinical study, a set of combinations of the three hardware (HW) modules of the CLs++ ortho-prosthesis, namely the Active Trans-femoral Prosthesis (ATP), the Active Pelvis Orthosis (APO) and the Active Knee Orthosis (AKO) will be tested, along with the Wearable Sensory Apparatus (WSA), the Bidirectional Interface (BI) and the control software (SW).
The recruitment of potential participants will be carried out by a multidisciplinary team (physicians, physiotherapists and psychologists) and will be aimed at ascertaining the inclusion and exclusion criteria as reported in the "Eligibility" section. If the potential participant fulfills 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. An appointment will also be arranged with the orthopedic workshop to make a spare socket to be used with the ATP.
The protocol of the CLs++ first clinical study will be constituted by two main phases.
The first phase is expected to last one week and it has the goal to explore the functionality of the CLs++ HW and SW modules in structured or semi-structured clinical settings by means of a preliminary initial set of activities. In particular, the enrolled participants will be testing 4 different combinations of CLs++ modules:
a) APO + WSA + BI; b) ATP + WSA; c) APO + ATP + WSA; d) APO + AKO + WSA.
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
- 否
入选标准
- •Unilateral trans-femoral amputation (any cause)
- •Completed the post amputation rehabilitation process
- •Medicare Functional Classification Level ≤ K3
排除标准
- •Poor cognitive skills (Mini Mental State Examination)
- •Severe anxiety or depression (State-Trait Anxiety Inventory Form Y and Beck Depression Inventory II, respectively)
- •Relevant comorbidity (hemiplegia, degenerative nervous system diseases, hip or knee replacement, chronic heart failure, chronic obstructive pulmonary disease, act.)
- •Stump pain/socket poor fitting
- •Implantable cardiac devices (PMK and AICD)
- •Inability to walk on a treadmill
结局指标
主要结局
Change in the physical effort needed for walking with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules.
时间窗: Before and after the familiarization/training period lasting one month.
While performing the six-minute walk test, oxygen uptake will be assessed using a portable gas analyzer and will be considered as an objective measure of the physical effort.
次要结局
- Change in the self-perceived physical effort needed for walking with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules.(Before and after the familiarization/training period lasting one month.)
- Change in the cognitive effort needed for walking with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules(Before and after the familiarization/training period lasting one month.)
- Change in gait asymmetry with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules(Before and after the familiarization/training period lasting one month.)
- Change in the performance during stair climbing/descending with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules.(Before and after the familiarization/training period lasting one month.)
- Change in the performance during sitting down/standing-up and turning with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules(Before and after the familiarization/training period lasting one month.)
- Change in muscle electrical activity with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules(Before and after the familiarization/training period lasting one month.)
研究者
Raffaele Molino Lova
MD
Fondazione Don Carlo Gnocchi Onlus