Effects of Active Upper-Limb Exoskeleton Training in Simulated Hyper-Gravity on Fine Motor Performance, Brain-Muscle Connectivity, Cardiovascular System and Stress Responses in Real Hyper-Gravity: the EGOS Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Task performance (movement accuracy)
研究概览
简要总结
The aim of the study presented here is to assess the effects of exoskeleton training on performance in a real hypergravity situation. In particular, it will analyze fine motor control, autonomic nervous system regulation and metabolic responses. To this end, the study will compare two groups during a pointing exercise in a centrifuge (hypergravity). One group will have been trained to do this exercise using an exoskeleton, while the other will have been familiarized with the task without the exoskeleton. It will assess whether the exoskeleton can be an effective and accessible training tool for astronauts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maximum weight of 90 kg
- •Maximum sitting butt-to-shoulder distance of 70 cm
- •Certified as healthy by a comprehensive clinical assessment
- •Normal or corrected to normal vision
- •Right-handed tested with Edinburgh-Handedness-Inventory-Test (≥6th percentile, on https://www.brainmapping.org/shared/Edinburgh.php)
- •Non smokers
- •No alcohol or drug dependence, no medical treatment on a regular basis
- •Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC) or a Global Health Insurance Card (GHIC).
- •Free of any engagement during the study
- •Test subjects must be able to understand and speak English
- •Who agreed to take part in the study and signed the informed consent
排除标准
- •Left-handed tested with Edinburgh-Handedness-Inventory-Test (<6th percentile)
- •Subjects with experience in experiments on a short arm human centrifuge or under real hyper-gravity
- •Non-tolerance to the centrifugation
- •Any history or presence of clinically relevant chronic disease
- •Refusal to give permission to contact his general practitioner,
- •Subject who, in the judgment of the investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development,
- •Subject in the exclusion period of a clinical research,
- •Subject who has received more than 6000 Euros within 12 months for being a research subject,
- •Subject who cannot be contacted in case of emergency,
- •Vulnerable people according to law "Code de la Santé Publique" (L1121-5 to L1121-8)
研究组 & 干预措施
Control
Untrained group
Trained
Trained with the exoskeleton
干预措施: Training with an exoskeleton (Other)
结局指标
主要结局
Task performance (movement accuracy)
时间窗: From familiarisation sessions (Day 1 to Day 4) to testing day at Day 5.
Task performance (movement accuracy) is defined as the difference between the position touched on the screen and the position of the displayed target. The participants will be required to perform an aiming movement task using their right arm, directed toward a target.The participants will need to point to the center of the displayed target.
次要结局
未报告次要终点