Effect of Virtual Reality Combined With Cycloergometer Versus Conventional Cycloergometer on Distance for ICU Non-sedated Participants: Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Distance actively covered (in kilometers with one decimal)
研究概览
简要总结
Management in intensive care unit (ICU) has gradually evolved to early mobilization. Studies have confirmed a 50% decrease impact on the functional abilities and quality of life after ICU. The cycloergometer is particularly studied and effective for early rehabilitation. Current practices encounter obstacles as fatigue, pain or a lack of motivation to mobilize. Several studies have been carried out to evaluate the effects of virtual reality (VR) on mental health and on cognitive abilities. To date, there is little evidence about VR on distraction and the impact on physical activity motivation in ICU.
The main hypothesis is that the use of combine cycloergometer and VR would improve the travelled distance by patients in ICU. Adverse effects would be observed initially in order to consolidate the safety data of this device. It would also allow a better participant experience.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old hospitalized in the surgical intensive care unit (USC or reanimation) of the Centre Hospitalier Régional d'Orléans
- •Glasgow 15
- •Satisfying the chair installation criteria before the inclusion
- •With or without :
- •any type of invasive or non-invasive ventilation
- •any type of oxygenation
- •Stable within its medically determined target parameters
- •Hemodynamically stable (MAP>65)
排除标准
- •Person presenting a medical contraindication to cycloergometer
- •Person under guardianship or curatorship
- •Person under court protection
- •Stay less than 48 hours (post-neurosurgery surveillance)
- •Persons weighing over 180 kg
- •Person not affiliated to a social security system
- •Pregnant or breast-feeding Women
- •Deaf and visually impaired people
- •Patient included in another study with the same endpoint
研究组 & 干预措施
Virtual reality and Cycloergometer
The session performed uses a standard cycloergometer, with the participant pedaling in a seated position with the lower limbs. A 43 inches TV screen is placed in front of the cycloergometer where the participant will watch a video of a walk through a natural environment on. The speed of the walk is linked to the pedaling speed so that the faster the participant pedals, the faster the video goes too. The session last 30 minutes in the participant's room.
干预措施: Virtual reality and Cycloergometer (Device)
Standard cycloergometer
For the "standard cycloergometer" intervention, the session uses usual cycloergometer with the participant pedaling in a seated position with the lower limbs. No virtual reality is used. The session last 30 minutes in the participant's room
干预措施: Standard cycloergometer (Other)
结局指标
主要结局
Distance actively covered (in kilometers with one decimal)
时间窗: Day 2
Distance actively covered (in kilometers) with the combination of virtual reality and cycloergometer versus distance actively covered (in kilometers with one decimal) with conventional seated cycloergometer session
次要结局
- Number of adverse effects noted during the session(Day 2)
- Measure of patient's experience with Visual Analogic Scale (on /10)(Day 2)