Design of a Cognitive Motor Intervention Using a Video Game to Enhance Brain Activity: A Feasibility Study Including Healthy Participants and Heart Patients on the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility & usibility 1
研究概览
简要总结
This project proposes the development and design of a motor intervention using a cognitive video game and describes the feasibility, safety and acceptability of virtual augmented video gaming device named Virtual Reality on the Intensive Care Unit (VRICU). The project in two phases is performed in healthy participants (Phase 1) and heart patients after elective heart surgery on the Intensive Care Unit (Phase 2).
Furthermore, brain function will be measured during exer-gaming with the VRICU device with non-invasive instruments (fNIRS/EEG) in both the healthy participants and the heart patients.
The VRICU device is a patient friendly construction to allow a patient exergaming in bed. The project is a cooperation between scientist at the USZ (physiotherapist / anaesthsiologists / engineers), human movement scientist at the ETHZ and (poly- / electro-) mechanics at the Paul Scherrer Institut.
详细描述
There is converging evidence at systems levels that physical exercise participation is beneficial to cognition, especially to the different subtypes of attention. Such evidence highlights the importance of promoting physical exercise to prevent or reverse cognitive and neural decline. Accordingly, physical exercise can serve to promote function in patients. Physical exercise games may be engaged to gauge performance increases in motor learning and early rehabilitation programs as performed on an intensive care unit.
This project proposes the development and design of a cognitive motor intervention using a custom video game (which will be performed in supine position in bed) to enhance brain activity and describes the feasibility, safety and acceptability of virtual augmented video dance gaming.
This project is divided in two (2) phases:
Phase1 The patients are not expected to exercise the video game in the usual standing position due to their condition. Thus, we designed a patient friendly construction with colleagues of the construction department of the Paul Scherrer Institute (Villigen, Switzerland), which enables video game exercising in supine position. This construction and custom video game will be tested first in healthy participants for feasibility, acceptability and safety. Furthermore, brain activity of the participants will be measured and evaluated, before during and shortly after playing the video game in 15 healthy participants.
Phase 2 After the device and procedures tested in phase 1 is feasible, acceptable and safe, maximal 10 patients on the ICU ward (receiving elective heart surgery, will be recruited to evaluate the feasibility, safety, acceptability and effect on brain function of a custom video exercise game.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants
- •18 years or older of age.
- •In good health and not under treatment of a physician
- •Patient on the intensive care unit. Inclusion criteria
- •Adult patients (>18 years).
- •Signed informed consent by patient.
- •Patient awake and close to full cooperation needed to Participate actively in the experimental intervention.
排除标准
- •No exclusion criteria
- •Exclusion criteria for the patients are:
- •Known epilepsy
- •Inability to obtain consent
- •known or suspected non-compliance
- •raised intracranial pressure
- •participation in conflicting study
- •known dementia
- •absence of a limb
- •Incapable of discernment -
结局指标
主要结局
Feasibility & usibility 1
时间窗: Healthy participants 120 minutes, patients: dependent on physical ability
Intensity: Level of gameplay
Feasibility & usibility 2 Feasibility & Usibility 2
时间窗: Healthy participants 120 minutes, patients: dependent on physical ability
Accuracy: Percentage
Feasibility & usibility 3
时间窗: Healthy participants 120 minutes, patients: dependent on physical ability
Time: Minutes
次要结局
- Safety parameters & adverse effects of the VRICU device(Minimal 1 up to 30 Minutes (if applicable))
- MOSRAM Questionnaire(10 minutes)
- functional Near Infrared Spectroscopy (fNIRS)(healthy participants 90 minutes, patients: dependent on physical ability)
- EEG(healthy participants 90 minutes, patients: dependent on physical ability)
