Rehabilitation of HAND and Arm Function Using a Meta QUEST-based Virtual Reality Game in ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Handgrip strength
研究概览
简要总结
Patients admitted to the ICU due to critical illness often experience physical, mental, cognitive, or social issues. Research indicates that inadequate physical recovery is associated with lower handgrip strength, and hand function in ICU patients is lower compared to healthy individuals. To address this, a Virtual Reality (VR) exergame was developed to aid rehabilitation. This study aims to investigate the effect of a 4-week VR-exergame intervention on handgrip strength, hand and arm functionality, balance, mobility, and support needs in ICU patients staying for 48 hours or longer. It is a multicenter mixed-methods randomized controlled trial involving adult ICU patients. The intervention involves a 4-week VR-exergame program. Main study parameters include handgrip strength, hand and arm functionality, range of motion, balance, mobility, and support needs. The burden and risks associated with participation are minimal, as VR-based exercises are deemed safe and voluntary. Overall, the study aims to assess the effect of incorporating VR-based rehabilitation into standard care for ICU patients.
详细描述
Rationale: Patients admitted to the Intensive Care Unit (ICU) due to critical illness may experience new or increased physical, mental, cognitive or social problems. Research from the MCL showed that patients with inadequate physical recovery after one year also have lower handgrip strength at discharge from the ICU and after three months. In addition, a recent study indicated that hand function after ICU admission is lower than in a healthy control group. Early mobilisation focussing on regain of function is therefore essential in ICU patients. Previously, the MCL and 8D Games developed a Virtual Reality exergame that is safe and feasible to use as an addition to standard care mobilisation in the ICU ward. Although the primary goal of the VR-exergame is to provide personalised and fun options in rehabilitation, it may also have additional benefits when it comes to recovery after critical illness. In addition, the VR-exergame may be a feasible option for performing rehabilitation exercises after hospital discharge.
Objective:
Primary:
To investigate the effect of a 4-week VR-exergame intervention on handgrip strength in patients staying in the ICU for 48 hours or longer compared to standard rehabilitation practices.
Secondary:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Length of stay ICU ≥48 hours
- •Lives in catchment area of one of the Frisian hospitals
- •Understands the Dutch language
- •Intact motor skills of at least one upper extremity
排除标准
- •Active delirium (CAM-ICU ≥1)
- •Severe cognitive dysfunction
- •Internal cardiac defibrillator
结局指标
主要结局
Handgrip strength
时间窗: 4 weeks after baseline
Handgrip strength measured by handheld dynamometer in kg/m2
次要结局
- Arm and hand functionality(4 and 12 weeks after baseline)
- Support need and experience with VR training(at baseline, 4 weeks and 12 weeks)
- Handgrip strength(12 weeks after baseline)
- Arm and hand range of motion(4 and 12 weeks after baseline)
- Balance and mobility(4 and 12 weeks after baseline)
研究者
Lise Beumeler
Principal Investigator
Frisius Medisch Centrum