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Virtual Reality for Recovery After Intensive Care (PICS) (VR4ICU)

2026年5月8日 更新者：Adriana Sampaio、University of Minho

Virtual Reality Intervention for Post-Intensive Care Syndrome (PICS): A Protocol for a Pilot Randomized Controlled Trial for Cognitive, Physical and Psychological Outcomes

The goal of this clinical trial is to learn if virtual reality (VR) helps improve thinking and memory skills in adults who have stayed in the intensive care unit (ICU). The study focuses on people who needed a breathing machine or stayed in the ICU for several days and are at risk for memory or "brain fog" issues.

The main questions it aims to answer are:

  • Does using VR improve a participant's memory, attention, and thinking skills after an ICU stay?
  • Does the "immersive" feel of a VR headset work better to improve these skills than using a handheld tablet?

Researchers will compare three groups to see how different types of care affect the brain:

  • VR-Rehab: Participants use a VR headset to play brain-training games.
  • Tablet-Rehab: Participants use a handheld tablet to play the same brain-training games.
  • Standard Care: Participants receive the usual hospital care without digital brain games.

Participants will:

  • Play brain-training games for 12 minutes every day for up to one week while in the hospital.
  • Complete memory and thinking tests with a researcher at the start of the study and again after two weeks.
  • Answer follow-up questions about their memory and thinking skills for 6 months after leaving the hospital.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Study Rationale and the Immersion Hypothesis Survivors of critical illness often face significant cognitive impairments, a key component of Post-Intensive Care Syndrome (PICS). While early rehabilitation is recommended, traditional methods often struggle to address cognitive recovery in the acute ICU setting.

This trial is designed to investigate the "Immersion Hypothesis." This hypothesis suggests that the neurological engagement provided by a fully immersive virtual reality (VR) environment offers superior cognitive benefits compared to standard digital content delivered via a 2D interface. By utilizing a three-arm randomized design, the study seeks to isolate whether the therapeutic value comes from the digital exercises themselves or the physiological and psychological impact of total immersion.

Study Design and Arms

Participants are randomized into one of three parallel groups with a 1:1:1 allocation ratio:

  1. VR-Based Rehabilitation (VR-Rehab): Participants use a Meta Quest Pro head-mounted display (HMD) to engage in the Enhance VR platform (Virtuleap). This involves 6 specific games targeting information processing, problem-solving, attention, memory, and motor control.
  2. Tablet-Based Rehabilitation (Tablet-Rehab): Participants engage in the exact same cognitive exercises and gameplay durations as the VR group, but via a 2D tablet interface. This arm serves as a "digital control" to account for the effects of cognitive stimulation without immersion.
  3. Standard of Care (SOC): Participants receive conventional ICU rehabilitation, including physical and respiratory physiotherapy, without structured digital cognitive training.

Intervention Protocol All digital interventions are performed at the bedside with the participant positioned at a 30° to 60° angle for safety. Sessions are designed for a target "dose" of 12 minutes of active gameplay per day for up to 7 consecutive days (or until ICU discharge).

A "Minimum Therapeutic Dose" is defined for this study as the successful completion of at least 12 individual game sessions. This threshold ensures that participants have reached a level of engagement sufficient to evaluate the impact of the technology on cognitive recovery.

Procedural Rigor and Bias Mitigation

To ensure high-quality data in a non-blinded clinical environment, the trial enforces a strict separation of duties:

  • Researcher Roles: Different researchers facilitate the daily intervention sessions and conduct the primary cognitive assessments. Those delivering the VR or Tablet therapy are prohibited from scoring the recovery outcomes.
  • Automated Analysis: To eliminate subjective interpretation, primary group comparisons are performed using pre-developed, automated scripts in Python.
  • Sanitization: Strict infection control protocols are followed, using medical-grade, non-corrosive disinfectant wipes for all hardware between uses.

Safety Monitoring Participant safety is monitored continuously during every session. Predefined stop criteria include physiological instability (such as a drop in oxygen saturation or significant changes in heart rate) or any verbal/non-verbal signs of distress or "cybersickness."

研究类型

介入性

注册 (估计的)

51

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 葡萄牙
    • Porto District
      • Porto、Porto District、葡萄牙、4200-319
        • 招聘中
        • Centro Hospitalar Universitário São João
        • 接触：
        • 首席研究员：
          • João Ferreira-Coimbra, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adult patients, 18 years or older
  • Patients in the Intensive Care Unit
  • Ventilated patients must be in the post-extubation period
  • The patient has a projected remaining hospital stay of at least 4 days (assessed by the clinical team)
  • The patient has RASS score between -1 and +1
  • The patient has the ability to move both arms, even if with difficulties, as assessed by the clinical team, to be able to interact with the software
  • The patient can maintain a stable sitting position (30° to 60°)
  • The patient is able to communicate (speech, gesturing, or writing)
  • The patient can communicate and understand Portuguese
  • The patient or a legal representative provided informed consent

Exclusion Criteria:

  • Severe cognitive and neurodegenerative diseases: mental illness requiring institutionalization; acquired or congenital intellectual disability; known severe brain injuries (e.g., stroke with significant residual deficits); moderate to severe Traumatic Brain Injury (TBI) (defined by the duration of loss of consciousness/post-traumatic amnesia or documented residual deficits); diagnosed neurodegenerative diseases (e.g., Parkinson's disease with severe movement impairment, Huntington's disease, severe Alzheimer's disease, or dementia of any etiology that prevents autonomy in daily life at baseline)
  • The patient uses neuromuscular blocking agents
  • The patient has a positive CAM-ICU result at the time of initial screening
  • The patient has active psychotic disorders or suicidal ideation
  • The patient has documented epilepsy or history of seizures
  • The patient has a "Do Not Resuscitate" (DNR) order, is on life support with exclusive focus on comfort, or has an unexpected survival predicted to be less than 24 hours
  • The patient has intoxication by an active substance or withdrawal syndrome requiring ongoing medical management that prevents safe and meaningful participation or accurate cognitive assessment
  • Patients with immobility or severe motor limitations in the upper limbs, fine motor skills, or cervical region
  • The patient has open wounds on the head or face that may affect the comfortable/safe use of VR glasses, cause discomfort, or present a hygiene risk
  • The patient has uncorrected blindness or deafness that prevents the safe/effective use of VR/tablet devices.
  • Patients are participating in another rehabilitation study with interventions
  • Patients with a scheduled surgery where the ICU stay is expected to be less than 24 hours
  • Patients in need of respiratory support

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：VR-Based Rehabilitation (VR-Rehab)
Participants receive immersive cognitive training using the Meta Quest Pro headset and the Enhance VR platform in addition to standard care. The intervention consists of daily 12-minute sessions for up to 7 days, targeting cognitive domains such as memory and attention.
设备：Immersive VR Multi-Domain Rehabilitation
A bedside multi-domain rehabilitation program using a head-mounted display. Participants perform 6 gamified tasks targeting both cognitive domains (information processing, attention, memory) and motor domains (motor control, dexterity, and bimanual coordination). The protocol consists of daily 12-minute sessions for a maximum of 7 days.
其他名称：
  • Meta Quest Pro
  • Enhance VR (Virtuleap)
  • VR-Rehab
有源比较器：Tablet-Based Rehabilitation (Tablet-Rehab)
Participants receive the same cognitive training exercises as the VR group via a 2D tablet interface in addition to standard care. This arm serves to isolate the effect of digital content from immersion. Sessions are 12 minutes daily for up to 7 days.
设备：Tablet-Based Multi-Domain Training
A bedside rehabilitation program delivered via a handheld tablet. Participants perform 2D versions of the same 6 tasks used in the VR arm, targeting the same cognitive and motor skills. The protocol consists of daily 12-minute sessions for a maximum of 7 days.
其他名称：
  • Samsung Galaxy S5e
  • 2D Digital Rehabilitation
  • Tablet-Rehab
无干预：Standard of Care (SOC)
Participants receive the conventional ICU rehabilitation protocol provided by the clinical team, which includes standard physical and respiratory physiotherapy. No structured digital cognitive training is provided to this group.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Montreal Cognitive Assessment (MoCA)
大体时间：Baseline (T0), Post-intervention (T2: approx. 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge), and Follow-up 2 (T4: 3 to 6 months post-discharge).
The MoCA is a tool used to screen for cognitive impairment. It assesses various cognitive domains including attention, concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive function. For assessments conducted remotely (T3 and T4), a validated blinded/telephone version of the MoCA will be used.
Baseline (T0), Post-intervention (T2: approx. 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge), and Follow-up 2 (T4: 3 to 6 months post-discharge).

次要结果测量

结果测量
措施说明
大体时间
Medical Research Council Sum Score (MRC-SS)
大体时间：Baseline (T0), Post-intervention (T2: approx. 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge), and Follow-up 2 (T4: 3 to 6 months post-discharge).
The MRC-SS is used to assess muscle strength in six bilateral muscle groups (shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and foot dorsiflexors). Each muscle group is scored from 0 (total paralysis) to 5 (normal strength). The total sum score ranges from 0 to 60, where higher scores indicate better physical strength and motor function.
Baseline (T0), Post-intervention (T2: approx. 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge), and Follow-up 2 (T4: 3 to 6 months post-discharge).
Impact of Event Scale-Revised (IES-R)
大体时间：Post-intervention (T2: approximately 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).
A self-report measure used to assess subjective distress caused by traumatic events (in this case, the ICU stay). It contains 22 items covering three subscales: intrusion, avoidance, and hyperarousal. Scores range from 0 to 88, with higher scores indicating a higher level of post-traumatic stress symptoms.
Post-intervention (T2: approximately 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
大体时间：Post-intervention (T2: approximately 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge), and Follow-up 2 (T4: 3 to 6 months post-discharge).
A standardized instrument for measuring generic health status. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of severity. It also includes a Visual Analogue Scale (VAS) where patients rate their health from 0 to 100. Higher index scores and VAS scores indicate better quality of life.
Post-intervention (T2: approximately 15-22 days from start), Follow-up 1 (T3: 30-45 days post-discharge), and Follow-up 2 (T4: 3 to 6 months post-discharge).
Patient Health Questionnaire-9 (PHQ-9)
大体时间：Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).
A 9-item multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Each item is scored from 0 to 3. The total score ranges from 0 to 27, where 0-4 is minimal depression and 20-27 is severe depression. Higher scores indicate greater severity of depressive symptoms.
Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).
Generalized Anxiety Disorder-7 (GAD-7)
大体时间：Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).
A 7-item self-report questionnaire for screening and severity measuring of generalized anxiety disorder. Items are scored from 0 to 3. Total scores range from 0 to 21. Scores of 5, 10, and 15 represent cut-off points for mild, moderate, and severe anxiety, respectively. Higher scores indicate greater anxiety.
Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).
Simulator Sickness Questionnaire (SSQ)
大体时间：During the intervention period for the VR arm, after intervention (daily for up to 7 days).
A standard tool used to measure "cybersickness" symptoms in VR. It assesses 16 symptoms (like nausea, oculomotor strain, and disorientation) on a 4-point scale. This will be used to monitor the safety and tolerability of the immersive VR intervention compared to the tablet. Higher scores indicate greater discomfort.
During the intervention period for the VR arm, after intervention (daily for up to 7 days).
System Usability Scale (SUS)
大体时间：Post-intervention (T1: from the day after the last intervention (Day 8) to the day before T2).
A 10-item questionnaire used to evaluate the usability of the VR and Tablet systems. It covers aspects like complexity and ease of use. The final score is converted to a range of 0 to 100, where higher scores represent better user experience and higher system "acceptability."
Post-intervention (T1: from the day after the last intervention (Day 8) to the day before T2).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Minho

合作者

Universidade do Porto
Virtuleap
Centro Hospitalar De São João, E.P.E.
INESC TEC Porto
Fundação para a Ciência e a Tecnologia (FCT)

调查人员

  • 首席研究员：João Ferreira-Coimbra, MD、Centro Hospitalar de São João, E.P.E.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月6日

初级完成 (估计的)

2026年5月1日

研究完成 (估计的)

2026年6月1日

研究注册日期

首次提交

2026年4月29日

首先提交符合 QC 标准的

2026年5月8日

首次发布 (实际的)

2026年5月13日

研究记录更新

最后更新发布 (实际的)

2026年5月13日

上次提交的符合 QC 标准的更新

2026年5月8日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 319-22 - VR4ICU
  • 2022.13901.BDANA (其他标识符：FCT)
  • support UID/50014/2025 (其他标识符：FCT)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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