Virtual Reality for Recovery After Intensive Care (PICS)

Официальное название

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

Обзор

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.

Подробное описание

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."

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Montreal Cognitive Assessment (MoCA) [Срок оценки: 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).]

Вторичные конечные точки (7)

• Medical Research Council Sum Score (MRC-SS) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).]
• Simulator Sickness Questionnaire (SSQ) [Срок оценки: During the intervention period for the VR arm, after intervention (daily for up to 7 days).]
• System Usability Scale (SUS) [Срок оценки: Post-intervention (T1: from the day after the last intervention (Day 8) to the day before T2).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Португалия · 1 центр

• Centro Hospitalar Universitário São João — Porto

Публикации

• Lai B, Powell M, Clement AG, Davis D, Swanson-Kimani E, Hayes L. Examining the Feasibility of Early Mobilization With Virtual Reality Gaming Using Head-Mounted Display and Adaptive Software With Adolescents in the Pediatric Intensive Care Unit: Case Report. JMIR Rehabil Assist Technol. 2021 May 27;8(2):e28210. doi: 10.2196/28210. PMID 34042602
• Locke BW, Tsai TY, Reategui-Rivera CM, Gabriel AS, Smiley A, Finkelstein J. Immersive Virtual Reality Use in Medical Intensive Care: Mixed Methods Feasibility Study. JMIR Serious Games. 2024 Aug 9;12:e62842. doi: 10.2196/62842. PMID 39046869
• Badke CM, Krogh-Jespersen S, Flynn RM, Shukla A, Essner BS, Malakooti MR. Virtual Reality in the Pediatric Intensive Care Unit: Patient Emotional and Physiologic Responses. Front Digit Health. 2022 Mar 28;4:867961. doi: 10.3389/fdgth.2022.867961. eCollection 2022. PMID 35419557
• Rousseaux F, Dardenne N, Massion PB, Ledoux D, Bicego A, Donneau AF, Faymonville ME, Nyssen AS, Vanhaudenhuyse A. Virtual reality and hypnosis for anxiety and pain management in intensive care units: A prospective randomised trial among cardiac surgery patients. Eur J Anaesthesiol. 2022 Jan 1;39(1):58-66. doi: 10.1097/EJA.0000000000001633. PMID 34783683
• Vlake JH, van Bommel J, Hellemons ME, Wils EJ, Gommers D, van Genderen ME. Intensive Care Unit-Specific Virtual Reality for Psychological Recovery After ICU Treatment for COVID-19; A Brief Case Report. Front Med (Lausanne). 2021 Feb 5;7:629086. doi: 10.3389/fmed.2020.629086. eCollection 2020. PMID 33614677
• Vlake JH, van Bommel J, Wils EJ, Bienvenu J, Hellemons ME, Korevaar TI, Schut AF, Labout JA, Schreuder LL, van Bavel MP, Gommers D, van Genderen ME. Intensive Care Unit-Specific Virtual Reality for Critically Ill Patients With COVID-19: Multicenter Randomized Controlled Trial. J Med Internet Res. 2022 Jan 31;24(1):e32368. doi: 10.2196/32368. PMID 34978530
• Gerber SM, Jeitziner MM, Knobel SEJ, Mosimann UP, Muri RM, Jakob SM, Nef T. Perception and Performance on a Virtual Reality Cognitive Stimulation for Use in the Intensive Care Unit: A Non-randomized Trial in Critically Ill Patients. Front Med (Lausanne). 2019 Dec 10;6:287. doi: 10.3389/fmed.2019.00287. eCollection 2019. PMID 31921867
• Ong TL, Ruppert MM, Akbar M, Rashidi P, Ozrazgat-Baslanti T, Bihorac A, Suvajdzic M. Improving the Intensive Care Patient Experience With Virtual Reality-A Feasibility Study. Crit Care Explor. 2020 Jun 8;2(6):e0122. doi: 10.1097/CCE.0000000000000122. eCollection 2020 Jun. PMID 32695991

Идентификаторы

NCT: NCT07585500 · 319-22 - VR4ICU · 2022.13901.BDANA · support UID/50014/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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