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

8 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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."

Type d'étude

Interventionnel

Inscription (Estimé)

51

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Le Portugal
    • Porto District
      • Porto, Porto District, Le Portugal, 4200-319
        • Recrutement
        • Centro Hospitalar Universitário São João
        • Contact:
        • Chercheur principal:
          • João Ferreira-Coimbra, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.
Autres noms:
  • Meta Quest Pro
  • Enhance VR (Virtuleap)
  • VR-Rehab
Comparateur actif: 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.
Dispositif: 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.
Autres noms:
  • Samsung Galaxy S5e
  • 2D Digital Rehabilitation
  • Tablet-Rehab
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Montreal Cognitive Assessment (MoCA)
Délai: 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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Medical Research Council Sum Score (MRC-SS)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Minho

Collaborateurs

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

Les enquêteurs

  • Chercheur principal: João Ferreira-Coimbra, MD, Centro Hospitalar de São João, E.P.E.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

6 décembre 2025

Achèvement primaire (Estimé)

1 mai 2026

Achèvement de l'étude (Estimé)

1 juin 2026

Dates d'inscription aux études

Première soumission

29 avril 2026

Première soumission répondant aux critères de contrôle qualité

8 mai 2026

Première publication (Réel)

13 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 319-22 - VR4ICU
  • 2022.13901.BDANA (Autre identifiant: FCT)
  • support UID/50014/2025 (Autre identifiant: FCT)

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

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Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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