Virtual Reality for Recovery After Intensive Care (PICS)

NCT07585500 | Recruiting

• 3 other identifiers: 319-22 - VR4ICU2022.13901.BDANAsupport UID/50014/2025
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Intensive Care Syndrome (PICS); Rehabilitation After Critical Illness; Cognitive Impairment; Critical Illness; Intensive Care Unit (ICU); Critical Illness Recovery; Rehabilitation Exercise of ICU Patients

Keywords

Post-Intensive Care Syndrome (PICS); Cognitive Impairment; Critical Illness; Virtual Reality (VR); Digital Health; Rehabilitation; Intensive Care Unit (ICU); Critical Care; ICU Survivors; Pilot Study; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment (MoCA)

  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).

Secondary Outcomes (7)

• Medical Research Council Sum Score (MRC-SS)

  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)

  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)

  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)

  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)

  Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).

Study Arms (3)

VR-Based Rehabilitation (VR-Rehab)

EXPERIMENTAL

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.

Device: Immersive VR Multi-Domain Rehabilitation

Tablet-Based Rehabilitation (Tablet-Rehab)

ACTIVE COMPARATOR

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.

Device: Tablet-Based Multi-Domain Training

Standard of Care (SOC)

NO INTERVENTION

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.

Interventions

Tablet-Based Multi-Domain Training DEVICE

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.

Also known as: Samsung Galaxy S5e, 2D Digital Rehabilitation, Tablet-Rehab

Tablet-Based Rehabilitation (Tablet-Rehab)

Immersive VR Multi-Domain Rehabilitation DEVICE

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.

Also known as: Meta Quest Pro, Enhance VR (Virtuleap), VR-Rehab

VR-Based Rehabilitation (VR-Rehab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minho: lead
• Universidade do Porto: collaborator
• INESC TEC Porto: collaborator
• Virtuleap: collaborator
• Fundação para a Ciência e a Tecnologia (FCT): collaborator
• Centro Hospitalar De São João, E.P.E.: collaborator

Study Sites (1)

Centro Hospitalar Universitário São João

Porto, Porto District, 4200-319, Portugal

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

postintensive care syndrome; Cognitive Dysfunction; Critical Illness

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• João Ferreira-Coimbra, MD

  Centro Hospitalar De São João, E.P.E.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuno F. Rodrigues

CONTACT

929145931; nunofeixa@gmail.com

Inês Oliveira

CONTACT

965796047; ines.t.oliveira@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: While this is an open-label trial, bias is mitigated through a strict separation of data management duties. The researchers conducting the cognitive assessments do not calculate the final scores or enter them into the primary analysis sheets. Other outcomes are calculated by another researcher or via a stipulated formula. For the full analysis, automated Python scripts are used to ensure objective reporting.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: This is a 3-arm, parallel-group, pilot randomized controlled trial comparing two active digital intervention groups (Immersive VR and 2D Tablet) against a Standard of Care control group.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 13, 2026
• Study Start: December 6, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

PT (1)