RecruitingNot ApplicableNCT07585500

Virtual Reality for Recovery After Intensive Care (PICS)

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

Sponsor

University of Minho

Enrollment

51 participants

Start Date

Dec 6, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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 Criteria13

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

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Interventions

DEVICEImmersive 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.

DEVICETablet-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.