Post-Intensive Care Syndrome (PICS)Critical Illness RecoveryRehabilitation After Critical IllnessRehabilitation Exercise of ICU PatientsCognitive ImpairmentCritical IllnessIntensive Care Unit (ICU)
Investigational drug(s) / intervention(s)
Immersive VR Multi-Domain RehabilitationTablet-Based Multi-Domain Training
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.
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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Montreal Cognitive Assessment (MoCA) — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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