RecruitingNANCT07585500

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

Trial Details

ConditionPost-Intensive Care Syndrome (PICS), Critical Illness Recovery, Rehabilitation After Critical Illness, Rehabilitation Exercise of ICU Patients, Cognitive Impairment, Critical Illness, Intensive Care Unit (ICU)
InterventionImmersive VR Multi-Domain Rehabilitation; Tablet-Based Multi-Domain Training
PhaseNA
StatusRecruiting
Participants51
Est. Completion1 May 2026
Last Updated13 May 2026

Primary Outcome

Montreal Cognitive Assessment (MoCA)

Eligibility Criteria

Inclusion Criteria

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

Trial Sites

Countries

Portugal
View Registry Entry

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