An interventional study of Immersive VR Multi-Domain Rehabilitation and Tablet-Based Multi-Domain Training in Post-Intensive Care Syndrome (PICS), Critical Illness Recovery and Rehabilitation After Critical Illness, sponsored by University of Minho. Recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by University of Minho · Not applicable, Interventional, and Treatment
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:
Researchers will compare three groups to see how different types of care affect the brain:
Participants will:
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:
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:
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."
105 studies on the registry are indexed under postintensive care syndrome; 48 are open to participants now.
This study's planned enrollment of 51 is below the median of 78 across 47 interventional studies indexed under postintensive care syndrome.
Browse postintensive care syndrome studies →University of Minho is the lead sponsor of 39 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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
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
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.
Time frame: 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).
Medical Research Council Sum Score (MRC-SS)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: Follow-up 1 (T3: 30-45 days post-discharge) and Follow-up 2 (T4: 3 to 6 months post-discharge).
Simulator Sickness Questionnaire (SSQ)
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.
Time frame: During the intervention period for the VR arm, after intervention (daily for up to 7 days).
System Usability Scale (SUS)
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."
Time frame: Post-intervention (T1: from the day after the last intervention (Day 8) to the day before T2).
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Dec 2025 (actual). Primary completion is estimated for May 2026, 5 months after the start.
Of 39 interventional studies with no phase under postintensive care syndrome, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
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