Cognitive Impairment, Critical Illness, Critical Illness Recovery, Intensive Care Unit (ICU), Post-Intensive Care Syndrome (PICS), Rehabilitation After Critical Illness, Rehabilitation Exercise of ICU Patients
Conditions
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
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.
Detailed description
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: 1. VR-Based Rehabilitation (VR-Rehab): Participants use a Meta Quest Pro head-mounted display (HMD) to engage in the Enhance VR platform (Virtuleap). This involves 6 specific games targeting information processing, problem-solving, attention, memory, and motor control. 2. Tablet-Based Rehabilitation (Tablet-Rehab): Participants engage in the exact same cognitive exercises and gameplay durations as the VR group, but via a 2D tablet interface. This arm serves as a "digital control" to account for the effects of cognitive stimulation without immersion. 3. Standard of Care (SOC): Participants receive conventional ICU rehabilitation, including physical and respiratory physiotherapy, without structured digital cognitive training. 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: * Researcher Roles: Different researchers facilitate the daily intervention sessions and conduct the primary cognitive assessments. Those delivering the VR or Tablet therapy are prohibited from scoring the recovery outcomes. * Automated Analysis: To eliminate subjective interpretation, primary group comparisons are performed using pre-developed, automated scripts in Python. * Sanitization: Strict infection control protocols are followed, using medical-grade, non-corrosive disinfectant wipes for all hardware between uses. 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."
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.
Sponsors
University of Minho
Universidade do Porto
INESC TEC Porto
Virtuleap
Fundação para a Ciência e a Tecnologia (FCT)
Centro Hospitalar De São João, E.P.E.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
| Simulator Sickness Questionnaire (SSQ) | During the intervention period for the VR arm, after intervention (daily for up to 7 days). | 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. |
| System Usability Scale (SUS) | Post-intervention (T1: from the day after the last intervention (Day 8) to the day before T2). | 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." |
Countries
Portugal
Contacts
CONTACTNuno F. Rodrigues
CONTACTInês Oliveira
PRINCIPAL_INVESTIGATORJoão Ferreira-Coimbra, MD
Centro Hospitalar De São João, E.P.E.
Outcome results
None listed