An interventional study of Conventional Physiotherapy and Occupational Therapy and Fully Immersive Virtual Reality Training in Intensive Care Unit (ICU) Acquired Weakness (ICU - AW) and Critical Illness, sponsored by National and Kapodistrian University of Athens. Recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by National and Kapodistrian University of Athens · Not applicable, Interventional, and Treatment
Millions of people are hospitalized every year in Intensive Care Units (ICUs) with severe health conditions due to various causes and categories of diseases, such as stroke, Traumatic Brain Injuries (TBI), polytrauma, sepsis, and others. In recent years, there has been a remarkable increase in survival rates among patients from all diagnostic categories admitted to the ICU. However, the stay of critically ill patients in the ICU is associated with a significant reduction in physical activity, even in cases where patients can participate in an active, voluntary rehabilitation program. This prolonged immobility has been linked to the development of Intensive Care Unit-Acquired Weakness (ICU-AW) and a decline in health-related quality of life (HRQOL).
During the performance of Activities of Daily Living (ADLs), eye-hand coordination plays a crucial role. It depends on the integration of multiple brain systems and is therefore often impaired in many pathological conditions. Moreover, in recent years, the use of exercises that simulate functional tasks and activities of daily living, has been continuously increasing in physiotherapy and occupational therapy programs. Additionally, the implementation of purposeful, repetitive activity in patients with central nervous system lesions (e.g., stroke, traumatic brain injury) can lead to significant neuroplastic changes in the brain that may help improve upper limb function.
Nowadays, Virtual Reality (VR) applications are increasingly used in patient rehabilitation.
However, the application of fully immersive virtual reality devices for purposeful activities aiming to improve upper limb function in critically ill patients is an innovative intervention that has not yet been sufficiently studied to inform the development of Clinical Guidelines. Furthermore, despite its clinical significance, eye-hand coordination is not routinely assessed , and there is a limited amount of data regarding its rehabilitation, especially through VR technology.
The aim of this study, therefore, is to investigate the effect of fully immersive virtual reality on the rehabilitation of sensorimotor perception and visuomotor coordination skills, as well as on the improvement of upper limb function in critically ill patients.
The study will involve patients from the 1st University Intensive Care Unit (ICU) of the Medical School of the National and Kapodistrian University of Athens (NKUA), located at the "Evangelismos" General Hospital of Athens. To be eligible for inclusion in the study, patients must have remained in the ICU for at least 10 days, exhibit upper limb weakness, and be in a stable clinical condition (see more information in the Inclusion Criteria section). Exclusion from the study will be based on the criteria listed in the Exclusion Criteria section.
After enrollment, patients will be assigned to one of two groups using dynamic allocation methodology, based on age and degree of muscle weakness.
Before the Experimental Procedure All participants will be evaluated using the assessment tools listed in detail in the What is the study measuring? sub-section of the Study Design section.
Control Group The control group will follow the conventional rehabilitation program (physiotherapy and occupational therapy) currently applied in the ICU.
Experimental Group Participants in the experimental group will follow the conventional rehabilitation program in the ICU (physiotherapy and occupational therapy) and, additionally, will engage in motor and sensorimotor rehabilitation exercises-senarios using the immersive Virtual Reality (VR) system. Prior to beginning the VR interventions, participants in the experimental group will undergo familiarization with the VR device.
Rehabilitation Exercise Program - Motor Rehabilitation Scenarios Using the Immersive Virtual Reality (VR) System In the experimental group, the latest Oculus VR technology devices by Microsoft will be used, in conjunction with the program "Virtual Reality Applications in Medical Rehabilitation - REACT." The REACT project was developed through the Unified Action for State Aid Research, Technological Development, and Innovation under the "Research - Create - Innovate" program, in collaboration with the "Clinical Exercise and Rehabilitation Ergometry Laboratory" at the Medical School of EKPA.
More specifically, the patients will wear the Virtual Reality headset without any other physical intervention on their body and will interact with specific exercise scenarios.
In these exercise senarios, the patient will be guided by a virtual assistant (Non-Playing Character, NPC) and will receive instructions and feedback or reinforcement based on her/his choices.
Duration of Intervention The total duration of the intervention for the experimental group will be 10 VR sessions for 10 consecutive days, each lasting 15 minutes plus the conventional rehabilitation applied in the ICU. The duration of the conventional rehabilitation program for the control group will be 10 days.
Outcome Measures All participants in the study (both control and intervention groups) will be assessed before the start and immediately after the end of the intervention, using the evaluation tools detailed in the What is the study measuring? sub-section of the Study Design section.
Specifically for the intervention group, vital signs will also be recorded at the beginning, midpoint, and end of each intervention session. After completing the intervention, this group will additionally complete a questionnaire designed to evaluate the safety, usability, and any adverse effects that may arise from the use of Virtual Reality.
The researchers/evaluators will have undergone prior training and familiarization with the assessment tools. Each assessment will be carried out simultaneously by two experienced researchers, each blinded to the other's evaluations, in order to ensure inter-rater reliability.
Furthermore, the evaluators will be blinded to group allocation (control vs. intervention). The implementation of the motor rehabilitation scenarios via the fully immersive virtual reality system will be carried out by a third independent researcher, who will be unaware of the pre- and post-intervention evaluation results.
1,931 studies on the registry are indexed under Critical Illness; 469 are open to participants now.
This study's planned enrollment of 48 is below the median of 90 across 1,007 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →National and Kapodistrian University of Athens is the lead sponsor of 175 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
Participants receive conventional physiotherapy and occupational therapy as provided in the intensive care unit.
Other: Conventional Physiotherapy and Occupational Therapy
Participants receive conventional physiotherapy and occupational therapy as provided in the intensive care unit, plus fully immersive virtual reality training using the REACT software. The virtual reality programme consists of one 15-minute session daily for 10 consecutive days, following an initial familiarization session.
Other: Conventional Physiotherapy and Occupational Therapy · Device: Fully Immersive Virtual Reality Training
Conventional physiotherapy and occupational therapy provided in the intensive care unit. This intervention is administered to participants in both the control and experimental groups.
Fully immersive virtual reality training using the REACT software through a head-mounted display. Participants perform interactive exercises targeting upper limb function, eye-hand coordination, and visual perception. The programme duration is 15-minute session daily for 10 consecutive days. This intervention is provided only to the experimental group, in addition to conventional physiotherapy and occupational therapy.
Also known as: REACT
Change in Eye-Hand Coordination Assessed Using the Rapid Assessment of Eye-Hand Coordination Test
Eye-hand coordination is assessed using finger-to-nose, finger-to-knee, and finger-chase tasks, with five trials per testing condition. Each upper limb is assessed separately.. Recorded measures include completion time in seconds, movement speed and coordination categories, reaching accuracy, and error type
Time frame: Baseline (before the intervention) and Day 11 (after completion of the 10-day intervention programme).
Change in Fugl-Meyer Assessment of Upper Extremity Function (FMA-UE) scores.
Change from baseline to Day 11 in upper extremity motor function assessed using the Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score. The assessment covers arm movements, wrist and hand function, coordination, sensation, passive joint motion, joint pain. Scores range from 0 to 126 points per assessed upper limb, with higher scores indicating better motor function.
Time frame: Baseline and day 11
Changes in Motor Assessment Scale Upper Limb (UL-MAS). Time frame: Baseline and day 11
Upper limb motor function assessed using the three upper limb sections of the Motor Assessment Scale: upper arm function, hand movements, and advanced hand activities (items 6-8). Each section is scored from 0 to 6, giving a total score from 0 to 18 points per assessed upper limb.
Time frame: Baseline and day 11
Changes in Box and Block Test scores
The Box and Block Test assesses unilateral gross manual dexterity. Participants transfer blocks one at a time over a partition between two compartments of a box for 60 seconds. Multiple blocks carried at the same time count as a single block. Each hand is assessed seperately. The score is the number of blocks successfully transferred within the 60 sec, with a minimum of 0 blocks and a maximum of 150. Higher scores indicate better gross manual dexterity. Change is calculated, for each hand, as the difference of score between day 11 and baseline score.
Time frame: Baseline (Before the intervention) and day 11 (After completion of the 10-day intervention)
Changes in Motor-FreeVisualPerceptionTEST-4 (MVPT-4) scores
The Motor-Free Visual Perception Test (MVPT-4) is a performance based measure comprised of 45 items presented on separated cards in one spiral bound book. The test assesses domains of visual discrimination, spatial relationships, visual memory, figure ground perception and visual closure. Answers are presented on a multiple choice format with no motor ability needed. Higher scores indicating better visuo-perceptual skills. Administration and scoring following the test manual.
Time frame: Baseline (before the intervention) and day 11 (after completion of the 10-day programme)
Changes in Suitability Evaluation Questionnaire (SEQ)
Participants in the virtual reality group complete the Suitability Evaluation Questionnaire (SEQ) after the intervention programme. Thirteen items are rated seperately from 1 to 5 and a 14th which is an open ended question. For items 1-11 scores answers range from 1 (not at all) to 5 (very much). Higher scores on 1-6 and 11 show greater enjoyment, presence, perceived performance, realism, clarity of instructions and perceived rehabilitation benefit. For items 7- 10 higher scores show greater discomfort, dizziness/nausea, eye discomfort and disorientation. For items 12 and 13 answers range from 1 (very easy) to 5 (very) difficult with higher scores indicating more difficulty of the application and device. Item 14 asks if participants felt comfortable during the vr sessions (yes/no) and if the answer is no, participants asked to explain the reasons.
Time frame: Day 11, after completion of the 10-day virtual reality intervention programme.
Changes in handgrip strength using the Jamar hydraulic hand dynamometer
Grip strength is recorded in kilograms (kg) for each tested hand. Higher values indicate greater grip strength
Time frame: Baseline and day 11
Changes in Oxford Muscle Scale
Each tested muscle group is graded from 0 (no contraction) to 5 (normal muscle strength)
Time frame: Baseline and day 11
Changes in Motricity Index Upper Extremity score
The assessment includes pinch grip, elbow flexion, and shoulder abduction. Each component is assigned a score from 0 to 33. The three component scores are summed and one point is added, giving a total score from 1 to 100 for each upper limb.
Time frame: Baseline and day 11
Changes in Medical Research Council (MRC) Manual Muscle Testing Scale
Six muscle groups are tested bilaterally: shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors. Each is graded from 0 (no contraction) to 5 (normal muscle strength), giving a total score from 0 to 60
Time frame: Baseline and day 11
Changes in Heart Rate during VR sessions
Heart rate is measured in beats per minute in participants of the Virtual Reality Group , immediately before, at the midpoint and immediately after the completion of each VR session. Measures assess within session changes of the heart rate compared to the pre-session value.
Time frame: Immediately before, at the midpoint and immediately after the completion of each 15- minute VR session.
Changes in Systolic blood pressure during VR sessions
Systolic blood pressure is measured in millimeters of mercury (mmHg) in participants of the Virtual Reality Group , immediately before, at the midpoint and immediately after the completion of each VR session. Measures assess within session changes of the systolic blood pressure compared to the pre-session value.
Time frame: Immediately before, at the midpoint and immediately after the completion of each 15- minute VR session.
Changes in Diastolic blood pressure during VR sessions
Diastolic blood pressure is measured in millimeters of mercury (mmHg) in participants of the Virtual Reality Group , immediately before, at the midpoint and immediately after the completion of each VR session. Measures assess within session changes of the Diastolic blood pressure compared to the pre-session value.
Time frame: Immediately before, at the midpoint and immediately after the completion of each 15- minute VR session.
Changes in Peripheral Oxygen saturation (SpO2) during VR sessions
Changes in Peripheral Oxygen saturation (SpO2) is measured as a percentage (%) in participants of the Virtual Reality Group , immediately before, at the midpoint and immediately after the completion of each VR session. Measures assess within session changes of the SpO2 compared to the pre-session value.
Time frame: Immediately before, at the midpoint and immediately after the completion of each 15- minute VR session.
Functional Independence Assessed Using the Barthel Index at Three Months
Functional independence in activities of daily living is assessed using the Barthel Index three months after completion of the intervention programme. The index assesses ten activities: feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers, mobility, and stair use. Total scores range from 0 to 100
Time frame: Three months after completion of the intervention
Plan to share: No
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