Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)EVOLUTIONNCT07901855
Effectiveness of Virtual Reality in Improving Upper Limb Function in Critically Ill Patients
A study testing Conventional Physiotherapy and Occupational Therapy and Fully Immersive Virtual Reality Training in people with Intensive Care Unit (ICU) Acquired Weakness (ICU - AW) and Critical Illness, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Critical Illness
- What is being tested?
- Conventional Physiotherapy and Occupational Therapy and Fully Immersive Virtual Reality Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGreece
- Study dates
- 3 Apr 2026to 10 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill patients
- From all diagnostic categories
- Age 18 years or older
- Stabel clinical condition
- Presence of upper limb weakness
- ICU stay at least 10 days
- Regardless of educational level
- Provision of written consent form
Who cannot join
- Diagnosed intellectual disability IQ≤70
- Pre-existing cognitive impairment
- Glasgow Coma Scale (GCS) < 12
- Visual impairments or need for visual aids
- ICU delirium (CAM-ICU positive)
- Inability to control head movements
Show all 17Show fewer
- Nausea
- Paralysis of both upper limbs
- Reduced communication ability
- Recent or current epileptic seizure
- Acute, active psychiatric symptoms
- Cranial bone defect/fracture/pressure ulcer/surgical head wound
- Age < 18
- History of vertigo or other vestibular disorders
- Participation in another research protocol
- ICU stay <10 days
- Death
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Evangelismos General Hospital of Athens
Athens, Attica, 10676
Marios Kalyviotis, MSc, +306972296389, marioskalyv@med.uoa.gr
Dimitra Tzoumi, MSc, +306945393678, dtzoumi@hotmail.com
About this study
Official title: Effectiveness of Virtual Reality in Functionality of Upper Limb in Critically Ill Patients (EVOLUTION)
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Conventional Physiotherapy and Occupational Therapy, Fully Immersive Virtual Reality Training
- Keywords
- Fully Immersive Virtual Reality, Upper Limb Rehabilitation, Eye-Hand Coordination, Visual Perception, Physiotherapy, Occupational Therapy, REACT, Rehabilitation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physiotherapy and Occupational TherapyOther
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 TrainingDevice
Also called REACT
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy and Occupational therapy | Active comparator | Participants receive conventional physiotherapy and occupational therapy as provided in the intensive care unit. Receives: Other: Conventional Physiotherapy and Occupational Therapy |
| Conventional Therapy plus Fully Immersive Virtual Reality REACT | Experimental | 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. Receives: Other: Conventional Physiotherapy and Occupational Therapy; Device: Fully Immersive Virtual Reality Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (before the intervention) and day 11 (after completion of the 10-day programme)
Secondary outcomes (10)
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.
Measured: 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
Measured: Baseline and day 11
Changes in Oxford Muscle Scale
Each tested muscle group is graded from 0 (no contraction) to 5 (normal muscle strength)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Three months after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start3 Apr 2026
- Primary completion10 Jun 2027 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- University of West Attica
- Responsible party
- Principal investigator, ELENI MAGIRA, National and Kapodistrian University of Athens
- Investigators
- Eleni Magira, PhD, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901855
- Sponsor's protocol ID
- EVOLUTION-ICU-01
- Acronym
- EVOLUTION
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality in Functionality of Upper Limb in Critically Ill Patients (EVOLUTION)
- ClinicalTrials.gov ID
- NCT07901855
- Acronym / sponsor ID
- EVOLUTION / EVOLUTION-ICU-01
- Keywords
- Fully Immersive Virtual Reality, Upper Limb Rehabilitation, Eye-Hand Coordination, Visual Perception, Physiotherapy, Occupational Therapy, REACT, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- University of West Attica
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 10 Jun 2027 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy and Occupational therapy | Active comparator | Other: Conventional Physiotherapy and Occupational TherapyParticipants receive conventional physiotherapy and occupational therapy as provided in the intensive care unit. |
| Conventional Therapy plus Fully Immersive Virtual Reality REACT | Experimental | Other: Conventional Physiotherapy and Occupational Therapy, Device: Fully Immersive Virtual Reality TrainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Critically ill patients
- From all diagnostic categories
- Age 18 years or older
- Stabel clinical condition
- Presence of upper limb weakness
Key exclusion criteria (17 listed)
- Diagnosed intellectual disability IQ≤70
- Pre-existing cognitive impairment
- Glasgow Coma Scale (GCS) < 12
- Visual impairments or need for visual aids
- ICU delirium (CAM-ICU positive)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Physiotherapy and Occupational TherapyConventional physiotherapy and occupational therapy provided in the intensive care unit. This intervention is administered to participants in both the control and experimental groups. | Other | Conventional Physiotherapy and Occupational therapy, Conventional Therapy plus Fully Immersive Virtual Reality REACT |
| Fully Immersive Virtual Reality TrainingAlso: REACTFully 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. | Device | Conventional Therapy plus Fully Immersive Virtual Reality REACT |
Primary outcome
Change in Eye-Hand Coordination Assessed Using the Rapid Assessment of Eye-Hand Coordination Test
Time frame: Baseline (before the intervention) and Day 11 (after completion of the 10-day intervention programme).
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
Change in Fugl-Meyer Assessment of Upper Extremity Function (FMA-UE) scores.
Time frame: Baseline and day 11
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.
Changes in Motor Assessment Scale Upper Limb (UL-MAS). Time frame: Baseline and day 11
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.
Changes in Box and Block Test scores
Time frame: Baseline (Before the intervention) and day 11 (After completion of the 10-day intervention)
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.
Changes in Motor-FreeVisualPerceptionTEST-4 (MVPT-4) scores
Time frame: Baseline (before the intervention) and day 11 (after completion of the 10-day programme)
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.
10 secondary outcomes
Changes in Suitability Evaluation Questionnaire (SEQ)
Time frame: Day 11, after completion of the 10-day virtual reality intervention programme.
Changes in handgrip strength using the Jamar hydraulic hand dynamometer
Time frame: Baseline and day 11
Changes in Oxford Muscle Scale
Time frame: Baseline and day 11
Changes in Motricity Index Upper Extremity score
Time frame: Baseline and day 11
Changes in Medical Research Council (MRC) Manual Muscle Testing Scale
Time frame: Baseline and day 11
Changes in Heart Rate during VR sessions
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
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
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
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
Time frame: Three months after completion of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eleni Magira, PhD principal investigator
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy and Occupational Therapy and Fully Immersive Virtual Reality Training in people with Intensive Care Unit (ICU) Acquired Weakness (ICU - AW) and Critical Illness, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Eye-Hand Coordination Assessed Using the Rapid Assessment of Eye-Hand Coordination Test (time frame: Baseline (before the intervention) and Day 11 (after completion of the 10-day intervention programme).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.