About this trial
Background: Virtual reality is recognized as a progressive technology with the potential to enhance the rehabilitation process. Immersive virtual reality-based treatments can improve motor outcomes in physical rehabilitation, reduce stress caused by the intensive care unit environment and maximize patients' recovery processes.
Objective: To analyze the efficacy of rehabilitation using immersive virtual reality on patient satisfaction and experience, functional and clinical outcomes and the feasibility of its application during the hospitalization period in an intensive care unit (ICU).
Methods: This is a randomized controlled clinical trial involving ICU patients aged 18 years or older, with an estimated ICU stay of ≥ 72 hours, the ability to understand and follow verbal instructions and no diagnosis of psychotic disorders, visual impairment, or hearing loss. Patients will be divided into two groups: one undergoing traditional physiotherapy rehabilitation - control group (CG), and the other receiving physiotherapy using immersive virtual reality (IVR group). The following evaluations will be conducted: mobility condition, physical and psychological discomfort, estimated physical activity level, occurrence of delirium, cognitive decline screening, functionality classification, motivation level, patient experience, sense of immersion in the virtual reality environment, patient satisfaction during the rehabilitation process, occurrence of adverse events, and protocol feasibility. Data will be presented in graphs and tables. Results will be considered statistically significant at a 5% significance level (p ≤ 0.05), and all analyses will be performed using SPSS Statistics version 22.
Expected results: The investigators expect to find evidence that rehabilitation using immersive virtual reality can promote and enable a more pleasant and less traumatic experience during the patient's hospitalization, with greater satisfaction and adherence to the proposed rehabilitation, in addition to being an effective tool to optimize patients' functional and clinical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years
Glasgow Coma Scale (GCS) score ≥14
Richmond Agitation-Sedation Scale (RASS) score between -1 and +1
Negative for delirium according to the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Disqualifiers
Hemodynamic instability
Signs of respiratory distress
Contact isolation for infectious diseases
Conditions that limit head and neck movement
Trial design
Parallel
Treatments tested in this trial
reabilitação fisioterapêutica tradicional
Procedure/SurgeryActive and passive exercises, and walking
fisioterapia utilizando realidade virtual imersiva
Procedure/SurgeryUse of immersive virtual reality headset for rehabilitation sessions
Treatment groups
Trial outcomes
Primary outcomes
Patient satisfaction
To assess patient satisfaction, the investigators will use the Net Promoter Score (NPS) method, it is a methodology that indicates the likelihood of a consumer recommending products or services to others. The results are interpreted using the following parameters: 75-100% is considered "excellent," 50-74% is classified as "very good" and below 49% as "poor."
Patient experience: Perceived workload
To evaluate patient experience, the Raw Task Load Index (RTLX) will be used to assess perceived workload during or immediately after rehabilitation sessions. It is a multidimensional scale scored from 0 to 100, with higher scores indicating greater cognitive load.
Patient experience: Perceived motivation
Perceived motivation will be assessed using the Intrinsic Motivation Inventory (IMI), a 7-point Likert scale evaluating the individual's subjective experience during an activity (1 = strongly disagree; 7 = strongly agree).
Patient experience: Perceived presence
Patients in the immersive virtual reality group will also complete the Presence Questionnaire (PQ), a self-report tool that measures perceived presence in the VR environment across four domains: Engagement, Immersion/Adaptation, Sensory Fidelity, and Interface Quality. The PQ uses a 5-point Likert scale, with higher scores reflecting a stronger sense of presence.
Secondary outcomes
Classification of physical activity level
Physical activity assessment will be conducted using the International Physical Activity Questionnaire (IPAQ). The short version consists of seven open-ended questions, allowing estimation of the time spent per week in different dimensions of physical activity (walking, moderate and vigorous activities) and physical inactivity (sitting time). Based on IPAQ scoring guidelines, patients can be classified as: very active, active, irregularly active, or sedentary.
Muscle Strength
Muscle strength will be assessed using the Medical Research Council (MRC) manual muscle test. This evaluation involves testing key upper limb muscles (shoulder abduction, elbow flexion, wrist extension) and lower limb muscles (hip flexion, knee extension, ankle dorsiflexion) against the examiner's resistance. Strength is rated on a scale from 0 (no muscle activation) to 5 (full range of motion against full examiner resistance). Classification is based on the degree of muscle contraction or range of motion for each muscle evaluated. The total score ranges from 0 (complete tetraparesis) to 60 points (normal muscle strength).
Mobility Assessment
Patient mobility will be assessed using the ICU Mobility Scale. This scale ranges from 0 to 10 within a single domain, where a score of 0 indicates very low mobility (e.g., the patient performs only passive exercises in bed), and a score of 10 indicates high mobility (e.g., the patient walks independently without assistance).
Functionality Classification
The International Classification of Functioning, Disability and Health (ICF) will be used to describe functionality and disability related to health conditions, considering body functions and structures, activity limitations, and participation restrictions in the patient's environment. A customized checklist adapted to the ICU context of Hospital Sírio-Libanês will be used in this study. Qualifiers specify the level of functioning, ranging from 0 (no impairment) to 4 (complete impairment). Codes 8 and 9 indicate lack of information or not applicable. In the body structure category, three qualifiers are used to describe the nature of the impairment. In the activity and participation category, two qualifiers are used: performance and capacity. For environmental factors, a positive score (1 to 4) indicates facilitators, while a negative score (-1 to -4) indicates barriers.
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