Rehabilitation Gaming System for Intensive Care Units

NCT06267911 | Active Not Recruiting

• 2 other identifiers: 202223-10160/U/2022
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 3

Brief Summary

Admission to an Intensive Care Unit (ICU) is a potentially traumatic experience for a mentally vulnerable person. Beyond the stress and anxiety associated with the ICU environment and medical procedures, survivors of critical illness are at risk of developing cognitive and psychological sequelae related to Post-Intensive Care Syndrome (PICS). These disorders are associated with high economic, medical and personal costs. This trial aims to evaluate the efficacy of an innovative neuropsychological e-health intervention for early cognitive stimulation and psychological support of people in critical care, i.e. the Rehabilitation Gaming System for Intensive Care Units (RGS-ICU) intervention, in improving comfort during ICU admission and cognition and mental health three and 12 months after ICU discharge. The RGS-ICU intervention, applied as an adjunct to standard ICU care, is based on non-immersive virtual reality techniques and has been specifically designed and developed to suit the needs of people in critical care and the characteristics of the ICU environment. To ensure the safety of the intervention, participants' physiological parameters will be automatically recorded by advanced continuous monitoring systems as part of standard ICU care. The investigators hypothesize that the cognitive stimulation and psychological support protocols of the RGS-ICU intervention, applied as an adjunct to standard ICU care, in addition to being safe for people in critical care units, will improve comfort during ICU admission and cognitive and mental health outcomes after ICU discharge, compared to receiving standard ICU care alone. The findings derived from this trial may contribute to establish a novel and superior paradigm of human-centered ICU care to improve the comfort of people admitted to the ICU. This achievement could also have a relevant impact on medical and economic costs during ICU admission, and on functionality and health-related quality of life after ICU discharge associated with the reduction of cognitive and psychological sequelae linked to PICS. The RGS-ICU intervention has been designed at Corporacion Parc Taulí with the collaboration of the University of the Balearic Islands and has been developed by Eodyne Systems S.L., a company dedicated to the development of science-based technological solutions for intervention, monitoring, diagnosis, and prognosis in stroke and other brain disorders.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (6)

• Attention performance

  Difference in attention performance (Z scores) between experimental and non-intervention groups assessed with the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Forward Digit Span subtest 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better attention performance.

  12 months after discharge from the ICU

• Working memory performance

  Difference in working memory performance (Z scores) between experimental and non-intervention groups assessed with the WAIS-IV Backward Digit Span subtest 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better working memory performance.

  12 months after discharge from the ICU

• Learning/memory performance

  Difference in learning/memory performance (Z scores) between experimental and non-intervention groups assessed with the Rey Auditory Verbal Learning Test (RAVLT) 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better learning/memory performance.

  12 months after discharge from the ICU

• Executive function performance

  Difference in executive function performance (Z scores) between experimental and non-intervention groups assessed with the Trail Making Test (TMT), the Stroop Color and Word Test (SCWT), and the verbal phonemic fluency (FAS) test 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better executive function performance.

  12 months after discharge from the ICU

• Processing speed performance

  Difference in processing speed performance (Z scores) between experimental and non-intervention groups assessed with the WAIS-IV Digit Symbol-Coding subtest and the Symbol Digit Modalities Test (SDMT) 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better executive function performance.

  12 months after discharge from the ICU

• Incidence of Treatment-Emergent Adverse Events [Safety]

  Number of interrupted sessions due to adverse events in the patients' physiological parameters (oxygen saturation, respiratory rate and heart rate) during admission to the ICU. The higher the number of interrupted sessions, the less safe the intervention.

  From ICU admission to ICU discharge or up to a maximum of 28 days after randomization

Secondary Outcomes (8)

• Dyspnea intensity

  From ICU admission to ICU discharge or up to a maximum of 28 days after randomization

• Pain intensity

  From ICU admission to ICU discharge or up to a maximum of 28 days after randomization

• Worry intensity

  From ICU admission to ICU discharge or up to a maximum of 28 days after randomization

• Sadness intensity

  From ICU admission to ICU discharge or up to a maximum of 28 days after randomization

• Comfort experienced

  Discharge from the ICU

Other Outcomes (4)

• Objective cognition

  12 months after discharge from the ICU

• Subjective cognition

  12 months after discharge from the ICU

• Functionality

  12 months after discharge from the ICU

Study Arms (2)

Cognitive stimulation and psychological support (RGS-ICU)

EXPERIMENTAL

Other: Cognitive stimulation and psychological support (RGS-ICU)

Treatment as usual (TAU)

NO INTERVENTION

Interventions

Cognitive stimulation and psychological support (RGS-ICU) OTHER

The RGS-ICU intervention consists of daily 20-minute sessions of early cognitive stimulation and psychological support adjuvant to standard ICU care administered by research staff and supervised by clinical staff each morning in the patient's own room during ICU admission and until ICU discharge or up to a maximum of 28 days after randomization. The sessions consist of orienting the patient to space and time, cognitive training of attention, working memory, learning/memory, executive function and processing speed, viewing of relaxing videos inspired by nature and fantasy scenarios to reduce stress and anxiety, and psychoeducation about the ICU environment and the characteristics of the cognitive, mental and physical state of critically ill patients.

Cognitive stimulation and psychological support (RGS-ICU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years)
• Admitted to a medical/surgical ICU
• For respiratory failure, cardiogenic shock, or septic shock
• With an expected ICU stay of ≥48 hours
• Residing in Catalonia or Majorca (Balearic Islands)
• Who speak Catalan and/or Spanish
• Who are able to give informed consent by themselves or through an authorized representative

You may not qualify if:

• History of intellectual disability or other neurodevelopmental disorders, such as autism spectrum disorder
• History of neurological disorders, dementia or other neurodegenerative diseases, such as epilepsy, Alzheimer's disease, Parkinson's disease or multiple sclerosis
• History of brain damage, such as traumatic brain injury or stroke
• History of severe psychiatric illness, such as psychotic, bipolar, depressive, obsessive-compulsive, post-traumatic or personality disorder
• Suspected or confirmed substance use disorder
• Suspected or confirmed communicable disease in an isolated patient
• Uncorrected hearing or visual impairment
• Any medical condition that prevents safe upper extremity mobility, such as skin lesions, burns, or fractures
• Life expectancy \<12 months
• Enrolled in another trial that does not allow co-enrollment

Sponsors & Collaborators

• Corporacion Parc Tauli: collaborator
• Hospital Son Llatzer: collaborator
• Fundació La Marató de TV3: collaborator
• University of the Balearic Islands: lead

Study Sites (3)

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

Location

Hospital Universitari Son Llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Corporacion Parc Tauli

Sabadell, Catalonia, 08208, Spain

Location

Related Publications (1)

• Godoy-Gonzalez M, Lopez-Aguilar J, Fernandez-Gonzalo S, Goma G, Blanch L, Brandi S, Ramirez S, Blasi J, Verschure P, Rialp G, Roca M, Gili M, Jodar M, Navarra-Ventura G. Efficacy and safety of a non-immersive virtual reality-based neuropsychological intervention for cognitive stimulation and relaxation in patients with critical illness: study protocol of a randomized clinical trial (RGS-ICU). BMC Psychiatry. 2024 Dec 18;24(1):917. doi: 10.1186/s12888-024-06360-4.

  PMID: 39696098 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guillem Navarra-Ventura, PhD

  University of the Balearic Islands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)