Rehabilitation Gaming System for Intensive Care Units
NCT06267911, Not applicable, Active not recruiting, University of the Balearic Islands
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Rehabilitation Gaming System for Intensive Care Units | ClinicalTrials.gov |
| NCT number | NCT06267911 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 93 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of the Balearic Islands | ClinicalTrials.gov |
| Conditions | Critical Illness | ClinicalTrials.gov |
| Interventions | Cognitive stimulation and psychological support (RGS-ICU) | ClinicalTrials.gov |
| First posted | 2024-02-20 | ClinicalTrials.gov |
| Last updated | 2026-01-30 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Attention performance | 12 months after discharge from the ICU | 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. | ClinicalTrials.gov |
| Primary | Working memory performance | 12 months after discharge from the ICU | 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. | ClinicalTrials.gov |
| Primary | Learning/memory performance | 12 months after discharge from the ICU | 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. | ClinicalTrials.gov |
| Primary | Executive function performance | 12 months after discharge from the ICU | 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. | ClinicalTrials.gov |
| Primary | Processing speed performance | 12 months after discharge from the ICU | 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. | ClinicalTrials.gov |
| Primary | Incidence of Treatment-Emergent Adverse Events [Safety] | From ICU admission to ICU discharge or up to a maximum of 28 days after randomization | 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. | ClinicalTrials.gov |
| Secondary | Dyspnea intensity | From ICU admission to ICU discharge or up to a maximum of 28 days after randomization | Change in dyspnea intensity before and after the intervention evaluated with a Visual Analogue Scale (VAS) with range 0-10. Higher scores indicate more intense dyspnea. | ClinicalTrials.gov |
| Secondary | Pain intensity | From ICU admission to ICU discharge or up to a maximum of 28 days after randomization | Change in pain intensity before and after the intervention evaluated with a Visual Analogue Scale (VAS) with range 0-10. Higher scores indicate more intense pain. | ClinicalTrials.gov |
| Secondary | Worry intensity | From ICU admission to ICU discharge or up to a maximum of 28 days after randomization | Change in worry intensity before and after the intervention evaluated with a Visual Analogue Scale (VAS) with range 0-10. Higher scores indicate more intense worry. | ClinicalTrials.gov |
| Secondary | Sadness intensity | From ICU admission to ICU discharge or up to a maximum of 28 days after randomization | Change in sadness intensity before and after the intervention evaluated with a Visual Analogue Scale (VAS) with range 0-10. Higher scores indicate more intense sadness. | ClinicalTrials.gov |
| Secondary | Comfort experienced | Discharge from the ICU | Difference in experienced comfort between experimental and non-intervention groups assessed with the Patient Evaluation of Emotional Comfort Experienced (PEECE) questionnaire at ICU discharge, a 12-item instrument with range 0-48. Higher scores indicate better subjective psychological well-being. | ClinicalTrials.gov |
| Secondary | Anxiety symptoms | 12 months after discharge from the ICU | Difference in anxiety symptoms between experimental and non-intervention groups assessed with the Generalized Anxiety Disorder (GAD-7) questionnaire 12 months after ICU discharge, a 7-item instrument with range 0-21. Higher scores indicate more severe anxiety symptoms. | ClinicalTrials.gov |
| Secondary | Symptoms of depression | 12 months after discharge from the ICU | Difference in symptoms of depression between experimental and non-intervention groups assessed with the Patient Health Questionnaire-9 (PHQ-9) 12 months after ICU discharge, a 9-item instrument with range 0-27. Higher scores indicate more severe symptoms of depression. | ClinicalTrials.gov |
| Secondary | Symptoms of post-traumatic stress disorder | 12 months after discharge from the ICU | Difference in post-traumatic stress disorder symptoms between experimental and non-intervention groups assessed with the Treatment-Outcome Post-Traumatic Stress Disorder Scale (TOP-8) 12 months after ICU discharge, a 8-item instrument with range 0-32. Higher scores indicate more severe symptoms of post-traumatic stress disorder. | ClinicalTrials.gov |
| Other | Objective cognition | 12 months after discharge from the ICU | Difference in objective cognition between experimental and non-intervention groups assessed with the Montreal Cognitive Assessment (MoCA) 12 months after ICU discharge, a screening instrument with range 0-30. Higher scores indicate better objective cognitive performance. | ClinicalTrials.gov |
| Other | Subjective cognition | 12 months after discharge from the ICU | Difference in subjective cognition between experimental and non-intervention groups assessed with the Perceived Deficits Questionaire-5 (PDQ-5) 12 months after ICU discharge, a 5-item instrument with range 0-20. Higher scores indicate greater perceived cognitive deficits. | ClinicalTrials.gov |
| Other | Functionality | 12 months after discharge from the ICU | Difference in functionality between experimental and non-intervention groups assessed with the self-reported 12-item version of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) 12 months after ICU discharge, an instrument with range 0-100. Higher scores indicate worse functionality. | ClinicalTrials.gov |
| Other | Health-related quality of life | 12 months after discharge from the ICU | Difference in health-related quality of life between experimental and non-intervention groups assessed with the 12-item Short-Form Health Survey (SF-12) 12 months after ICU discharge, an instrument with range 0-100. Higher scores indicate better health-related quality of life. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 39696098 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)