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Completed

NCT Number: NCT05591248

Virtual Reality Rehabilitation on the Intensive Care Unit for Critically Ill Patients

Feasibility study of the use of an interactive Virtual Reality device in rehabilitation of critically ill patients on the Intensive Care Unit. Patients will use the upper limb muscles and memory playing the 2 games in our "MotiVeeR UZeLf"-app. This will be the case 3x/week as part of the conventional rehabilitation program.

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Key information

Conditions

Critical Illness Disease Attributes Intensive Care Unit Acquired Weakness Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ KU Leuven

Leuven, Vlaams-Brabant, 3020, Belgium

About this study

Virtual Reality (VR) is the simulation of a real environment generated by a computer software and experienced by the user through glasses that are slid over the head. VR is already known for its use in the entertainment and technology industry, but there is a growing interest in the use of VR for medical purposes. Also in the field of rehabilitation, virtual reality rehabilitation (VRR) has been studied in different patient populations, with beneficial effect.

For intensive care, VRR is a new but promising application domain. Patients in intensive care (IC) need specific medical care and rehabilitation. Critically ill patients who are in an intensive care for a long time (8 or more days) often show a severe muscle weakness caused by being critically ill in itself.

The importance and benefits of starting rehabilitation as soon as possible has been undeniably established in the literature. Early mobilization and exercises during the stay at IC prevents the occurrence of muscle weakness or reduces its onset, shortens the duration of the stay at IC and improves functionality.

In addition to the muscle problems, changes in the brain or impaired mental functioning can also occur in IC patients.

A rehabilitation program for ICU patients that stimulates memory and attention, combined with physical and functional training, could potentially be effective in improving mental performance and functional outcomes.

The investigators will record the time required for the setup, learning, use and cleaning of the advanced device, and note any problems that delay this process. Patients will be encouraged to report any type of problem (technical, medical, emotional) at any time (before/during/after the procedure). Any problem spontaneously reported by the patient will be registered. The study will cover the virtual world in a closed headset, completely blocking any other vision, while the patient will be encouraged/triggered to move the arms. The feasibility and safety of using such a closed VR headset on IC patients during rehabilitation exercises is being studied.

Many of the VR modules available today are focused on passive forms of VR, with the aim of relaxation. With this project, the investigators created an interactive ICU-specific VRR app, using a closed VR headset, to stimulate motivation for muscle and attention training in ICU patients through a game.

The exercise program will be gradually build up from low to medium training intensity. Only the therapist (and not the patient) can change the level of difficulty/intensity, so that a correct training intensity is guaranteed.

With this study the investigators want to test whether this form of support of exercise therapy is feasible and safe in Intensive Care. The investigators also want to test whether the patient and the physiotherapist / occupational therapist remain motivated with this VRR for exercise therapy, also for bedridden ICU patients with a long stay.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admission to surgical ICU >= 3 days, with a prognosis of ICU admission at least 2 more weeks
  • Adult
  • Alert and calm (RASS -1 to +1)
  • Adequate (Standard 5 Questions; S5Q >= 4/5)
  • Indication for rehabilitation therapy
  • Able to lift (at least) 1 arm against gravity

Exclusion criteria

  • Blind
  • Schizophrenia, advanced dementia, dissociative disorder, serious claustrophobia
  • Age < 18 years and/or mental age < 18 years
  • Incapacity
  • Pregnancy
  • No understanding of Dutch or French or English
  • No informed consent

Treatment and study plan

VRR

Device

Eligible patients meeting the inclusion criteria and signed a consent, will have 3x/week the guided rehabilitation session with the VR-tool (with a maximum of 9 VRR-sessions).

Primary outcomes

  1. Safety of VRR on ICU? (Adverse Events?)

    Time frame: Inclusion between 31/10/2022 and 31/10/2023. Screening for this particular outcome will happen during the 3-week-VR-training period for each patient.

    Screening for minor and major adverse events of VRR on ICU patients.

  2. Feasibility (related to time) of VRR on ICU?

    Time frame: Inclusion between 31/10/2022 and 31/10/2023. Screening for this particular outcome will happen during the 3-week-VR-training period for each patient.

    Time needed for set-up, explication, use and cleaning of the device will be registrated (in minutes). Set-up or explication or cleaning taking longer than 15min will be labeled as 'not feasible'.

  3. Feasibility (related to practicability) of VRR on ICU?

    Time frame: Inclusion between 31/10/2022 and 31/10/2023. Screening for this particular outcome will happen during the 3-week-VR-training period for each patient.

    Screening for technical/practical/logistical issues will happen through a self-made (and by protocol accepted) questionnaire. For every question there is a 5-point Likert Scale (1 meaning "not at all" and 5 meaning "very much") that needs to be answered.

Secondary outcomes

  1. Patient's satisfaction of the use of VR as a tool for rehabilitation on ICU

    Time frame: Inclusion between 31/10/2022 and 31/10/2023. Screening for this particular outcome will happen during the 3-week-VR-training period for each patient + 1 month after ICU-discharge.

    Motivation, happiness, ... (through self-made questionnaire based on existing literature and approved by protocol). For every question there is a 5-point Likert Scale (1 meaning "not at all" and 5 meaning "very much") that needs to be answered.

  2. Therapist's satisfaction of the use of VR as a tool for rehabilitation on ICU

    Time frame: Inclusion between 31/10/2022 and 31/10/2023. Screening for this particular outcome will happen during the 3-week-VR-training period for each patient.

    Motivation, time consuming, ... (through self-made questionnaire based on existing literature and approved by protocol). For every question there is a 5-point Likert Scale (1 meaning "not at all" and 5 meaning "very much") that needs to be answered.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Virtual Reality Rehabilitation (VRR) on the Intensive Care Unit (ICU) for Critically Ill Patients: a Feasibility Study and Further Development of the "MotiVeeR UZeLf"-App

Acronym: VRR-ICU

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 24, 2022
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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