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

NCT ID: NCT05591248

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2023-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Critical Illness; Intensive Care Unit Acquired Weakness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Intervention Group Virtual Reality Rehabilitation

All included patients will receive 3 - 9 sessions (3x/w) of VR rehabilitation during their stay at the intensive care unit. The games will stimulate them to move the arm(s). How long they play the game(s) is not decided in advance (patient-therapist-decision at the time of playing).

Group Type: EXPERIMENTAL

VRR

Intervention Type: 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).

Interventions

VRR

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renata Haghedooren, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

UZ KU Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

S66360

Identifier Type: -

Identifier Source: org_study_id