Virtual Reality Rehabilitation on the Intensive Care Unit for Critically Ill Patients (VRR-ICU)
Primary Purpose
Critical Illness, Intensive Care Unit Acquired Weakness
Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
VRR
Sponsored by
About this trial
This is an interventional screening trial for Critical Illness focused on measuring Virtual Reality, Rehabilitation
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
Sites / Locations
- UZ KU Leuven
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Group Virtual Reality Rehabilitation
Arm Description
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).
Outcomes
Primary Outcome Measures
Safety of VRR on ICU? (Adverse Events?)
Screening for minor and major adverse events of VRR on ICU patients.
Feasibility (related to time) of VRR on ICU?
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'.
Feasibility (related to practicability) of VRR on ICU?
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 Outcome Measures
Patient's satisfaction of the use of VR as a tool for rehabilitation on ICU
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.
Therapist's satisfaction of the use of VR as a tool for rehabilitation on ICU
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.
Full Information
NCT ID
NCT05591248
First Posted
September 28, 2022
Last Updated
May 9, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT05591248
Brief Title
Virtual Reality Rehabilitation on the Intensive Care Unit for Critically Ill Patients
Acronym
VRR-ICU
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
April 9, 2023 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Intensive Care Unit Acquired Weakness
Keywords
Virtual Reality, Rehabilitation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group Virtual Reality Rehabilitation
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
VRR
Intervention Description
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 Outcome Measure Information:
Title
Safety of VRR on ICU? (Adverse Events?)
Description
Screening for minor and major adverse events of VRR on ICU patients.
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.
Title
Feasibility (related to time) of VRR on ICU?
Description
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'.
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.
Title
Feasibility (related to practicability) of VRR on ICU?
Description
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.
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.
Secondary Outcome Measure Information:
Title
Patient's satisfaction of the use of VR as a tool for rehabilitation on ICU
Description
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.
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.
Title
Therapist's satisfaction of the use of VR as a tool for rehabilitation on ICU
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata Haghedooren, MD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ KU Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3020
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
General data will be shared through a scientific article. No individual participant data will be shared.
Learn more about this trial
Virtual Reality Rehabilitation on the Intensive Care Unit for Critically Ill Patients
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