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

NCT05591248 | Completed DMC

• 1 other identifier: S66360
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Intensive Care Unit Acquired Weakness

Keywords

Virtual Reality; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Safety of VRR on ICU? (Adverse Events?)

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

  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.

• 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'.

  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.

• 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.

  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 Outcomes (2)

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

  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.

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

  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.

Study Arms (1)

Intervention Group Virtual Reality Rehabilitation

EXPERIMENTAL

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).

Device: VRR

Interventions

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).

Intervention Group Virtual Reality Rehabilitation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ KU Leuven

Leuven, Vlaams-Brabant, 3020, Belgium

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

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

Study Officials

• Renata Haghedooren, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 24, 2022
• Study Start: January 9, 2023
• Primary Completion: April 9, 2023
• Study Completion: June 30, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)