跳至主要内容
临床试验/NCT05591248
NCT05591248已完成不适用

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

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Feasibility (related to practicability) of VRR on ICU?

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admission to surgical ICU >= 3 days, with a prognosis of ICU admission at least 2 more weeks
  • 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

排除标准

  • 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

结局指标

主要结局

Feasibility (related to practicability) of VRR on ICU?

时间窗: 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.

Safety of VRR on ICU? (Adverse Events?)

时间窗: 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.

Feasibility (related to time) of VRR on ICU?

时间窗: 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'.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验