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Clinical Trials/NCT02661230
NCT02661230
Completed
Not Applicable

Design of a Cognitive Motor Intervention Using a Video Game to Enhance Brain Activity: A Feasibility Study Including Healthy Participants and Heart Patients on the Intensive Care Unit

University of Zurich1 site in 1 country30 target enrollmentMarch 2015
ConditionsMotor Activity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Motor Activity
Sponsor
University of Zurich
Enrollment
30
Locations
1
Primary Endpoint
Feasibility & usibility 1
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

This project proposes the development and design of a motor intervention using a cognitive video game and describes the feasibility, safety and acceptability of virtual augmented video gaming device named Virtual Reality on the Intensive Care Unit (VRICU). The project in two phases is performed in healthy participants (Phase 1) and heart patients after elective heart surgery on the Intensive Care Unit (Phase 2).

Furthermore, brain function will be measured during exer-gaming with the VRICU device with non-invasive instruments (fNIRS/EEG) in both the healthy participants and the heart patients.

The VRICU device is a patient friendly construction to allow a patient exergaming in bed. The project is a cooperation between scientist at the USZ (physiotherapist / anaesthsiologists / engineers), human movement scientist at the ETHZ and (poly- / electro-) mechanics at the Paul Scherrer Institut.

Detailed Description

There is converging evidence at systems levels that physical exercise participation is beneficial to cognition, especially to the different subtypes of attention. Such evidence highlights the importance of promoting physical exercise to prevent or reverse cognitive and neural decline. Accordingly, physical exercise can serve to promote function in patients. Physical exercise games may be engaged to gauge performance increases in motor learning and early rehabilitation programs as performed on an intensive care unit. This project proposes the development and design of a cognitive motor intervention using a custom video game (which will be performed in supine position in bed) to enhance brain activity and describes the feasibility, safety and acceptability of virtual augmented video dance gaming. This project is divided in two (2) phases: Phase1 The patients are not expected to exercise the video game in the usual standing position due to their condition. Thus, we designed a patient friendly construction with colleagues of the construction department of the Paul Scherrer Institute (Villigen, Switzerland), which enables video game exercising in supine position. This construction and custom video game will be tested first in healthy participants for feasibility, acceptability and safety. Furthermore, brain activity of the participants will be measured and evaluated, before during and shortly after playing the video game in 15 healthy participants. Phase 2 After the device and procedures tested in phase 1 is feasible, acceptable and safe, maximal 10 patients on the ICU ward (receiving elective heart surgery, will be recruited to evaluate the feasibility, safety, acceptability and effect on brain function of a custom video exercise game. The aims of this study are: Phase 1 Objective To determine the feasibility, safety acceptability and effect of brain function of a cognitive motor intervention using a custom video game in healthy participants. Phase 2 Objectives To determine the feasibility, safety and acceptability (if possible) of a cognitive motor intervention using a custom video game at the Intensive Care Unit. Evaluation of brain functions before, during and after exercising using a video game.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
February 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy participants
  • 18 years or older of age.
  • In good health and not under treatment of a physician
  • Patient on the intensive care unit. Inclusion criteria
  • Adult patients (\>18 years).
  • Signed informed consent by patient.
  • Patient awake and close to full cooperation needed to Participate actively in the experimental intervention.

Exclusion Criteria

  • No exclusion criteria
  • Exclusion criteria for the patients are:
  • Known epilepsy
  • Inability to obtain consent
  • known or suspected non-compliance
  • raised intracranial pressure
  • participation in conflicting study
  • known dementia
  • absence of a limb
  • Incapable of discernment -

Outcomes

Primary Outcomes

Feasibility & usibility 1

Time Frame: Healthy participants 120 minutes, patients: dependent on physical ability

Intensity: Level of gameplay

Feasibility & usibility 2 Feasibility & Usibility 2

Time Frame: Healthy participants 120 minutes, patients: dependent on physical ability

Accuracy: Percentage

Feasibility & usibility 3

Time Frame: Healthy participants 120 minutes, patients: dependent on physical ability

Time: Minutes

Secondary Outcomes

  • Safety parameters & adverse effects of the VRICU device(Minimal 1 up to 30 Minutes (if applicable))
  • MOSRAM Questionnaire(10 minutes)
  • functional Near Infrared Spectroscopy (fNIRS)(healthy participants 90 minutes, patients: dependent on physical ability)
  • EEG(healthy participants 90 minutes, patients: dependent on physical ability)

Study Sites (1)

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