NCT02661230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

January 11, 2016

Last Update Submit

February 16, 2017

Conditions

Motor Activity

Keywords

exergamingintensive care unitfeasibility acceptabilityheartbrain function

Outcome Measures

Primary Outcomes (3)

  • Feasibility & usibility 1

    Intensity: Level of gameplay

    Healthy participants 120 minutes, patients: dependent on physical ability

  • Feasibility & usibility 2 Feasibility & Usibility 2

    Accuracy: Percentage

    Healthy participants 120 minutes, patients: dependent on physical ability

  • Feasibility & usibility 3

    Time: Minutes

    Healthy participants 120 minutes, patients: dependent on physical ability

Secondary Outcomes (4)

  • 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 Arms (1)

COGNIPLUS

EXPERIMENTAL

Exercise-Gaming

Device: COGNIPLUS

Interventions

COGNIPLUSDEVICE

Run 1 Video game: Phasic Alertness (Alert S1) Instruction phase 2 minutes, 2 x 3 minutes of rest, followed by 5 x 60 sec of video game activity, alternating with 60 sec of rest. Run 2 Video game: Intrinsic Alertness (Alert S2) Instruction phase 2 minutes, 2 x 3 minutes of rest, followed by 5 x 60 sec of video game activity, alternating with 60 sec of rest. Run 3 Video game: Visual modality (Select S1) Instruction phase 2 minutes, 2 x 3 minutes of rest, followed by 5 x 60 sec of video game activity, alternating with 60 sec of rest. Run 4 Video game: Acoustic / Stimulus Combinations (Select S2) Instruction phase 2 minutes, 2 x 3 minutes of rest, followed by 5 x 60 sec of video game activity, alternating with 60 sec of rest.

COGNIPLUS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Phase 1
  • Healthy participants
  • years or older of age.
  • In good health and not under treatment of a physician
  • Phase 2
  • Adult patients (\>18 years).
  • Signed informed consent by patient.
  • Patient awake and close to full cooperation needed to Participate actively in the experimental intervention.

You may not qualify if:

  • Phase 1
  • Phase 2
  • Known epilepsy
  • Inability to obtain consent
  • known or suspected non-compliance
  • raised intracranial pressure
  • participation in conflicting study
  • known dementia
  • absence of a limb
  • Sepsis
  • Incapable of discernment -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Jaap Swanenburg

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ruud Knols, Dr.

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 22, 2016

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

CH(1)