Motor ActivityVRICUGAMINGNCT02661230
Virtual Reality Exercise on the Intensive Care Unit in Heart Patients
A study testing COGNIPLUS in people with Motor Activity, run by University of Zurich at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- What is being tested?
- COGNIPLUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase 1
- Healthy participants
- 18 years or older of age.
- In good health and not under treatment of a physician
- Phase 2
- Patient on the intensive care unit. Inclusion criteria
Show all 9Show fewer
- Adult patients (>18 years).
- Signed informed consent by patient.
- Patient awake and close to full cooperation needed to Participate actively in the experimental intervention.
Who cannot join
- Phase 1
- No exclusion criteria
- Phase 2
- Known epilepsy
- Inability to obtain consent
- known or suspected non-compliance
Show all 12Show fewer
- raised intracranial pressure
- participation in conflicting study
- known dementia
- absence of a limb
- Sepsis
- Incapable of discernment -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Motor Activity
- Being tested
- COGNIPLUS
- Keywords
- exergaming, intensive care unit, feasibility acceptability, heart, brain function
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| COGNIPLUS | Experimental | Exercise-Gaming Receives: Device: COGNIPLUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility & usibility 1
Intensity: Level of gameplay
Measured: Healthy participants 120 minutes, patients: dependent on physical ability
Feasibility & usibility 2 Feasibility & Usibility 2
Accuracy: Percentage
Measured: Healthy participants 120 minutes, patients: dependent on physical ability
Feasibility & usibility 3
Time: Minutes
Measured: Healthy participants 120 minutes, patients: dependent on physical ability
Secondary outcomes (4)
Safety parameters & adverse effects of the VRICU device
Assessment of (Serious) Adverse Events and Other Safety Related Events An unexpected SAE refers to any AE, the nature or severity of which is not consistent with the applicable product information, namely please specify for unapproved investigational medicinal products the current Investigator's Brochure and the approved instructions for devices with CE-marking.
The investigator will promptly review documented AEs and abnormal test findings to determine
- if the abnormal test finding should be classified as an AE,
- if there is a reasonable possibility that the AE was caused by the investigational device or study treatment(s), and
- if the AE meets the criteria for an SAE.
Measured: Minimal 1 up to 30 Minutes (if applicable)
MOSRAM Questionnaire
Participant \& Patient satisfactory questionnaire concerning use off technical devices and software.
Measured: 10 minutes
functional Near Infrared Spectroscopy (fNIRS)
fNirs outcome of frontal lobe measured in SP02%; Baseline during gameplay and during recuperation of exercise gameplay
Measured: healthy participants 90 minutes, patients: dependent on physical ability
EEG
EEG outcome of frontal lobe during exerciseplay and recupperation measured in milliseconds
Measured: healthy participants 90 minutes, patients: dependent on physical ability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruud Knols, Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661230
- Sponsor's protocol ID
- VRICU-Study
- Acronym
- VRICUGAMING
- Status last verified
- Feb 2017
- First submitted
- 11 Jan 2016
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02661230
- Acronym / sponsor ID
- VRICUGAMING / VRICU-Study
- Conditions
- Motor Activity
- Keywords
- exergaming, intensive care unit, feasibility acceptability, heart, brain function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COGNIPLUS | Experimental | Device: COGNIPLUSExercise-Gaming |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Phase 1
- Healthy participants
- 18 years or older of age.
- In good health and not under treatment of a physician
- Phase 2
Key exclusion criteria (12 listed)
- Phase 1
- No exclusion criteria
- Phase 2
- Known epilepsy
- Inability to obtain consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COGNIPLUSRun 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. | Device | COGNIPLUS |
Primary outcome
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
4 secondary outcomes
Safety parameters & adverse effects of the VRICU device
Time frame: Minimal 1 up to 30 Minutes (if applicable)
MOSRAM Questionnaire
Time frame: 10 minutes
functional Near Infrared Spectroscopy (fNIRS)
Time frame: healthy participants 90 minutes, patients: dependent on physical ability
EEG
Time frame: healthy participants 90 minutes, patients: dependent on physical ability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruud Knols, Dr. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COGNIPLUS in people with Motor Activity, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility & usibility 1 (time frame: Healthy participants 120 minutes, patients: dependent on physical ability). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.