StrokeNCT04714645
Effectiveness of Virtual Reality Training on Unilateral Spatial Neglect After Stroke
A study testing VR neglect training in people with Stroke and Neglect, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The aim of this study is to examine the effect of an additional VR training program on unilateral spatial neglect (USN) after stroke. Principally, clinical assessment of the presence of unilateral spatial neglect and additionally the severity of USN will be measured using the Behavioral Inattention test (BIT), using… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- VR neglect training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Feb 2021to 31 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a right-hemisphere hemorrhagic or ischemic stroke, confirmed by CT or MRI
- only subacute (>2 weeks) and chronic (>6 months) unilateral spatial neglect patients
- scoring below the cut-off value of 129 points on the standard BITC test
- being 18 years or older at the time of lesion
Who cannot join
- patients with dementia (Mini Mental State Examination (MMSE) < 24) or aphasia (Mississippi Aphasia Screening Test (MAST) < 45)
- patients whose visual or hearing impairment does not allow possibility of interaction with the VR system
- patients with depression (Patient Health Questionnaire (PHQ-9) >= 10)
- patients unable to sit for at least 30 minutes in a wheelchair or chair
- patients with sensorimotor alterations that can interfere with the performance with the VR system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Virtual Reality Training on Unilateral Spatial Neglect After Stroke - a Randomized Controlled Trial
The aim of this study is to examine the effect of an additional VR training program on unilateral spatial neglect (USN) after stroke. Principally, clinical assessment of the presence of unilateral spatial neglect and additionally the severity of USN will be measured using the Behavioral Inattention test (BIT), using only the BIT Conventional subtest (BITC). Secondarily, the VR outcomes will be included as well.
Finally, we want to determine if the effects last over a short period of time. It is important to know whether the potential effects of the VR-training remain without continuing the intervention. Therefore, we will perform a follow-up assessment after 1 week.
Read the detailed description
STUDY DESIGN
The design of this study is a 1-week, assessor-blinded randomized controlled trial with a 1-week follow up.
MATERIALS
The HMD VR system 'Oculus Rift' (Oculus, LLS, US) is a low-cost HMD that fully integrates the user into the virtual environment by blocking out perception of the real-world. It includes a headset, two oculus touch controllers and two sensors. To power the Oculus Rift, a compatible laptop will be used. The "Oculus Rift" will assure a fully immersive virtual environment.
PROCEDURE
Pre-treatment assessment: First, eligible patients will be screened and assessed. For screening and assessment, patients will undergo 2 tests: a VR test and a conventional test. The patient will be seated in a (wheel)chair while performing the assessment tests, with one of the researchers present for safety. All patients will immediately complete the tests, without a try-out session. Instructions will be given in a consistent way and during the tests no feedback will be given.
For the VR-test, the HMD will be used. The VR test consists of 5 different tasks:
- penguin search (1min)
- smartphone search (1min)
- apple examination (12 apples)
- penguin extinction (10 times)
- grabbing cubes (6 cubes)
For the conventional test, patients will need to perform the Behavioral Inattention test - conventional subtest (BITC), which consists of 6 different tasks:
- line crossing
- letter cancellation
- star cancellation
- figure and shape copying
- line bisection
- representational drawing
Once the assessment is completed, all patients will receive a standard care program provided by the rehabilitation hospital.
Intervention group:
Additionally, the intervention group will receive a VR training for 30 min consisting of various specific developed tasks for unilateral neglect training for a period of five consecutive days (one session a day). The VR training consists of the same 5 tasks used for the assessment. On the last day of the intervention and one week after, patients will be assessed again by completing the BITC test and the VR tasks.
Task 1: Penguin search: the patient has to search a penguin, which is randomly placed in the virtual environment. The patient has to aim for the penguin with this crosshair for a certain amount of time (until the loading bar is filled) in order to receive a point. The penguin is teleported to a new position afterwards. The subject has 2 minutes to gain as many points as possible. When the patient is not able to locate the penguin, arrows will indicate the direction of the penguin.
Task 2: Smartphone search: The Smartphone Search task is similar to the Penguin Search task. This time it takes place in a kitchen and the subject has to search for a smartphone on the kitchen counter. This kitchen counter is located in front of the subject. As in task 1, a crosshair is placed in the center of the camera canvas and the player receives points by aiming at the target. Like before, the subject has 2 minutes to gain as many points as possible. Like in the previous task, some arrows show up after ten seconds to help the subjects when they are not able to find the smartphone.
Task 3: Apple examination: In the Apple Examination task, the patient has to distinguish normal apples from distractors. The subject is placed in a grass landscape with 8 normal apples and 12 distractors. As in the previous tasks, a crosshair is attached to the canvas of the camera. The subject has to aim for the normal apples and press button A or X of the oculus controllers to get a point. The task ends when all normal apples are found.
Task 4: Penguin extinction: This task takes place in the same mountain environment as the Penguin Search task. In contrast with the other tasks, the subject doesn't have to search in the virtual environment, since everything takes place in the subject's field of view. There are three scenario's: either there is one penguin present on the right side, either there is one present on the left, or two penguins are present, one on each side. The subject has to say which scenario was presented by moving the thumbstick of the right or left oculus controller accordingly to the right (correct answer for scenario 1), to the left (correct answer for scenario 2) or upwards (correct answer for scenario 3). A point is gained for every correct answer. The task is completed when the subject has reached a score of thirty.
Task 5: Grabbing cubes: The last task is called Grabbing Cubes. Ten cubes are randomly placed on a table which is located in front of the player. The subjects have to grab the cubes and remove them from the table by dropping them on the ground. Grabbing an object is done by pressing the hand trigger of the left or right oculus controller. In order to complete the task, they have to remove all the cubes from the table.
Control group:
The control group will receive a placebo VR intervention. Patients in the control group will also use the HMD but they will look at another virtual environment with no specific tasks. The virtual environment represents a park outside where other avatars (hikers, joggers) are passing by. Patients will be looking at the environment for the same time as the VR training of the intervention group, i.e. 1 session a day for 5 days. On the last day of the intervention and one week after, patients will be assessed again by completing the BITC test and the VR tasks.
RANDOMIZATION
Participants will be randomly allocated to either the intervention group or the control group (1:1 ratio). Patients will be assigned to a group by block randomization.
STUDY ANALYSIS
Since heterogeneity between groups will be present at baseline, an ANCOVA analysis will be conducted to correct this matter. If significant changes are found at postintervention and follow-up, post-hoc analyses for multiple comparisons will be performed using the Bonferroni correction.
- Being tested
- VR neglect training, VR control training
- Keywords
- virtual reality, neglect, stroke, intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR neglect trainingDevice
Patients will undergo 1 session a day for 30 minutes for 5 consecutive days. The training consists of 5 different VR tasks specifically designed for neglect training.
VR control trainingDevice
Patients will undergo 1 session a day for 30 minutes for 5 consecutive days. This is a placebo training, where patients will also wear the HMD. Patients will be immersed in a virtual environment without a specific task.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | VR+ training Receives: Device: VR neglect training |
| Control group | Sham comparator | VR- training Receives: Device: VR control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
BITC test
The BITC test will be taken before, immediately after and 1-week after the intervention.
Measured: through study completion, i.e. 12 days
Secondary outcomes (3)
VR specific outcome: head rotations
The head rotations (left/right) will be recorded continuously during the VR tasks. The head rotations made during the VR tasks before, immediately after and 1-week after the intervention will be compared
Measured: through study completion, i.e. 12 days
VR specific outcome: time
The time needed to complete the different VR tasks will be recorded. The time needed to complete the VR tasks before, immediately after and 1-week after the intervention will be compared.
Measured: through study completion, i.e. 12 days
VR specific outcome: number of errors
The number of errors made by the patient during the different VR tasks will be recorded. The number of errors made during the VR tasks before, immediately after and 1-week after the intervention will be compared.
Measured: through study completion, i.e. 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start15 Feb 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma De Keersmaecker, Vrije Universiteit Brussel
- Investigators
- Eva Swinnen, Prof. Ph.D, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714645
- Sponsor's protocol ID
- VR study - neglect
- Status last verified
- May 2022
- First submitted
- 11 Jan 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality Training on Unilateral Spatial Neglect After Stroke - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04714645
- Acronym / sponsor ID
- VR study - neglect
- Keywords
- virtual reality, neglect, stroke, intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Jan 2021 (actual)
- 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.
The aim of this study is to examine the effect of an additional VR training program on unilateral spatial neglect (USN) after stroke. Principally, clinical assessment of the presence of unilateral spatial neglect and additionally the severity of USN will be measured using the Behavioral Inattention test (BIT), using only the BIT Conventional subtest (BITC). Secondarily, the VR outcomes will be included as well.
Finally, we want to determine if the effects last over a short period of time. It is important to know whether the potential effects of the VR-training remain without continuing the intervention. Therefore, we will perform a follow-up assessment after 1 week.
Detailed description
STUDY DESIGN
The design of this study is a 1-week, assessor-blinded randomized controlled trial with a 1-week follow up.
MATERIALS
The HMD VR system 'Oculus Rift' (Oculus, LLS, US) is a low-cost HMD that fully integrates the user into the virtual environment by blocking out perception of the real-world. It includes a headset, two oculus touch controllers and two sensors. To power the Oculus Rift, a compatible laptop will be used. The "Oculus Rift" will assure a fully immersive virtual environment.
PROCEDURE
Pre-treatment assessment: First, eligible patients will be screened and assessed. For screening and assessment, patients will undergo 2 tests: a VR test and a conventional test. The patient will be seated in a (wheel)chair while performing the assessment tests, with one of the researchers present for safety. All patients will immediately complete the tests, without a try-out session. Instructions will be given in a consistent way and during the tests no feedback will be given.
For the VR-test, the HMD will be used. The VR test consists of 5 different tasks:
- penguin search (1min)
- smartphone search (1min)
- apple examination (12 apples)
- penguin extinction (10 times)
- grabbing cubes (6 cubes)
For the conventional test, patients will need to perform the Behavioral Inattention test - conventional subtest (BITC), which consists of 6 different tasks:
- line crossing
- letter cancellation
- star cancellation
- figure and shape copying
- line bisection
- representational drawing
Once the assessment is completed, all patients will receive a standard care program provided by the rehabilitation hospital.
Intervention group:
Additionally, the intervention group will receive a VR training for 30 min consisting of various specific developed tasks for unilateral neglect training for a period of five consecutive days (one session a day). The VR training consists of the same 5 tasks used for the assessment. On the last day of the intervention and one week after, patients will be assessed again by completing the BITC test and the VR tasks.
Task 1: Penguin search: the patient has to search a penguin, which is randomly placed in the virtual environment. The patient has to aim for the penguin with this crosshair for a certain amount of time (until the loading bar is filled) in order to receive a point. The penguin is teleported to a new position afterwards. The subject has 2 minutes to gain as many points as possible. When the patient is not able to locate the penguin, arrows will indicate the direction of the penguin.
Task 2: Smartphone search: The Smartphone Search task is similar to the Penguin Search task. This time it takes place in a kitchen and the subject has to search for a smartphone on the kitchen counter. This kitchen counter is located in front of the subject. As in task 1, a crosshair is placed in the center of the camera canvas and the player receives points by aiming at the target. Like before, the subject has 2 minutes to gain as many points as possible. Like in the previous task, some arrows show up after ten seconds to help the subjects when they are not able to find the smartphone.
Task 3: Apple examination: In the Apple Examination task, the patient has to distinguish normal apples from distractors. The subject is placed in a grass landscape with 8 normal apples and 12 distractors. As in the previous tasks, a crosshair is attached to the canvas of the camera. The subject has to aim for the normal apples and press button A or X of the oculus controllers to get a point. The task ends when all normal apples are found.
Task 4: Penguin extinction: This task takes place in the same mountain environment as the Penguin Search task. In contrast with the other tasks, the subject doesn't have to search in the virtual environment, since everything takes place in the subject's field of view. There are three scenario's: either there is one penguin present on the right side, either there is one present on the left, or two penguins are present, one on each side. The subject has to say which scenario was presented by moving the thumbstick of the right or left oculus controller accordingly to the right (correct answer for scenario 1), to the left (correct answer for scenario 2) or upwards (correct answer for scenario 3). A point is gained for every correct answer. The task is completed when the subject has reached a score of thirty.
Task 5: Grabbing cubes: The last task is called Grabbing Cubes. Ten cubes are randomly placed on a table which is located in front of the player. The subjects have to grab the cubes and remove them from the table by dropping them on the ground. Grabbing an object is done by pressing the hand trigger of the left or right oculus controller. In order to complete the task, they have to remove all the cubes from the table.
Control group:
The control group will receive a placebo VR intervention. Patients in the control group will also use the HMD but they will look at another virtual environment with no specific tasks. The virtual environment represents a park outside where other avatars (hikers, joggers) are passing by. Patients will be looking at the environment for the same time as the VR training of the intervention group, i.e. 1 session a day for 5 days. On the last day of the intervention and one week after, patients will be assessed again by completing the BITC test and the VR tasks.
RANDOMIZATION
Participants will be randomly allocated to either the intervention group or the control group (1:1 ratio). Patients will be assigned to a group by block randomization.
STUDY ANALYSIS
Since heterogeneity between groups will be present at baseline, an ANCOVA analysis will be conducted to correct this matter. If significant changes are found at postintervention and follow-up, post-hoc analyses for multiple comparisons will be performed using the Bonferroni correction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: VR neglect trainingVR+ training |
| Control group | Sham comparator | Device: VR control trainingVR- training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a right-hemisphere hemorrhagic or ischemic stroke, confirmed by CT or MRI
- only subacute (>2 weeks) and chronic (>6 months) unilateral spatial neglect patients
- scoring below the cut-off value of 129 points on the standard BITC test
- being 18 years or older at the time of lesion
Key exclusion criteria (5 listed)
- patients with dementia (Mini Mental State Examination (MMSE) < 24) or aphasia (Mississippi Aphasia Screening Test (MAST) < 45)
- patients whose visual or hearing impairment does not allow possibility of interaction with the VR system
- patients with depression (Patient Health Questionnaire (PHQ-9) >= 10)
- patients unable to sit for at least 30 minutes in a wheelchair or chair
- patients with sensorimotor alterations that can interfere with the performance with the VR system
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 |
|---|---|---|
| VR neglect trainingPatients will undergo 1 session a day for 30 minutes for 5 consecutive days. The training consists of 5 different VR tasks specifically designed for neglect training. | Device | Intervention group |
| VR control trainingPatients will undergo 1 session a day for 30 minutes for 5 consecutive days. This is a placebo training, where patients will also wear the HMD. Patients will be immersed in a virtual environment without a specific task. | Device | Control group |
Primary outcome
BITC test
Time frame: through study completion, i.e. 12 days
The BITC test will be taken before, immediately after and 1-week after the intervention.
3 secondary outcomes
VR specific outcome: head rotations
Time frame: through study completion, i.e. 12 days
VR specific outcome: time
Time frame: through study completion, i.e. 12 days
VR specific outcome: number of errors
Time frame: through study completion, i.e. 12 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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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.
Eva Swinnen, Prof. Ph.D principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR neglect training in people with Stroke and Neglect, run by Vrije Universiteit Brussel at 1 site in Belgium.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 May 2022. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
BITC test (time frame: through study completion, i.e. 12 days). 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 10 May 2022.