Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04714645 |
| Other study ID # |
VR study - neglect |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2021 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Vrije Universiteit Brussel |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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:
1. penguin search (1min)
2. smartphone search (1min)
3. apple examination (12 apples)
4. penguin extinction (10 times)
5. 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:
1. line crossing
2. letter cancellation
3. star cancellation
4. figure and shape copying
5. line bisection
6. 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.
