Stroke, ComplicationNCT05145699
A Pilot Study on the Feasibility Study of a Novel Virtual Reality (VR)-Based Post-stroke Hemineglect Evaluation System
A study testing VR-based post-stroke hemineglect evaluation system in people with Stroke, Complication, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The normal value of the new virtual reality (VR)-based hemineglect evaluation system is obtained and its validity is checked by whether there is a difference in the evaluation results between normal people, stroke patients with hemineglect, and stroke patients without hemineglect. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Complication
- What is being tested?
- VR-based post-stroke hemineglect evaluation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Aug 2021to 31 Dec 2023
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (Stroke patients)
- Right handed
- Patients with first onset stroke, with right brain lesions confirmed by imaging tests (MRI, CT)
- Onset of stroke more than 1week (Normal people)
- Right handed
- Who has no problem in identifying objects with wearing VR head gear.
Who cannot join
- (Stroke patients)
- Patients with unilateral neglect due to other causes.
- Patients with neurological diseases other than stroke (Parkinson's disease, Alzheimer's disease, etc.)
- Patients with severe cognitive impairment.
- Patients with underlying diseases or medical history that may cause visual impairment.
- (Normal people)
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- Who has a neurological disease such as stroke, traumatic brain injury, Parkinson's disease, or Alzheimer's disease.
- Who has a severe cognitive impairment.
- Who has a underlying diseases or medical history that may cause visual impairment.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: A Pilot Study on the Feasibility Study of a Novel VR-based Post-stroke Hemineglect Evaluation System
The normal value of the new virtual reality (VR)-based hemineglect evaluation system is obtained and its validity is checked by whether there is a difference in the evaluation results between normal people, stroke patients with hemineglect, and stroke patients without hemineglect. And, the usability of the virtual reality-based hemineglect evaluation system is confirmed.
Read the detailed description
This pilot study included 50 stroke patients with right hemisphere lesion and 25 healthy people.
The normal value for each item is determined based on the result value for each item of the virtual reality (VR)-based hemineglect evaluation system in normal people.
It is checked whether there is a difference in the results measured using the VR-based hemineglect evaluation system in normal persons, stroke patients with hemineglect, and stroke patients without hemineglect.
Structural validity is confirmed by examining the correlation between the measured values of the virtual VR-based hemineglect evaluation system and Korean Version of Modified Barthel Index (K-MBI), Mini Mental State Examination (MMSE), and Behavioral Inattention Test-Conventional (BIT-C) in stroke patients with hemineglect.
Check the required time and test stability of the evaluation using the VR-based hemineglect evaluation system.
- Conditions
- Stroke, Complication
- Being tested
- VR-based post-stroke hemineglect evaluation system
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based post-stroke hemineglect evaluation systemDevice
Evaluation system applied with virtual environment using Pico Neo 2 eye
| Study group | Role | What they receive |
|---|---|---|
| Right hemispheric stroke with hemineglect | Experimental | Not described Receives: Device: VR-based post-stroke hemineglect evaluation system |
| Right hemispheric stroke without hemineglect | Active comparator | Not described Receives: Device: VR-based post-stroke hemineglect evaluation system |
| Normal people | Other | Not described Receives: Device: VR-based post-stroke hemineglect evaluation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
8 items of virtual reality-based hemineglect evaluation system
(1)Visual extinction, (2)Visual tracking, (3-6)Visual scanning, (7)Auditory, (8)Activities of Daily Living (ADL)
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start31 Aug 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, ComplicationStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nam-Jong Paik, Seoul National University Bundang Hospital
- Investigators
- Nam-Jong Paik, Ph.D, Principal investigator, Seoul National University Bundang Hospital, Seongnam, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145699
- Sponsor's protocol ID
- B-2108-705-302
- Status last verified
- Jun 2025
- First submitted
- 11 Nov 2021
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Feasibility Study of a Novel VR-based Post-stroke Hemineglect Evaluation System
- ClinicalTrials.gov ID
- NCT05145699
- Acronym / sponsor ID
- B-2108-705-302
- Conditions
- Stroke, Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Dec 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 normal value of the new virtual reality (VR)-based hemineglect evaluation system is obtained and its validity is checked by whether there is a difference in the evaluation results between normal people, stroke patients with hemineglect, and stroke patients without hemineglect. And, the usability of the virtual reality-based hemineglect evaluation system is confirmed.
Detailed description
This pilot study included 50 stroke patients with right hemisphere lesion and 25 healthy people.
The normal value for each item is determined based on the result value for each item of the virtual reality (VR)-based hemineglect evaluation system in normal people.
It is checked whether there is a difference in the results measured using the VR-based hemineglect evaluation system in normal persons, stroke patients with hemineglect, and stroke patients without hemineglect.
Structural validity is confirmed by examining the correlation between the measured values of the virtual VR-based hemineglect evaluation system and Korean Version of Modified Barthel Index (K-MBI), Mini Mental State Examination (MMSE), and Behavioral Inattention Test-Conventional (BIT-C) in stroke patients with hemineglect.
Check the required time and test stability of the evaluation using the VR-based hemineglect evaluation system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Right hemispheric stroke with hemineglect | Experimental | Device: VR-based post-stroke hemineglect evaluation system |
| Right hemispheric stroke without hemineglect | Active comparator | Device: VR-based post-stroke hemineglect evaluation system |
| Normal people | Other | Device: VR-based post-stroke hemineglect evaluation system |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (Stroke patients)
- Right handed
- Patients with first onset stroke, with right brain lesions confirmed by imaging tests (MRI, CT)
- Onset of stroke more than 1week (Normal people)
- Right handed
Key exclusion criteria (9 listed)
- (Stroke patients)
- Patients with unilateral neglect due to other causes.
- Patients with neurological diseases other than stroke (Parkinson's disease, Alzheimer's disease, etc.)
- Patients with severe cognitive impairment.
- Patients with underlying diseases or medical history that may cause visual impairment.
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-based post-stroke hemineglect evaluation systemEvaluation system applied with virtual environment using Pico Neo 2 eye | Device | Normal people, Right hemispheric stroke with hemineglect, Right hemispheric stroke without hemineglect |
Primary outcome
8 items of virtual reality-based hemineglect evaluation system
Time frame: up to 1 year
(1)Visual extinction, (2)Visual tracking, (3-6)Visual scanning, (7)Auditory, (8)Activities of Daily Living (ADL)
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 3 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Nam-Jong Paik, Ph.D principal investigator
Seoul National University Bundang Hospital, Seongnam, South Korea
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-based post-stroke hemineglect evaluation system in people with Stroke, Complication, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 6 inclusion and 9 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 3 Jul 2025. 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 South Korea. 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?
8 items of virtual reality-based hemineglect evaluation system (time frame: up to 1 year). 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 3 Jul 2025.