Stroke ( 3 Months After Onset)NCT07102927
The Effects of Virtual Reality-based Training for the Treatment of Neglect Syndrome in Stroke: a Randomized Controlled Trial
A study testing Virtual reality-based training for the treatment of neglect syndrom in stroke and Conventional occupational therapy in people with Stroke ( 3 Months After Onset) and Cognitive Dysfunction ( MMSE < 24 ), run by Yonsei University at 1 site in South Korea.
Trial summary
This study aims to investigate the effectiveness and underlying recovery mechanisms of a virtual reality-based training program for the treatment of neglect syndrome in stroke patients in the chronic phase (more than three months after onset). Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Stroke ( 3 Months After Onset), Cognitive Dysfunction ( MMSE < 24 ), Unilateral Neglect Syndrome
- What is being tested?
- Virtual reality-based training for the treatment of neglect syndrom in stroke and Conventional occupational therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Sep 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients diagnosed with right cerebral hemisphere stroke confirmed by MRI or CT, with left hemiplegia, and at least three months post-stroke 2. Patients confirmed to have unilateral neglect based on the BIT score (total BIT score ≤ 196, or subtest scores BITC ≤ 129 or BITB ≤ 67) 3. Individuals with sufficient cognitive ability to participate in virtual reality training (MMSE > 18) 4. Adults aged 19 years or older
Who cannot join
- 1. Presence of Hemianopsia 2. Impaired neck movement due to orthopedic issues or other causes 3. Visual or hearing impairments that interfere with evaluation and treatment 4. Difficulty maintaining a seating posture in a chair with a backrest and armrests 5. Presence of other medical issues that may affect general cognitive decline 6. Experiencing Cybersickness symptoms such as nausea, vomiting, eye strain, disorientation, ataxia, or dizziness repeatedly, making continued training difficult and requiring discontinuation as determined by the researcher
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
Seoul
Deog Young Kim, +82-2-2228-3714, KIMDY@yuhs.ac
About this study
This study aims to investigate the effectiveness and underlying recovery mechanisms of a virtual reality-based training program for the treatment of neglect syndrome in stroke patients in the chronic phase (more than three months after onset).
Neglect is a neurological condition characterized by a failure to attend to stimuli presented on the side contralateral to a brain lesion, despite preserved visual acuity and visual fields. Patients with neglect commonly exhibit impairments in activities of daily living, including dressing, eating, grooming, reading, and writing, and are prone to collisions with objects on the neglected side. This syndrome is widely acknowledged as a significant negative prognostic indicator for functional recovery following stroke.
Read more
Previous treatments for neglect syndrome have shown promising results. Pizzamiglio et al. reported the effectiveness of visuo-spatial scanning training, while Julkunen et al. confirmed improvement using computer-based therapy. Frascineti et al. demonstrated benefits from prism adaptation therapy, and Robertson et al. found that activating the left limbs helped reduce neglect symptoms. Additionally, Brighina et al. reported that repetitive transcranial magnetic stimulation applied to the unaffected cerebral hemisphere effectively alleviated neglect.
Recently, computer-based diagnostic tools have been developed to more accurately quantify and objectify neglect. Among them, Kim et al. developed a 3D VR program that can be applied regardless of the severity of motor impairment on the affected side. Virtual reality provides simulated, immersive environments that allow users to interact as if in real-world settings, enabling objective and quantitative assessment of neglect symptoms. In particular, visual fixation training within VR encourages spontaneous visual exploration and focused attention toward the affected side, which has been shown to be an effective strategy in reducing neglect in stroke patients.
Virtual reality-based training has been increasingly applied clinically abroad. For example, the University of California's Institute for Creative Technologies uses VR for treating PTSD in Iraq war veterans, and the VRMC in the U.S. applies it for phobia and stress treatments. In Switzerland, programs like Mind Motion Pro are used for neuroregeneration-focused rehabilitation, and Japan has developed mediVR for trunk balance training. Although research on neglect using VR is active, it generally requires active therapist involvement. Few studies have clearly demonstrated the efficacy of VR treatment specifically in stroke patients, and VR applications in rehabilitation medicine remain relatively limited compared to psychiatric fields.
In light of this background, our research team developed a virtual reality-based training program (NEGTREA) for the treatment of neglect syndrome in stroke. To evaluate its clinical feasibility, we conducted a targeted focus group interview with four out of five stroke patients with neglect who used the program. The study found that the VR-based neglect treatment was well tolerated without adverse effects and achieved high patient satisfaction, alongside improved assessment scores before and after program participation.
- Conditions
- Stroke ( 3 Months After Onset), Cognitive Dysfunction ( MMSE < 24 ), Unilateral Neglect Syndrome
- Being tested
- Virtual reality-based training for the treatment of neglect syndrom in stroke, Conventional occupational therapy
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality-based training for the treatment of neglect syndrom in strokeDevice
An occupational therapist provided 1:1 assistance with fitting and removing the virtual reality headset (HMD), operating the software and explaining the procedures, as well as offering physical support and movement assistance when necessary to enable participants to engage in the virtual reality-based training program for neglect syndrome.
Following measurement of each participant's interpupillary distance, the headset (HTC VIVE PRO) was adjusted and fitted while the participant was seated. The lens distance was fine-tuned using adjustment knobs to match the individual's eyes.
The training for neglect was performed with participants seated and wearing the headset. The NEGTREA program provided a virtual environment along with visual fixation training.
Conventional occupational therapyBehavioural
An occupational therapist conducted conventional neglect therapy in a 1:1 setting for 30 minutes per session. The therapy comprised therapist-supervised, table-top tasks carefully designed to parallel the virtual reality exercises as closely as possible.
These table-top tasks primarily focused on promoting visual scanning and sustained attention toward the neglected hemifield through practical, goal-oriented activities such as object search and manipulation. The therapist utilized a variety of tools to facilitate and optimize patient engagement in these training.
| Study group | Role | What they receive |
|---|---|---|
| control | Experimental | In the experimental group, the virtual reality-based training program for neglect syndrom (NEGTREA) was administered once a day for 30 minutes per session. Receives: Device: Virtual reality-based training for the treatment of neglect syndrom in stroke |
| Care Provider | Experimental | In the control group, conventional occupational therapy was administered once a day for 30 minutes per session. Receives: Behavioral: Conventional occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Inattention Test (BIT)
The following assessment tool, developed by Wilson et al. in 1987, is designed to screen for neglect syndrome and consists of two subtests: Conventional and Behavioral. Lower scores indicate a more severe degree of neglect. It is considered a reliable tool for identifyingneglect in stroke patients and is widely used in studies assessing the validity of research related to neglect syndrome.
Measured: up to 1 day
Secondary outcomes (4)
Line Bisection
Line Bisection provides a quik method for evaluating neglect syndrome by requiring individuals to mark the center of a series of horizontal lines using a pencil. A consistent deviation of the bisection marks toward one side is typically interpreted as an indication of neglect syndrome.
Measured: after 7 weeks of treatment
Letter Cancellation
Letter Cancellation offers a quick method for evaluating neglect syndrome by having individuals erase specific target letters distributed across a page among various letters using a pencil. The extent and direction of the erased letters-typically showing a bias toward one side-are used to assess the severity of neglect syndrome.
Letter Cancellation offers a quick method for evaluating neglect syndrome by having individuals erase specific target letters distributed across a page among various letters using a pencil. The extent and direction of the erased letters-typically showing a bias toward one side-are used to assess the severity of neglect syndrome.
Letter Cancellation offers a quick method for evaluating neglect syndrome by having individuals erase specific target letters distributed across a page among various letters using a pencil. The extent and direction of the erased letters-typically showing a bias toward one side-are used to assess the severity of neglect syndrome.
Measured: after 7 weeks of treatment
Korean Catherine Bergego Scale (K-CBS)
K-CBS, developed by Bergego et al. in 1995, is a checklist designed to evaluate the presence and severity of behavioral neglect syndrome in activities of daily living. It consists of 10 items that cover tasks such as personal hygiene, dressing, eating, and wheelchair mobility. The evaluation is conducted through direct observation by a Investigator, making it a useful tool for identifying neglect syndrome in real-life functional contexts.
Measured: after 7 weeks of treatment
MRI data(T1 weighted image, Diffusion Tensor Image, resting state functional MRI)
This study investigate the recovery mechanisms of neglect syndrome by conducting MRI scans((T1 weighted image, Diffusion Tensor Image, resting state functional MRI) before and after the intervention.
Measured: after 7 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start22 Sep 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke ( 3 Months After Onset)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102927
- Sponsor's protocol ID
- 1-2022-0053
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Virtual Reality-based Training for the Treatment of Neglect Syndrome in Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07102927
- Acronym / sponsor ID
- 1-2022-0053
- Conditions
- Stroke ( 3 Months After Onset), Cognitive Dysfunction ( MMSE < 24 ), Unilateral Neglect Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Aug 2025 (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.
This study aims to investigate the effectiveness and underlying recovery mechanisms of a virtual reality-based training program for the treatment of neglect syndrome in stroke patients in the chronic phase (more than three months after onset).
Neglect is a neurological condition characterized by a failure to attend to stimuli presented on the side contralateral to a brain lesion, despite preserved visual acuity and visual fields. Patients with neglect commonly exhibit impairments in activities of daily living, including dressing, eating, grooming, reading, and writing, and are prone to collisions with objects on the neglected side. This syndrome is widely acknowledged as a significant negative prognostic indicator for functional recovery following stroke.
Previous treatments for neglect syndrome have shown promising results. Pizzamiglio et al. reported the effectiveness of visuo-spatial scanning training, while Julkunen et al. confirmed improvement using computer-based therapy. Frascineti et al. demonstrated benefits from prism adaptation therapy, and Robertson et al. found that activating the left limbs helped reduce neglect symptoms. Additionally, Brighina et al. reported that repetitive transcranial magnetic stimulation applied to the unaffected cerebral hemisphere effectively alleviated neglect.
Recently, computer-based diagnostic tools have been developed to more accurately quantify and objectify neglect. Among them, Kim et al. developed a 3D VR program that can be applied regardless of the severity of motor impairment on the affected side. Virtual reality provides simulated, immersive environments that allow users to interact as if in real-world settings, enabling objective and quantitative assessment of neglect symptoms. In particular, visual fixation training within VR encourages spontaneous visual exploration and focused attention toward the affected side, which has been shown to be an effective strategy in reducing neglect in stroke patients.
Virtual reality-based training has been increasingly applied clinically abroad. For example, the University of California's Institute for Creative Technologies uses VR for treating PTSD in Iraq war veterans, and the VRMC in the U.S. applies it for phobia and stress treatments. In Switzerland, programs like Mind Motion Pro are used for neuroregeneration-focused rehabilitation, and Japan has developed mediVR for trunk balance training. Although research on neglect using VR is active, it generally requires active therapist involvement. Few studies have clearly demonstrated the efficacy of VR treatment specifically in stroke patients, and VR applications in rehabilitation medicine remain relatively limited compared to psychiatric fields.
In light of this background, our research team developed a virtual reality-based training program (NEGTREA) for the treatment of neglect syndrome in stroke. To evaluate its clinical feasibility, we conducted a targeted focus group interview with four out of five stroke patients with neglect who used the program. The study found that the VR-based neglect treatment was well tolerated without adverse effects and achieved high patient satisfaction, alongside improved assessment scores before and after program participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Experimental | Device: Virtual reality-based training for the treatment of neglect syndrom in strokeIn the experimental group, the virtual reality-based training program for neglect syndrom (NEGTREA) was administered once a day for 30 minutes per session. |
| Care Provider | Experimental | Behavioral: Conventional occupational therapyIn the control group, conventional occupational therapy was administered once a day for 30 minutes per session. |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients diagnosed with right cerebral hemisphere stroke confirmed by MRI or CT, with left hemiplegia, and at least three months post-stroke 2. Patients confirmed to have unilateral neglect based on the BIT score (total BIT score ≤ 196, or subtest scores BITC ≤ 129 or BITB ≤ 67) 3. Individuals with sufficient cognitive ability to participate in virtual reality training (MMSE > 18) 4. Adults aged 19 years or older
Key exclusion criteria (1 listed)
- 1. Presence of Hemianopsia 2. Impaired neck movement due to orthopedic issues or other causes 3. Visual or hearing impairments that interfere with evaluation and treatment 4. Difficulty maintaining a seating posture in a chair with a backrest and armrests 5. Presence of other medical issues that may affect general cognitive decline 6. Experiencing Cybersickness symptoms such as nausea, vomiting, eye strain, disorientation, ataxia, or dizziness repeatedly, making continued training difficult and requiring discontinuation as determined by the researcher
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 |
|---|---|---|
| Virtual reality-based training for the treatment of neglect syndrom in strokeAn occupational therapist provided 1:1 assistance with fitting and removing the virtual reality headset (HMD), operating the software and explaining the procedures, as well as offering physical support and movement assistance when necessary to enable participants to engage in the virtual reality-based training program for neglect syndrome. Following measurement of each participant's interpupillary distance, the headset (HTC VIVE PRO) was adjusted and fitted while the participant was seated. The lens distance was fine-tuned using adjustment knobs to match the individual's eyes. The training for neglect was performed with participants seated and wearing the headset. The NEGTREA program provided a virtual environment along with visual fixation training. | Device | control |
| Conventional occupational therapyAn occupational therapist conducted conventional neglect therapy in a 1:1 setting for 30 minutes per session. The therapy comprised therapist-supervised, table-top tasks carefully designed to parallel the virtual reality exercises as closely as possible. These table-top tasks primarily focused on promoting visual scanning and sustained attention toward the neglected hemifield through practical, goal-oriented activities such as object search and manipulation. The therapist utilized a variety of tools to facilitate and optimize patient engagement in these training. | Behavioural | Care Provider |
Primary outcome
Behavioral Inattention Test (BIT)
Time frame: up to 1 day
The following assessment tool, developed by Wilson et al. in 1987, is designed to screen for neglect syndrome and consists of two subtests: Conventional and Behavioral. Lower scores indicate a more severe degree of neglect. It is considered a reliable tool for identifyingneglect in stroke patients and is widely used in studies assessing the validity of research related to neglect syndrome.
4 secondary outcomes
Line Bisection
Time frame: after 7 weeks of treatment
Letter Cancellation
Time frame: after 7 weeks of treatment
Korean Catherine Bergego Scale (K-CBS)
Time frame: after 7 weeks of treatment
MRI data(T1 weighted image, Diffusion Tensor Image, resting state functional MRI)
Time frame: after 7 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
Seoul, 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 Virtual reality-based training for the treatment of neglect syndrom in stroke and Conventional occupational therapy in people with Stroke ( 3 Months After Onset) and Cognitive Dysfunction ( MMSE < 24 ), run by Yonsei University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Inattention Test (BIT) (time frame: up to 1 day). 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 5 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.