StrokeNCT03463122
Head Mount Display-based Virtual Reality Rehabilitation of Hemispatial Neglect
A study testing field of regard-focused visual exploration therapy and conventional therapy in people with Stroke and Neglect, Hemispatial, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
Trial summary
Head-mounted display based virtual reality rehabilitation for hemispatial neglect. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke, Neglect, Hemispatial
- What is being tested?
- field of regard-focused visual exploration therapy and conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2014to 31 Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of left hemispatial neglect as demonstrated by a score above the cut-off on the line bisection test or star cancellation test of the Behavioral Inattention Test, or mild-to-moderate neglect-related functional impairment defined by a score of 1-20 points on the Catherine Bergego Scale
- age 19 to 65 years
- first-time right hemispheric ischemic or haemorrhagic stroke as evidenced by brain imaging and medical records
- a score >25 on the Mini-Mental State Examination
Who cannot join
- presence of oculomotor palsies or visual defects as assessed via standard neurological examination
- orthopaedic disorders affecting neck movement
- inability to maintain a seated position.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Based Visual Perception Evaluation and Rehabilitation-pilot Study
Head-mounted display based virtual reality rehabilitation for hemispatial neglect.
Read the detailed description
The investigators examine about the efficacy of field-of-regard-focused visual exploration therapy implemented using a head-mounted display virtual reality system for hemispatial neglect rehabilitation following stroke.
- Conditions
- Stroke, Neglect, Hemispatial
- Being tested
- field of regard-focused visual exploration therapy, conventional therapy
- Keywords
- stroke, neglect, virtual reality, head mount display, rehabilitation
- Medical subject headings
- Stroke, Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
field of regard-focused visual exploration therapyDevice
Also called head mount display
field of regard-focused visual exploration therapy in addition to conventional therapy
conventional therapyOther
conventional therapy for stroke rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Training first | Other | This group completed 20 sessions of a field of regard-focused visual exploration therapy program using an head mount display (five daily sessions per week over a period of four weeks) in addition to conventional therapy followed by four weeks of conventional therapy Receives: Device: field of regard-focused visual exploration therapy; Other: conventional therapy |
| Waiting first | Other | This group completed four weeks of conventional therapy followed by 20 sessions of a field of regard-focused visual exploration therapy program using an head mount display (five daily sessions per week over a period of four weeks) in addition to conventional therapy. Receives: Device: field of regard-focused visual exploration therapy; Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Field of regard-response time
time interval between target onset and response with field of regard setting
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Change in Field of regard-success rate
percentage of correct responses (clicking the left or right mouse button in response to a blue or red target, respectively) with field of regard setting
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Change in Field of regard-head movement
sum of all quantified head-rotations with field of regard setting
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Secondary outcomes (5)
Field of view-response time
time interval between target onset and response with field of view setting
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Field of view-success rate
percentage of correct responses (clicking the left or right mouse button in response to a blue or red target, respectively) with field of view setting
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Line bisection test
Participants were asked to bisect the given lines by marking the centre of each line using their preferred or unaffected hand
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Star cancellation test
The experimenter crossed out the two small, central stars of the sheet as an example, following which participants were asked to mark the remaining small stars.
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Catherine Bergego Scale
a standardised checklist designed to detect the degree of neglect during everyday life via direct observation of functioning during ten tasks
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start1 Aug 2014
- Primary completion30 Oct 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Rehabilitation Center, Seoul, Korea
- Sponsor type
- Other government
- Collaborators
- Hanyang University
- Responsible party
- Principal investigator, Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
- Investigators
- Joon-Ho Shin, Principal investigator, National Rehabilitation Center of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463122
- Sponsor's protocol ID
- NRC-2014-04-022
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shin JH, Kim M, Lee JY, Kim MY, Jeon YJ, Kim K. Feasibility of hemispatial neglect rehabilitation with virtual reality-based visual exploration therapy among patients with stroke: randomised controlled trial. Front Neurosci. 2023 Apr 20;17:1142663. doi: 10.3389/fnins.2023.1142663. eCollection 2023.
PubMed 37152602Kim TL, Kim K, Choi C, Lee JY, Shin JH. FOPR test: a virtual reality-based technique to assess field of perception and field of regard in hemispatial neglect. J Neuroeng Rehabil. 2021 Feb 18;18(1):39. doi: 10.1186/s12984-021-00835-1.
PubMed 33602254
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Based Visual Perception Evaluation and Rehabilitation-pilot Study
- ClinicalTrials.gov ID
- NCT03463122
- Acronym / sponsor ID
- NRC-2014-04-022
- Conditions
- Stroke, Neglect, Hemispatial
- Keywords
- stroke, neglect, virtual reality, head mount display, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- National Rehabilitation Center, Seoul, KoreaOther government
- Collaborators
- Hanyang University
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 13 Mar 2018 (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.
Head-mounted display based virtual reality rehabilitation for hemispatial neglect.
Detailed description
The investigators examine about the efficacy of field-of-regard-focused visual exploration therapy implemented using a head-mounted display virtual reality system for hemispatial neglect rehabilitation following stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training first | Other | Device: field of regard-focused visual exploration therapy, Other: conventional therapyThis group completed 20 sessions of a field of regard-focused visual exploration therapy program using an head mount display (five daily sessions per week over a period of four weeks) in addition to conventional therapy followed by four weeks of conventional therapy |
| Waiting first | Other | Device: field of regard-focused visual exploration therapy, Other: conventional therapyThis group completed four weeks of conventional therapy followed by 20 sessions of a field of regard-focused visual exploration therapy program using an head mount display (five daily sessions per week over a period of four weeks) in addition to conventional therapy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- presence of left hemispatial neglect as demonstrated by a score above the cut-off on the line bisection test or star cancellation test of the Behavioral Inattention Test, or mild-to-moderate neglect-related functional impairment defined by a score of 1-20 points on the Catherine Bergego Scale
- age 19 to 65 years
- first-time right hemispheric ischemic or haemorrhagic stroke as evidenced by brain imaging and medical records
- a score >25 on the Mini-Mental State Examination
Key exclusion criteria (3 listed)
- presence of oculomotor palsies or visual defects as assessed via standard neurological examination
- orthopaedic disorders affecting neck movement
- inability to maintain a seated position.
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 |
|---|---|---|
| field of regard-focused visual exploration therapyAlso: head mount displayfield of regard-focused visual exploration therapy in addition to conventional therapy | Device | Training first, Waiting first |
| conventional therapyconventional therapy for stroke rehabilitation | Other | Training first, Waiting first |
Primary outcome
Change in Field of regard-response time
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
time interval between target onset and response with field of regard setting
Change in Field of regard-success rate
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
percentage of correct responses (clicking the left or right mouse button in response to a blue or red target, respectively) with field of regard setting
Change in Field of regard-head movement
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
sum of all quantified head-rotations with field of regard setting
5 secondary outcomes
Field of view-response time
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Field of view-success rate
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Line bisection test
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Star cancellation test
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Catherine Bergego Scale
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
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 13 Mar 2018.
- Derived from this study: PubMed 37152602Shin JH, Kim M, Lee JY, Kim MY, Jeon YJ, Kim K. Feasibility of hemispatial neglect rehabilitation with virtual reality-based visual exploration therapy among patients with stroke: randomised controlled trial. Front Neurosci. 2023 Apr 20;17:1142663. doi: 10.3389/fnins.2023.1142663. eCollection 2023.
- Derived from this study: PubMed 33602254Kim TL, Kim K, Choi C, Lee JY, Shin JH. FOPR test: a virtual reality-based technique to assess field of perception and field of regard in hemispatial neglect. J Neuroeng Rehabil. 2021 Feb 18;18(1):39. doi: 10.1186/s12984-021-00835-1.
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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.
Joon-Ho Shin principal investigator
National Rehabilitation Center of 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 field of regard-focused visual exploration therapy and conventional therapy in people with Stroke and Neglect, Hemispatial, run by National Rehabilitation Center, Seoul, Korea 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 4 inclusion and 3 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 13 Mar 2018. 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?
Change in Field of regard-response time (time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline). 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?
On the ClinicalTrials.gov record for NCT03463122, which also lists 2 linked publications.
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 13 Mar 2018.