StrokeNCT03771872
Virtual Prism Adaptation Therapy on Hemispatial Neglect
A study testing Virtual Prism Adaptation Therapy in people with Stroke and Recovery of Function, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
The purpose of this study is to investigate the effect of virtual prism adaptation therapy on hemispatial neglect in chronic stroke patients. This study is the randomized, double-blind, sham-controlled, cross-over design. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Recovery of Function, Rehabilitation
- What is being tested?
- Virtual Prism Adaptation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Dec 2018to 15 Feb 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 3 months after stroke onset
- 2 or more tests indicative of hemispatial neglect in following 3 tests: 1)line bisection test, 2)Albert's test, 3)Drawing test.
- Ability to recognize the target object, hand trajectory in the immersive virtual reality
- 16 points or more in the Korean version of mini-mental state examination
Who cannot join
- Previous stroke or traumatic brain injury history
- Can not cooperate during the therapy, due to delirium or aphasia
- Unstable medical conditions
- Severe psychiatric symptoms that interfere with the therapy participation (e.g. severe depression, agitation, psychotic symptoms)
- Pregnancy
- Can not maintain sitting posture
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Bundang Rusk Rehabilitation Specialty Hospital
Seongnam-si, Gyeonggi-do, 13558
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Effects of Virtual Prism Adaptation Therapy in Stroke Patients With Hemispatial Neglect
The purpose of this study is to investigate the effect of virtual prism adaptation therapy on hemispatial neglect in chronic stroke patients. This study is the randomized, double-blind, sham-controlled, cross-over design. Total 10 patients will be allocated randomly to either real virtual prism adaptation therapy or sham therapy with the wash-out period of more than 2 weeks. Two sessions (20min/session) per day, for 5days (total 10 sessions) will be provided. Behavioral outcomes will be measured before and after completing a total of 10 sessions therapy.
- Conditions
- Stroke, Recovery of Function, Rehabilitation, Perceptual Disorders, Virtual Reality Exposure Therapy
- Being tested
- Virtual Prism Adaptation Therapy, Sham Therapy
- 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.
Virtual Prism Adaptation TherapyDevice
Hand trajectory will deviate to the right side in the virtual reality.
Sham TherapyDevice
The therapy is the same as the real virtual prism adaptation therapy, but there will be no deviation of the hand trajectory in the virtual reality.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Prism Adaptation Therapy | Experimental | This group will be provided with real virtual prism adaptation therapy. In the real therapy session, the hand trajectory will deviate to the right side in the virtual reality. The deviation angle will be adjusted according to the subject's adaptation. 20min-session will be provided twice a day for 5 days, then the total 10 sessions of therapy will be provided. Receives: Device: Virtual Prism Adaptation Therapy |
| Sham Therapy | Sham comparator | The therapy is the same as the real virtual prism adaptation therapy, but there will be no deviation of the hand trajectory in the virtual reality. Receives: Device: Sham Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Inattention Test (BIT) Score
Range: 0(best) to 227(worst)
Measured: Change from Baseline at 5 days
Secondary outcomes (4)
BIT Conventional subtest score (BITC)
Range: 0(best) to 146(worst)
Measured: Change from Baseline at 5 days
BIT Behavioral subtest score (BITB)
Range: 0(best) to 81(worst)
Measured: Change from Baseline at 5 days
Comb and Razor Test
Range: 0% deviation (best) to 100% deviation (worst)
Measured: Change from Baseline at 5 days
Catherine Bergego Scale (CBS)
Range: 0 (best) to 30 (worst)
Measured: Change from baseline at 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start1 Dec 2018
- Primary completion15 Feb 2020
- Study completion15 Feb 2020
Why it stopped: Recruitment of subjects has been difficult.
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 Seoul National University 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bundang Rusk Rehabilitation Specialty Hospital
- Responsible party
- Principal investigator, Won-Seok Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771872
- Sponsor's protocol ID
- 2018-0154-004
- Status last verified
- Mar 2020
- First submitted
- 9 Dec 2018
- Last updated
- 18 Mar 2020
- 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 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Prism Adaptation Therapy in Stroke Patients With Hemispatial Neglect
- ClinicalTrials.gov ID
- NCT03771872
- Acronym / sponsor ID
- 2018-0154-004
- Conditions
- Stroke, Recovery of Function, Rehabilitation, Perceptual Disorders, Virtual Reality Exposure Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment of subjects has been difficult.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Bundang Rusk Rehabilitation Specialty Hospital
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 11 Dec 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.
The purpose of this study is to investigate the effect of virtual prism adaptation therapy on hemispatial neglect in chronic stroke patients. This study is the randomized, double-blind, sham-controlled, cross-over design. Total 10 patients will be allocated randomly to either real virtual prism adaptation therapy or sham therapy with the wash-out period of more than 2 weeks. Two sessions (20min/session) per day, for 5days (total 10 sessions) will be provided. Behavioral outcomes will be measured before and after completing a total of 10 sessions therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Prism Adaptation Therapy | Experimental | Device: Virtual Prism Adaptation TherapyThis group will be provided with real virtual prism adaptation therapy. In the real therapy session, the hand trajectory will deviate to the right side in the virtual reality. The deviation angle will be adjusted according to the subject's adaptation. 20min-session will be provided twice a day for 5 days, then the total 10 sessions of therapy will be provided. |
| Sham Therapy | Sham comparator | Device: Sham TherapyThe therapy is the same as the real virtual prism adaptation therapy, but there will be no deviation of the hand trajectory in the virtual reality. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 3 months after stroke onset
- 2 or more tests indicative of hemispatial neglect in following 3 tests: 1)line bisection test, 2)Albert's test, 3)Drawing test.
- Ability to recognize the target object, hand trajectory in the immersive virtual reality
- 16 points or more in the Korean version of mini-mental state examination
Key exclusion criteria (6 listed)
- Previous stroke or traumatic brain injury history
- Can not cooperate during the therapy, due to delirium or aphasia
- Unstable medical conditions
- Severe psychiatric symptoms that interfere with the therapy participation (e.g. severe depression, agitation, psychotic symptoms)
- Pregnancy
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 Prism Adaptation TherapyHand trajectory will deviate to the right side in the virtual reality. | Device | Virtual Prism Adaptation Therapy |
| Sham TherapyThe therapy is the same as the real virtual prism adaptation therapy, but there will be no deviation of the hand trajectory in the virtual reality. | Device | Sham Therapy |
Primary outcome
Behavioral Inattention Test (BIT) Score
Time frame: Change from Baseline at 5 days
Range: 0(best) to 227(worst)
4 secondary outcomes
BIT Conventional subtest score (BITC)
Time frame: Change from Baseline at 5 days
BIT Behavioral subtest score (BITB)
Time frame: Change from Baseline at 5 days
Comb and Razor Test
Time frame: Change from Baseline at 5 days
Catherine Bergego Scale (CBS)
Time frame: Change from baseline at 5 days
Results and safety
The study was stopped early (reason given: Recruitment of subjects has been difficult.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Prism Adaptation Therapy in people with Stroke and Recovery of Function, run by Seoul National University Hospital at 2 sites 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 6 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: stopped early, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study was stopped early (reason given: Recruitment of subjects has been difficult.). 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?
Behavioral Inattention Test (BIT) Score (time frame: Change from Baseline at 5 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 18 Mar 2020.