Hemispatial NeglectRehAttNCT02258789
Assessment and Training Visio Spatial Neglect in a Virtual Reality Environment
A study testing VR-method in people with Hemispatial Neglect and Stroke, run by Umeå University at 1 site in Sweden.
Trial summary
There is a lack of effective rehabilitation methods for visio-spatial neglect (VSN). By using virtual technology, a new method (virtual reality, VR method) has been created which focuses on stimulating attention networks: top down scanning training in a 3D game, combined with intense visual, audio and tactile… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Hemispatial Neglect, Stroke
- What is being tested?
- VR-method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2010to Jun 2012
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neglect > 6 months and after regular rehabilitation Stroke due to right sided ischemic infarcts
Who cannot join
- Severe visual impairment, severe medical illness, severe depression or cognitive dysfunction (MMSE ≤ 23 points).
Trial locations and contacts
1 site in 1 country.
About this study
There is a lack of effective rehabilitation methods for visio-spatial neglect (VSN). By using virtual technology, a new method (virtual reality, VR method) has been created which focuses on stimulating attention networks: top down scanning training in a 3D game, combined with intense visual, audio and tactile bottom-up stimulation, also including visuo-motor training.
Objective. To evaluate clinical and functional improvement in stroke patients with VSN, as well as before and after training with the new VR method Method:- An intense visio spatial scanning training, enhanced by directed visual, audio and tactile stimulation cues and feedback, also including visio-motor activation was designed in a VR game. The in-house developed software was based on the Tetris game. The VR method consists of an interactive 3D environment: a desktop computer, a monitor, 3D glasses and a force feedback interface. 15 patients with chronic (>6 months) visio spatial neglect was included due to right-sided ischemia. A VR neglect test battery including a Posner task were repeated three times during a 5 weeks baseline before the training started (to establish the chronic state) and again after 15 hours training (3x1 h for 5 weeks). Evaluation of a new method for training attention after stroke causing visio spatial neglect.
The method has been designed for home rehabilitation and is well suited for a tele-medicine approach. It was built with standard components and is easy to manufacture at a low cost. The idea is to give access to effective training, to make it available at the stroke unit with the possibility for the patient to loan it it at discharge for home rehabilitation. The concept of an all in one, easy-to-use device for testing, training and outcome evaluation should be beneficial These preliminare results has been promising and indicates that the RehAtt™ method could become an further developed into an effective and stimulating intervention tool that would lower rehabilitation costs and reduce tiresome travelling to hospitals for training.
Read the detailed description
A VR environment was used training (RehAtt) of post-stroke patients with neglect. Patients played the VR games three times a week for five weeks, totally 15 hours.
A neglect test battery five neglect tests was repeated three times during a five week baseline to estabish a chronic state and reduce the test by test learning effect, then again after the 5 weeks training period. The main outcome results were thereafter obtained by comparing the 5 neglect tests: Star cancellation test, Baking Tray Task, Line Bisection,, Extinction and Posner task - unified index by SPSS Repeated Measurement ANOVA from the 3 baseline visits to the results after intervention. The Catherine Bergego neglect scale was used to assess activities in daily life before and after intervention as well as after six months.
Patients were included if they had a neglect that had persisted for more than six months after a right sided ishemic stroke.
Neglect was diagnosed if one or more of the four neglect subtests of the VR test battery was below cut off (See below and Appendix for details).
The exclusion criteria were severe visual impairment, severe medical illness, severe depression or cognitive dysfunction (MMSE ≤ 23 points). All patients received oral and written information with an informed and signed consent. The Umeå university ethics review board (IRB) approved the study (2010-266-31M).
The hardware consists of a standard PC, a video graphics card, a sound card, headphones and a separate numeric keyboard to measure behavioural responses. In the VR test part, we used a 19" CRT monitor and shutter glasses for stereoscopic vision. A 27" monitor and 3D vision glasses (Nvidia, Santa Clara, CA, USA) replaced them in the VR game part. A robotic pen (Phantom omni haptic device, Sensable technologies, Wilmington, USA) was used as a pointer using the right hand for assessment activities and the paretic left hand when playing the VR game for intervention.
- Conditions
- Hemispatial Neglect, Stroke
- Being tested
- VR-method
- Keywords
- Stroke, rehabilitation, spatial neglect
- Medical subject headings
- Perceptual Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-methodOther
Also called RehAtt
Neglect rehabilitation by intense scanning training and multi sensory stimuli using Virtual Reality
| Study group | Role | What they receive |
|---|---|---|
| intervention - control | Experimental | 15 hours ( 3 times a week in 5 weeks) intense visio spatial scanning training Virtual Reality-method Receives: Other: VR-method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neglect assessment clinical and behavioural
Change in score in; Star cancellation test, Line Bisection, Baking tray task, Posner task, Extinction, Catherine Bergego scale (CBS)
Measured: within 1 week after intervention
Secondary outcomes (1)
Catherine Bergego scale
Change in score in a scale for spatial attention in daily life activities, self report from patient and relative
Measured: 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startSep 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemispatial NeglectStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helena Fordell, MD,, Principal investigator, Department of Pharmacology and Clinical Neuroscience Umea University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258789
- Sponsor's protocol ID
- UmeaU ClinNeuro HF Neglect
- Other IDs
- UMU-2010-266-31M
- Acronym
- RehAtt
- Status last verified
- Oct 2014
- First submitted
- 9 Jun 2014
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Training Visio Spatial Neglect in a Virtual Reality Environment
- ClinicalTrials.gov ID
- NCT02258789
- Acronym / sponsor ID
- RehAtt / UmeaU ClinNeuro HF Neglect
- Conditions
- Hemispatial Neglect, Stroke
- Keywords
- Stroke, rehabilitation, spatial neglect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Oct 2014 (estimated)
- 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.
There is a lack of effective rehabilitation methods for visio-spatial neglect (VSN). By using virtual technology, a new method (virtual reality, VR method) has been created which focuses on stimulating attention networks: top down scanning training in a 3D game, combined with intense visual, audio and tactile bottom-up stimulation, also including visuo-motor training.
Objective. To evaluate clinical and functional improvement in stroke patients with VSN, as well as before and after training with the new VR method Method:- An intense visio spatial scanning training, enhanced by directed visual, audio and tactile stimulation cues and feedback, also including visio-motor activation was designed in a VR game. The in-house developed software was based on the Tetris game. The VR method consists of an interactive 3D environment: a desktop computer, a monitor, 3D glasses and a force feedback interface. 15 patients with chronic (>6 months) visio spatial neglect was included due to right-sided ischemia. A VR neglect test battery including a Posner task were repeated three times during a 5 weeks baseline before the training started (to establish the chronic state) and again after 15 hours training (3x1 h for 5 weeks). Evaluation of a new method for training attention after stroke causing visio spatial neglect.
The method has been designed for home rehabilitation and is well suited for a tele-medicine approach. It was built with standard components and is easy to manufacture at a low cost. The idea is to give access to effective training, to make it available at the stroke unit with the possibility for the patient to loan it it at discharge for home rehabilitation. The concept of an all in one, easy-to-use device for testing, training and outcome evaluation should be beneficial These preliminare results has been promising and indicates that the RehAtt™ method could become an further developed into an effective and stimulating intervention tool that would lower rehabilitation costs and reduce tiresome travelling to hospitals for training.
Detailed description
A VR environment was used training (RehAtt) of post-stroke patients with neglect. Patients played the VR games three times a week for five weeks, totally 15 hours.
A neglect test battery five neglect tests was repeated three times during a five week baseline to estabish a chronic state and reduce the test by test learning effect, then again after the 5 weeks training period. The main outcome results were thereafter obtained by comparing the 5 neglect tests: Star cancellation test, Baking Tray Task, Line Bisection,, Extinction and Posner task - unified index by SPSS Repeated Measurement ANOVA from the 3 baseline visits to the results after intervention. The Catherine Bergego neglect scale was used to assess activities in daily life before and after intervention as well as after six months.
Patients were included if they had a neglect that had persisted for more than six months after a right sided ishemic stroke.
Neglect was diagnosed if one or more of the four neglect subtests of the VR test battery was below cut off (See below and Appendix for details).
The exclusion criteria were severe visual impairment, severe medical illness, severe depression or cognitive dysfunction (MMSE ≤ 23 points). All patients received oral and written information with an informed and signed consent. The Umeå university ethics review board (IRB) approved the study (2010-266-31M).
The hardware consists of a standard PC, a video graphics card, a sound card, headphones and a separate numeric keyboard to measure behavioural responses. In the VR test part, we used a 19" CRT monitor and shutter glasses for stereoscopic vision. A 27" monitor and 3D vision glasses (Nvidia, Santa Clara, CA, USA) replaced them in the VR game part. A robotic pen (Phantom omni haptic device, Sensable technologies, Wilmington, USA) was used as a pointer using the right hand for assessment activities and the paretic left hand when playing the VR game for intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention - control | Experimental | Other: VR-method15 hours ( 3 times a week in 5 weeks) intense visio spatial scanning training Virtual Reality-method |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Neglect > 6 months and after regular rehabilitation Stroke due to right sided ischemic infarcts
Key exclusion criteria (1 listed)
- Severe visual impairment, severe medical illness, severe depression or cognitive dysfunction (MMSE ≤ 23 points).
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-methodAlso: RehAttNeglect rehabilitation by intense scanning training and multi sensory stimuli using Virtual Reality | Other | intervention - control |
Primary outcome
Neglect assessment clinical and behavioural
Time frame: within 1 week after intervention
Change in score in; Star cancellation test, Line Bisection, Baking tray task, Posner task, Extinction, Catherine Bergego scale (CBS)
1 secondary outcome
Catherine Bergego scale
Time frame: 6 month follow up
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 7 Oct 2014.
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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.
Helena Fordell, MD, principal investigator
Department of Pharmacology and Clinical Neuroscience Umea University, Sweden
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-method in people with Hemispatial Neglect and Stroke, run by Umeå University at 1 site in Sweden.
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: finished, as of the sponsor's last update on 7 Oct 2014. 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 Sweden. 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?
Neglect assessment clinical and behavioural (time frame: within 1 week after intervention). 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 7 Oct 2014.