StrokePhase 2VIRTUESNCT02079103
Virtual Reality Training for Upper Extremity After Stroke
A Phase 2 study testing Virtual Reality and Conventional arm training in people with Stroke, run by University of Bergen at 5 sites in 3 countries.
Trial summary
Background: High intensity training of challenging tasks with many repetitions is a key factor for regaining motor function after stroke. Novel virtual reality (VR) rehabilitation systems provide the potential to increase intensity and offer challenging and motivating tasks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual Reality and Conventional arm training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Mar 2014to Aug 2016
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First ever ischemic or hemorrhagic stroke or former stroke without any residual motor impairment
- 1 - 12 weeks post stroke
- Impaired arm motor function but some residual arm motor activity as defined by a score of less than 52 on Action Research Arm Test (ARAT), and the ability to execute at least 20 degrees of active shoulder extension and abduction against gravity.
Who cannot join
- Severe cognitive impairment defined as < 20 on Mini Mental Status Examination
- Orthopedic impairment, limiting mobility substantially or causing pain
- Visual disorders limiting the ability to comply with treatment regimen - < 18 years
- Unable to give informed consent
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Denmark2 sites
Hammel Neurocenter
Hammel, 8450
Skive Neurorehabilitation
Skive, 7800
Norway2 sites
Haukeland University Hospital
Bergen, 5021
Sunnaas Rehabilitation Hospital
Nesoddtangen, 1450
About this study
Official title: Virtual Reality Based Training - a Motivating and Effective Way of Regaining Arm Motor Function After Stroke? The VIRTUES Trial: A Multi-center RCT
Background: High intensity training of challenging tasks with many repetitions is a key factor for regaining motor function after stroke. Novel virtual reality (VR) rehabilitation systems provide the potential to increase intensity and offer challenging and motivating tasks. The efficacy of VR systems has not been demonstrated yet in sufficiently powered studies.
Methods: In 5 participating rehabilitation centers patients in the subacute phase after stroke will be randomized to either a group receiving 4 weeks of VR training in addition to conventional arm training or a group receiving dose-matched and therapist attention-matched conventional arm-training.
Hypothesis: VR training is more effective in improving arm motor function than conventional arm training in the subacute phase after stroke.
Read the detailed description
Background: Approximately two thirds of patients with stroke experience impaired arm motor function, which compromises independence in activities of daily living, occupational areas and quality of life. High intensity training of challenging tasks with many repetitions are key factors for regaining motor function after stroke. Novel virtual reality (VR) rehabilitation systems provide the potential to increase intensity and offer challenging and motivating tasks. The efficacy of VR systems has not been demonstrated yet in sufficiently powered studies.
Methods: In this study 120 patients in 5 participating Norwegian, Danish and Belgian rehabilitation institutions will be randomized to either a group receiving VR training in addition to conventional arm training or a group receiving dose-matched and therapist attention-matched conventional arm-training. During a period of 4 weeks the patients will be offered additional 4-5 training sessions weekly of 45-60 minutes duration by a physiotherapist or an occupational therapist. Arm motor function, dexterity and independence in daily life activities will be evaluated at baseline, post and 3 months follow-up assessments with the Action Research Arm Test, Box and Blocks Test and the Functional Independence Measure. Patient satisfaction and therapist satisfaction with the implementation of a new technology based rehabilitation system will also be assessed with questionnaires and interviews.
Objective: The objective of the VIRTUES trial is to study the effectiveness and acceptance of a novel VR training approach. The study will provide evidence-based knowledge of new virtual reality based treatment strategies to clinicians, patients and health economists.
- Conditions
- Stroke
- Being tested
- Virtual Reality, Conventional arm training
- Keywords
- Virtual reality, Stroke, Arm motor function, Neurorehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called YouGrabber®
During a 4 weeks period the patients will be offered 4-5 Virtual reality training sessions weekly of 45-60 minutes duration in addition to other rehabilitation. The Virtual reality training will be supervised by a physical or an occupational therapist. Virtual reality gaming parameters are adapted according to improving arm motor function.
Conventional arm trainingBehavioural
During a 4 weeks period the patients will be offered 4-5 supervised self-training sessions weekly of 45-60 minutes duration in addition to other rehabilitation. The training will be task-related and supervised by a physical or an occupational therapist. Exercises increase in difficulty according to improving arm motor function.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Virtual reality training using the YouGrabber® for patients with impaired arm motor function after stroke. The YouGrabber exercises focus on intensity, repetitions and motivating tasks and are adapted to the patient's motor abilities. Receives: Device: Virtual Reality |
| Conventional arm training | Active comparator | The patients receive supervised self-training exercises with focus on functional tasks adapted to their motor abilities. Receives: Behavioral: Conventional arm training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Action Research Arm Test score from baseline
Assessment of changes in arm motor function from baseline to 3 months follow up
Measured: Baseline, after 4 weeks and at 3 months follow-up
Secondary outcomes (3)
Change in Box and Blocks Test score from baseline
Assessment of dexterity
Measured: Baseline, after 4 weeks, and at 3 months follow-up
Change in Functional Independence Measure from baseline
Assessment of independence in daily life activities
Measured: Baseline, after 4 weeks, and 3 months follow-up
ABILHAND questionnaire
Self-reported use of both hands in daily life activities
Measured: After 4 weeks of intervention and at 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Sunnaas Rehabilitation Hospital, Regionshospitalet Hammel Neurocenter, Regionshospitalet Viborg, Skive, KU Leuven, Jessa Hospital, The Research Council of Norway, Helse Vest, Norwegian Fund for Postgraduate Training in Physiotherapy
- Responsible party
- Principal investigator, Iris Ch. Brunner, University of Bergen
- Investigators
- Jan Sture Skouen, MD, PhD, Study director, University of Bergen, Helse VestIris Brunner, PhD, Principal investigator, University of Bergen, Helse Vest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079103
- Sponsor's protocol ID
- UiB-228792
- Acronym
- VIRTUES
- Status last verified
- Sep 2016
- First submitted
- 27 Feb 2014
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Brunner I, Skouen JS, Hofstad H, Assmus J, Becker F, Sanders AM, Pallesen H, Qvist Kristensen L, Michielsen M, Thijs L, Verheyden G. Virtual Reality Training for Upper Extremity in Subacute Stroke (VIRTUES): A multicenter RCT. Neurology. 2017 Dec 12;89(24):2413-2421. doi: 10.1212/WNL.0000000000004744. Epub 2017 Nov 15.
PubMed 29142090Brunner I, Skouen JS, Hofstad H, Assmuss J, Becker F, Pallesen H, Thijs L, Verheyden G. Is upper limb virtual reality training more intensive than conventional training for patients in the subacute phase after stroke? An analysis of treatment intensity and content. BMC Neurol. 2016 Nov 11;16(1):219. doi: 10.1186/s12883-016-0740-y.
PubMed 27835977Brunner I, Skouen JS, Hofstad H, Strand LI, Becker F, Sanders AM, Pallesen H, Kristensen T, Michielsen M, Verheyden G. Virtual reality training for upper extremity in subacute stroke (VIRTUES): study protocol for a randomized controlled multicenter trial. BMC Neurol. 2014 Sep 28;14:186. doi: 10.1186/s12883-014-0186-z.
PubMed 25261187
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Based Training - a Motivating and Effective Way of Regaining Arm Motor Function After Stroke? The VIRTUES Trial: A Multi-center RCT
- ClinicalTrials.gov ID
- NCT02079103
- Acronym / sponsor ID
- VIRTUES / UiB-228792
- Conditions
- Stroke
- Keywords
- Virtual reality, Stroke, Arm motor function, Neurorehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Sunnaas Rehabilitation Hospital, Regionshospitalet Hammel Neurocenter, Regionshospitalet Viborg, Skive, KU Leuven, Jessa Hospital, The Research Council of Norway, Helse Vest, Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- Mar 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Mar 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.
Background: High intensity training of challenging tasks with many repetitions is a key factor for regaining motor function after stroke. Novel virtual reality (VR) rehabilitation systems provide the potential to increase intensity and offer challenging and motivating tasks. The efficacy of VR systems has not been demonstrated yet in sufficiently powered studies.
Methods: In 5 participating rehabilitation centers patients in the subacute phase after stroke will be randomized to either a group receiving 4 weeks of VR training in addition to conventional arm training or a group receiving dose-matched and therapist attention-matched conventional arm-training.
Hypothesis: VR training is more effective in improving arm motor function than conventional arm training in the subacute phase after stroke.
Detailed description
Background: Approximately two thirds of patients with stroke experience impaired arm motor function, which compromises independence in activities of daily living, occupational areas and quality of life. High intensity training of challenging tasks with many repetitions are key factors for regaining motor function after stroke. Novel virtual reality (VR) rehabilitation systems provide the potential to increase intensity and offer challenging and motivating tasks. The efficacy of VR systems has not been demonstrated yet in sufficiently powered studies.
Methods: In this study 120 patients in 5 participating Norwegian, Danish and Belgian rehabilitation institutions will be randomized to either a group receiving VR training in addition to conventional arm training or a group receiving dose-matched and therapist attention-matched conventional arm-training. During a period of 4 weeks the patients will be offered additional 4-5 training sessions weekly of 45-60 minutes duration by a physiotherapist or an occupational therapist. Arm motor function, dexterity and independence in daily life activities will be evaluated at baseline, post and 3 months follow-up assessments with the Action Research Arm Test, Box and Blocks Test and the Functional Independence Measure. Patient satisfaction and therapist satisfaction with the implementation of a new technology based rehabilitation system will also be assessed with questionnaires and interviews.
Objective: The objective of the VIRTUES trial is to study the effectiveness and acceptance of a novel VR training approach. The study will provide evidence-based knowledge of new virtual reality based treatment strategies to clinicians, patients and health economists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: Virtual RealityVirtual reality training using the YouGrabber® for patients with impaired arm motor function after stroke. The YouGrabber exercises focus on intensity, repetitions and motivating tasks and are adapted to the patient's motor abilities. |
| Conventional arm training | Active comparator | Behavioral: Conventional arm trainingThe patients receive supervised self-training exercises with focus on functional tasks adapted to their motor abilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First ever ischemic or hemorrhagic stroke or former stroke without any residual motor impairment
- 1 - 12 weeks post stroke
- Impaired arm motor function but some residual arm motor activity as defined by a score of less than 52 on Action Research Arm Test (ARAT), and the ability to execute at least 20 degrees of active shoulder extension and abduction against gravity.
Key exclusion criteria (4 listed)
- Severe cognitive impairment defined as < 20 on Mini Mental Status Examination
- Orthopedic impairment, limiting mobility substantially or causing pain
- Visual disorders limiting the ability to comply with treatment regimen - < 18 years
- Unable to give informed consent
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 RealityAlso: YouGrabber®During a 4 weeks period the patients will be offered 4-5 Virtual reality training sessions weekly of 45-60 minutes duration in addition to other rehabilitation. The Virtual reality training will be supervised by a physical or an occupational therapist. Virtual reality gaming parameters are adapted according to improving arm motor function. | Device | Virtual reality |
| Conventional arm trainingDuring a 4 weeks period the patients will be offered 4-5 supervised self-training sessions weekly of 45-60 minutes duration in addition to other rehabilitation. The training will be task-related and supervised by a physical or an occupational therapist. Exercises increase in difficulty according to improving arm motor function. | Behavioural | Conventional arm training |
Primary outcome
Change in Action Research Arm Test score from baseline
Time frame: Baseline, after 4 weeks and at 3 months follow-up
Assessment of changes in arm motor function from baseline to 3 months follow up
3 secondary outcomes
Change in Box and Blocks Test score from baseline
Time frame: Baseline, after 4 weeks, and at 3 months follow-up
Change in Functional Independence Measure from baseline
Time frame: Baseline, after 4 weeks, and 3 months follow-up
ABILHAND questionnaire
Time frame: After 4 weeks of intervention and at 3 months 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 5 Sep 2016.
- Derived from this study: PubMed 29142090Brunner I, Skouen JS, Hofstad H, Assmus J, Becker F, Sanders AM, Pallesen H, Qvist Kristensen L, Michielsen M, Thijs L, Verheyden G. Virtual Reality Training for Upper Extremity in Subacute Stroke (VIRTUES): A multicenter RCT. Neurology. 2017 Dec 12;89(24):2413-2421. doi: 10.1212/WNL.0000000000004744. Epub 2017 Nov 15.
- Derived from this study: PubMed 27835977Brunner I, Skouen JS, Hofstad H, Assmuss J, Becker F, Pallesen H, Thijs L, Verheyden G. Is upper limb virtual reality training more intensive than conventional training for patients in the subacute phase after stroke? An analysis of treatment intensity and content. BMC Neurol. 2016 Nov 11;16(1):219. doi: 10.1186/s12883-016-0740-y.
- Derived from this study: PubMed 25261187Brunner I, Skouen JS, Hofstad H, Strand LI, Becker F, Sanders AM, Pallesen H, Kristensen T, Michielsen M, Verheyden G. Virtual reality training for upper extremity in subacute stroke (VIRTUES): study protocol for a randomized controlled multicenter trial. BMC Neurol. 2014 Sep 28;14:186. doi: 10.1186/s12883-014-0186-z.
- Individual participant dataSharing planned: Yes
Related trials for Stroke
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Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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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.
Jan Sture Skouen, MD, PhD study director
University of Bergen, Helse Vest
Iris Brunner, PhD principal investigator
University of Bergen, Helse Vest
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Virtual Reality and Conventional arm training in people with Stroke, run by University of Bergen at 5 sites in 3 countries.
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 3 inclusion and 4 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 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Norway, Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Action Research Arm Test score from baseline (time frame: Baseline, after 4 weeks and at 3 months follow-up). 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 NCT02079103, which also lists 3 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 5 Sep 2016.