Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
| Sunnaas Rehabilitation Hospital | OTHER |
| Regionshospitalet Hammel Neurocenter | OTHER |
| Regionshospitalet Viborg, Skive |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Conventional arm training | Active Comparator | The patients receive supervised self-training exercises with focus on functional tasks adapted to their motor abilities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Action Research Arm Test score from baseline | Assessment of changes in arm motor function from baseline to 3 months follow up | Baseline, after 4 weeks and at 3 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Box and Blocks Test score from baseline | Assessment of dexterity | Baseline, after 4 weeks, and at 3 months follow-up |
| Change in Functional Independence Measure from baseline | Assessment of independence in daily life activities |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jan Sture Skouen, MD, PhD | University of Bergen, Helse Vest | Study Director |
| Iris Brunner, PhD | University of Bergen, Helse Vest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Campus Sint-Ursula | Herk-de-Stad | 3540 | Belgium | |||
| Hammel Neurocenter |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29142090 | Derived | 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. | |
| 27835977 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| OTHER |
| KU Leuven | OTHER |
| Jessa Hospital | OTHER |
| The Research Council of Norway | OTHER |
| Helse Vest | OTHER |
| Norwegian Fund for Postgraduate Training in Physiotherapy | OTHER |
Not provided
Not provided
Not provided
Not provided
|
|
| Conventional arm training | Behavioral | 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. |
|
| Baseline, after 4 weeks, and 3 months follow-up |
| ABILHAND questionnaire | Self-reported use of both hands in daily life activities | After 4 weeks of intervention and at 3 months follow-up |
| Hammel |
| 8450 |
| Denmark |
| Skive Neurorehabilitation | Skive | 7800 | Denmark |
| Haukeland University Hospital | Bergen | 5021 | Norway |
| Sunnaas Rehabilitation Hospital | Nesoddtangen | 1450 | Norway |
| Brunner 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. |
| 25261187 | Derived | Brunner 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |