Virtual Reality Training for Upper Extremity After Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Virtual Reality Based Training - a Motivating and Effective Way of Regaining Arm Motor Function After Stroke? The VIRTUES Trial: A Multi-center RCT

Conditions
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Stroke

Intervention / Treatment
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* Device: Virtual Reality
* Behavioral: Conventional arm training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality<br>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. | Device: Virtual Reality<br>* 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.<br>* Other names: YouGrabber®;|
| Active Comparator: Conventional arm training<br>The patients receive supervised self-training exercises with focus on functional tasks adapted to their motor abilities. | Behavioral: Conventional arm training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Virtual reality, Arm motor function, Neurorehabilitation