Abstract
BackgroundNovel virtual reality rehabilitation systems provide the potential to increase intensity and offer challenging and motivating tasks. The efficacy of virtual reality systems to improve arm motor function early after stroke has not been demonstrated yet in sufficiently powered studies. The objective of the study is to investigate whether VR training as an adjunct to conventional therapy is more effective in improving arm motor function in the subacute phase after stroke than dose-matched conventional training, to assess patient and therapist satisfaction when working with novel virtual reality training and to calculate cost-effectiveness in terms of resources required to regain some degree of dexterity.Methods/DesignRandomized controlled observer-blind trial.One hundred and twenty patients up to 12 weeks after stroke will be randomized to either a group receiving VR training or dose-matched and therapist attention-matched conventional arm training in addition to standard rehabilitation. During a period of four weeks the patients will be offered additional 4–5 training sessions a week of 45–60 minutes duration by a physiotherapist or an occupational therapist.Study outcomes: Arm motor function, dexterity and independence in daily life activities will be evaluated at baseline, post treatment and three months follow-up assessments with the Action Research Arm Test, Box and Blocks Test and the Functional Independence Measure, respectively. Patient and therapist satisfaction with the implementation of a VR rehabilitation system will also be assessed with questionnaires and interviews.DiscussionVirtual reality systems are promising tools for rehabilitation of arm motor function after stroke. Their introduction in combination with traditional physical and occupational therapy may enhance recovery after stroke, and at the same time demand little personnel resources to increase training intensity. The VIRTUES trial will provide further evidence of VR-based treatment strategies to clinicians, patients and health economists.Trial registrationClinicalTrials.gov NCT02079103
Highlights
Novel virtual reality rehabilitation systems provide the potential to increase intensity and offer challenging and motivating tasks
The objectives of this study are: 1. to investigate whether Virtual reality (VR) training as an adjunct to conventional therapy is more effective in improving arm motor function in the subacute phase after onset of stroke than dose- and therapist attention-matched conventional training; 2. to assess patient and therapist satisfaction when working with novel virtual reality training; 3. to calculate cost-effectiveness in terms of resources required to regain some degree of dexterity
Patient population All patients with stroke confirmed by clinical neuroimaging admitted for rehabilitation at the participating centers within 1 to 12 weeks after stroke will be considered for inclusion
Summary
Novel virtual reality rehabilitation systems provide the potential to increase intensity and offer challenging and motivating tasks. The efficacy of virtual reality systems to improve arm motor function early after stroke has not been demonstrated yet in sufficiently powered studies. The objective of the study is to investigate whether VR training as an adjunct to conventional therapy is more effective in improving arm motor function in the subacute phase after stroke than dose-matched conventional training, to assess patient and therapist satisfaction when working with novel virtual reality training and to calculate cost-effectiveness in terms of resources required to regain some degree of dexterity. Many systems allow for a graded adaption to increasing motor abilities, maintaining the challenging character of the tasks
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