Stroke
Conditions
Keywords
Virtual reality, Stroke, Arm motor function, Neurorehabilitation
Brief 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. 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.
Interventions
DEVICEVirtual Reality
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.
BEHAVIORALConventional arm training
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.
Sponsors
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
University of Bergen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Action Research Arm Test score from baseline | Baseline, after 4 weeks and at 3 months follow-up | Assessment of changes in arm motor function from baseline to 3 months follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Box and Blocks Test score from baseline | Baseline, after 4 weeks, and at 3 months follow-up | Assessment of dexterity |
| Change in Functional Independence Measure from baseline | Baseline, after 4 weeks, and 3 months follow-up | Assessment of independence in daily life activities |
| ABILHAND questionnaire | After 4 weeks of intervention and at 3 months follow-up | Self-reported use of both hands in daily life activities |
Countries
Belgium, Denmark, Norway
Outcome results
None listed