Virtual Reality Training for Upper Extremity After Stroke (VIRTUES)
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|ClinicalTrials.gov Identifier: NCT02079103|
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : September 5, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Virtual Reality Behavioral: Conventional arm training||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Virtual reality
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
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.
Other Name: YouGrabber®
Active Comparator: Conventional arm training
The patients receive supervised self-training exercises with focus on functional tasks adapted to their motor abilities.
Behavioral: Conventional 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.
- 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
- Change in Box and Blocks Test score from baseline [ Time Frame: Baseline, after 4 weeks, and at 3 months follow-up ]Assessment of dexterity
- Change in Functional Independence Measure from baseline [ Time Frame: Baseline, after 4 weeks, and 3 months follow-up ]Assessment of independence in daily life activities
- ABILHAND questionnaire [ Time Frame: After 4 weeks of intervention and at 3 months follow-up ]Self-reported use of both hands in daily life activities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079103
|Rehabilitation Campus Sint-Ursula|
|Herk-de-Stad, Belgium, 3540|
|Hammel, Denmark, 8450|
|Skive, Denmark, 7800|
|Haukeland University Hospital|
|Bergen, Norway, 5021|
|Sunnaas Rehabilitation Hospital|
|Nesoddtangen, Norway, 1450|
|Study Director:||Jan Sture Skouen, MD, PhD||University of Bergen, Helse Vest|
|Principal Investigator:||Iris Brunner, PhD||University of Bergen, Helse Vest|