Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-01-02 @ 7:51 AM
Study NCT ID:
NCT02079103
Status:
COMPLETED
Last Update Posted:
2016-09-05
First Post:
2014-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Training for Upper Extremity After Stroke
Sponsor:
University of Bergen
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIRTUES
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: