Virtual Reality Training for Upper Extremity After Stroke "VIRTUES"

Completed

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Virtual Reality Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Virtual reality
    Description: 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.
  • Conventional arm training Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Conventional arm training
    Description: The patients receive supervised self-training exercises with focus on functional tasks adapted to their motor abilities.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Action Research Arm Test Pre-intervention, after 4 weeks of intervention, and at 3 months follow-up No
Secondary Box and Blocks Test Pre-intervention, after 4 weeks of intervention, and at 3 months follow-up No
Secondary Functional Independence Measure Pre-intervention, after 4 weeks of intervention, and 3 months follow-up No
Secondary ABILHAND questionnaire After 4 weeks of intervention and at 3 months follow-up No
Primary Change in Action Research Arm Test score from baseline Baseline, after 4 weeks and at 3 months follow-up No
Secondary Change in Box and Blocks Test score from baseline Baseline, after 4 weeks, and at 3 months follow-up No
Secondary Change in Functional Independence Measure from baseline Baseline, after 4 weeks, and 3 months follow-up No
Primary Change in Action Research Arm Test score from baseline Baseline, after 4 weeks and at 3 months follow-up No

Sponsors