Virtual Reality Training for Upper Extremity After Stroke (VIRTUES)

Virtual Reality Based Training - a Motivating and Effective Way of Regaining Arm Motor Function After Stroke? The VIRTUES Trial: A Multi-center RCT

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Virtual Reality; Behavioral: Conventional arm training

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Herk-de-Stad, Belgium, 3540
    • Rehabilitation Campus Sint-Ursula
• Denmark
  • Hammel, Denmark, 8450
    • Hammel Neurocenter
  • Skive, Denmark, 7800
    • Skive Neurorehabilitation
• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital
  • Nesoddtangen, Norway, 1450
    • Sunnaas rehabilitation hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Action Research Arm Test score from baseline	Assessment of changes in arm motor function from baseline to 3 months follow up	Baseline, after 4 weeks and at 3 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Box and Blocks Test score from baseline	Assessment of dexterity	Baseline, after 4 weeks, and at 3 months follow-up
Change in Functional Independence Measure from baseline	Assessment of independence in daily life activities	Baseline, after 4 weeks, and 3 months follow-up
ABILHAND questionnaire	Self-reported use of both hands in daily life activities	After 4 weeks of intervention and at 3 months follow-up

Collaborators and Investigators

• Sponsor: University of Bergen
• Collaborators: KU Leuven; The Research Council of Norway; Jessa Hospital; Haukeland University Hospital; Helse Vest; Regionshospitalet Viborg, Skive; Sunnaas Rehabilitation Hospital; Regionshospitalet Hammel Neurocenter; Norwegian Fund for Postgraduate Training in Physiotherapy
• Investigators: Study Director: Jan Sture Skouen, MD, PhD, University of Bergen, Helse Vest; Principal Investigator: Iris Brunner, PhD, University of Bergen, Helse Vest

Publications and helpful links

General Publications

• Brunner I, Skouen JS, Hofstad H, Assmus J, Becker F, Sanders AM, Pallesen H, Qvist Kristensen L, Michielsen M, Thijs L, Verheyden G. Virtual Reality Training for Upper Extremity in Subacute Stroke (VIRTUES): A multicenter RCT. Neurology. 2017 Dec 12;89(24):2413-2421. doi: 10.1212/WNL.0000000000004744. Epub 2017 Nov 15.
• Brunner I, Skouen JS, Hofstad H, Assmuss J, Becker F, Pallesen H, Thijs L, Verheyden G. Is upper limb virtual reality training more intensive than conventional training for patients in the subacute phase after stroke? An analysis of treatment intensity and content. BMC Neurol. 2016 Nov 11;16(1):219. doi: 10.1186/s12883-016-0740-y.
• Brunner I, Skouen JS, Hofstad H, Strand LI, Becker F, Sanders AM, Pallesen H, Kristensen T, Michielsen M, Verheyden G. Virtual reality training for upper extremity in subacute stroke (VIRTUES): study protocol for a randomized controlled multicenter trial. BMC Neurol. 2014 Sep 28;14:186. doi: 10.1186/s12883-014-0186-z.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: February 27, 2014
• First Submitted That Met QC Criteria: March 1, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Estimate): September 5, 2016
• Last Update Submitted That Met QC Criteria: September 2, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Stroke; Virtual reality; Neurorehabilitation; Arm motor function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: UiB-228792

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES