ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Reality Training for Upper Extremity After Stroke (VIRTUES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02079103
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : September 5, 2016
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Iris Ch. Brunner, University of Bergen

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.


Condition or disease Intervention/treatment Phase
Stroke Device: Virtual Reality Behavioral: Conventional arm training Phase 2

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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

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 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in Box and Blocks Test score from baseline [ Time Frame: Baseline, after 4 weeks, and at 3 months follow-up ]
    Assessment of dexterity

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Belgium
Rehabilitation Campus Sint-Ursula
Herk-de-Stad, Belgium, 3540
Denmark
Hammel Neurocenter
Hammel, Denmark, 8450
Skive Neurorehabilitation
Skive, Denmark, 7800
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sunnaas Rehabilitation Hospital
Nesoddtangen, Norway, 1450
Sponsors and Collaborators
University of Bergen
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
Investigators
Study Director: Jan Sture Skouen, MD, PhD University of Bergen, Helse Vest
Principal Investigator: Iris Brunner, PhD University of Bergen, Helse Vest

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Iris Ch. Brunner, PhD, PT, University of Bergen
ClinicalTrials.gov Identifier: NCT02079103     History of Changes
Other Study ID Numbers: UiB-228792
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Iris Ch. Brunner, University of Bergen:
Virtual reality
Stroke
Arm motor function
Neurorehabilitation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases