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Virtual Reality Training for Upper Extremity After Stroke (VIRTUES)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Virtual Reality
Conventional arm training
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Virtual reality, Stroke, Arm motor function, Neurorehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation Campus Sint-Ursula
  • Hammel Neurocenter
  • Skive Neurorehabilitation
  • Haukeland University Hospital
  • Sunnaas Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual reality

Conventional arm training

Arm 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.

The patients receive supervised self-training exercises with focus on functional tasks adapted to their motor abilities.

Outcomes

Primary Outcome Measures

Change in Action Research Arm Test score from baseline
Assessment of changes in arm motor function from baseline to 3 months follow up

Secondary Outcome Measures

Change in Box and Blocks Test score from baseline
Assessment of dexterity
Change in Functional Independence Measure from baseline
Assessment of independence in daily life activities
ABILHAND questionnaire
Self-reported use of both hands in daily life activities

Full Information

First Posted
February 27, 2014
Last Updated
September 2, 2016
Sponsor
University of Bergen
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
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1. Study Identification

Unique Protocol Identification Number
NCT02079103
Brief Title
Virtual Reality Training for Upper Extremity After Stroke
Acronym
VIRTUES
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Virtual reality, Stroke, Arm motor function, Neurorehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality
Arm Type
Experimental
Arm 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.
Arm Title
Conventional arm training
Arm Type
Active Comparator
Arm Description
The patients receive supervised self-training exercises with focus on functional tasks adapted to their motor abilities.
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Other Intervention Name(s)
YouGrabber®
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional arm training
Intervention Description
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 Measure Information:
Title
Change in Action Research Arm Test score from baseline
Description
Assessment of changes in arm motor function from baseline to 3 months follow up
Time Frame
Baseline, after 4 weeks and at 3 months follow-up
Secondary Outcome Measure Information:
Title
Change in Box and Blocks Test score from baseline
Description
Assessment of dexterity
Time Frame
Baseline, after 4 weeks, and at 3 months follow-up
Title
Change in Functional Independence Measure from baseline
Description
Assessment of independence in daily life activities
Time Frame
Baseline, after 4 weeks, and 3 months follow-up
Title
ABILHAND questionnaire
Description
Self-reported use of both hands in daily life activities
Time Frame
After 4 weeks of intervention and at 3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Sture Skouen, MD, PhD
Organizational Affiliation
University of Bergen, Helse Vest
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Iris Brunner, PhD
Organizational Affiliation
University of Bergen, Helse Vest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Campus Sint-Ursula
City
Herk-de-Stad
ZIP/Postal Code
3540
Country
Belgium
Facility Name
Hammel Neurocenter
City
Hammel
ZIP/Postal Code
8450
Country
Denmark
Facility Name
Skive Neurorehabilitation
City
Skive
ZIP/Postal Code
7800
Country
Denmark
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Sunnaas Rehabilitation Hospital
City
Nesoddtangen
ZIP/Postal Code
1450
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
29142090
Citation
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.
Results Reference
derived
PubMed Identifier
27835977
Citation
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.
Results Reference
derived
PubMed Identifier
25261187
Citation
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.
Results Reference
derived

Learn more about this trial

Virtual Reality Training for Upper Extremity After Stroke

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