Clinical trial NCT02079103: Virtual Reality Training for Upper Extremity After Stroke
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Virtual reality
Stroke
Arm motor function
Neurorehabilitation
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: Sunnaas Rehabilitation Hospital
name: Regionshospitalet Hammel Neurocenter
name: Regionshospitalet Viborg, Skive
name: KU Leuven
name: Jessa Hospital
name: The Research Council of Norway
name: Helse Vest
name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2014-03-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Action Research Arm Test score from baseline
timeFrame: Baseline, after 4 weeks and at 3 months follow-up
Secondary outcomes:
measure: Change in Box and Blocks Test score from baseline
timeFrame: Baseline, after 4 weeks, and at 3 months follow-up
measure: Change in Functional Independence Measure from baseline
timeFrame: Baseline, after 4 weeks, and 3 months follow-up
measure: ABILHAND questionnaire
timeFrame: After 4 weeks of intervention and at 3 months follow-up
Other outcomes:
Locations:
city: Herk-de-Stad
country: Belgium
facility: Rehabilitation Campus Sint-Ursula
city: Hammel
country: Denmark
facility: Hammel Neurocenter
city: Skive
country: Denmark
facility: Skive Neurorehabilitation
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Nesoddtangen
country: Norway
facility: Sunnaas Rehabilitation Hospital
Study officials:
affiliation: University of Bergen, Helse Vest
name: Jan Sture Skouen, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Bergen, Helse Vest
name: Iris Brunner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.