Virtual Reality Training for Upper Extremity After Stroke

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079103
• Other study ID #: UiB-228792
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2014
• Last updated: September 2, 2016
• Start date: March 2014
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardDenmark: Ethics CommitteeNorway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.

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.

Locations

Country	Name	City	State
Belgium	Rehabilitation Campus Sint-Ursula	Herk-de-Stad
Denmark	Hammel Neurocenter	Hammel
Denmark	Skive Neurorehabilitation	Skive
Norway	Haukeland University Hospital	Bergen
Norway	Sunnaas Rehabilitation Hospital	Nesoddtangen

Sponsors (10)

Lead Sponsor	Collaborator
University of Bergen	Haukeland University Hospital, Helse Vest, Jessa Hospital, Katholieke Universiteit Leuven, Norwegian Fund for Postgraduate Training in Physiotherapy, Regionshospitalet Hammel Neurocenter, Regionshospitalet Viborg, Skive, Sunnaas Rehabilitation Hospital, The Research Council of Norway

Countries where clinical trial is conducted

Belgium,  Denmark,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Box and Blocks Test score from baseline	Assessment of dexterity	Baseline, after 4 weeks, and at 3 months follow-up	No
Secondary	Change in Functional Independence Measure from baseline	Assessment of independence in daily life activities	Baseline, after 4 weeks, and 3 months follow-up	No
Secondary	ABILHAND questionnaire	Self-reported use of both hands in daily life activities	After 4 weeks of intervention and at 3 months follow-up	No