Virtual Reality Training for Upper Extremity After Stroke

Phase 2

Completed

• Conditions: Stroke
• Interventions: Device: Virtual Reality; Behavioral: Conventional arm training

• Registration Number: NCT02079103
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-02-27
• Study Start: 2014-03
• Study First Submitted QC: 2014-03-01
• Study First Posted: 2014-03-05
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality	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.
Conventional arm training	Conventional arm training	The patients receive supervised self-training exercises with focus on functional tasks adapted to their motor abilities.

Primary Outcome Measures

Name	Time	Method
Change in Action Research Arm Test score from baseline	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

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

Trial Locations

Locations (5)

Hammel Neurocenter; 🇩🇰 Hammel, Denmark

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Sunnaas Rehabilitation Hospital; 🇳🇴 Nesoddtangen, Norway

Rehabilitation Campus Sint-Ursula; 🇧🇪 Herk-de-Stad, Belgium

Skive Neurorehabilitation; 🇩🇰 Skive, Denmark