Virtual Reality Training for Upper Extremity After Stroke

NCT02079103 | Completed Phase 2

• 1 other identifier: UiB-228792
• Study Type: interventional
• Target: 120
• Locations: 3 countries
• Sites: 5

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.

Conditions

Stroke

Keywords

Virtual reality; Stroke; Arm motor function; Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in Box and Blocks Test score from baseline

  Baseline, after 4 weeks, and at 3 months follow-up

• Change in Functional Independence Measure from baseline

  Baseline, after 4 weeks, and 3 months follow-up

• ABILHAND questionnaire

  After 4 weeks of intervention and at 3 months follow-up

Study Arms (2)

Virtual reality

EXPERIMENTAL

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

Conventional arm training

ACTIVE COMPARATOR

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

Behavioral: Conventional arm training

Interventions

Virtual Reality DEVICE

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.

Also known as: YouGrabber®

Virtual reality

Conventional arm training BEHAVIORAL

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.

Conventional arm training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First ever ischemic or hemorrhagic stroke or former stroke without any residual motor impairment
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator
• Sunnaas Rehabilitation Hospital: collaborator
• Regionshospitalet Hammel Neurocenter: collaborator
• Regionshospitalet Viborg, Skive: collaborator
• KU Leuven: collaborator
• Jessa Hospital: collaborator
• The Research Council of Norway: collaborator
• Helse Vest: collaborator
• Norwegian Fund for Postgraduate Training in Physiotherapy: collaborator

Study Sites (5)

Rehabilitation Campus Sint-Ursula

Herk-de-Stad, 3540, Belgium

Location

Hammel Neurocenter

Hammel, 8450, Denmark

Location

Skive Neurorehabilitation

Skive, 7800, Denmark

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Sunnaas Rehabilitation Hospital

Nesoddtangen, 1450, Norway

Location

Related Publications (3)

• 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.

  PMID: 29142090 DERIVED

• 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.

  PMID: 27835977 DERIVED

• 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.

  PMID: 25261187 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jan Sture Skouen, MD, PhD

  University of Bergen, Helse Vest

  STUDY DIRECTOR

• Iris Brunner, PhD

  University of Bergen, Helse Vest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, PT

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 5, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 5, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

BE (1); DK (2); NO (2)