Assessment and Training Visio Spatial Neglect in a Virtual Reality Environment (RehAtt)

October 2, 2014 updated by: Umeå University

There is a lack of effective rehabilitation methods for visio-spatial neglect (VSN). By using virtual technology, a new method (virtual reality, VR method) has been created which focuses on stimulating attention networks: top down scanning training in a 3D game, combined with intense visual, audio and tactile bottom-up stimulation, also including visuo-motor training.

Objective. To evaluate clinical and functional improvement in stroke patients with VSN, as well as before and after training with the new VR method Method:- An intense visio spatial scanning training, enhanced by directed visual, audio and tactile stimulation cues and feedback, also including visio-motor activation was designed in a VR game. The in-house developed software was based on the Tetris game. The VR method consists of an interactive 3D environment: a desktop computer, a monitor, 3D glasses and a force feedback interface. 15 patients with chronic (>6 months) visio spatial neglect was included due to right-sided ischemia. A VR neglect test battery including a Posner task were repeated three times during a 5 weeks baseline before the training started (to establish the chronic state) and again after 15 hours training (3x1 h for 5 weeks). Evaluation of a new method for training attention after stroke causing visio spatial neglect.

The method has been designed for home rehabilitation and is well suited for a tele-medicine approach. It was built with standard components and is easy to manufacture at a low cost. The idea is to give access to effective training, to make it available at the stroke unit with the possibility for the patient to loan it it at discharge for home rehabilitation. The concept of an all in one, easy-to-use device for testing, training and outcome evaluation should be beneficial These preliminare results has been promising and indicates that the RehAtt™ method could become an further developed into an effective and stimulating intervention tool that would lower rehabilitation costs and reduce tiresome travelling to hospitals for training.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

A VR environment was used training (RehAtt) of post-stroke patients with neglect. Patients played the VR games three times a week for five weeks, totally 15 hours.

A neglect test battery five neglect tests was repeated three times during a five week baseline to estabish a chronic state and reduce the test by test learning effect, then again after the 5 weeks training period. The main outcome results were thereafter obtained by comparing the 5 neglect tests: Star cancellation test, Baking Tray Task, Line Bisection,, Extinction and Posner task - unified index by SPSS Repeated Measurement ANOVA from the 3 baseline visits to the results after intervention. The Catherine Bergego neglect scale was used to assess activities in daily life before and after intervention as well as after six months.

Patients were included if they had a neglect that had persisted for more than six months after a right sided ishemic stroke.

Neglect was diagnosed if one or more of the four neglect subtests of the VR test battery was below cut off (See below and Appendix for details).

The exclusion criteria were severe visual impairment, severe medical illness, severe depression or cognitive dysfunction (MMSE ≤ 23 points). All patients received oral and written information with an informed and signed consent. The Umeå university ethics review board (IRB) approved the study (2010-266-31M).

The hardware consists of a standard PC, a video graphics card, a sound card, headphones and a separate numeric keyboard to measure behavioural responses. In the VR test part, we used a 19" CRT monitor and shutter glasses for stereoscopic vision. A 27" monitor and 3D vision glasses (Nvidia, Santa Clara, CA, USA) replaced them in the VR game part. A robotic pen (Phantom omni haptic device, Sensable technologies, Wilmington, USA) was used as a pointer using the right hand for assessment activities and the paretic left hand when playing the VR game for intervention.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Umea, Sweden, 903 21
        • Department of Clinical Neuroscience

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Neglect > 6 months and after regular rehabilitation Stroke due to right sided ischemic infarcts

Exclusion Criteria:

  • Severe visual impairment, severe medical illness, severe depression or cognitive dysfunction (MMSE ≤ 23 points).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention - control
15 hours ( 3 times a week in 5 weeks) intense visio spatial scanning training Virtual Reality-method
Neglect rehabilitation by intense scanning training and multi sensory stimuli using Virtual Reality
Other Names:
  • RehAtt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neglect assessment clinical and behavioural
Time Frame: within 1 week after intervention
Change in score in; Star cancellation test, Line Bisection, Baking tray task, Posner task, Extinction, Catherine Bergego scale (CBS)
within 1 week after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catherine Bergego scale
Time Frame: 6 month follow up
Change in score in a scale for spatial attention in daily life activities, self report from patient and relative
6 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Helena Fordell, MD,, Department of Pharmacology and Clinical Neuroscience Umea University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

October 2, 2014

First Posted (Estimate)

October 7, 2014

Study Record Updates

Last Update Posted (Estimate)

October 7, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • UmeaU ClinNeuro HF Neglect
  • UMU-2010-266-31M (Other Grant/Funding Number: Umea University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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