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

Primary Purpose

Hemispatial Neglect, Stroke

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
VR-method
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemispatial Neglect focused on measuring Stroke, rehabilitation, spatial neglect

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Clinical Neuroscience

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervention - control

Arm Description

15 hours ( 3 times a week in 5 weeks) intense visio spatial scanning training Virtual Reality-method

Outcomes

Primary Outcome Measures

Neglect assessment clinical and behavioural
Change in score in; Star cancellation test, Line Bisection, Baking tray task, Posner task, Extinction, Catherine Bergego scale (CBS)

Secondary Outcome Measures

Catherine Bergego scale
Change in score in a scale for spatial attention in daily life activities, self report from patient and relative

Full Information

First Posted
June 9, 2014
Last Updated
October 2, 2014
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT02258789
Brief Title
Assessment and Training Visio Spatial Neglect in a Virtual Reality Environment
Acronym
RehAtt
Official Title
Assessment and Training Visio Spatial Neglect in a Virtual Reality Environment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemispatial Neglect, Stroke
Keywords
Stroke, rehabilitation, spatial neglect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention - control
Arm Type
Experimental
Arm Description
15 hours ( 3 times a week in 5 weeks) intense visio spatial scanning training Virtual Reality-method
Intervention Type
Other
Intervention Name(s)
VR-method
Other Intervention Name(s)
RehAtt
Intervention Description
Neglect rehabilitation by intense scanning training and multi sensory stimuli using Virtual Reality
Primary Outcome Measure Information:
Title
Neglect assessment clinical and behavioural
Description
Change in score in; Star cancellation test, Line Bisection, Baking tray task, Posner task, Extinction, Catherine Bergego scale (CBS)
Time Frame
within 1 week after intervention
Secondary Outcome Measure Information:
Title
Catherine Bergego scale
Description
Change in score in a scale for spatial attention in daily life activities, self report from patient and relative
Time Frame
6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena Fordell, MD,
Organizational Affiliation
Department of Pharmacology and Clinical Neuroscience Umea University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Neuroscience
City
Umea
ZIP/Postal Code
903 21
Country
Sweden

12. IPD Sharing Statement

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