A virtual environment-based training system for the blind wheelchair user through use of 3D audio supported by EEG

ISRCTN	ISRCTN14024663
DOI	https://doi.org/10.1186/ISRCTN14024663
Secondary identifying numbers	BrainChair2017

Submission date: 14/08/2017
Registration date: 06/09/2017
Last edited: 06/09/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
People with physical and visual disability sometimes are not able to do tasks independently. Wheelchair users sometimes have difficulty moving around in their wheelchair, especially if they have visual problems. According to the Brazilian Association of Physical Medicine and Rehabilitation (2012), the use of wheelchairs for daily activities can be helpful for rehabilitation and the training is done using wheelchairs. These devices can be adapted using technology to improve the quality of life of the users. Virtual Reality can be used to create an artificial (fake) environment that can be helpful for training blind wheelchair users. The aim of this study is to see if virtual technology and EEG technology, applies to the training context of blind wheelchair users, has the potential to assist them in mobility and to evaluate the behavior of people when using the system.

Who can participate?
Adults aged 18 and older who are blind and use wheelchairs.

What does the study involve?
Participants are told about the study and provide consent. They then fill out a questionnaire in order to get information about the virtual reality system. Participant then use the system for around 30 and 60 minutes. They then complete another questionnaire about the use of the system and their behaviour in order to see if there are any improvements or errors that need to be addressed.

What are the possible benefits and risks of participating?
Participants may benefit from facilitating mobility and accessibility of people who have physical and visual disability through assisted technology. There are risks that participants may have their identity revealed without their authorization.

Where is the study run from?
Associacao de Apoio a Crianca Deficiente (AACD) (Brazil)

When is the study starting and how long is it expected to run for?
May 2017 to August 2017

Who is funding the study?
Universidade Federal de Uberlandia (Brazil)

Who is the main contact?
Mr Everton Silva de Souza

Contact information

Mr Everton Silva de Souza
Scientific

Rua Nove de Julho, 73 apto 52
Santos/SP - Marapé
Santos
11070-151
Brazil

Phone	+55 (0)13 98143 0004
Email	eevesou@me.com

Study information

Study design	Non-randomised study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Community
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A virtual environment-based training system for the blind wheelchair user through use of 3D audio supported by EEG
Study objectives	The aim of this study is to investigate whether Virtual Reality and EEG technology, applied to the training context of blind wheelchair users, has the potential to assist them in mobility, and to evaluate the behavior of people when using the system.
Ethics approval(s)	University Federal of Uberlandia, 09/05/2017, ref: CAAE: 68117717.0.0000.5152
Health condition(s) or problem(s) studied	User BCI Emotiv Epoc with adapted wheelchair
Intervention	The proposed path for the research will be: 1. Presentation of the research proposal, clarification as to its importance, and the invitation to the individuals and the responsible ones so that the people are collaborators, in the first moment 2. Read and explain the Term of Free and Informed Consent, together with the collection of signatures of the responsible and the individuals, in the second meeting 3. Application of a questionnaire with the purpose of knowing the profile of individuals and collecting information relevant to the development of the system 4. Use of the system in the association. The user will the System Virtual Brain Chair between 30 and 60 minutes. The system is composed of wheelchair adapted and integrated with Emotiv Epoc and Virtual Environment for replicated the movements. 5. Application of the questionnaire after use of the system 6. Analysis of the evaluation of the results obtained. It is important to point out that the individual can detect possible errors or needs for improvement of the tool which will feed back the process of analysis and development of the tool.
Intervention type	Other
Primary outcome measure	1. The patient satisfaction is measured using the experience of patient and doctors that participate in the sessions with questionnaires and feedback as well as validation of time for execution of movements, percentage of correct movements and the quality of experience control 2. The viability of project is measured by assessing the validity of movements using EEG and Facial expressions, use of stereo sound for orientation and commands of movememnts, if the Virtual Environment support the doctors for validiting the movements and the immersion of blind users with Sound 3D
Secondary outcome measures	Sync between 3D interface, hardware and real movements with patients is assessed using the wheelchair adaopted integrated with Emotiv Epoch, trying to move the wheelchair with brainwaves (EEG), check if the movement is correct and examining the movements if they are oriented by sound and sync between Virtual Environment, Brainwaves and Wheelchair integration.
Overall study start date	01/05/2017
Completion date	13/08/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	10
Key inclusion criteria	Blind wheelchair users aged over 18
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	20/06/2017
Date of final enrolment	01/07/2017

Locations

Countries of recruitment

Brazil

Study participating centre

Associação de Apoio a Criança Deficiente (AACD)

02037-001
Brazil

Sponsor information

Universidade Federal de Uberlândia
University/education

Campus Santa Mônica Bloco 3N – Sala114
Av. João Naves de Ávila 2121
Uberlândia
+55 (0)38408 100
Brazil

Phone	3239-4707
Email	copel@ufu.br
Website	www.ufu.br
"ROR"	https://ror.org/04x3wvr31

Funders

Funder type

University/education

Universidade Federal de Uberlândia
Government organisation / Local government

Alternative name(s): Federal University of Uberlandia, UFU
Location: Brazil

Results and Publications

Intention to publish date	13/08/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a publically available repository at www.ufu.br digital library for 10 years for free. The data will be anonymised based on legal restriction.