Condition category
Not Applicable
Date applied
14/08/2017
Date assigned
06/09/2017
Last edited
06/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Everton Silva de Souza

ORCID ID

Contact details

Rua Nove de Julho
73 apto 52
Santos/SP - Marapé
Santos
11070-151
Brazil
+55 (0)13 98143 0004
eevesou@me.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BrainChair2017

Study information

Scientific title

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

Acronym

Study hypothesis

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

University Federal of Uberlandia, 09/05/2017, ref: CAAE: 68117717.0.0000.5152

Study design

Non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/05/2017

Overall trial end date

13/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Blind wheelchair users aged over 18

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

10

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

20/06/2017

Recruitment end date

01/07/2017

Locations

Countries of recruitment

Brazil

Trial participating centre

Associação de Apoio a Criança Deficiente (AACD)
02037-001
Brazil

Sponsor information

Organisation

Universidade Federal de Uberlândia

Sponsor details

Campus Santa Mônica Bloco 3N – Sala114
Av. João Naves de Ávila 2121
Uberlândia
+55 (0)38408 100
Brazil
3239-4707
copel@ufu.br

Sponsor type

University/education

Website

www.ufu.br

Funders

Funder type

University/education

Funder name

Universidade Federal de Uberlândia

Alternative name(s)

"Federal University of Uberlandia", UFU

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Brazil

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
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.

Intention to publish date

13/08/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes