Autism Spectrum DisorderVR4VRNCT02498262
Using Virtual Reality and Robotics Technologies for Vocational Evaluation, Training and Placement
A study testing Virtual Reality System in people with Autism Spectrum Disorder and Traumatic Brain Injury, run by University of South Florida at 1 site in United States.
Trial summary
Using Virtual Reality and Robotics Technologies for Vocational Evaluation, Training and Placement (VR4VR) is a project that incorporates Virtual Reality into job training to increase job opportunities for people who have physical or mental disabilities. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Traumatic Brain Injury
- What is being tested?
- Virtual Reality System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The general inclusion criteria are as follows:
- Adults of 18-60 years of age
- Participants must display the capacity to understand the objectives of each of the skill tasks below, that will take place in various virtual environments.
- Skill tasks:
- Cleaning skills such as vacuum cleaning, mopping and litter collection.
- Loading virtual boxes into back of a virtual truck using a haptic stick controller.
Show all 20Show fewer
- Fulfilling orders and deliveries in a virtual warehouse with tangible boxes.
- Navigating to different checkpoints in an outdoor virtual environment.
- Money management skills such as recognizing coin and bill amounts, counting money and giving correct amount of change to virtual customers.
- Communicating with virtual characters.
- Each target population will have additional inclusion criteria as follows:
- Autism Inclusion Criteria:
- High, medium or low functioning with the ability to verbally communicate with the research team
- Being able to perform basic gestures such as extending arms and walking in place
- Traumatic Brain Injury Inclusion Criteria:
- Participants will include individuals that have suffered a moderate to severe traumatic brain
- Participants must be deemed Rancho Los Amigos score of 7 or higher
- Being able to perform basic gestures such as extending arms and walking in place
- Severe Mobility and Manipulation Impairments Inclusion Criteria:
- Persons with spinal cord injury, muscle dystrophy, multiple sclerosis or cerebral palsy
Who cannot join
- The general exclusion criteria are as follows:
- Children less than 18 years of age
- Adults older than 60 years of age
- Pregnant women
- Participants unable to control a joystick
- Participants unable to verbally communicate
Show all 15Show fewer
- Each target population will have additional exclusion criteria as follows:
- Autism Exclusion Criteria:
- Participants unable to control a joystick
- Participants unable to verbally communicate
- Traumatic Brain Injury Exclusion Criteria:
- Participants unable to control a joystick
- Participants unable to verbally communicate
- Severe Mobility and Manipulation Impairments Exclusion Criteria:
- Participants unable to control a joystick
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Robotics & Prosthetics Testbed (RRT) Laboratory on the campus of the University of South Florida
Tampa, Florida, 33620
About this study
Using Virtual Reality and Robotics Technologies for Vocational Evaluation, Training and Placement (VR4VR) is a project that incorporates Virtual Reality into job training to increase job opportunities for people who have physical or mental disabilities. The investigators are using Virtual Reality and robotics for job evaluation, training and placement of people with disabilities. The investigators' goal is to assess and train people in a safe, adaptable, and fun virtual environment similar to a video game.
This is an interventional study with three target populations: autism spectrum disorder, traumatic brain injury, and severe mobility and manipulation impairments. The prototype system allows for a wide range of environments with the vocational evaluator easily controlling the virtual experience, while the job seekers interact realistically.
Read the detailed description
Study Procedures
If the participant takes part in this study, they will be asked to:
- Arrive at the Rehabilitation Robotics \& Prosthetics Testbed (RRT) building at the times agreed to between the participant, the job coach and the key research personnel.
- Use a virtual reality system that is like a large video game with the job coach.
- Complete some skill tasks in the virtual world video game:
- Cleaning skills such as vacuum cleaning, mopping and litter collection.
- Loading virtual boxes into back of a virtual truck.
- Fulfilling orders and deliveries with tangible boxes in a virtual warehouse.
- Navigating to different checkpoints in an outdoor virtual environment.
- Money management skills such as recognizing coin and bill amounts, counting money and giving correct amount of change to virtual customers.
- Communicating with virtual characters.
- These tasks will take place in non-real virtual environments such as: warehouse, grocery, parking lot, and outside.
- The job coach or counselor will be with the participant just as they would in a traditional job training.
- The researchers will ask the participant questions about what they liked and disliked about the virtual reality system video game. These questions can be asked directly or via a form.
- There will be 15 minutes break times every hour and the total time will be equal to the participant's normal job coach interactions.
- The participant will be asked to participate no more than 5 hours each day, up to 15 days. Number of training days will be decided by the participant, the job coach, and the research staff.
- Data related to the time and the performance from the start to the end of each task will be recorded at the background automatically.
- Audio/visual and/or video documentation of the study may be recorded. Video and photographic recordings will be used only to aid in presenting the study for academic purposes. All information will be kept anonymous.
- Subjects' screening will be performed by the subjects' therapists beforehand, who will decide whether the subject is eligible for this study or not, based on the investigators' inclusion/exclusion requirements.
- Total Number of Participants: Up to 100 people (Up to 50 individuals with disabilities and Up to 50 healthy individuals) will take part in this study.
A $50 gift card will be given to each participant on their first training session as a thank you gift and an incentive to participate in the study.
- Conditions
- Autism Spectrum Disorder, Traumatic Brain Injury
- Being tested
- Virtual Reality System
- Keywords
- Severe Mobility and Manipulation Impairments
- Medical subject headings
- Autism Spectrum Disorder, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality SystemOther
The participants will use a virtual reality system that is like a large video game and complete some job skill tasks in the virtual world video game.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Training System | Experimental | Not described Receives: Other: Virtual Reality System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in composite score of performing the vocational tasks of shelving, cleaning, environmental awareness, loading back of a truck, money management and social skills.
Measured: Completion of the training (maximum three months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department Of Education
- Responsible party
- Sponsor
- Investigators
- Redwan Alqasemi, Ph.D., Study director, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498262
- Sponsor's protocol ID
- Ame2_Pro00013008
- Acronym
- VR4VR
- Status last verified
- Sep 2018
- First submitted
- 25 Jun 2015
- Last updated
- 12 Jul 2019
- Results posted
- No
Publications
L. Bozgeyikli, E. Bozgeyikli, M. Clevenger, S. Gong, A. Raij, R. Alqasemi, S. Sundarrao, and R. Dubey, "VR4VR: Towards Vocational Rehabilitation of Individuals with Disabilities in Immersive Virtual Reality Environments," in proc. of Workshop on Virtual and Augmented Assistive Technologies (VAAT) at IEEE Virtual Reality 2014, Minneapolis, MN, April 2014.
E. Bozgeyikli, L. Bozgeyikli, M. Clevenger, A. Raij, R. Alqasemi, S. Sundarrao, and R. Dubey, "Poster: Design and Development of a Virtual Reality System for Vocational Rehabilitation of Individuals with Disabilities," IEEE Symposium on 3D User Interfaces 2014, Minneapolis, MN, April 2014.
L. Bozgeyikli, E. Bozgeyikli, M. Clevenger, S. Gong, A. Raij, R. Alqasemi, S. Sundarrao and R. Dubey, "Poster: A Virtual Reality System for Vocational Rehabilitation of Individuals with Disabilities," College of Engineering Research Day, Tampa, FL, November 2014.
E. Bozgeyikli, L. Bozgeyikli, M. Clevenger, A. Raij, R. Alqasemi, and R. Dubey, "Poster: A Virtual Reality System for Vocational Rehabilitation of Individuals with Disabilities," College of Engineering Research Day, Tampa, FL, November 2013.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Reality and Robotics Technologies for Vocational Evaluation, Training and Placement
- ClinicalTrials.gov ID
- NCT02498262
- Acronym / sponsor ID
- VR4VR / Ame2_Pro00013008
- Conditions
- Autism Spectrum Disorder, Traumatic Brain Injury
- Keywords
- Severe Mobility and Manipulation Impairments
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Florida Department Of Education
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using Virtual Reality and Robotics Technologies for Vocational Evaluation, Training and Placement (VR4VR) is a project that incorporates Virtual Reality into job training to increase job opportunities for people who have physical or mental disabilities. The investigators are using Virtual Reality and robotics for job evaluation, training and placement of people with disabilities. The investigators' goal is to assess and train people in a safe, adaptable, and fun virtual environment similar to a video game.
This is an interventional study with three target populations: autism spectrum disorder, traumatic brain injury, and severe mobility and manipulation impairments. The prototype system allows for a wide range of environments with the vocational evaluator easily controlling the virtual experience, while the job seekers interact realistically.
Detailed description
Study Procedures
If the participant takes part in this study, they will be asked to:
- Arrive at the Rehabilitation Robotics \& Prosthetics Testbed (RRT) building at the times agreed to between the participant, the job coach and the key research personnel.
- Use a virtual reality system that is like a large video game with the job coach.
- Complete some skill tasks in the virtual world video game:
- Cleaning skills such as vacuum cleaning, mopping and litter collection.
- Loading virtual boxes into back of a virtual truck.
- Fulfilling orders and deliveries with tangible boxes in a virtual warehouse.
- Navigating to different checkpoints in an outdoor virtual environment.
- Money management skills such as recognizing coin and bill amounts, counting money and giving correct amount of change to virtual customers.
- Communicating with virtual characters.
- These tasks will take place in non-real virtual environments such as: warehouse, grocery, parking lot, and outside.
- The job coach or counselor will be with the participant just as they would in a traditional job training.
- The researchers will ask the participant questions about what they liked and disliked about the virtual reality system video game. These questions can be asked directly or via a form.
- There will be 15 minutes break times every hour and the total time will be equal to the participant's normal job coach interactions.
- The participant will be asked to participate no more than 5 hours each day, up to 15 days. Number of training days will be decided by the participant, the job coach, and the research staff.
- Data related to the time and the performance from the start to the end of each task will be recorded at the background automatically.
- Audio/visual and/or video documentation of the study may be recorded. Video and photographic recordings will be used only to aid in presenting the study for academic purposes. All information will be kept anonymous.
- Subjects' screening will be performed by the subjects' therapists beforehand, who will decide whether the subject is eligible for this study or not, based on the investigators' inclusion/exclusion requirements.
- Total Number of Participants: Up to 100 people (Up to 50 individuals with disabilities and Up to 50 healthy individuals) will take part in this study.
A $50 gift card will be given to each participant on their first training session as a thank you gift and an incentive to participate in the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Training System | Experimental | Other: Virtual Reality System |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Adults of 18-60 years of age
- Participants must display the capacity to understand the objectives of each of the skill tasks below, that will take place in various virtual environments.
- Cleaning skills such as vacuum cleaning, mopping and litter collection.
- Loading virtual boxes into back of a virtual truck using a haptic stick controller.
- Fulfilling orders and deliveries in a virtual warehouse with tangible boxes.
Key exclusion criteria (15 listed)
- Children less than 18 years of age
- Adults older than 60 years of age
- Pregnant women
- Participants unable to control a joystick
- Participants unable to verbally communicate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality SystemThe participants will use a virtual reality system that is like a large video game and complete some job skill tasks in the virtual world video game. | Other | Virtual Reality Training System |
Primary outcome
Improvement in composite score of performing the vocational tasks of shelving, cleaning, environmental awareness, loading back of a truck, money management and social skills.
Time frame: Completion of the training (maximum three months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- BackgroundL. Bozgeyikli, E. Bozgeyikli, M. Clevenger, S. Gong, A. Raij, R. Alqasemi, S. Sundarrao, and R. Dubey, "VR4VR: Towards Vocational Rehabilitation of Individuals with Disabilities in Immersive Virtual Reality Environments," in proc. of Workshop on Virtual and Augmented Assistive Technologies (VAAT) at IEEE Virtual Reality 2014, Minneapolis, MN, April 2014.
- BackgroundE. Bozgeyikli, L. Bozgeyikli, M. Clevenger, A. Raij, R. Alqasemi, S. Sundarrao, and R. Dubey, "Poster: Design and Development of a Virtual Reality System for Vocational Rehabilitation of Individuals with Disabilities," IEEE Symposium on 3D User Interfaces 2014, Minneapolis, MN, April 2014.
- BackgroundL. Bozgeyikli, E. Bozgeyikli, M. Clevenger, S. Gong, A. Raij, R. Alqasemi, S. Sundarrao and R. Dubey, "Poster: A Virtual Reality System for Vocational Rehabilitation of Individuals with Disabilities," College of Engineering Research Day, Tampa, FL, November 2014.
- BackgroundE. Bozgeyikli, L. Bozgeyikli, M. Clevenger, A. Raij, R. Alqasemi, and R. Dubey, "Poster: A Virtual Reality System for Vocational Rehabilitation of Individuals with Disabilities," College of Engineering Research Day, Tampa, FL, November 2013.
Related trials for Autism Spectrum Disorder
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
RecruitingPhase 2
TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS
Autism Disorder
Not yet recruitingObservational study
EEG As a Genetic Selection Lever in Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Redwan Alqasemi, Ph.D. study director
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality System in people with Autism Spectrum Disorder and Traumatic Brain Injury, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in composite score of performing the vocational tasks of shelving, cleaning, environmental awareness, loading back of a truck, money management and social skills. (time frame: Completion of the training (maximum three months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02498262, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.