- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05836038
VR, Visio-tactile Stimulation and Embodiment
Creating Embodiment in Virtual Reality: A Pilot Study Evaluating Visio-tactile Stimulation and Feasibility
Study Overview
Detailed Description
Embodiment refers to a subjective experience where a person views a simulated body and its properties are experienced as if they were the person's own biological body (1). Embodiment is notably seen in the rubber hand illusion (2): a rubber hand is made to substitute for the real hand using visio-tactile stimulation to connect the rubber hand to the participant. In visio-tactile stimulation, the real hand is hidden from view and the rubber hand is positioned where the real hand should be. Both hands are simultaneously stroked while the participant views the rubber hand. Within a short time, the rubber hand "feels" touch and pain, independent of the real hand.
In this study investigators will evaluate the ability to enable embodiment in a virtual reality environment. After providing background information, participants will then complete the "Real Hand Session" of the Study Protocol (See below) using their real hand to move the same side virtual hand (e.g. left real hand movements will move left virtual hand). Participants will complete Usability and Embodiment /Presence surveys After the Actual Protocol, participants in the VTS group will receive visio-tactile stimuli. They will see their virtual hand touched while simultaneously feel their opposite real hand touched in the same pattern. Participants in the NoVTS will spend the same amount of time looking at their virtual hand without the touching (~1 minute).
For the "Puppet Session" participants will complete the same tasks as the "Real Hand Session"(See Below) but movement of the real hand will "puppet" the opposite virtual hand (right real hand movements will move left virtual hand). After completing the session participants will complete Usability and Embodiment /Presence surveys
Study Protocol Sessions.(20 to 30 minutes). All take place in the virtual environment Hand Movement- Press a 36-button sequence 4x Bilateral Task - "Catch" 36 "fireflies" with both hands 4x. Unilateral Task - "Catch 36 "fireflies" with one hand 4x. Avoidance Task - Press a 36-button sequence. A "dangerous" virtual obstacle (e.g., sawblade) will be placed in the path of the virtual hand during some of the trajectories. Investigators will see how far from the most efficient trajectory participants moves to avoid the object
Hypotheses H1: Participants will demonstrate a greater sense of embodiment with visio-tactile stimuli (VTS) than without visio-tactile stimuli (NoVTS) H1a: Participants in the VTS group will report higher levels of embodiment than those in the NoVTS group.
H1b: Participants will demonstrate significantly better motor performance in the VTS group than the NoVTS group.
H1c: Participants in the VTS group will demonstrate greater avoidance of "dangerous items" than those in the NoVTS group H1d: Participants in the VTS group will report better usability of the embodied virtual hand than those in the NoVTS group.
H2: Motor Performance of the "Puppeted" virtual hand will be similar to the "Actual" virtual hand.
Study Type
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• 30 adult participants (18+)
- Right Handed
Exclusion Criteria:
Seizure, loss of awareness, or other symptom linked to an epileptic condition in the last 5 years
- Blind;
- Unable to use hands to reach and grasp items
- Implanted medical device such as a pacemaker, defibrillator, or hearing aid.
- Contagious disorder on the face (such as pink eye) that could be transmitted via the VR head set or has open areas on the face or head that would come in contact with the headset;
- Unable to understand and respond to English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Visio-tactile stimulation (VTS) during Virtual Reality
Participants in this group will receive visio-tactile stimulation prior to engaging with the VR program.
They will see their virtual hand touched while simultaneously feel their opposite real hand touched in the same pattern.
|
They will see their virtual hand touched while simultaneously feel their opposite real hand touched in the same pattern.
|
|
No Intervention: No Visio-Tactile Stimulation (NoVTS) during Virtual Reality
Participants in this group will not receive visio-tactile stimulation prior to engaging with the VR program.
They will be asked to look at their virtual hands for approximately the same amount of time as the VST group receive their stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor Performance - Speed
Time Frame: Through study completion, 1 day
|
We will track and store participant movements during each task via the VR headset.
These movements will be downloaded and processed to calculate speed
|
Through study completion, 1 day
|
|
Motor Performance - Velocity
Time Frame: Through study completion, 1 day
|
We will track and store participant movements during each task via the VR headset.
These movements will be downloaded and processed to calculate velocity
|
Through study completion, 1 day
|
|
Motor Performance - Precision
Time Frame: Through study completion, 1 day
|
We will track and store participant movements during each task via the VR headset.
These movements will be downloaded and processed to calculate Precision
|
Through study completion, 1 day
|
|
Motor Performance - Trajectory
Time Frame: Through study completion, 1 day
|
We will track and store participant movements during each task via the VR headset.
These movements will be downloaded and processed to calculate trajectory
|
Through study completion, 1 day
|
|
Motor Performance - Path Length
Time Frame: Through study completion, 1 day
|
We will track and store participant movements during each task via the VR headset.
These movements will be downloaded and processed to calculate path length
|
Through study completion, 1 day
|
|
Motor Performance - Time to Target
Time Frame: Through study completion, 1 day
|
We will track and store participant movements during each task via the VR headset.
These movements will be downloaded and processed to calculate Time to target
|
Through study completion, 1 day
|
|
Motor Performance - Error rate
Time Frame: Through study completion, 1 day
|
We will track and store participant movements during each task via the VR headset.
These movements will be downloaded and processed to calculate error rate
|
Through study completion, 1 day
|
|
Embodiment
Time Frame: Through study completion, 1 day
|
Participants perception of immersion during VR experience: Using Peck's Embodiment Scale (16 items scored on a 7 point likert scale with a final score between 1 and 7 with a higher score indicating greater emobidment) and the IPQ Presence questionnaire (14 items on a 7 point likert scale with a higher score indicating greater embodiment)
|
Through study completion, 1 day
|
|
Presence
Time Frame: Through study completion, 1 day
|
Participants perception of immersion during VR experience: IPQ Presence questionnaire (14 items on a 7 point likert scale with a score between 7 and 98 and a higher score indicating greater presence)
|
Through study completion, 1 day
|
|
Usability - Engagement
Time Frame: Through study completion, 1 day
|
Participants perception of the ease of use of the VR system using the User Engagement Scale (a 12 item 1-5 pt likert scale with scores between 12 and 60 and a higher score indicating greater usability)
|
Through study completion, 1 day
|
|
Usability - Task Demands
Time Frame: Through study completion, 1 day
|
Participants perception of the ease of use of the VR system using the NASA Task Index (6-item scored on 10 point VAS.
Items are weighted by subject perception of what is important part of task.
Higher score indicates greater task demand)
|
Through study completion, 1 day
|
|
Usability - ease of use
Time Frame: Through study completion, 1 day
|
Participants perception of the ease of use of the VR system using the System Usability Scale (10 item scored on 1-5 likert, scores are converted to a 100 scale with a higher score indicating greater ease of use)
|
Through study completion, 1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HM&E123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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