NCT05836038

Brief Summary

Investigators will evaluate the feasibility of "puppeting" a virtual hand with the opposite hand in increasing complex movements and the effect of visio-tactile stimuli on embodiment to determine if it is a necessary part of the process.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2024

Typical duration for not_applicable healthy

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

March 8, 2023

Last Update Submit

March 4, 2026

Conditions

Keywords

Virtual RealityVisio-tactile stimulationFeasibilityEmbodiment

Outcome Measures

Primary Outcomes (12)

  • Motor Performance - Speed

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

Study Arms (2)

Visio-tactile stimulation (VTS) during Virtual Reality

EXPERIMENTAL

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.

Behavioral: Visio-Tactile Stimulation

No Visio-Tactile Stimulation (NoVTS) during Virtual Reality

NO INTERVENTION

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

Interventions

They will see their virtual hand touched while simultaneously feel their opposite real hand touched in the same pattern.

Visio-tactile stimulation (VTS) during Virtual Reality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 30 adult participants (18+)
  • Right Handed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 8, 2023

First Posted

May 1, 2023

Study Start

October 1, 2024

Primary Completion

April 30, 2025

Study Completion

October 31, 2025

Last Updated

March 6, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share