- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06836310
Effect of Virtual Reality Applied to a Task-Oriented Movement (VR-TOM)
The Effect of Virtual Reality Applied to a Task-Oriented Movement on the Upper Extremity for Healthy Individuals: Cross Over Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This description provides a summary of the key elements of the study protocol, focusing on the design, interventions, and general approach to evaluation. It does not include the full protocol document or detailed assessment procedures, which are available upon request.
This study is a randomized cross-over trial designed to investigate the acute effects of a task-oriented movement-based virtual reality (VR) application on upper extremity functions in healthy individuals. The primary aim is to evaluate the impact of VR-supported movement exercises on joint position sense (JPS), reaction time (RT), and gross manual dexterity.
The research involves 26 healthy participants who were randomly assigned to two intervention sequences:
Real Performance first (f-RP) group: Participants performed task-oriented movements in a real environment on the first day, followed by a VR-based task-oriented movement session on the second day.
Virtual Reality first (f-VR) group: Participants performed VR-based task-oriented movements on the first day, followed by a real environment session on the second day.
Each intervention lasted 10 minutes and included a task-oriented ball-throwing activity, where participants used repetitive wrist and upper limb movements to throw balls into a target pool placed 2 meters away. The VR intervention was delivered using the Oculus Quest 2 head-mounted display, with real-time visual, auditory, and tactile feedback integrated into the application. The real-world intervention matched the VR setup as closely as possible, including chair position, distance to the target, and ball size.
Assessments were conducted immediately before and after each intervention to observe acute effects. The primary focus was on changes in upper extremity functions and neuromuscular responses following task-oriented movements in VR and real environments.
Data were analyzed for within-group and between-group differences, as well as potential carryover and period effects, using parametric statistical methods appropriate for cross-over trials. The results indicated that VR-based task-oriented applications acutely enhanced reaction time and supported hand functions in healthy individuals. JPS measures remained stable across both intervention types, suggesting that VR-created movement perception can closely resemble real-world joint positioning.
These findings contribute to understanding the short-term effects of VR applications on upper extremity functions and support the potential for VR-based interventions in rehabilitation and performance enhancement.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Şehitkamil
-
Gaziantep, Şehitkamil, Turkey, 27350
- Gaziantep University, Faculty of Sport Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- to be over 18 years old,
- volunteering to participate in the study,
- having no upper extremity orthopedic disease (carpal tunnel syndrome, etc.).
Exclusion Criteria:
- not having an upper extremity injury in the last year,
- the presence of rheumatic disease,
- pregnancy,
- the presence of cervical disc herniation and thoracic outlet syndrome.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Real Performance First (f-RP)
Participants first performed the task-oriented movement in a real environment.
On the following day, they completed the same movement using a virtual reality (VR) system (Oculus Quest 2).
Joint Position Sense, Reaction Time, and Gross Manual Dexterity were measured before and after each intervention.
|
Participants performed a task-oriented movement in a real environment by throwing balls into a physical pool for 10 minutes.
The movement was designed to engage upper extremity function.
|
|
Experimental: Virtual Reality First (f-VR)
Participants first performed the task-oriented movement using a virtual reality (VR) system (Oculus Quest 2).
On the following day, they completed the same movement in a real environment.
Joint Position Sense, Reaction Time, and Gross Manual Dexterity were measured before and after each intervention.
|
Participants performed a task-oriented movement in a virtual environment using the Oculus Quest 2 VR system for 10 minutes.
The task involved throwing virtual balls into a virtual pool with real-time feedback.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reaction Time (RT) in milliseconds
Time Frame: Day 1 (immediately after intervention) and Day 2 (immediately after intervention)
|
Reaction time was measured using a mobile application ("Reaction Time Test" app) before and after the intervention.
Participants tapped the screen as quickly as possible when a visual stimulus appeared.
The average reaction time (in milliseconds) over 25 trials was recorded.
|
Day 1 (immediately after intervention) and Day 2 (immediately after intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Joint Position Sense (JPS) measured in degrees
Time Frame: Day 1 (immediately after intervention) and Day 2 (immediately after intervention)
|
Joint position sense was evaluated using a universal goniometer for both shoulder and wrist proprioception.
Participants were asked to reproduce specific joint angles without visual feedback, and the absolute angular error (in degrees) was recorded.
|
Day 1 (immediately after intervention) and Day 2 (immediately after intervention)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- GAUN-SBF-PANCAR-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
De-identified participant data will be available to researchers conducting related studies in the fields of virtual reality, motor control, proprioception, and reaction time.
The shared data will include:
Reaction time (RT) measurements Joint position sense (JPS) measurements Box and Block Test (BBT) scores How can they access it?
Researchers must submit a formal request explaining their research purpose and how they plan to use the data.
Requests should be sent via email to [z_pancar@hotmail.com]. URL will be available upon data publication on OSF. Approved researchers will receive access to the de-identified dataset via the Open Science Framework (OSF) repository.
A direct link to the dataset will be provided upon approval.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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