- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06413758
Attentional Focus in Virtual Reality
May 14, 2024 updated by: Aybike Senel, Istanbul University - Cerrahpasa (IUC)
Effect of Internal and External Focus on Balance Performance: Comparison of Virtual Reality and Real World Environment
The goal of this explorative observational study is to learn about the effect of internal and external focus on postural control in virtual reality and compare with the real world environment in young adults. The main question it aims to answer is:
Does attentional focus effect differently on postural control in virtual reality comparing to real world environment?
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Virtual Reality is used to improve postural control in various populations.
However, exercise with virtual reality glasses cause new challenges to the user in maintaining balance.
In this study, the effect of internal and external focus on postural control in the virtual reality environment will be revealed and compared with the performance in the real environment.
The results of the study will guide the customization and optimization of balance training programs implemented in the virtual reality environment.
A total of 38 healthy young adults will be included and allocated into Group I (Virtual Reality) or Group II (Real World) (ratio 1:1).
The balance performance of the participants will be assessed with single leg stance test and bipodal stance test.
The participants will be instructed to stand still and maintain balance on the forceplate in three conditions: (1) with an internal focus, (2) with an external focus, and (3) non-directional.
Conditions will be applied to the participants randomly to avoid bias.
Each condition will be measured three times and the mean values will be recorded as outcomes.
The total displacement of center of pressure (CoP), the mean velocity of CoP, the CoP area, total mediolateral (ML) displacement, the mean velocity in ML, total anteroposterior (AP) displacement and the mean velocity in AP will assessed with K-Force Plates (Kinvent, France).
Study Type
Observational
Enrollment (Estimated)
38
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aybike Şenel, PT, MSc
- Phone Number: 05315839924
- Email: Aybikesenel@hotmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
healthy young adults between the ages of 18-26
Description
Inclusion Criteria:
- Being a healthy individual between the ages of 18-26
- Lower extremity functional motor signs or sensory features should be normal or corrected
- No lower extremity injury within 6 months
- Not taking alcohol or medication 12 hours before
- Having no virtual reality experience
Exclusion Criteria:
- History of epilepsy, marked dissociative seizures
- Needing assistive devices to maintain upright posture
- Other comorbidities that may affect postural control (dizziness, vestibular disorders, orthopedic or cardiovascular comorbidities)
- Being an athlete
- Positive Fukuda stepping test
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Group I-Virtual Reality
In this group, participants will be in a virtual environment with a VR glass put on.
The balance performance of the participants will be assessed with single leg stance test and bipodal stance test.
The participants will be instructed to stand still and maintain balance on the forceplate in three conditions: (1) with an internal focus, (2) with an external focus, and (3) non-directional.
Conditions will be applied to the participants randomly to avoid bias.
Each condition will be measured three times and the mean values will be recorded as outcomes.
The total displacement of center of pressure (CoP), the mean velocity of CoP, the CoP area, total mediolateral (ML) displacement, the mean velocity in ML, total anteroposterior (AP) displacement and the mean velocity in AP will assessed with K-Force Plates (Kinvent, France).
|
Group II-Real World
The balance performance of the participants will be assessed with single leg stance test and bipodal stance test.
The participants will be instructed to stand still and maintain balance on the forceplate in three conditions: (1) with an internal focus, (2) with an external focus, and (3) non-directional.
Conditions will be applied to the participants randomly to avoid bias.
Each condition will be measured three times and the mean values will be recorded as outcomes.
The total displacement of center of pressure (CoP), the mean velocity of CoP, the CoP area, total mediolateral (ML) displacement, the mean velocity in ML, total anteroposterior (AP) displacement and the mean velocity in AP will assessed with K-Force Plates (Kinvent, France).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total displacement of center of pressure
Time Frame: baseline
|
Total displacement of center of pressure on the force plate
|
baseline
|
The mean velocity of center of pressure
Time Frame: baseline
|
the mean velocity of center of pressure on the force plate
|
baseline
|
The area of center of pressure
Time Frame: baseline
|
the area drawn by the movement of center of pressure on the force plate
|
baseline
|
total mediolateral displacement
Time Frame: baseline
|
total mediolateral displacement of center of pressure on the force plate
|
baseline
|
total anterolateral displacement
Time Frame: baseline
|
total anterolateral displacement of center of pressure on the force plate
|
baseline
|
the mean velocity in mediolateral
Time Frame: baseline
|
the mean velocity of total mediolateral displacement of center of pressure on the force plate
|
baseline
|
the mean velocity in anterolateral
Time Frame: baseline
|
the mean velocity of total anterolateral displacement of center of pressure on the force plate
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 15, 2024
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
July 15, 2024
Study Registration Dates
First Submitted
May 9, 2024
First Submitted That Met QC Criteria
May 9, 2024
First Posted (Actual)
May 14, 2024
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 14, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 06052024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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