## Protocol Section
### Identification Module
**NCT ID:** NCT06413758

**Brief Title:** Attentional Focus in Virtual Reality

**Official Title:** Effect of Internal and External Focus on Balance Performance: Comparison of Virtual Reality and Real World Environment

#### Organization Study ID Info
**ID:** 06052024
#### Organization
**Class:** OTHER
**Full Name:** Istanbul University - Cerrahpasa (IUC)
### Status Module
#### Completion Date
**Date:** 2024-07-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istanbul University - Cerrahpasa (IUC)

#### Responsible Party

**Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC)

**Investigator Full Name:** Aybike Senel

**Investigator Title:** Research assistant, PT, PhD(c)

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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?

**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).

### Conditions Module

**Conditions:**

- Attentional Focus in Virtual Reality

**Keywords:**

- Postural Control

- Virtual Reality

- Focus of Attention

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 38

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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).

**Label:** Group I-Virtual Reality

#### Arm Group 2

**Description:** 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).

**Label:** Group II-Real World

### Outcomes Module

#### Primary Outcomes

**Description:** Total displacement of center of pressure on the force plate

**Measure:** Total displacement of center of pressure

**Time Frame:** baseline

**Description:** the mean velocity of center of pressure on the force plate

**Measure:** The mean velocity of center of pressure

**Time Frame:** baseline

**Description:** the area drawn by the movement of center of pressure on the force plate

**Measure:** The area of center of pressure

**Time Frame:** baseline

**Description:** total mediolateral displacement of center of pressure on the force plate

**Measure:** total mediolateral displacement

**Time Frame:** baseline

**Description:** total anterolateral displacement of center of pressure on the force plate

**Measure:** total anterolateral displacement

**Time Frame:** baseline

**Description:** the mean velocity of total mediolateral displacement of center of pressure on the force plate

**Measure:** the mean velocity in mediolateral

**Time Frame:** baseline

**Description:** the mean velocity of total anterolateral displacement of center of pressure on the force plate

**Measure:** the mean velocity in anterolateral

**Time Frame:** baseline

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 26 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**Study Population:** healthy young adults between the ages of 18-26

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Aybikesenel@hotmail.com

**Name:** Aybike Şenel, PT, MSc

**Phone:** 05315839924

**Role:** CONTACT

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
