NCT06151093

Brief Summary

The aim of our study is to examine the effects of balance exercises performed in virtual and real environments on visual-spatial attention and mental rotation in healthy young adult individuals using EEG brain oscillations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 8, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

November 21, 2023

Last Update Submit

June 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • EEG - event related oscillations

    In our research, EEG recordings will be made with the Brain Vision Recorder (Brainproduct, Munich, Germany) device. Recording will be made on 30 channels with 0.1-250 Hz band pass and 500 sample rate features. An elastic cap with 32 Ag-AgCl electrode placement will be used as the cap. The placement of electrodes will be made according to the international 10-20 system and includes FP1, FP2, F7, F3, FZ, F4, F8, FT7, FC3, FCZ, FC4, FT8, T7, C3, CZ, C4, T8, TP7, CP3, CPZ. Recordings will be taken from the electrodes CP4, TP8, P7, P3, PZ, P4, P8, O1, OZ and O2. Additionally, two connected electrodes (A1+A2) will be placed on the front of both earlobes as a reference, and the ground electrode will be placed on the back of the right earlobe. In addition, electrodes placed in the medial upper part and lateral orbital part of the left eye will be used for EOG recording. During shooting, care will be taken to ensure that the impedance values of the electrodes are below 10 kΩ.

    Baseline-6 week

Study Arms (2)

Video-based balance games group

EXPERIMENTAL
Other: Video-based games intervention

Balance exercises group

EXPERIMENTAL
Other: Balance exercises

Interventions

These games are applied via using Nintendo Wii 1st - 2nd Week Applications * Basic Step * Penguin slide (right-left weight transfer) * Snowball flight (right-left weight transfer) * Tilt city (right-left weight transfer) 3rd-4th Week Applications * Advanced Step * Snowball flight (right-left weight transfer) * Penguin slide (right-left weight transfer) * Table tilt (weight transfer in 4 directions) 5th-6th Week Applications * Advanced Step * Table tilt (weight transfer in 4 directions) * Balance bubble (weight transfer to 4 directions) * Ski slalom (weight transfer in 4 directions)

Video-based balance games group

1st-2nd Week Applications On a flat-hard surface; * Standing on 2 legs * Stepping forward and backward (separately for both feet) * Getting into the tandem position and maintaining the position (separately for both feet) * Standing on one leg (separately for both feet) * Weight transfer in four directions * Taking a step back towards the step * Stepping on the stability ball 3rd-4th Week Applications All exercises which applied in 1st and 2nd week are applied on mat. 5th-6th Week Applications On the balance board; * Standing on 2 legs * Stepping forward and backward (separately for both feet) * Getting into the tandem position and maintaining the position (separately for both feet) * Standing on one leg (separately for both feet) * Weight transfer in four directions * Catching balls thrown by the enforcer

Balance exercises group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • There wouldn't be any neurological conditions
  • There wouldn't be drug use such as psychiatric drug
  • There wouldn't be lower extremity surgery
  • There wouldn't be epilepsy
  • Be healthy
  • Take minimum 68 points of System Usability Scale

You may not qualify if:

  • Neurologic disorder
  • Epilepsy
  • Active sport life
  • Colour blindness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34820, Turkey (Türkiye)

Location

Study Officials

  • Bahar Güntekin, Prof. Dr.

    Medipol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, MSc

Study Record Dates

First Submitted

November 21, 2023

First Posted

November 30, 2023

Study Start

September 8, 2023

Primary Completion

June 3, 2024

Study Completion

June 5, 2024

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations