EEG Brain OscillationsNCT06151093
The Effect of Balance Exercises on Cognitive Function
A study testing Video-based games intervention and Balance exercises in people with EEG Brain Oscillations and Balance Exercises, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- EEG Brain Oscillations, Balance Exercises
- What is being tested?
- Video-based games intervention and Balance exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Sep 2023to 5 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Neurologic disorder
- Epilepsy
- Active sport life
- Colour blindness
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34820
About this study
Official title: Investigating the Effects of Video-Based Balance Games and Balance Exercises on Visual-Spatial Attention With EEG Brain Oscillations
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.
- Conditions
- EEG Brain Oscillations, Balance Exercises
- Being tested
- Video-based games intervention, Balance exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based games interventionOther
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)
Balance exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Video-based balance games group | Experimental | Not described Receives: Other: Video-based games intervention |
| Balance exercises group | Experimental | Not described Receives: Other: Balance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline-6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start8 Sep 2023
- Primary completion3 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EEG Brain OscillationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, yasin yildirim, Istanbul Medipol University Hospital
- Investigators
- Bahar Güntekin, Prof. Dr., Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151093
- Sponsor's protocol ID
- E-10840098-772.02.7781
- Status last verified
- Jun 2024
- First submitted
- 21 Nov 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Video-Based Balance Games and Balance Exercises on Visual-Spatial Attention With EEG Brain Oscillations
- ClinicalTrials.gov ID
- NCT06151093
- Acronym / sponsor ID
- E-10840098-772.02.7781
- Conditions
- EEG Brain Oscillations, Balance Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-based balance games group | Experimental | Other: Video-based games intervention |
| Balance exercises group | Experimental | Other: Balance exercises |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Neurologic disorder
- Epilepsy
- Active sport life
- Colour blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-based games interventionThese 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) | Other | Video-based balance games group |
| Balance exercises1st-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 | Other | Balance exercises group |
Primary outcome
EEG - event related oscillations
Time frame: Baseline-6 week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bahar Güntekin, Prof. Dr. study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-based games intervention and Balance exercises in people with EEG Brain Oscillations and Balance Exercises, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG - event related oscillations (time frame: Baseline-6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.