HealhtyNCT07433608
Video Game Intervention In Older Adults
A study testing Game-Based Virtual Reality Intervention in people with Healhty and Aging, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical trial is to investigate the effects of a rehabilitative game-based intervention on self-efficacy, balance, and visual-motor integration in individuals aged 60 years and older. Read more about this study
- Who is it for?
- Ages 60 to 69 years, women onlyHealthy volunteers can take part
- What is being tested?
- Game-Based Virtual Reality Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2026to 7 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 years or older A score of 24 or higher on the Mini Mental State Examination (MMSE) Ability to understand and follow verbal instructions Willingness to participate voluntarily
Who cannot join
- Presence of a neurological, orthopedic, or psychiatric diagnosis Medical contraindications to exercise Diagnosis of dementia Acute orthopedic injury Visual or hearing impairment that would interfere with participation Inability to attend sessions regularly
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Biruni University
Istanbul, Zeytinburnu
Remziye A Akarsu, Assistant Professor, +90 544 439 30 91, rakarsu@biruni.edu.tr
About this study
Official title: The Effects Of A Video-Based Game Intervention On Cognitive, Physical And Psychosocial Outcomes In Older Adults
The purpose of this clinical trial is to investigate the effects of a rehabilitative game-based intervention on self-efficacy, balance, and visual-motor integration in individuals aged 60 years and older.
The primary research questions are:
Read more
Does the rehabilitative game-based intervention improve balance and visual-motor integration? Does the rehabilitative game-based intervention improve self-efficacy levels?
Researchers will compare a rehabilitative game intervention group with a control group. Participants will complete baseline and post-intervention assessments. Individuals in the intervention group will participate in rehabilitative game sessions twice per week for 6 weeks, while the control group will not receive any intervention.
Read the detailed description
This study is a randomized controlled experimental trial designed to examine the effects of a rehabilitative game-based intervention on self-efficacy, balance, and visual-motor integration in individuals aged 60 years and older. The study will be conducted using a two-group parallel design.
Participants who meet the inclusion criteria will be randomly assigned to either the intervention group or the control group. All participants will complete baseline assessments before the intervention period and post-intervention assessments after the completion of the study.
Participants in the intervention group will receive rehabilitative game-based training using the BeCure system. The intervention will last for 6 weeks, with sessions conducted twice per week. Each session will last approximately 30 minutes. The sessions will include structured interactive tasks targeting balance, coordination, and visual-motor integration.
Participants in the control group will not receive any intervention during the study period and will only participate in baseline and post-intervention assessments.
The primary outcomes of the study are balance performance, visual-motor integration and self-efficacy. These variables will be evaluated by comparing pre-intervention and post-intervention measurements within and between groups. The study procedures will be carried out according to the planned intervention protocol and standardized assessment procedures.
- Conditions
- Healhty, Aging, Balance, Self Efficacy, Visual Motor Integration
- Being tested
- Game-Based Virtual Reality Intervention
- Keywords
- Virtual Reality, Visual-Motor Integration, Older Adults, Balance, Self-Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game-Based Virtual Reality InterventionOther
The intervention consists of a structured rehabilitative game-based training program delivered using the BeCure system. The program includes interactive tasks that require active weight shifting, postural control, coordinated upper and lower extremity movements, and visually guided motor responses.
The intervention will be implemented over a 6-week period, with sessions conducted twice per week. Each session will last approximately 30 minutes. Task difficulty will be progressively adjusted according to participant performance to maintain engagement and provide an appropriate level of challenge.
The training sessions will be conducted individually under supervision. Real-time visual feedback provided by the system will enable participants to monitor their performance during task execution. No additional rehabilitation program will be provided concurrently within the scope of this study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in this group will receive rehabilitative game-based training using the BeCure system. The intervention will be delivered for 6 weeks, twice per week, with each session lasting approximately 30 minutes. The sessions will consist of structured interactive tasks designed to target balance, coordination, and visual-motor integration. Receives: Other: Game-Based Virtual Reality Intervention |
| Control Group | No intervention | Participants in this group will not receive any intervention during the study period. They will complete baseline and post-intervention assessments only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function
Cognitive functions will be assessed using the Loewenstein Occupational Therapy Cognitive Assessment (LOTCA), a standardized cognitive assessment tool evaluating orientation, perception, visual-motor organization, and thinking operations.
In this study, particular emphasis will be placed on the visual-motor organization subtests to assess visual-motor skills. Depending on the version used, the total LOTCA score generally ranges from 27 to 123 points, with higher scores indicating better cognitive performance.
Results obtained at baseline and at the end of the 6-week intervention will be compared within and between groups.
Measured: Baseline and Week 6
Balance Performance
Balance performance will be assessed using the Timed Up and Go Test (TUG).
The time (in seconds) required for the participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down will be measured. The theoretical minimum value is 0 seconds, and there is no fixed upper limit. Shorter duration indicates better functional mobility and balance performance.
Baseline and post-intervention measurements obtained from both tests will be compared within and between groups.
Measured: Baseline and Week 6
Balance Performance
Balance performance will be assessed using the Single-Leg Stance Test.
The duration (in seconds) that the participant is able to maintain balance while standing on one leg will be recorded. The minimum value is 0 seconds, and the maximum value is determined according to the test protocol (e.g., 30 or 60 seconds). Longer duration indicates better balance performance.
Baseline and post-intervention measurements obtained from both tests will be compared within and between groups.
Measured: Baseline and Week 6
Secondary outcomes (1)
Self-Efficacy
Self-efficacy levels will be measured using the General Self-Efficacy Scale (GSES), a validated self-report instrument assessing an individual's belief in their ability to cope with challenging situations and achieve goals.
The scale consists of 10 items rated on a 4-point Likert scale. Total scores range from 10 to 40, with higher scores indicating higher levels of self-efficacy.
Differences between pre-intervention and post-intervention scores will be examined within and between groups.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start17 Feb 2026
- Primary completion7 Apr 2026 (estimated)
- Study completion7 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealhtyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IremY, Biruni University
- Investigators
- Remziye A Akarsu, Assistant Professor, Study director, Birui University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433608
- Sponsor's protocol ID
- 62.2025fbu
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Öztürk B, Akpınar E, Akarsu R, Çelik Y. Investigation of the Relationship Between Functional Skills, Sensory Functions, and Anthropometric Properties of the Hand in Occupational Therapy Students Using Hierarchical Clustering Analysis. Ergoterapi ve Rehabilitasyon Dergisi. 2023;11(3):101-112. doi:10.30720/ered.1238943
Akarsu R, Tatar Y, Acar N. The Effectiveness of PEO Model-Based Occupational Therapy Intervention on Occupational Performance and Quality of Life in Individuals Working from Home due to Covid-19. Int J Basic Clin Stud. 2022;11(2):24-37.
Akarsu R, Özturk B, Kalkan E. Effect of Mental Status, Mobility and Depression Levels on Activities of Daily Living in Patients with Multiple Sclerosis. Int J Basic Clin Stud. 2019;8(2):33-38.
Akarsu R, Bumin G. Ergoterapi alanında tele-rehabilitasyon çalışmaları. Turkiye Klinikleri J Health Sci. 2021;6(3):682-694. doi:10.5336/healthsci.2020-77309
Akarsu R, Özturk B, Toraman MA, Akpınar B, Göbül S, Temiz TN. Effects of X-Box Kinect Games on Individuals with Anxiety, Social Phobia and Depression Symptoms. Int J Basic Clin Stud. 2019;8(2):24-32.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of A Video-Based Game Intervention On Cognitive, Physical And Psychosocial Outcomes In Older Adults
- ClinicalTrials.gov ID
- NCT07433608
- Acronym / sponsor ID
- 62.2025fbu
- Conditions
- Healhty, Aging, Balance, Self Efficacy, Visual Motor Integration
- Keywords
- Virtual Reality, Visual-Motor Integration, Older Adults, Balance, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 7 Apr 2026 (estimated)
- Study completion
- 7 Apr 2026 (estimated)
- First posted
- 25 Feb 2026 (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 purpose of this clinical trial is to investigate the effects of a rehabilitative game-based intervention on self-efficacy, balance, and visual-motor integration in individuals aged 60 years and older.
The primary research questions are:
Does the rehabilitative game-based intervention improve balance and visual-motor integration? Does the rehabilitative game-based intervention improve self-efficacy levels?
Researchers will compare a rehabilitative game intervention group with a control group. Participants will complete baseline and post-intervention assessments. Individuals in the intervention group will participate in rehabilitative game sessions twice per week for 6 weeks, while the control group will not receive any intervention.
Detailed description
This study is a randomized controlled experimental trial designed to examine the effects of a rehabilitative game-based intervention on self-efficacy, balance, and visual-motor integration in individuals aged 60 years and older. The study will be conducted using a two-group parallel design.
Participants who meet the inclusion criteria will be randomly assigned to either the intervention group or the control group. All participants will complete baseline assessments before the intervention period and post-intervention assessments after the completion of the study.
Participants in the intervention group will receive rehabilitative game-based training using the BeCure system. The intervention will last for 6 weeks, with sessions conducted twice per week. Each session will last approximately 30 minutes. The sessions will include structured interactive tasks targeting balance, coordination, and visual-motor integration.
Participants in the control group will not receive any intervention during the study period and will only participate in baseline and post-intervention assessments.
The primary outcomes of the study are balance performance, visual-motor integration and self-efficacy. These variables will be evaluated by comparing pre-intervention and post-intervention measurements within and between groups. The study procedures will be carried out according to the planned intervention protocol and standardized assessment procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Game-Based Virtual Reality InterventionParticipants in this group will receive rehabilitative game-based training using the BeCure system. The intervention will be delivered for 6 weeks, twice per week, with each session lasting approximately 30 minutes. The sessions will consist of structured interactive tasks designed to target balance, coordination, and visual-motor integration. |
| Control Group | No intervention | –Participants in this group will not receive any intervention during the study period. They will complete baseline and post-intervention assessments only. |
Who may qualify
- Ages
- 60 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 60 years or older A score of 24 or higher on the Mini Mental State Examination (MMSE) Ability to understand and follow verbal instructions Willingness to participate voluntarily
Key exclusion criteria (1 listed)
- Presence of a neurological, orthopedic, or psychiatric diagnosis Medical contraindications to exercise Diagnosis of dementia Acute orthopedic injury Visual or hearing impairment that would interfere with participation Inability to attend sessions regularly
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 |
|---|---|---|
| Game-Based Virtual Reality InterventionThe intervention consists of a structured rehabilitative game-based training program delivered using the BeCure system. The program includes interactive tasks that require active weight shifting, postural control, coordinated upper and lower extremity movements, and visually guided motor responses. The intervention will be implemented over a 6-week period, with sessions conducted twice per week. Each session will last approximately 30 minutes. Task difficulty will be progressively adjusted according to participant performance to maintain engagement and provide an appropriate level of challenge. The training sessions will be conducted individually under supervision. Real-time visual feedback provided by the system will enable participants to monitor their performance during task execution. No additional rehabilitation program will be provided concurrently within the scope of this study. | Other | Intervention Group |
Primary outcome
Cognitive Function
Time frame: Baseline and Week 6
Cognitive functions will be assessed using the Loewenstein Occupational Therapy Cognitive Assessment (LOTCA), a standardized cognitive assessment tool evaluating orientation, perception, visual-motor organization, and thinking operations. In this study, particular emphasis will be placed on the visual-motor organization subtests to assess visual-motor skills. Depending on the version used, the total LOTCA score generally ranges from 27 to 123 points, with higher scores indicating better cognitive performance. Results obtained at baseline and at the end of the 6-week intervention will be compared within and between groups.
Balance Performance
Time frame: Baseline and Week 6
Balance performance will be assessed using the Timed Up and Go Test (TUG). The time (in seconds) required for the participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down will be measured. The theoretical minimum value is 0 seconds, and there is no fixed upper limit. Shorter duration indicates better functional mobility and balance performance. Baseline and post-intervention measurements obtained from both tests will be compared within and between groups.
Balance Performance
Time frame: Baseline and Week 6
Balance performance will be assessed using the Single-Leg Stance Test. The duration (in seconds) that the participant is able to maintain balance while standing on one leg will be recorded. The minimum value is 0 seconds, and the maximum value is determined according to the test protocol (e.g., 30 or 60 seconds). Longer duration indicates better balance performance. Baseline and post-intervention measurements obtained from both tests will be compared within and between groups.
1 secondary outcome
Self-Efficacy
Time frame: Baseline and Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- BackgroundÖztürk B, Akpınar E, Akarsu R, Çelik Y. Investigation of the Relationship Between Functional Skills, Sensory Functions, and Anthropometric Properties of the Hand in Occupational Therapy Students Using Hierarchical Clustering Analysis. Ergoterapi ve Rehabilitasyon Dergisi. 2023;11(3):101-112. doi:10.30720/ered.1238943
- BackgroundAkarsu R, Tatar Y, Acar N. The Effectiveness of PEO Model-Based Occupational Therapy Intervention on Occupational Performance and Quality of Life in Individuals Working from Home due to Covid-19. Int J Basic Clin Stud. 2022;11(2):24-37.
- BackgroundAkarsu R, Özturk B, Kalkan E. Effect of Mental Status, Mobility and Depression Levels on Activities of Daily Living in Patients with Multiple Sclerosis. Int J Basic Clin Stud. 2019;8(2):33-38.
- BackgroundAkarsu R, Bumin G. Ergoterapi alanında tele-rehabilitasyon çalışmaları. Turkiye Klinikleri J Health Sci. 2021;6(3):682-694. doi:10.5336/healthsci.2020-77309
- BackgroundAkarsu R, Özturk B, Toraman MA, Akpınar B, Göbül S, Temiz TN. Effects of X-Box Kinect Games on Individuals with Anxiety, Social Phobia and Depression Symptoms. Int J Basic Clin Stud. 2019;8(2):24-32.
- 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.
Remziye A Akarsu, Assistant Professor study director
Birui 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 Game-Based Virtual Reality Intervention in people with Healhty and Aging, run by Biruni University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (time frame: Baseline and Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07433608, which also lists 5 linked publications.
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 6 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.