- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433608
Video Game Intervention In Older Adults
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:
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zeytinburnu
-
Istanbul, Zeytinburnu, Turkey (Türkiye)
- Recruiting
- Biruni University
-
Contact:
- Remziye A Akarsu, Assistant Professor
- Phone Number: +90 544 439 30 91
- Email: rakarsu@biruni.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
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.
|
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. |
|
No Intervention: Control Group
Participants in this group will not receive any intervention during the study period.
They will complete baseline and post-intervention assessments only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline and Week 6
|
|
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. |
Baseline and Week 6
|
|
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. |
Baseline and Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Efficacy
Time Frame: Baseline and Week 6
|
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. |
Baseline and Week 6
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Remziye A Akarsu, Assistant Professor, Birui University
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 62.2025fbu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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