NCT07433608

Brief 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. 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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 17, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2026

Completed
Last Updated

March 6, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 20, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

Virtual RealityVisual-Motor IntegrationOlder AdultsBalanceSelf-Efficacy

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline and Week 6

Secondary Outcomes (1)

  • Self-Efficacy

    Baseline and Week 6

Study Arms (2)

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.

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.

Interventions

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.

Intervention Group

Eligibility Criteria

Age60 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Zeytinburnu, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND

Study Officials

  • Remziye A Akarsu, Assistant Professor

    Birui University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Investigator

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 25, 2026

Study Start

February 17, 2026

Primary Completion

April 7, 2026

Study Completion

April 7, 2026

Last Updated

March 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations