- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07809412
Xbox-Based Exergames Versus Structured Home-Based Cognitive Training for Attention and Executive Functions in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
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Beykoz, Istanbul, Turkey (Türkiye)
- Istanbul Medipol University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being 50 years of age or older
- Obtaining a score of 24-30 on the Standardized Mini-Mental State Examination (SMMSE)
Exclusion Criteria:
- A Geriatric Depression Scale (GDS) score ≥9
- A Berg Balance Scale (BBS) score ≤40
- A history of head trauma
- A diagnosis of a psychiatric or neurodegenerative disorder
- A history of alcohol dependence
- The presence of any physical illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Xbox-based exergames intervention group
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The intervention was delivered using the Microsoft Xbox 360 Kinect™ as a non-VR exergaming platform.
The Kinect system detects and tracks participants' body movements in real time without requiring a handheld controller.
Exergames were selected by the researchers (DT, HA, and MK) based on their cognitive demands and relevance to the targeted cognitive functions.
The selected games were incorporated into a predetermined intervention session plan.
Before the intervention, each game was demonstrated once to familiarize participants with the gameplay and required movements.
All games started at a basic level, and progression to advanced levels was determined by the therapists according to each participant's performance.
Game levels and repetition numbers were individually adjusted to ensure appropriate progression throughout the intervention.
The Xbox-based exergames group received 12 sessions twice weekly.
|
|
Active Comparator: Structured home-based cognitive training group
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The structured home-based cognitive training program consisted of tasks specifically designed to improve different cognitive skills. The program included cognitive activities such as mathematical sequences, identifying differences between two pictures, finding missing objects, pattern completion, Sudoku, and maze completion. Taken together, these tasks provided a comprehensive and individualized program aimed at strengthening fundamental cognitive skills such as attention, EFs, spatial orientation, and visuomotor coordination. The cognitive tasks included in the structured home-based cognitive training program and their targeted parameters were specified, and the activities were explained to the participants once before implementation. The cognitive tasks and homework assignments were planned and adjusted based on the participants' initial assessment findings and in accordance with their individual performance capacities. This groups also received 12 sessions twice weekly. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Standardized Mini-Mental State Examination (SMMSE)
Time Frame: Baseline and 1 week after completion of the 12-session intervention
|
The SMMSE is a brief 30-item cognitive screening tool that assesses attention, memory, orientation, language, and visuospatial abilities.
The Turkish validity and reliability of the Standardized Mini-Mental State Examination (SMMSE) were established by Güngen et al. (2002).
In the Turkish version, a cutoff score of 23/24 has been established for dementia.
|
Baseline and 1 week after completion of the 12-session intervention
|
|
d2 Test of Attention
Time Frame: Baseline and 1 week after completion of the 12-session intervention
|
The d2 Test assesses sustained and selective attention, visual scanning, and mental concentration.
The d2 Test of Attention consists of 14 rows, each containing 47 characters/items.
Each row includes lowercase "p" and "d" letters accompanied by one to four marks positioned above or below the letters.
Participants are required to identify and mark the letter "d" accompanied by two marks within a time limit of 20 seconds for each row.
Scoring is based on the total number of items processed (TN), errors of omission (E1), errors of commission (E2), and concentration performance (CP).
Higher TN and CP scores indicate better attentional performance, whereas higher E1 and E2 scores indicate a greater number of errors.
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Baseline and 1 week after completion of the 12-session intervention
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Stroop Test
Time Frame: Baseline and 1 week after completion of the 12-session intervention
|
The Stroop Test is a neuropsychological measure of selective attention, inhibitory control, processing speed, and cognitive flexibility.
The Stroop Test Çapa Version consists of three parts: Stroop A, in which participants name the colors of colored rectangles; Stroop B, in which they read color words printed in incongruent ink colors; and Stroop C, in which they name the ink color while inhibiting the tendency to read the word.
Completion time is recorded for each part.
In the present study, the Stroop Test Interference Time Difference was calculated by subtracting the completion time of Stroop B from that of Stroop C. The Turkish validity and reliability of the Stroop Test Çapa Version were established by Emek-Savaş et al.
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Baseline and 1 week after completion of the 12-session intervention
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|
WMS-R Digit Span Test (DST)
Time Frame: Baseline and 1 week after completion of the 12-session intervention
|
The Digit Span Subtest of the Wechsler Memory Scale-Revised (WMS-R) assesses attention, short-term memory, and working memory.
It consists of Forward and Backward Digit Span conditions, in which participants repeat progressively longer digit sequences in the presented or reverse order, respectively.
Each sequence length includes two trials, and the respective condition is discontinued when both trials are answered incorrectly.
The Turkish standardization of the WMS-R has been established, and normative data are available for the Digit Span Test in Turkish adults aged 50-83 years.
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Baseline and 1 week after completion of the 12-session intervention
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The Trail Making Test (TMT)
Time Frame: Baseline and 1 week after completion of the 12-session intervention
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The Trail Making Test (TMT) consists of two parts, TMT-A and TMT-B.
TMT-A primarily assesses visual scanning, attention, and processing speed, whereas TMT-B additionally requires cognitive flexibility, set-shifting, working memory, and inhibitory control.
The basic scores for TMT-A and TMT-B are completion times in seconds, with longer completion times indicating poorer performance.
The Turkish validity and reliability of the Trail Making Test were established.
|
Baseline and 1 week after completion of the 12-session intervention
|
|
Benton Judgment of Line Orientation Test
Time Frame: Baseline and 1 week after completion of the 12-session intervention
|
The Benton Judgment of Line Orientation Test was developed by Benton et al. (1978), and its Turkish standardization was conducted within the BİLNOT battery.
The Benton Judgment of Line Orientation Test (BJLOT) is a neuropsychological measure of visuospatial perception and spatial orientation.
The test assesses the ability to perceive and identify angular relationships between lines and comprises five practice items followed by 30 test items.
Each correct response is scored as one point, yielding a maximum score of 30, with higher scores indicating better visuospatial performance.
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Baseline and 1 week after completion of the 12-session intervention
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Halime Avunç, PhD Candidate, Medipol University
- Principal Investigator: Ayşe Seren Taner, Occupational Therapist, Medipol University
- Principal Investigator: Eylül Eşin, Occupational Therapist, Medipol University
- Principal Investigator: Zeynep Demir, Occupational Therapist, Medipol University
- Study Chair: Merve Keskin, PhD Candidate, Medipol University
- Study Chair: Devrim Tarakcı, Prof. Dr., Medipol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- E-10840098-202.3.02-1964
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
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