- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07028333
- Original Trial
Effects of Different Dual-Task Exercises in Children With Mild Mental Retardation
Effects of Different Dual-Task Exercises on Motor and Cognitive Functions in Children With Mild Mental Retardation
Study Overview
Status
Conditions
Detailed Description
Physical activity is a cornerstone of health and social well-being across all age groups. It holds significant physical, psychological, and social importance throughout an individual's life. Particularly in childhood, physical activity plays a critical role in shaping growth and development, enhancing cognitive functions, and establishing healthy habits that persist into adulthood. The World Health Organization (WHO) emphasizes the importance of physical activity for all age groups, highlighting its positive effects on children's cardiorespiratory fitness, muscle strength, bone health, mental health, cognitive functions, academic performance, and obesity prevention.
Children with mental retardation exhibit developmental delays across multiple domains compared to their typically developing peers. Mental retardation not only affects language, comprehension, learning, and socialization skills but also impairs motor abilities. These motor deficits contribute to reduced physical activity levels, increased sedentary behavior, and associated physical and psychological problems, which further restrict motor skill development. This cyclical relationship among mental retardation, motor function, and physical inactivity leads to decreased functionality, balance, strength, endurance, fitness, and flexibility. Consequently, children with mental retardation face challenges in daily activities and reduced quality of life.
In order to address these challenges, it is essential to implement exercise programs that target cognitive, social, and physical development in children with mental retardation. Performing daily movements often requires simultaneous execution of motor and cognitive tasks, known as dual-task activities. However, mental retardation significantly impairs the ability to perform such dual tasks. Existing literature indicates that dual-task interventions can improve balance, functional mobility, gait, and cognitive performance.
The current study aims to investigate the effects of dual-task exercise programs on motor and cognitive functions in children with mild mental retardation. Specifically, it examines whether motor-motor and motor-cognitive dual-task exercises improve these functions compared to a control group receiving standard walking and balance exercises. The intervention will be conducted over six weeks, with assessments performed before and after the program to measure motor skills, cognitive function, and quality of life.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Melike N AKGÖĞ, MScStudent
- Phone Number: +90 535 548 69 73
- Email: melikenurakgog@ogr.iuc.edu.tr
Study Contact Backup
- Name: Yıldız ANALAY AKBABA, AssocProfDr
- Phone Number: 40169 +90 212 411 52 84
- Email: yildizanalay@iuc.edu.tr
Study Locations
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-
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Istanbul, Turkey, 34000
- Recruiting
- Istanbul University Cerrahpasa
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Contact:
- Yıldız ANALAY AKBABA, AssocProfDr
- Phone Number: 40169 +90 212 411 52 84
- Email: yildizanalay@iuc.edu.tr
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Contact:
- İstanbul University Cerrahpaşa
- Phone Number: 53101 +90 212 404 03 00
- Email: lisansustuegitim@iuc.edu.tr
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Principal Investigator:
- Melike N AKGÖĞ, MScStudent
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Sub-Investigator:
- Yıldız ANALAY AKBABA, AssocProfDr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Obtaining parental consent
- Having an Intelligence Quotient between 51-70
- Having an educational diagnosis of mild mental retardation
- Being between the ages of 8-12
- Ability to understand Turkish instructions
- Ability to follow commands during the exercise program
- No additional disabilities that would prevent participation in the program
Exclusion Criteria:
- Having a metabolic or systemic disease
- Engaging in regular physical exercise
- Having visual or hearing impairments
- Presence of any condition that would interfere with compliance to assessment parameters
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: motor-motor dual task exercise group
While this group performs walking and balance exercises accompanied by a physiotherapist, it will perform motor tasks.
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Participants in this group will perform motor tasks (such as ball handling, throwing, holding) accompanied by physiotherapist.
Exercises will last about 40 minutes, 2 days a week, 6 weeks.
|
|
Experimental: Motor-Cognitive Dual Task Exercise Group
While this group performs walking and balance exercises accompanied by a physiotherapist, it will perform cognitive tasks.
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This group will also do walking and balance exercises with the physiotherapist, while simultaneously doing cognitive tasks (rhythmic counting, saying color names, finding words, etc.).
The exercises will last approximately 40 minutes, 2 days a week, for 6 weeks.
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Placebo Comparator: Control Group
Standard walking and balance exercises will be given to the control group at home and followed by parents.
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Standard walking and balance exercises will be given to the control group at home and followed by parents.
Exercises will last about 40 minutes, 2 days a week, 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale (BBS)
Time Frame: 6 weeks
|
The Pediatric Balance Scale (PBS), used to assess functional balance in children during daily activities, is a highly reliable measurement tool.
It is an adapted version of the Berg Balance Scale specifically designed for children.
The scale consists of 14 items evaluating functional movements such as standing up, picking up an object from the floor, transferring, balancing on one foot, and sitting.
Each item is scored on a scale from 0 to 4, with 4 indicating the ability to perform the task independently.
The maximum score is 56.
Scores between 0-20 indicate poor balance, 21-40 indicate acceptable balance, and 41-56 indicate good balance.
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6 weeks
|
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Timed Up and Go Test
Time Frame: 6 weeks
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Description: The Timed Up and Go Test (TUG) is used to assess functional mobility by measuring walking speed, postural control, and balance.
The test involves standing up from a standard-height chair without armrests, walking a distance of 3 meters, turning around, walking back to the chair, and sitting down.
Participants perform one practice trial followed by three test trials, with the average time recorded in seconds.
A shorter duration indicates better functional mobility and balance.
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6 weeks
|
|
Tandem Walking Test
Time Frame: 6 weeks
|
Description: The Tandem Walking Test is used to assess dynamic balance, a function primarily controlled by the cerebellum.
Participants are instructed to walk 10 steps in a straight line, placing the heel of one foot directly in front of the toes of the other foot with each step, minimizing the base of support.
The time taken to complete the 10 steps is recorded, and a shorter time indicates better dynamic balance.
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6 weeks
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Stroop Test
Time Frame: 6 weeks
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Description: The Stroop Test is a neuropsychological assessment that measures cognitive processing speed, selective attention, response inhibition, and cognitive flexibility-functions associated with the frontal lobe.
It includes four cards, each containing six rows with four items per row.
Participants are required to name the color of the ink used rather than the word itself, evaluating their ability to inhibit habitual responses and adapt to cognitive interference.
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6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Quality of Life Inventory (PedsQL)
Time Frame: 6 weeks
|
The Pediatric Quality of Life Inventory (PedsQL), developed by Varni et al., is a validated tool used to assess health-related quality of life in children aged 2 to 18.
The scale consists of four subdomains: physical, emotional, social, and school functioning.
It provides a total score, a physical health summary score, and a psychosocial health summary score (derived from emotional, social, and school subscales).
Each item is scored on a 5-point Likert scale, then transformed into a 0-100 scale, where higher scores indicate better perceived quality of life.
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Melike N AKGÖĞ, MScStudent, Istanbul University - Cerrahpasa
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUCAkgog001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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