Mental RetardationNCT07028333
Effects of Different Dual-Task Exercises in Children With Mild Mental Retardation
A study testing Motor-Motor Dual Task Exercise Group and Motor-Cognitive Dual Task Exercise Group in people with Mental Retardation, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effects of motor-motor and motor-cognitive dual-task exercises applied to children with mild mental retardation on their functional mobility, balance, cognitive function, and quality of life. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Mental Retardation
- What is being tested?
- Motor-Motor Dual Task Exercise Group and Motor-Cognitive Dual Task Exercise Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 10 Nov 2025
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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
Istanbul University Cerrahpasa
Istanbul, 34000
İstanbul University Cerrahpaşa, +90 212 404 03 00 ext. 53101, lisansustuegitim@iuc.edu.tr
Yıldız ANALAY AKBABA, AssocProfDr, +90 212 411 52 84 ext. 40169, yildizanalay@iuc.edu.tr
About this study
Official title: Effects of Different Dual-Task Exercises on Motor and Cognitive Functions in Children With Mild Mental Retardation
The purpose of this study is to investigate the effects of motor-motor and motor-cognitive dual-task exercises applied to children with mild mental retardation on their functional mobility, balance, cognitive function, and quality of life.
Read the 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.
- Conditions
- Mental Retardation
- Being tested
- Motor-Motor Dual Task Exercise Group, Motor-Cognitive Dual Task Exercise Group, Control Group
- Keywords
- Dual-Task Exercise, Motor Function, Cognitive Function, Rehabilitation, mental retardation, Balance, physiotherapy and Rehabilitation
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor-Motor Dual Task Exercise GroupBehavioural
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.
Motor-Cognitive Dual Task Exercise GroupBehavioural
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.
Control GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| motor-motor dual task exercise group | Experimental | While this group performs walking and balance exercises accompanied by a physiotherapist, it will perform motor tasks. Receives: Behavioral: Motor-Motor Dual Task Exercise Group |
| Motor-Cognitive Dual Task Exercise Group | Experimental | While this group performs walking and balance exercises accompanied by a physiotherapist, it will perform cognitive tasks. Receives: Behavioral: Motor-Cognitive Dual Task Exercise Group |
| Control Group | Placebo comparator | Standard walking and balance exercises will be given to the control group at home and followed by parents. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
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.
Measured: 6 weeks
Timed Up and Go Test
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.
Measured: 6 weeks
Tandem Walking Test
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.
Measured: 6 weeks
Stroop Test
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.
Measured: 6 weeks
Secondary outcomes (1)
Pediatric Quality of Life Inventory (PedsQL)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start15 Nov 2024
- Primary completion5 Jul 2025 (estimated)
- Study completion10 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental RetardationStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Model description
- This study is a three-arm, randomized controlled trial involving children aged 8-12 with mild mental retardation. Participants will be randomly assigned to one of three groups: Motor-Motor Dual Task Exercise, Motor-Cognitive Dual Task Exercise, or Control. The Motor-Motor group will perform walking and balance exercises combined with motor tasks under physiotherapist supervision. The Motor-Cognitive group will perform the same physical exercises combined with cognitive tasks. The Control group will follow standard walking and balance exercises at home, monitored by parents. Interventions will last six weeks, conducted twice a week for about 40 minutes per session. Assessments of motor function, cognitive performance, and quality of life will be conducted before and after the intervention by blinded evaluators. Data will be analyzed to compare group outcomes and determine the effects of dual-task exercises on motor and cognitive functions in children with mild mental re
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Nur AKGÖĞ, Istanbul University - Cerrahpasa
- Investigators
- Melike N AKGÖĞ, MScStudent, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028333
- Sponsor's protocol ID
- IUCAkgog001
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared due to privacy concerns and the sensitive nature of the data involving children with mild mental retardation. Additionally, sharing may be restricted to protect participant confidentiality and comply with ethical approvals. Data may be made available upon reasonable request and after necessary approvals to qualified researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Dual-Task Exercises on Motor and Cognitive Functions in Children With Mild Mental Retardation
- ClinicalTrials.gov ID
- NCT07028333
- Acronym / sponsor ID
- IUCAkgog001
- Conditions
- Mental Retardation
- Keywords
- Dual-Task Exercise, Motor Function, Cognitive Function, Rehabilitation, mental retardation, Balance, physiotherapy and Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 5 Jul 2025 (estimated)
- Study completion
- 10 Nov 2025 (estimated)
- First posted
- 19 Jun 2025 (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 study is to investigate the effects of motor-motor and motor-cognitive dual-task exercises applied to children with mild mental retardation on their functional mobility, balance, cognitive function, and quality of life.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a three-arm, randomized controlled trial involving children aged 8-12 with mild mental retardation. Participants will be randomly assigned to one of three groups: Motor-Motor Dual Task Exercise, Motor-Cognitive Dual Task Exercise, or Control. The Motor-Motor group will perform walking and balance exercises combined with motor tasks under physiotherapist supervision. The Motor-Cognitive group will perform the same physical exercises combined with cognitive tasks. The Control group will follow standard walking and balance exercises at home, monitored by parents. Interventions will last six weeks, conducted twice a week for about 40 minutes per session. Assessments of motor function, cognitive performance, and quality of life will be conducted before and after the intervention by blinded evaluators. Data will be analyzed to compare group outcomes and determine the effects of dual-task exercises on motor and cognitive functions in children with mild mental re
| Arm | Type | Receives |
|---|---|---|
| motor-motor dual task exercise group | Experimental | Behavioral: Motor-Motor Dual Task Exercise GroupWhile this group performs walking and balance exercises accompanied by a physiotherapist, it will perform motor tasks. |
| Motor-Cognitive Dual Task Exercise Group | Experimental | Behavioral: Motor-Cognitive Dual Task Exercise GroupWhile this group performs walking and balance exercises accompanied by a physiotherapist, it will perform cognitive tasks. |
| Control Group | Placebo comparator | Behavioral: Control GroupStandard walking and balance exercises will be given to the control group at home and followed by parents. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Motor-Motor Dual Task Exercise GroupParticipants 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. | Behavioural | motor-motor dual task exercise group |
| Motor-Cognitive Dual Task Exercise GroupThis 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. | Behavioural | Motor-Cognitive Dual Task Exercise Group |
| Control GroupStandard 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. | Behavioural | Control Group |
Primary outcome
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.
Timed Up and Go Test
Time frame: 6 weeks
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.
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.
Stroop Test
Time frame: 6 weeks
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.
1 secondary outcome
Pediatric Quality of Life Inventory (PedsQL)
Time frame: 6 weeks
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 19 Jun 2025.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared due to privacy concerns and the sensitive nature of the data involving children with mild mental retardation. Additionally, sharing may be restricted to protect participant confidentiality and comply with ethical approvals. Data may be made available upon reasonable request and after necessary approvals to qualified researchers.
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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.
Melike N AKGÖĞ, MScStudent principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor-Motor Dual Task Exercise Group and Motor-Cognitive Dual Task Exercise Group in people with Mental Retardation, run by Istanbul University - Cerrahpasa 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 7 inclusion and 4 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 19 Jun 2025. 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. Some participants in this study may receive a placebo. 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?
Contact Melike N AKGÖĞ, MScStudent (+90 535 548 69 73, melikenurakgog@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS) (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2025.