Down SyndromeNCT06146907
A Comparison of Cognitive-Motor Dual-Task Exercise and Exergaming on Balance, Functional Mobility, and Executive Function in Down Syndrome Children
A study testing cognitive motor dual task exercises and exergaming in people with Down Syndrome, run by safia Darweesh halwsh at 1 site in Saudi Arabia.
Trial summary
Down syndrome (DS) is a genetic condition that compromises physical and cognitive function. Motor development delays define DS. Additionally, there are executive function issues. Humans need dual-task activities to execute physical and cognitive tasks simultaneously. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- cognitive motor dual task exercises and exergaming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 28 Aug 2024to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with Down syndrome who are 8 to 14 years old.
- Mild mental retardation (IQ according to the intelligence scale, mild (IQ 50-70).
- Can stand and walk independently.
- Follow verbal directions.
Who cannot join
- Uncontrollable medical disorders or seizures.
- Any type of disability that limits activity, such as spinal deformity.
- Uncooperative or cannot follow instructions.
- Children who play video games on a regular basis to avoid the extraneous activity learning effect.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between the Effect of Cognitive-Motor Dual-Task Exercise Program and Exergaming on Balance, Functional Mobility, and Executive Function Among Children With Down Syndrome: A Randomized Comparative Trail
Down syndrome (DS) is a genetic condition that compromises physical and cognitive function. Motor development delays define DS. Additionally, there are executive function issues. Humans need dual-task activities to execute physical and cognitive tasks simultaneously. Cognitively challenged people may struggle to do dual tasks simultaneously. This shows that executive function modulation may boost motor function. Rehabilitation should include motor training and cognitive therapy to improve function. Dual-task training called exergaming combines video games with exercise and requires brain processing, decision-making, and problem-solving. Kids enjoy therapy and exercise using interactive exergames, improving adherence and results. Mental agility can be developed through simultaneous exercise. Exergaming improves balance, functional mobility, fitness, and well-being for DS youngsters. Most literature on DS children stresses physical ability over cognitive ability. Cognitive-Motor Dual-Task Exercise Program (CMDT) works in most therapy settings without equipment. Our study compares two dual-task intervention regimens for 8-14-year-old DS children's balance, functional mobility, and EF.
Read the detailed description
An extra copy of chromosome 21 causes Down syndrome (DS), a hereditary disorder that affects physical and cognitive function. Motor development delays characterize DS. Muscle weakness, hypotonia, and joint laxity cause motor delay. DS children demonstrated lower cognitive and motor performance in all categories than their chronological or mental-age peers. Physical traits cause DS children to struggle with balance, coordination, and functional mobility. Additionally, these kids may have executive function difficulties. Executive function helps people plan, organize, problem-solve, and control their behavior. Executive dysfunction affects impulse control, memory, attention, and decision-making. Executive and motor function are linked in several studies. Motor coordination and regulation need inhibition, working memory, and cognitive flexibility. Inhibitory control helps people stop unimportant motions for better motor skills. Working memory stores and manipulates motor plans, improving complex action execution. Motor skills affect cognitive flexibility, or the ability to alter tasks or conceptual groups. DS children show moderate inhibitory control and task initiation but poor working memory, monitoring, planning, organizing, and cognitive flexibility. Most abilities stayed consistent from 2 to 18 years. Motor and cognitive skill interventions may help DS youngsters realize their potential. EF improves with training. The dual-task physical therapy rehabilitation strategy is well studied. Living requires DT because it lets individuals perform physical and cognitive tasks simultaneously. Soccer and basketball involve coordination of motor (running, passing, and shooting) and cognitive (strategic thinking, decision-making, situation awareness) skills. DT tasks can be difficult to execute simultaneously, especially for cognitively impaired people. DT and multitasking abilities are needed. This suggests EF modulation may improve motor function. To increase function, rehabilitation programs should include motor training and cognitive therapy. Little is known about organizing physical and cognitive skill intervention programs. Exergaming is DT training that blends video games with exercise, requires mental processing, decision-making, and problem-solving. Interactive exergames make treatment and exercise more fun for kids, enhancing adherence and results. Mental agility can be increased by exercising simultaneously. DS kids can improve balance, functional mobility, fitness, and well-being through exergaming. Even so, most literature on DS children emphasizes physical capabilities over cognitive capabilities. The Cognitive-Motor Dual-Task Exercise Program (CMDT) by is a new, simple intervention that works in most therapy settings without equipment. Children's balance and movement improve with DS. The program involves walking, sitting, leaping, cognitive exercises like naming fruits and vegetables, and motor ones like carrying an empty box. our study aim to compare two DT intervention regimens for 8-14-year-old DS children's balance, functional mobility, and EF.
- Conditions
- Down Syndrome
- Being tested
- cognitive motor dual task exercises, exergaming
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive motor dual task exercisesOther
exercise program that combined motor tasks such as walking and juggling with cognitive task such as naming fruits or colors in the room.
exergamingOther
Nintendo switch games that involve physical activity by participants to complete
| Study group | Role | What they receive |
|---|---|---|
| cognitive motor dual task | Active comparator | 24 participants Receives: Other: cognitive motor dual task exercises |
| exergaming | Active comparator | 24 participants Receives: Other: exergaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effect of the cognitive-motor dual-task training on balance.
investigators will use Four-Square Step Test, which measures in seconds and will be compared to normative data for Down syndrome children
Measured: 6 weeks
To investigate the effect of Cognitive Motor Dual Task training on functional mobility
investigators will use the Timed Up and Go test (measured in seconds) and compare the results for each child as pre- and post-intervention, with less time indicating improvements.
Measured: 6 weeks
To investigate the effect of the exergaming training on balance.
investigators will use Four-Square Step Test, which measures in seconds and will be compared to normative data for Down syndrome children
Measured: 6 weeks.
To investigate the effect of exergaming training on functional mobility
investigators will use the Timed Up and Go test (measured in seconds) and compare the results for each child as pre- and post-intervention, with less time indicating improvements.
Measured: 6 weeks
To investigate the effect of the cognitive-motor dual-task training on balance.
investigators will use Pediatric Balance Scale (Maximum score = 56 points, with 56 points being a perfect score)
Measured: 6 weeks
To investigate the effect of the exergaming training on balance.
investigators will use Pediatric Balance Scale (maximum score = 56 points, with 56 points being a perfect score).
Measured: 6 weeks
Secondary outcomes (2)
To examine the effect of cognitive-motor Motor Dual Task on Executive Function
investigators will use the Cambridge Neuropsychological Test Automated Battery (measured in seconds; less time to complete the test indicates improvement).
Measured: 6 weeks
To examine the effect of exergaming on Executive Function
investigators will use the Cambridge Neuropsychological Test Automated Battery (measured in seconds; less time to complete the test indicates improvement).
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 posted27 Nov 2023
- Study start28 Aug 2024
- Primary completion20 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- safia Darweesh halwsh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, safia Darweesh halwsh, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146907
- Sponsor's protocol ID
- exergaming and CMDT
- Status last verified
- Mar 2025
- First submitted
- 7 Nov 2023
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study's individual participant data (IPD) will be shared in conformity with Saudi Arabian law, PNU/IRB policy, and ICH Good Clinical Practice recommendations. IPD will include study protocol and statistics analysis plan. With PNU/IRB permission and a data sharing agreement, we will make the IPD available to other researchers upon request. To request IPD, contact the investigator with the subject line "Request for IPD from \[study title\]." Within a year following the primary study results, we will provide the IPD. IPD requests beyond this period will be examined individually. We will not disclose IPD with participant names, addresses, or contact information. We will protect the IPD according to PNU/IRB policies and ICH Good Clinical Practice recommendations. The IPD will be securely stored and only authorized personnel can access it.
Publications
Algabbani MF, Halwsh SD, Alqabbani S, Alhusaini AA, Alhammad SA, Abdelkader SMI, Gwada RFM, Almurdi MM, Tounsi N, Rezk MZA, Najmaldeen GTA, Shaheen AAM. Effects of a cognitive-motor dual-task exercise program versus exergaming on cognitive function in children with down syndrome: A single-blinded randomized trial. Psychol Sport Exerc. 2026 Sep;86:103190. doi: 10.1016/j.psychsport.2026.103190. Epub 2026 Jun 17.
PubMed 42309334Halwsh SD, Algabbani MF, Alqabbani S, Alahmad TA, Almurdi MM, Alshubaily RA, Aldera M, Al-Dubisi HA, Almedlej RM, Shaheen AAM. The Effects of Cognitive-Motor Dual-Task Exercise and Exergaming on Balance and Functional Mobility in Children with Down Syndrome: A Comparative Randomized Trial. Brain Sci. 2026 Jan 6;16(1):79. doi: 10.3390/brainsci16010079.
PubMed 41594800
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between the Effect of Cognitive-Motor Dual-Task Exercise Program and Exergaming on Balance, Functional Mobility, and Executive Function Among Children With Down Syndrome: A Randomized Comparative Trail
- ClinicalTrials.gov ID
- NCT06146907
- Acronym / sponsor ID
- exergaming and CMDT
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- safia Darweesh halwshUniversity, hospital or other
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 27 Nov 2023 (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.
Down syndrome (DS) is a genetic condition that compromises physical and cognitive function. Motor development delays define DS. Additionally, there are executive function issues. Humans need dual-task activities to execute physical and cognitive tasks simultaneously. Cognitively challenged people may struggle to do dual tasks simultaneously. This shows that executive function modulation may boost motor function. Rehabilitation should include motor training and cognitive therapy to improve function. Dual-task training called exergaming combines video games with exercise and requires brain processing, decision-making, and problem-solving. Kids enjoy therapy and exercise using interactive exergames, improving adherence and results. Mental agility can be developed through simultaneous exercise. Exergaming improves balance, functional mobility, fitness, and well-being for DS youngsters. Most literature on DS children stresses physical ability over cognitive ability. Cognitive-Motor Dual-Task Exercise Program (CMDT) works in most therapy settings without equipment. Our study compares two dual-task intervention regimens for 8-14-year-old DS children's balance, functional mobility, and EF.
Detailed description
An extra copy of chromosome 21 causes Down syndrome (DS), a hereditary disorder that affects physical and cognitive function. Motor development delays characterize DS. Muscle weakness, hypotonia, and joint laxity cause motor delay. DS children demonstrated lower cognitive and motor performance in all categories than their chronological or mental-age peers. Physical traits cause DS children to struggle with balance, coordination, and functional mobility. Additionally, these kids may have executive function difficulties. Executive function helps people plan, organize, problem-solve, and control their behavior. Executive dysfunction affects impulse control, memory, attention, and decision-making. Executive and motor function are linked in several studies. Motor coordination and regulation need inhibition, working memory, and cognitive flexibility. Inhibitory control helps people stop unimportant motions for better motor skills. Working memory stores and manipulates motor plans, improving complex action execution. Motor skills affect cognitive flexibility, or the ability to alter tasks or conceptual groups. DS children show moderate inhibitory control and task initiation but poor working memory, monitoring, planning, organizing, and cognitive flexibility. Most abilities stayed consistent from 2 to 18 years. Motor and cognitive skill interventions may help DS youngsters realize their potential. EF improves with training. The dual-task physical therapy rehabilitation strategy is well studied. Living requires DT because it lets individuals perform physical and cognitive tasks simultaneously. Soccer and basketball involve coordination of motor (running, passing, and shooting) and cognitive (strategic thinking, decision-making, situation awareness) skills. DT tasks can be difficult to execute simultaneously, especially for cognitively impaired people. DT and multitasking abilities are needed. This suggests EF modulation may improve motor function. To increase function, rehabilitation programs should include motor training and cognitive therapy. Little is known about organizing physical and cognitive skill intervention programs. Exergaming is DT training that blends video games with exercise, requires mental processing, decision-making, and problem-solving. Interactive exergames make treatment and exercise more fun for kids, enhancing adherence and results. Mental agility can be increased by exercising simultaneously. DS kids can improve balance, functional mobility, fitness, and well-being through exergaming. Even so, most literature on DS children emphasizes physical capabilities over cognitive capabilities. The Cognitive-Motor Dual-Task Exercise Program (CMDT) by is a new, simple intervention that works in most therapy settings without equipment. Children's balance and movement improve with DS. The program involves walking, sitting, leaping, cognitive exercises like naming fruits and vegetables, and motor ones like carrying an empty box. our study aim to compare two DT intervention regimens for 8-14-year-old DS children's balance, functional mobility, and EF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive motor dual task | Active comparator | Other: cognitive motor dual task exercises24 participants |
| exergaming | Active comparator | Other: exergaming24 participants |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with Down syndrome who are 8 to 14 years old.
- Mild mental retardation (IQ according to the intelligence scale, mild (IQ 50-70).
- Can stand and walk independently.
- Follow verbal directions.
Key exclusion criteria (4 listed)
- Uncontrollable medical disorders or seizures.
- Any type of disability that limits activity, such as spinal deformity.
- Uncooperative or cannot follow instructions.
- Children who play video games on a regular basis to avoid the extraneous activity learning effect.
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 |
|---|---|---|
| cognitive motor dual task exercisesexercise program that combined motor tasks such as walking and juggling with cognitive task such as naming fruits or colors in the room. | Other | cognitive motor dual task |
| exergamingNintendo switch games that involve physical activity by participants to complete | Other | exergaming |
Primary outcome
To investigate the effect of the cognitive-motor dual-task training on balance.
Time frame: 6 weeks
investigators will use Four-Square Step Test, which measures in seconds and will be compared to normative data for Down syndrome children
To investigate the effect of Cognitive Motor Dual Task training on functional mobility
Time frame: 6 weeks
investigators will use the Timed Up and Go test (measured in seconds) and compare the results for each child as pre- and post-intervention, with less time indicating improvements.
To investigate the effect of the exergaming training on balance.
Time frame: 6 weeks.
investigators will use Four-Square Step Test, which measures in seconds and will be compared to normative data for Down syndrome children
To investigate the effect of exergaming training on functional mobility
Time frame: 6 weeks
investigators will use the Timed Up and Go test (measured in seconds) and compare the results for each child as pre- and post-intervention, with less time indicating improvements.
To investigate the effect of the cognitive-motor dual-task training on balance.
Time frame: 6 weeks
investigators will use Pediatric Balance Scale (Maximum score = 56 points, with 56 points being a perfect score)
To investigate the effect of the exergaming training on balance.
Time frame: 6 weeks
investigators will use Pediatric Balance Scale (maximum score = 56 points, with 56 points being a perfect score).
2 secondary outcomes
To examine the effect of cognitive-motor Motor Dual Task on Executive Function
Time frame: 6 weeks
To examine the effect of exergaming on Executive Function
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Derived from this study: PubMed 42309334Algabbani MF, Halwsh SD, Alqabbani S, Alhusaini AA, Alhammad SA, Abdelkader SMI, Gwada RFM, Almurdi MM, Tounsi N, Rezk MZA, Najmaldeen GTA, Shaheen AAM. Effects of a cognitive-motor dual-task exercise program versus exergaming on cognitive function in children with down syndrome: A single-blinded randomized trial. Psychol Sport Exerc. 2026 Sep;86:103190. doi: 10.1016/j.psychsport.2026.103190. Epub 2026 Jun 17.
- Derived from this study: PubMed 41594800Halwsh SD, Algabbani MF, Alqabbani S, Alahmad TA, Almurdi MM, Alshubaily RA, Aldera M, Al-Dubisi HA, Almedlej RM, Shaheen AAM. The Effects of Cognitive-Motor Dual-Task Exercise and Exergaming on Balance and Functional Mobility in Children with Down Syndrome: A Comparative Randomized Trial. Brain Sci. 2026 Jan 6;16(1):79. doi: 10.3390/brainsci16010079.
- Individual participant dataSharing planned: Yes. This study's individual participant data (IPD) will be shared in conformity with Saudi Arabian law, PNU/IRB policy, and ICH Good Clinical Practice recommendations. IPD will include study protocol and statistics analysis plan. With PNU/IRB permission and a data sharing agreement, we will make the IPD available to other researchers upon request. To request IPD, contact the investigator with the subject line "Request for IPD from [study title]." Within a year following the primary study results, we will provide the IPD. IPD requests beyond this period will be examined individually. We will not disclose IPD with participant names, addresses, or contact information. We will protect the IPD according to PNU/IRB policies and ICH Good Clinical Practice recommendations. The IPD will be securely stored and only authorized personnel can access it.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive motor dual task exercises and exergaming in people with Down Syndrome, run by safia Darweesh halwsh at 1 site in Saudi Arabia.
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 4 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: finished, as of the sponsor's last update on 5 Mar 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 Saudi Arabia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the effect of the cognitive-motor dual-task training on balance. (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06146907, which also lists 2 linked publications.
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 5 Mar 2025.