A Comparison of Cognitive-Motor Dual-Task Exercise and Exergaming on Balance, Functional Mobility, and Executive Function in Down Syndrome Children
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
1 other identifier
interventional
23
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2024
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
November 7, 2023
CompletedFirst Posted
Study publicly available on registry
November 27, 2023
CompletedStudy Start
First participant enrolled
August 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2024
CompletedMarch 5, 2025
March 1, 2025
4 months
November 7, 2023
March 3, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
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
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.
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
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.
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)
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).
6 weeks
Secondary Outcomes (2)
To examine the effect of cognitive-motor Motor Dual Task on Executive Function
6 weeks
To examine the effect of exergaming on Executive Function
6 weeks
Study Arms (2)
cognitive motor dual task
ACTIVE COMPARATOR24 participants
exergaming
ACTIVE COMPARATOR24 participants
Interventions
exercise program that combined motor tasks such as walking and juggling with cognitive task such as naming fruits or colors in the room.
Nintendo switch games that involve physical activity by participants to complete
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Saud University
Riyadh, 12345, Saudi Arabia
Related Publications (1)
Halwsh 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.
PMID: 41594800DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- the assessor will be blind to the allocation of participants in the two groups. the participants will not be aware of the presence of other treatment groups.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 7, 2023
First Posted
November 27, 2023
Study Start
August 28, 2024
Primary Completion
December 20, 2024
Study Completion
December 28, 2024
Last Updated
March 5, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 1 year after publication
- Access Criteria
- The researcher is affiliated with a recognized academic or research institution. The researcher has a clear and well-defined research proposal that is relevant to the study and aims to generate new knowledge or insights. The researcher has the necessary expertise and resources to analyze the IPD and generate meaningful results. The researcher agrees to comply with all relevant rules and regulations, including those related to data privacy and confidentiality. The researcher agrees to use the IPD solely for the purpose of the approved research proposal and not for any commercial or other purposes. The researcher agrees to provide regular updates on the progress of the research and to share any resulting publications or findings with the study team. The researcher agrees to comply with any additional requirements or conditions set by the study team or the data provider.
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.