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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Down Syndrome
• Intervention / Treatment: Other: cognitive motor dual task exercises; Other: exergaming

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: safia halwsh, student; Phone Number: 0501558519; Email: 444204154@student.ksu.edu.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 12345
    • Princess Nourah bint Abdulrahman University
    • Contact: Maha F AL-Gabbani, PhD; Phone Number: 00966500599503; Email: malgabbani@ksu.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children with Down syndrome who are 8 to 14 years old.
2. Mild mental retardation (IQ according to the intelligence scale, mild (IQ 50-70).
3. Can stand and walk independently.
4. Follow verbal directions.

Exclusion Criteria:

1. Uncontrollable medical disorders or seizures.
2. Any type of disability that limits activity, such as spinal deformity.
3. Uncooperative or cannot follow instructions.
4. Children who play video games on a regular basis to avoid the extraneous activity learning effect.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cognitive motor dual task; 24 participants	Other: cognitive motor dual task exercises; exercise program that combined motor tasks such as walking and juggling with cognitive task such as naming fruits or colors in the room.
Active Comparator: exergaming; 24 participants	Other: exergaming; Nintendo switch games that involve physical activity by participants to complete

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 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.	8 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	8 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.	8 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)	8 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).	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	8 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).	8 weeks

Collaborators and Investigators

• Sponsor: safia Darweesh halwsh

Study record dates

Study Major Dates

• Study Start (Estimated): May 14, 2024
• Primary Completion (Estimated): August 20, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 24, 2023
• First Posted (Actual): November 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 7, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: exergaming and CMDT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 1 year after publication

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No