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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06146907
Other study ID # exergaming and CMDT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 14, 2024
Est. completion date June 20, 2025

Study information

Verified date April 2024
Source King Saud University
Contact safia halwsh, student
Phone 0501558519
Email 444204154@student.ksu.edu.sa
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 48
Est. completion date June 20, 2025
Est. primary completion date November 20, 2024
Accepts healthy volunteers No
Gender All
Age group 8 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
exergaming
Nintendo switch games that involve physical activity by participants to complete

Locations

Country Name City State
Saudi Arabia Princess Nourah bint Abdulrahman University Riyadh

Sponsors (1)

Lead Sponsor Collaborator
safia Darweesh halwsh

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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.
Primary 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
Primary 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
Primary 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 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
Secondary 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
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