Skip to main content
OpenTrials
Completed

NCT Number: NCT06196983

Effects of Rhythmic Aerobic Exercises on Functional Balance in Children With Down Syndrome

Down syndrome (DS) is the most commonly occurring chromosomal condition and it affects more than 400,000 people in the United States. The chances of having a child with DS increases as the mother ages. DS is a chromosomal disorder characterized by trisomy 21. These alterations are responsible for motor and cognitive development delay, due to abnormalities on the maturation of the central nervous system. DS presents generalized muscle hypotonia which interferes in motor coordination and postural reactions leading to changes in balance. Rhythmic aerobic exercises for people with intellectual disability are helpful. In these exercises body's large muscles move in a rhythmic manner for a sustained period of time. The aim of this study is to determine the effect of rhythmic aerobic exercises for improving functional balance in children with DS.

This will be a randomized controlled trial study. Study will be approved by ethical committee. After that informed consent will be taken and patients will be included in the study based on the inclusion criteria. 40 patients will be divided into two groups, interventions will be performed for 50 minutes per session twice a week for total of 8 weeks; In experimental group, rhythmic aerobic exercises will be performed. The rhythmic training group initially used rhythmic auditory stimulation with 8 beats, then progressed to 16 beats per minutes. In control group, strength and balance exercises will be performed. Functional balance of the patient will be assessed by checking the quality of Sit-to-stand and Stand to-Sit on the respective sections of Pediatric Balance Scale and Time Up and Go test. Data will be analyzed using SPSS 25. Mean and standard deviation will be calculated. Both groups will be compared by appropriate test.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah international university

Lahore, Pakistan

About this study

This will be a randomized controlled trial study. Study will be approved by ethical committee. After that informed consent will be taken and patients will be included in the study based on the inclusion criteria. 40 patients will be divided into two groups, interventions will be performed for 50 minutes per session twice a week for total of 8 weeks; In experimental group, rhythmic aerobic exercises will be performed. The rhythmic training group initially used rhythmic auditory stimulation with 8 beats, then progressed to 16 beats per minutes. In control group, strength and balance exercises will be performed. Functional balance of the patient will be assessed by checking the quality of Sit-to-stand and Stand to-Sit on the respective sections of Pediatric Balance Scale and Time Up and Go test. Data will be analyzed using SPSS 25. Mean and standard deviation will be calculated. Both groups will be compared by appropriate test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Down syndrome children
  • Aged 9- to 14-year-old
  • Functional ability sufficient to understand conversation, exercise guidance and direction
  • Have ability to walk 60 meters independently according to 6 minute walk test

Exclusion criteria

  • Patients did not adapt to the training program, or were not willing to participate in the study
  • Did not have ability to stand and walk independently
  • Did not have ability to follow simple verbal instructions
  • Participants with intellectual disabilities, such as those caused by encephalitis, meningitis, disorders due to metabolic disorders, vitamin deficiency, and tumors were excluded from the study

Treatment and study plan

Rhythmic aerobic exercises

Other

The experimental group's pattern of functional movements includes both right and left foot movements. To improve muscle strength and the capacity to maintain balance, exercises including running in place, side steps, walking while eating, and turning in place can also be used. The rhythmic aerobic group linked their motions to the rhythmic auditory stimuli in order to perform in a rhythmic manner.

Control group, strength and balance exercises

Other

The control group engaged in strength and balance exercises where they stood with weight on one leg and raised the other leg to the side or back. In a tandem stance, place your foot heel directly in front of your toe. Get out of a chair, then take a seat without using your hands.

Primary outcomes

  1. Pediatric balance scale (PBS)

    Time frame: 8 weeks

    Pediatric balance scale is a modified version of berg balance scale that is used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

  2. Time up and go test (TUG)

    Time frame: 8 weeks

    The TUG test measure is the time taken, in seconds, by an individual to stand up from a standard arm chair, walk a distance of 3 m, turn, walk back to the chair, and sit down again.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.