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

Not Applicable

Completed

• Conditions: Down Syndrome
• Interventions: Other: Rhythmic aerobic exercises; Other: Control group, strength and balance exercises

• Registration Number: NCT06196983
• Lead Sponsor: Riphah International University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2023-12-26
• Study First Submitted QC: 2023-12-26
• Study First Posted: 2024-01-09
• Primary Completion: 2024-02-05
• Study Completion: 2024-02-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group, Rhythmic aerobic exercises	Rhythmic aerobic exercises	Rhythmic aerobic exercises were used in experimental group.
control group, strength and balance exercises	Control group, strength and balance exercises	only strength and balance exercises were given to control group.

Primary Outcome Measures

Name	Time	Method
Pediatric balance scale (PBS)	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.
Time up and go test (TUG)	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.

Trial Locations

Locations (1)

Riphah international university; 🇵🇰 Lahore, Pakistan