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

NCT ID: NCT06196983

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-02-05

Brief Summary

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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

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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.

Conditions

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Down Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group, Rhythmic aerobic exercises

Rhythmic aerobic exercises were used in experimental group.

Group Type EXPERIMENTAL

Rhythmic aerobic exercises

Intervention Type 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

only strength and balance exercises were given to control group.

Group Type ACTIVE_COMPARATOR

Control group, strength and balance exercises

Intervention Type 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.

Interventions

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Rhythmic aerobic exercises

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.

Intervention Type OTHER

Control group, strength and balance exercises

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laraib -un-Nisa, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah international university

Lahore, , Pakistan

Site Status

Countries

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Pakistan

References

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Vazou S, Klesel B, Lakes KD, Smiley A. Rhythmic Physical Activity Intervention: Exploring Feasibility and Effectiveness in Improving Motor and Executive Function Skills in Children. Front Psychol. 2020 Sep 18;11:556249. doi: 10.3389/fpsyg.2020.556249. eCollection 2020.

Reference Type BACKGROUND
PMID: 33071879 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/33071879/

Rhythmic Physical Activity Intervention: Exploring Feasibility and Effectiveness in Improving Motor and Executive Function Skills in Children.

Other Identifiers

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REC/RCR&AHS/23/0731

Identifier Type: -

Identifier Source: org_study_id

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