Effect of Aerobic Exercises on Static & Dynamic Balance

Down Syndrome Clinical Trial

Official title:

Effects of Aerobic Exercises on Static & Dynamic Balance in Children With Down's Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05915780
• Other study ID #: REC/RCR & AHS/23/0712
• Status: Completed
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: June 6, 2023

Study information

• Verified date: June 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the effect of aerobic exercises on static & dynamic balance of children in Down syndrome. When a person has Down syndrome, they have an extra chromosome. In the body, chromosomes are discrete collections of genes. They control how a baby's body develops and works both throughout pregnancy and after birth. A newborn typically has 46 chromosomes. Down syndrome is a genetic disorder that affects physical and developmental growth and can cause minor to severe issues. Mental impairment, unusual facial features, an increased risk of cardiac defects, and digestive issues that can range in severity from mild to severe are all symptoms associated with the syndrome.

Description:

This will be a randomized controlled trial. Total sample size of 20 will be divided into control and experimental groups. Control group will be given with the standard physical therapy intervention as a baseline treatment while experimental group will be given with the aerobic exercise along with baseline treatment. Pediatric balance test and the six-minute walk test will be used before and after the intervention. Data will be analyzed on SPSS 26.0 and necessary analysis will be done after checking the normality of data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 6, 2023
• Est. primary completion date: May 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children with medical diagnosis of DS

• Children with mild (IQ 50-70) to moderate (IQ 35-40) mental retardation

• Age 5-12 Years

• Children who were able to stand and walk

Exclusion Criteria:

• Recent injury to lower extremities

• History of or ongoing vestibular neuritis

• Use of Walking Aids

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

Device:
• Cycling
The experimental group will be administered with the cycling exercises in addition to the complete plan of care that is being administered to the control group. The cycling intervention will be performed 3 times per week, for 30 minutes, within a 8-week period
• Balance Board
Control group will be given with the standard physical therapy intervention that includes progressive resistance training that will be performed using weights, two sets of 10 repetitions will be given for each muscle group, resistance will be increased by ½ Kg as children are able to complete without undue stresses); balance exercises (stand on a balance board, one-leg stance, heal-to-toes stance, walking on balance board, walking on a balance beam, walking on a line, and walking on the inclined surface); flexibility exercises (if required);

Locations

Country	Name	City	State
Pakistan	Riphah International University	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Berg Balance Scale	The scale quantifies balance impairments in daily life activities by scoring 0-4 points for the ability to maintain balance while sitting and standing, during 360 degree turns and transfers between juxtaposed chairs, when picking objects from the floor, placing an alternate feet on a stool and leaning forward in a standing position.	8 weeks
Primary	Time Up & Go	Time up & go test is a simple test used to assess a person's mobility & requires both static & dynamic balance.; It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair and sit down while turning 180 degrees Interpretation: = 10 seconds= normal. =20 seconds = good mobility, can go out alone, mobile without gait aid. = 30 seconds= problems, cannot go outside alone, requires gait aid. A score of = 14 seconds has been shown to indicate high risk of falls.	8 Weeks
Primary	6 Minutes Walk Test	The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity Six-Minute Walk Test recommend use of a 30 meter or 100 foot walkway with the length of the corridor marked every 3 meters.	8 weeks