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Effect of Aerobic Exercises on Static & Dynamic Balance

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Cycling
Balance Board
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring Down syndrome, aerobic exercises, Static & dynamic balance

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental

Controlled

Arm Description

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

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);

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
June 22, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05915780
Brief Title
Effect of Aerobic Exercises on Static & Dynamic Balance
Official Title
Effects of Aerobic Exercises on Static & Dynamic Balance in Children With Down's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
May 21, 2023 (Actual)
Study Completion Date
June 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Down syndrome, aerobic exercises, Static & dynamic balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a randomized control trial, used to compare the effect of aerobic exercises on static & dynamic balance in children with down's syndrome. Subjects with down syndrome meeting the predetermined inclusion & exclusion criteria will be divided into two groups using simple random sampling technique
Masking
Participant
Masking Description
Participants will get separate treatment protocols & possible efforts will be put to mask the both groups about their treatments
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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
Arm Title
Controlled
Arm Type
Other
Arm Description
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);
Intervention Type
Device
Intervention Name(s)
Cycling
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Balance Board
Intervention Description
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);
Primary Outcome Measure Information:
Title
Pediatric Berg Balance Scale
Description
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.
Time Frame
8 weeks
Title
Time Up & Go
Description
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.
Time Frame
8 Weeks
Title
6 Minutes Walk Test
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Usman Arif, *MS
Organizational Affiliation
Student
Official's Role
Study Chair
Facility Information:
Facility Name
Riphah International University
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Aerobic Exercises on Static & Dynamic Balance

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