跳至主要内容
临床试验/NCT05915780
NCT05915780已完成不适用

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

Riphah International University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Pediatric Berg Balance Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants will get separate treatment protocols & possible efforts will be put to mask the both groups about their treatments

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Recent injury to lower extremities
  • •History of or ongoing vestibular neuritis
  • •Use of Walking Aids

研究组 & 干预措施

Experimental

Experimental

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

干预措施: Cycling (Device)

Controlled

Other

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);

干预措施: Balance Board (Device)

结局指标

主要结局

Pediatric Berg Balance Scale

时间窗: 8 weeks

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.

6 Minutes Walk Test

时间窗: 8 weeks

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 Up & Go

时间窗: 8 Weeks

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验