Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in Children With Down Syndrome With and Without Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Fractional shortening (FS)
研究概览
简要总结
Congenital heart diseases (CHD) are detected in 40-60% of individuals with Down syndrome (DS) and increase the risk of developmental delay in the presence of syndromes. The aim of the study was to compare cardiopulmonary parameters, gross motor development and hand grip strength in DS children with and without CHD. Demographic variables, cardiopulmonary parameters and echocardiographic values were recorded. Gross motor development was evaluated with Gross Motor Function Measure (GMFM-88). Hand grip strength was measured with the Baseline Pneumatic Bulb Dynamometer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with Down syndrome as a result of genetic analysis,
- •For the congenital heart disease group; undergoing cardiac surgery at least 6 months before the evaluation, diagnosed as CHD by a pediatric cardiologist based on echocardiographic findings,
- •For the group without congenital heart disease, patients who have not undergone cardiac surgery, are asymptomatic with a septal defect smaller than 4-5 mm, are expected to close, and are hemodynamically normal by a pediatric cardiologist,
- •Children whose families were informed about the study and gave written consent to participate in the study were included in the study.
排除标准
- •Having another genetic abnormality other than Down syndrome,
- •undergoing surgery other than cardiac surgery,
- •Having an orthopedic or neurological problem,
- •Respiratory support,
- •With atlantoaxial instability,
- •Children with hematological disease were not included in the study.
结局指标
主要结局
Fractional shortening (FS)
时间窗: october 2020- june 2021
Echocardiographic findings performed in the last 6 months were evaluated by a pediatric cardiologist. Fractional shortening evaluates left ventricular systolic function. Fractional shortening value show as a percentage (%). The value of normal fractional shortening in children is between 28-44%.
Bulb Dynamometer
时间窗: october 2020- june 2021
Hand grip strength was measured with a Baseline Pneumatic Bulb Dynamometer (Fabrication Enterprises INC, Elmsford, NY USA). With a bulb dynamometer, the spherical grip force is measured using a rubber balloon tip. The bulb dynamometer has 3 removable sizes. The values measured on the manometer are recorded in kPa. The measurement is repeated 3 times and the highest value is taken.
Left ventricular ejection fraction (EF)
时间窗: october 2020- june 2021
Echocardiographic findings performed in the last 6 months were evaluated by a pediatric cardiologist. It is obtained by dividing the difference in left ventricular volume at end-diastolic and end-systolic by the end-diastolic left ventricular volume. Left ventricular ejection fraction (EF) indicate the systolic function of the left ventricle. Ejection fraction value show as a percentage (%). The ejection fraction normal value is between 50 percent and 70 percent.
Left ventricular end-diastolic diameter (LVDd)
时间窗: october 2020- june 2021
Echocardiographic findings performed in the last 6 months were evaluated by a pediatric cardiologist. It is important in the risk classification potential of left ventricular systolic function. Its value is show as millimeters (mm).
Wang Respiratory Score
时间窗: october 2020- june 2021
The Wang respiratory score assesses respiratory frequency, wheezing, retraction, and general condition. parameters are scored between 0-3 and summed. A higher score indicates that the situation is getting severe.
Gross Motor Function Measure-88
时间窗: october 2020- june 2021
Gross motor development of the participants was evaluated with the Gross Motor Function Measure-88 questionnaire. The value as a percentage was obtained as a result of the survey. Gross Motor Function Measure-88 consists of 5 sections that include the evaluation of Lying \& Rolling, Sitting, Crawling \& Kneeling, Standing, Walking, Running \& Jumping activities. Each item in the sections consists of a 4-point scale. Scores for each section are summed and divided by 5.The maximum score on the scale is 100. A high score indicates good gross motor development. 0 = does not initiate 1. = initiates 2. = partially completes 3. = completes
Interventricular septum wall thickness (IVS)
时间窗: october 2020- june 2021
Echocardiographic findings performed in the last 6 months were evaluated by a pediatric cardiologist. It is important in the risk classification potential of left ventricular systolic function. Its value is show as millimeters (mm).
次要结局
未报告次要终点
研究者
Tuğba Şanlı
Principal Investigator
Atılım University