Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in DS With and Without CHD

NCT05191654 | Completed

• 1 other identifier: 59394181-604.01.01-75
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Defects; Down Syndrome; Gross Motor Development Delay

Keywords

congenital heart defects; Down syndrome; motor skills

Outcome Measures

Primary Outcomes (7)

• Gross Motor Function Measure-88

  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

  october 2020- june 2021

• Bulb Dynamometer

  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.

  october 2020- june 2021

• Left ventricular ejection fraction (EF)

  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.

  october 2020- june 2021

• Interventricular septum wall thickness (IVS)

  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).

  october 2020- june 2021

• Left ventricular end-diastolic diameter (LVDd)

  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).

  october 2020- june 2021

• Fractional shortening (FS)

  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%.

  october 2020- june 2021

• Wang Respiratory Score

  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.

  october 2020- june 2021

Study Arms (2)

with Congenital heart diseases

Diagnostic Test: evaluation of cardiopulmonary parameters, gross motor development and hand grip strength

without Congenital heart diseases

Diagnostic Test: evaluation of cardiopulmonary parameters, gross motor development and hand grip strength

Interventions

evaluation of cardiopulmonary parameters, gross motor development and hand grip strength DIAGNOSTIC_TEST

Gross motor development was evaluated with Gross Motor Function Measure (GMFM-88). Hand grip strength was measured with the Baseline Pneumatic Bulb Dynamometer. Cardiopulmonary parameters values was evaluated with echocardiography.

with Congenital heart diseases; without Congenital heart diseases

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with down syndrome

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atılım University: lead

Study Sites (1)

Atılım University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Down Syndrome

Interventions

Hand Strength

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: January 13, 2022
• Study Start: October 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)