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

NCT ID: NCT05191654

Last Updated: 2022-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Defects Down Syndrome Gross Motor Development Delay

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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with Congenital heart diseases

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

Intervention Type 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.

without Congenital heart diseases

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

Intervention Type 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.

Interventions

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

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Atılım University

OTHER

Sponsor Role lead

Responsible Party

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Tuğba Şanlı

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Atılım University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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59394181-604.01.01-75

Identifier Type: -

Identifier Source: org_study_id

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