The Effect of DNS Therapy on Asymmetry in Children After Surgery of Congenital Heart Disease

January 16, 2025 updated by: Charles University, Czech Republic

The Effect of DNS Therapy in Children After Cardiac Surgery

This thesis will examine the consequences of congenital heart disease (CHD) surgery in children. The main goal of this work is to point out the possible development of late consequences after cardiac surgery in childhood (e.g. asymmetry, scoliosis, hypomobility of the spine) and to assess the effect of DNS therapy on the resolution of the consequences. For patients, after an intensive three-week rehabilitation intervention, an improvement in the monitored initial parameters is expected, which would lead to an improvement in the quality of life.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

As part of the diploma thesis, a study will be conducted in patients after cardiac surgery performed at the Motol Hospital within the Children's Cardiology Center. The intervention will be performed in Rehabilitation Clinic Teplice nad Bečvou. The study group will include children aged 6-18 years after VSV surgery without other serious health complications. The subjects will undergo therapy according to DNS for 3 weeks. Therapy according to DNS will take place twice a day (1x individual physiotherapy 40 minutes, 1x group 40 minutes) and will be supplemented with conventional therapy (e.g. scar care).

The initial examination will be performed by a doctor and a trained physiotherapist in a blinded mode (information about which patients are undergoing the intervention will not be known). The initial examination will include imaging of the spine, ideally EOS (low radiation exposure). During the initial and final examination, a trunk stabilization examination will be performed according to the DNS protocol with photo documentation, the values of MIP and MEP oral pressures (cm H₂O) will be measured, the symmetry index will be measured using the SCODIAC software, the mobility of the spine will be examined (Schober distance, Stibor distance, Otto inclination distance, Thomayer distance, in cm) and the respiratory amplitudes on the chest will be measured (mesosternal and xiphosternal, in cm). The subjects will complete the SF-36 quality of life questionnaire before the start of therapy and after its completion. The parameters will be compared during the initial and final examination.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 150 00
        • Motol University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • children 6-18 years, surgery of congenital heart disease

Exclusion Criteria:

  • any other disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children with congenital heart disease, 6-18 years
Other: Dynamic neuromuscular stabilisation
The nervous system establishes programs that control human posture, movement and gait. This 'motor control' is largely established during the first critical years of life. Therefore, the "Prague School" emphasizes neurodevelopmental aspects of motor control in order to assess and restore dysfunction of the locomotor system and associated syndromes.
Other Names:
  • DNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobility of the spine - Stibor distance
Time Frame: From enrollment to the end of treatment at 3 weeks
The Stibor distance shows the development of the thoracic and lumbar spine. The starting point is the spine of the L5 vertebra, the second point is the spine of the C7 vertebra. The distance between them is measured and its change during relaxed forward bending are observed. A healthy spine should lengthen by 7-10 cm.
From enrollment to the end of treatment at 3 weeks
Mobility of the spine - Otto's inclination distance
Time Frame: From enrollment to the end of treatment at 3 weeks
Otto's inclination distance measures the mobility of the thoracic spine during forward bending. The starting point is the spine of the C7 vertebra, from which we measure 30 cm caudally. The distance of the points shown increases by at least 3.5 cm with forward tilt.
From enrollment to the end of treatment at 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal and minimal expiratory pressure
Time Frame: From enrollment to the end of treatment at 3 weeks
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) are global measures of maximal strength of respiratory muscles and they are the greater pressure which may be generated during maximal inspiration and expiration against an occluded airway. MEP and MIP are assessed by using a pressure reading device (manometer) and is used for respiratory muscle strength testing to obtain objective measurements of positive (expiratory) and negative (inspiratory) pressures.
From enrollment to the end of treatment at 3 weeks
Anterior trunk symmetry index (ATSI)
Time Frame: From enrollment to the end of treatment at 3 weeks
Spinal deformities and postural disorders can be assessed by evaluation of trunk surface deformity. On patients, the anatomical landmarks are highlighted and examined with digital photography of the trunk, taken from the front. After that, the anatomical points are indicated on a digital photo and the index is measured. Pathologic is index above 27. Higher numbers mean more asymmetry.
From enrollment to the end of treatment at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Investigators

  • Study Director: Marcela Safarova, PhD., PhDr., Rehabilitation and Sports Medicine Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2024

Primary Completion (Estimated)

February 14, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-714/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD collected throughout the trial

IPD Sharing Time Frame

Unending - Beginning after publication with no end date

IPD Sharing Access Criteria

For anybody interested, the results of the study, on-line

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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