Congenital Heart Disease in ChildrenNCT06776822
The Effect of DNS Therapy on Asymmetry in Children After Surgery of Congenital Heart Disease
A study testing Dynamic neuromuscular stabilisation in people with Congenital Heart Disease in Children, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Congenital Heart Disease in Children
- What is being tested?
- Dynamic neuromuscular stabilisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Nov 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children 6-18 years, surgery of congenital heart disease
Who cannot join
- any other disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Congenital Heart Disease in Children
- Being tested
- Dynamic neuromuscular stabilisation
- Keywords
- Congenital heart disease, Rehabilitation, Complication of surgical treatment, Postural asymmetry, Maximal expiratory pressure, Minimal expiratory pressure
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic neuromuscular stabilisationOther
Also called DNS
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with congenital heart disease, 6-18 years | Experimental | Not described Receives: Other: Dynamic neuromuscular stabilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility of the spine - Stibor distance
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.
Measured: From enrollment to the end of treatment at 3 weeks
Mobility of the spine - Otto's inclination distance
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.
Measured: From enrollment to the end of treatment at 3 weeks
Secondary outcomes (2)
Maximal and minimal expiratory pressure
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.
Measured: From enrollment to the end of treatment at 3 weeks
Anterior trunk symmetry index (ATSI)
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.
Measured: From enrollment to the end of treatment at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start20 Nov 2024
- Primary completion14 Feb 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcela Safarova, PhD., PhDr., Study director, Rehabilitation and Sports Medicine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776822
- Sponsor's protocol ID
- EK-714/24
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of DNS Therapy in Children After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06776822
- Acronym / sponsor ID
- EK-714/24
- Conditions
- Congenital Heart Disease in Children
- Keywords
- Congenital heart disease, Rehabilitation, Complication of surgical treatment, Postural asymmetry, Maximal expiratory pressure, Minimal expiratory pressure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 14 Feb 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with congenital heart disease, 6-18 years | Experimental | Other: Dynamic neuromuscular stabilisation |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children 6-18 years, surgery of congenital heart disease
Key exclusion criteria (1 listed)
- any other disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic neuromuscular stabilisationAlso: DNSThe 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 | Children with congenital heart disease, 6-18 years |
Primary outcome
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.
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.
2 secondary outcomes
Maximal and minimal expiratory pressure
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcela Safarova, PhD., PhDr. study director
Rehabilitation and Sports Medicine Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic neuromuscular stabilisation in people with Congenital Heart Disease in Children, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility of the spine - Stibor distance (time frame: From enrollment to the end of treatment at 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.