Clinical trial NCT06776822: The Effect of DNS Therapy on Asymmetry in Children After Surgery of Congenital Heart Disease
Official title: The Effect of DNS Therapy in Children After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Congenital Heart Disease in Children
Keywords: Congenital heart disease
Rehabilitation
Complication of surgical treatment
Postural asymmetry
Maximal expiratory pressure
Minimal expiratory pressure
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* any other disease

Primary outcomes:
measure: Mobility of the spine - Stibor distance
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: Mobility of the spine - Otto's inclination distance
timeFrame: From enrollment to the end of treatment at 3 weeks
Secondary outcomes:
measure: Maximal and minimal expiratory pressure
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: Anterior trunk symmetry index (ATSI)
timeFrame: From enrollment to the end of treatment at 3 weeks
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Motol University Hospital
Study officials:
affiliation: Rehabilitation and Sports Medicine Clinic
name: Marcela Safarova, PhD., PhDr.
role: STUDY_DIRECTOR
References: