NCT06776822

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 10, 2025

Last Update Submit

January 16, 2025

Conditions

Congenital Heart Disease in Children

Keywords

Congenital heart diseaseRehabilitationComplication of surgical treatmentPostural asymmetryMaximal expiratory pressureMinimal expiratory pressure

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From enrollment to the end of treatment at 3 weeks

Secondary Outcomes (2)

  • Maximal and minimal expiratory pressure

    From enrollment to the end of treatment at 3 weeks

  • Anterior trunk symmetry index (ATSI)

    From enrollment to the end of treatment at 3 weeks

Study Arms (1)

Children with congenital heart disease, 6-18 years

EXPERIMENTAL
Other: Dynamic neuromuscular stabilisation

Interventions

Dynamic neuromuscular stabilisationOTHER

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.

Also known as: DNS
Children with congenital heart disease, 6-18 years

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • any other disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Motol University Hospital

Prague, 150 00, Czechia

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Marcela Safarova, PhD., PhDr.

    Rehabilitation and Sports Medicine Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 15, 2025

Study Start

November 20, 2024

Primary Completion

February 14, 2025

Study Completion

May 31, 2026

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

All IPD collected throughout the trial

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Unending - Beginning after publication with no end date
Access Criteria
For anybody interested, the results of the study, on-line

Locations

CZ(1)