Health-Related Quality of Life in Children and Adolescents With Clubfoot
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-15
SponsorVestre Viken Hospital Trust
About this trial
This prospective cohort study aims to evaluate the health-related quality of life (HRQoL) in children aged 2 to 15 years with congenital clubfoot, treated primarily according to the Ponseti method. The study will assess HRQoL using the Pediatric Quality of Life Inventory (PedsQL 4.0) and clinical outcomes using the PBS Clubfoot Score (PBS). Participants will be followed for 2 and 5 years to evaluate changes in HRQoL and clinical function. The primary objective is to understand the long-term impact of clubfoot and its treatment on patients' physical, emotional, and social well-being.
Eligibility criteria
Qualifiers
Children aged 2 to 15 years diagnosed with congenital clubfoot.
Undergoing treatment or follow-up at Drammen Hospital.
Both unilateral and bilateral cases included.
Written informed consent from parents or legal guardians.
Disqualifiers
Concurrent severe medical or psychological conditions affecting outcomes.
Lack of written informed consent.
Incomplete or missing data for PedsQL or PBS assessments.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov