Health-Related Quality of Life in Children and Adolescents With Clubfoot

Vestre Viken Hospital Trust

Status: Enrolling

Conditions: HRQOL (Health Related Quality Of Life); Children; Clubfoot

Study type: Observational

Funder types: Other

Identifiers

NCT06906406

1000323

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 2 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Concurrent severe medical or psychological conditions affecting outcomes.
• Lack of written informed consent.
• Incomplete or missing data for PedsQL or PBS assessments.