NCT06906406

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

Health-Related Quality of Life in Children and Adolescents With Clubfoot. A Prospective Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Vestre Viken Hospital Trust · Academic / Other
• Sex: All
• Age: 2 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Clubfoot
• Children
• HRQOL (Health Related Quality Of Life)

Timeline

• Start date: 2025-01-01
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2025-04-02
• Last updated: 2025-04-02

Locations

1 site across 1 country: Norway