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

Recruiting now

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

In brief

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.

Key facts

Study ID

NCT06906406

Run by

Vestre Viken Hospital Trust

People needed

30

Starts

2025-01-01

Expected to finish

2030-12-31

Last updated by the study team

2025-04-02

Who can join

Age: 2 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Vestreviken — Drammen, Buskerud, Norway (enrolling)

Full record on ClinicalTrials.gov

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