RecruitingNCT06906406

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


Sponsor

Vestre Viken Hospital Trust

Enrollment

30 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 15 Years

Inclusion Criteria4

  • 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 Criteria3

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

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Locations(1)

Vestreviken

Drammen, Buskerud, Norway

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NCT06906406


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