Clinical trial Recruiting at 1 site Observational Ages 2 to 15

Evaluating quality of life in children with clubfoot

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

Run by Vestre Viken Hospital Trust · NCT06906406 · Data updated 2026-11-12

This study looks at how living with clubfoot affects the quality of life for children aged 2 to 15 who have been treated with the Ponseti method, to see how they feel physically, emotionally, and socially over time.

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Quick facts

Study typeObservational
Ages2 Years to 15 Years
SexAll
Enrollment30 (estimated)
SponsorVestre Viken Hospital Trust
Academic / other
Locations1 site (Drammen, Buskerud)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedDecember 31, 2029
Study endsDecember 31, 2030
Registry record updatedApril 2, 2025
Trial IDNCT06906406 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged 2 to 15 years diagnosed with congenital clubfoot who are receiving treatment at Drammen Hospital.

Probably not a fit

Patients with concurrent severe medical or psychological conditions that may affect outcomes will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on assessing the health-related quality of life (HRQoL) in children aged 2 to 15 years diagnosed with congenital clubfoot, primarily treated using the Ponseti method. Participants will be evaluated using the Pediatric Quality of Life Inventory (PedsQL 4.0) and the PBS Clubfoot Score (PBS) over a follow-up period of 2 and 5 years. The study aims to understand the long-term effects of clubfoot and its treatment on the physical, emotional, and social well-being of these children.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term quality of life for children with clubfoot, guiding future treatment approaches.

How similar studies have gone: While there may be studies on clubfoot treatment, this specific focus on HRQoL in children using the Ponseti method is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Vestreviken
    Drammen, Buskerud, Norway
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.