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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years to 15 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Vestre Viken Hospital Trust Academic / other |
| Locations | 1 site (Drammen, Buskerud) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2030 |
| Registry record updated | April 2, 2025 |
| Trial ID | NCT06906406 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
- Study coordinator: Per Reidar Høiness, MD PhD
- Email: prhoines@gmail.com
- Phone: +47 97527911
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.