Evaluating quality of life in children with clubfoot
Health-Related Quality of Life in Children and Adolescents With Clubfoot. A Prospective Observational Study
Vestre Viken Hospital Trust · NCT06906406
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 2 Years to 15 Years |
| Sex | All |
| Sponsor | Vestre Viken Hospital Trust (other) |
| Locations | 1 site (Drammen, Buskerud) |
| Trial ID | NCT06906406 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with concurrent severe medical or psychological conditions that may affect outcomes will not benefit from this study.
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 performed: While there may be studies on clubfoot treatment, this specific focus on HRQoL in children using the Ponseti method is relatively novel.
Eligibility criteria
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 this trial is running
Drammen, Buskerud
- Vestreviken — Drammen, Buskerud, Norway (RECRUITING)
Study contacts
- Study coordinator: Per Reidar Høiness, MD PhD
- Email: prhoines@gmail.com
- Phone: +47 97527911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Clubfoot, Children, HRQOL, HRQoL, PedsQL, Ponseti