Health-Related Quality of Life in Children and Adolescents With Clubfoot
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Clubfoot, Children, HRQOL (Health Related Quality Of Life). Basic parameters: 2 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Health-Related Quality of Life in Children and Adolescents With Clubfoot. A Prospective Observational Study
Overview
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.
Primary outcome measures
- HRQoL Score [Time frame: Baseline, then at every follow-up over the study period of a total of 5 years.]
Secondary outcome measures (3)
- PBS Clubfoot Score [Time frame: Baseline, then at every follow-up over the study period of a total of 5 years.]
- Pain Assessment [Time frame: Baseline, then at every follow-up over the study period of a total of 5 years.]
- Satisfaction Assessment [Time frame: Baseline, then at every follow-up over the study period of a total of 5 years.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Norway · 1 center
- Vestreviken — Drammen
Identifiers
NCT: NCT06906406 · 1000323