Actively Recruiting
Health-Related Quality of Life in Children and Adolescents With Clubfoot. A Prospective Observational Study
Led by Vestre Viken Hospital Trust · Updated on 2025-04-02
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the health-related quality of life (HRQoL) in children aged 2 to 15 years who have congenital clubfoot and are treated mainly using the Ponseti method. This prospective observational study aims to understand how clubfoot and its treatment affect patients' physical, emotional, and social well-being over time. Participants will be observed over a period of 5 years, with assessments at the start and during follow-ups. The study uses the Pediatric Quality of Life Inventory (PedsQL 4.0) to measure HRQoL and the PBS Clubfoot Score (PBS) to evaluate clinical outcomes. Additional assessments include pain and satisfaction evaluations. Children and their families will participate in regular follow-up visits where questionnaires and clinical scores will be collected. These visits will monitor changes in quality of life, clinical function, pain, and satisfaction related to clubfoot and its treatment. The total participation duration extends up to 5 years to capture long-term effects.
CONDITIONS
Brief Title
Health-Related Quality of Life in Children and Adolescents With Clubfoot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 15 years diagnosed with congenital clubfoot
- Receiving treatment or follow-up at Drammen Hospital
- Includes both unilateral and bilateral clubfoot cases
- Written informed consent from parents or legal guardians
You will not qualify if you...
- Severe medical or psychological conditions that could affect study outcomes
- No written informed consent provided
- Missing or incomplete data for PedsQL or PBS assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 years
Participants are followed over a period of 5 years with assessments of health-related quality of life, clubfoot severity, pain, and satisfaction.
Baseline visit followed by regular follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
Vestreviken
Drammen, Buskerud, Norway, 3004
Actively Recruiting
Research Team
P
Per Reidar Høiness, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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