An observational study in Clubfoot, Children and HRQOL (Health Related Quality Of Life), sponsored by Vestre Viken Hospital Trust. Recruiting at 1 site in Norway. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Vestre Viken Hospital Trust · Observational
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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.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
This study's planned enrollment of 30 is below the median of 55 across 27 observational studies indexed under Clubfoot.
Browse Clubfoot studies →Vestre Viken Hospital Trust is the lead sponsor of 52 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study investigates the impact of congenital clubfoot and its treatment on the health-related quality of life (HRQoL) in children using a prospective cohort design. The participants will be evaluated using the Pediatric Quality of Life Inventory (PedsQL 4.0) to assess HRQoL and the PBS Clubfoot Score (PBS) for clinical outcomes. Assessments will occur at baseline, 2 years, and 5 years post-treatment initiation. Data collection will include clinical evaluations, standardized HRQoL questionnaires, and Visual Analogue Scale (VAS) assessments for pain and satisfaction. The findings will help optimize treatment protocols for clubfoot by providing comprehensive insights into how different treatment methods impact children's quality of life.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HRQoL Score
Health-Related Quality-of-Life (HRQoL) score as measured by The Pediatric Quality of Life Inventory™ (PedsQL) 4.0, assessing physical, emotional, social, and school functioning. Scored on a scale from 0 to 100, with higher scores indicating better HRQoL.
Time frame: Baseline, then at every follow-up over the study period of a total of 5 years.
PBS Clubfoot Score
The PBS (Ponseti, Barlow, and Stagnara) Clubfoot Score assesses clinical function, including foot shape, range of motion, and muscle balance. The score ranges from 7 to 18 points, in which a low score indicates good function, and a high score indicates poor function.
Time frame: Baseline, then at every follow-up over the study period of a total of 5 years.
Pain Assessment
Pain Assessment: Visual Analogue Scale (VAS) score ranging from 0 (no pain) to 100 (worst pain imaginable).
Time frame: Baseline, then at every follow-up over the study period of a total of 5 years.
Satisfaction Assessment
Satisfaction Assessment: Visual Analogue Scale (VAS) score for patient and parent satisfaction with treatment outcomes, ranging from 0 (not satisfied) to 100 (completely satisfied).
Time frame: Baseline, then at every follow-up over the study period of a total of 5 years.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2029, 59 months after the start.
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Vestre Viken Hospital Trust