Health-Related Quality of Life in Children and Adolescents With Clubfoot
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-15
SponsorVestre Viken Hospital Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Concurrent severe medical or psychological conditions affecting outcomes.
Lack of written informed consent.
Incomplete or missing data for PedsQL or PBS assessments.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.Sponsors and contacts
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Source ClinicalTrials.gov