Children, Clubfoot, HRQOL (Health Related Quality Of Life)
Conditions
Keywords
HRQoL, PedsQL, Children, Clubfoot, Ponseti
Brief summary
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.
Interventions
None listed
Sponsors
Vestre Viken Hospital Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HRQoL Score | Baseline, then at every follow-up over the study period of a total of 5 years. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PBS Clubfoot Score | Baseline, then at every follow-up over the study period of a total of 5 years. | 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. |
| Pain Assessment | Baseline, then at every follow-up over the study period of a total of 5 years. | Pain Assessment: Visual Analogue Scale (VAS) score ranging from 0 (no pain) to 100 (worst pain imaginable). |
| Satisfaction Assessment | Baseline, then at every follow-up over the study period of a total of 5 years. | Satisfaction Assessment: Visual Analogue Scale (VAS) score for patient and parent satisfaction with treatment outcomes, ranging from 0 (not satisfied) to 100 (completely satisfied). |
Countries
Norway
Contacts
Primary ContactPer Reidar Høiness, MD PhD
Outcome results
None listed