Health-Related Quality of Life in Children and Adolescents With Clubfoot

Vestre Viken Hospital Trust30 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Clubfoot Children HRQOL (Health Related Quality Of Life)

Eligibility

Sex: ALLMin age: 2 YearsMax age: 15 Years

Medical Language ↔ Plain English

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.

Locations (1)

Outcomes

Primary Outcomes

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

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.

Health-Related Quality of Life in Children and Adolescents With Clubfoot

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts