Health-Related Quality of Life in Children and Adolescents With Clubfoot. A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- HRQoL Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Concurrent severe medical or psychological conditions affecting outcomes.
- •Lack of written informed consent.
- •Incomplete or missing data for PedsQL or PBS assessments.
结局指标
主要结局
HRQoL Score
时间窗: 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.
次要结局
- PBS Clubfoot Score(Baseline, then at every follow-up over the study period of a total of 5 years.)
- Pain Assessment(Baseline, then at every follow-up over the study period of a total of 5 years.)
- Satisfaction Assessment(Baseline, then at every follow-up over the study period of a total of 5 years.)