Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06906406

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Clubfoot Children Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital HRQOL (Health Related Quality Of Life) Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vestreviken

Drammen, Buskerud, 3004, Norway

Location status: Recruiting

Location contact

Per Reidar Høiness, MD PhD

CONTACT

[email protected]

+47 97527911

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. HRQoL Score

    Time frame: 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 outcomes

  1. PBS Clubfoot Score

    Time frame: 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.

  2. Pain Assessment

    Time frame: 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).

  3. Satisfaction Assessment

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Per Reidar Høiness, MD PhD

CONTACT

[email protected]

+47 97527911

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Registry information

Official study title

Health-Related Quality of Life in Children and Adolescents With Clubfoot. A Prospective Observational Study

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.