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

NCT06906406 | Recruiting

• 1 other identifier: 1000323
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Clubfoot; Children; HRQOL (Health Related Quality Of Life)

Keywords

HRQoL; PedsQL; Children; Clubfoot; Ponseti

Outcome Measures

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.

  Baseline, then at every follow-up over the study period of a total of 5 years.

Secondary Outcomes (3)

• 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.

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Concurrent severe medical or psychological conditions affecting outcomes.
• Lack of written informed consent.
• Incomplete or missing data for PedsQL or PBS assessments.

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead

Study Sites (1)

Vestreviken

Drammen, Buskerud, 3004, Norway

RECRUITING

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Per Reidar Høiness, MD PhD

CONTACT

+47 97527911; prhoines@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: April 2, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)