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

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

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 Overview

• Status: Recruiting
• Conditions: Children; HRQOL (Health Related Quality Of Life); Clubfoot

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Per Reidar Høiness, MD PhD; Phone Number: +47 97527911; Email: prhoines@gmail.com

Study Locations

• Norway
  • Buskerud
    • Drammen, Buskerud, Norway, 3004
      • Recruiting
      • Vestreviken
      • Contact: Per Reidar Høiness, MD PhD; Phone Number: +47 97527911; Email: prhoines@vestreviken.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	Baseline, then at every follow-up over the study period of a total of 5 years.

Collaborators and Investigators

• Sponsor: Vestre Viken Hospital Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Children; HRQoL; Clubfoot; PedsQL; Ponseti
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Foot Deformities, Acquired; Foot Deformities, Congenital; Talipes; Foot Deformities; Clubfoot; Equinus Deformity
• Other Study ID Numbers: 1000323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No