NCT06033638

Video Documented PBS-Score in Children With Clubfoot

Agreement and Inter-rater Reliability of Video Documented PBS-Score - An International Cross-sectional Multicenter Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Region Stockholm · Other Government
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Accepted

Summary

Evaluate agreement and inter-rater reliability of PBS-score assessments based on video documented material.

Detailed description

120 children with idiopathic clubfoot will be included from four different countries 30 patients from each participating center. Inclusion criteria include: age 4-14 years, diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish, English, Portuguese, Urdu, or Pashto. All items of the PBS-score will be documented using video recordings. Six to eight senior orthopedic surgeons will score a total of 90 children each, not the children from their center of employment, according to the PBS-score based on videos. Collaborating centers include Karolinska University Hospital, Sweden, Hospital Pequeno Príncipe, Brazil, and Hayatabad Medical Complex, Orthopaedic Unit, Peshawar, Pakistan.

Conditions

• Clubfoot
• PBS

Interventions

Type	Name	Description
OTHER	Score assessment	PBS Score

Timeline

• Start date: 2023-01-10
• Primary completion: 2023-12-28
• Completion: 2024-06-18
• First posted: 2023-09-13
• Last updated: 2025-09-15

Locations

1 site across 1 country: Sweden