Video Documented PBS-Score in Children With Clubfoot

Recruiting

• Conditions: Clubfoot; PBS

• Registration Number: NCT06033638
• Lead Sponsor: Region Stockholm

Brief 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.

Study Timeline

• Study First Submitted: 2023-05-10
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-11
• Last Update Submitted: 2023-09-11
• Study Start: 2023-09-12
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Clubfoot

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PBS Score agreement and inter-rater reliability	1 year	PBS Score is a tool to grade the severity of clubfoot recurrence in the walking child, and was proposed to serve as an instrument to guide treatment. The sum of all points for all signs is scored between 7 and 18.

Trial Locations

Locations (1)

Astrid Lindgren Children´s Hospital; 🇸🇪 Stockholm, Region Stockholm, Sweden