Video Documented PBS-Score in Children With Clubfoot

Clubfoot Clinical Trial

— PEVA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033638
• Other study ID #: K 2022-10475
• Status: Recruiting
• Start date: September 12, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: September 2023
• Source: Region Stockholm
• Contact: Josefine E Naili, PhD
• Phone: +46 123 000 00
• Email: josefine.naili[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• Clubfoot

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity

Intervention

Other:
• Score assessment
PBS Score

Locations

Country	Name	City	State
Sweden	Astrid Lindgren Children´s Hospital	Stockholm	Region Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PBS Score agreement and inter-rater reliability	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.	1 year