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Completed

NCT Number: NCT06033638

Video Documented PBS-Score in Children With Clubfoot

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

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Key information

Conditions

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

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Astrid Lindgren Children´s Hospital

Stockholm, Region Stockholm, 17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clubfoot

Exclusion criteria

-

Treatment and study plan

Score assessment

Other

PBS Score

Other names: PBS-score, video evaluation, PROM

Primary outcomes

  1. PBS Score agreement and inter-rater reliability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Registry information

Official study title

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

Acronym: PEVA

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 13, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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