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Video Documented PBS-Score in Children With Clubfoot (PEVA)

R

Region Stockholm

Status

Completed

Conditions

PBS
Clubfoot

Treatments

Other: Score assessment

Study type

Observational

Funder types

Other

Identifiers

NCT06033638
K 2022-10475

Details and patient eligibility

About

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

Full 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.

Enrollment

55 patients

Sex

All

Ages

5 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Clubfoot

Exclusion criteria

-

Trial contacts and locations

1

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Central trial contact

Josefine E Naili, PhD; Eva W Broström, Professor

Data sourced from clinicaltrials.gov

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