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临床试验/NCT06033638
NCT06033638已完成不适用

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

Region Stockholm1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2023年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
PBS Score agreement and inter-rater reliability

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

PBS Score agreement and inter-rater reliability

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Eva Weidenhielm-Brostrom

Manager

Region Stockholm

研究点 (1)

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