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

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

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

Study Overview

• Status: Recruiting
• Conditions: Clubfoot; PBS
• Intervention / Treatment: Other: Score assessment

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Josefine E Naili, PhD; Phone Number: +46 123 000 00; Email: josefine.naili@ki.se
• Study Contact Backup: Name: Eva W Broström, Professor; Phone Number: +46 7002 1670; Email: eva.brostrom@ki.se

Study Locations

• Sweden
  • Region Stockholm
    • Stockholm, Region Stockholm, Sweden, 17176
      • Recruiting
      • Astrid Lindgren Children´s Hospital
      • Contact: Eva W Broström; Phone Number: +4670021670; Email: eva.brostrom@ki.se
      • Contact: Josefine E Naili; Phone Number: +4612300000; Email: josefine.naili@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Children born with clubfoot

Description

Inclusion Criteria:

• Clubfoot

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Region Stockholm
• Investigators: Principal Investigator: Eva W Broström, Professor, Astrid Lindgren Children´s Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Clubfoot; Talipes; Equinus Deformity
• Other Study ID Numbers: K 2022-10475

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No