Video Documented PBS-Score in Children With Clubfoot

NCT ID: NCT06033638

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-10

Study Completion Date

2024-06-18

Brief Summary

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

Detailed Description

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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.

Conditions

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Clubfoot PBS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Score assessment

PBS Score

Intervention Type OTHER

Other Intervention Names

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PBS-score, video evaluation, PROM

Eligibility Criteria

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Inclusion Criteria

* Clubfoot

Exclusion Criteria

\-
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role lead

Responsible Party

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Eva Weidenhielm-Brostrom

Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva W Broström, Professor

Role: PRINCIPAL_INVESTIGATOR

Astrid Lindgren Children´s Hospital

Locations

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Astrid Lindgren Children´s Hospital

Stockholm, Region Stockholm, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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K 2022-10475

Identifier Type: -

Identifier Source: org_study_id

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