NCT06033638

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2024

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

May 10, 2023

Last Update Submit

September 12, 2025

Conditions

ClubfootPBS

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Score assessmentOTHER

PBS Score

Also known as: PBS-score, video evaluation, PROM

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children born with clubfoot

You may qualify if:

  • Clubfoot

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Astrid Lindgren Children´s Hospital

Stockholm, Region Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Clubfoot

Interventions

Organ Dysfunction Scores

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Severity of Illness IndexPatient AcuityHealth Status IndicatorsHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Eva W Broström, Professor

    Astrid Lindgren Children´s Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manager

Study Record Dates

First Submitted

May 10, 2023

First Posted

September 13, 2023

Study Start

January 10, 2023

Primary Completion

December 28, 2023

Study Completion

June 18, 2024

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)