Skip to content

Predictive Value of the PBS-score in Children With Clubfoot

Predictive Value of the PBS-score - A Prospective Observational Cohort Study Evaluating Recurrence of Idiopathic Clubfoot and Need for Additional Treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06050746
Enrollment
60
Registered
2023-09-22
Start date
2023-01-10
Completion date
2030-06-30
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clubfoot

Keywords

PBS-score, Oxford Foot and Ankle Questionaire-child, Roye's score, Pedobarography

Brief summary

Evaluate the predictive value of the PBS-score in predicting recurrence of idiopathic clubfoot, measured as need for additional treatment.

Detailed description

Using a consecutive inclusion, we aim to include 60 children and register data proposed by the COS for PEVA. All items of the PBS-score are video-documented, and dynamic foot pressure during walking is recorded during a clinical visit at the Motion Analysis Lab at Karolinska University Hospital. Children and caregivers will complete Roye's score, a disease-specific PROM and Oxford Foot and Ankle Questionaire-child (OxFAQc). For children aged 6 years or older, standing radiographic imaging of both feet will be performed. Inclusion criteria include: age 4-8 years, a diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish or English. Included children will be followed prospectively during five years through clinical visits and medical records, where need for additional treatment (casting, braces and/or surgery) is the primary endpoint.

Interventions

Included children will be followed prospectively during five years through clinical visits and medical records, where need for additional treatment (casting, braces and/or surgery) is the primary endpoint.

Sponsors

Region Stockholm
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

* age 4-10 years, a diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish or English.

Exclusion criteria

* Syndromic clubfoot

Design outcomes

Primary

MeasureTime frameDescription
Need for further treatment5 yearstotal number of casting, type of braces and/or choice of orthopedic surgery

Secondary

MeasureTime frameDescription
Patient reported outcome measures (PROM)5 yearsChildren and caregivers will complete Roye's score, a disease-specific PROM. The Roye´s score consists of 10 items designed to measure treatment outcomes regarding overall satisfaction, appearance, pain, and physical limitations.
Patient reported outcome measures - The Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) is a child - or parent (proxy)5 yearsChildren and caregivers will complete The Oxford Foot and Ankle Questionaire-child (OxFAQc) and a proxy for caregivers measure subjective well-being in children affected by foot and ankle pain and function. The OxFAQc has 15 items. The response options to each item are on a 5-point scale rated from never (4), rarely (3), sometimes (2), very often (1) to always (0), where the number in brackets represents the value that should be applied by the scorer to each response. Domain scores are calculated as the total of the scale item scores divided by the maximum for each domain, physical 24, and school & play and emotional 16). Domain scores can be transformed to a percentage scale (0-100) to aid interpretation. A higher score for a domain represents better functioning.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026