Predictive Value of the PBS-score in Children With Clubfoot

Clubfoot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050746
• Other study ID #: k2022-10476-01
• Status: Recruiting
• Start date: September 12, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: September 2023
• Source: Region Stockholm
• Contact: Eva W Broström, Professor
• Phone: +4670021670
• Email: eva.brostrom[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity

Intervention

Other:
• Systematic screening
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.

Locations

Country	Name	City	State
Sweden	Astrid Lindgren Children´s Hospital	Stockholm	Region Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for further treatment	total number of casting, type of braces and/or choice of orthopedic surgery	5 years
Secondary	Patient reported outcome measures (PROM)	Children 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.	5 years
Secondary	Patient reported outcome measures - The Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) is a child - or parent (proxy)	Children 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.	5 years