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

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

Study Overview

• Status: Recruiting
• Conditions: Clubfoot
• Intervention / Treatment: Other: Systematic screening

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Eva W Broström, Professor; Phone Number: +4670021670; Email: eva.brostrom@ki.se
• Study Contact Backup: Name: Josefine E Naili, Ass Prof; Phone Number: +46812300000; Email: josefine.naili@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: No

• Sampling Method: Probability Sample

Study Population

Children with idopatic clubfoot treated at Astrdi lindgren Children´s Hospital

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for further treatment	total number of casting, type of braces and/or choice of orthopedic surgery	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

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: September 11, 2023
• First Submitted That Met QC Criteria: September 17, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 17, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Pedobarography; PBS-score; Oxford Foot and Ankle Questionaire-child; Roye's score
• 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: k2022-10476-01

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