Evaluating the PBS-score for predicting clubfoot recurrence in children
Predictive Value of the PBS-score - A Prospective Observational Cohort Study Evaluating Recurrence of Idiopathic Clubfoot and Need for Additional Treatment
This study is testing if a new scoring system can help predict if children with clubfoot will need more treatments as they grow up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 4 Years to 10 Years |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm, Region Stockholm) |
| Trial ID | NCT06050746 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the predictive value of the PBS-score in children diagnosed with idiopathic clubfoot. It will include 60 children aged 4 to 10 years, who will undergo video documentation of PBS-score items and dynamic foot pressure analysis during walking at the Motion Analysis Lab at Karolinska University Hospital. Participants and their caregivers will complete disease-specific questionnaires, and children aged 6 years or older will have standing radiographic imaging of both feet. The study will follow participants for five years to determine the need for additional treatments, such as casting or surgery.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 10 years with a diagnosis of idiopathic clubfoot who can walk and communicate in Swedish or English.
Not a fit: Patients with syndromic clubfoot will not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this study could improve the ability to predict the recurrence of clubfoot, leading to timely interventions and better outcomes for affected children.
How similar studies have performed: While the PBS-score is being evaluated in this context, similar predictive approaches in clubfoot management have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stockholm, Region Stockholm
- Astrid Lindgren Children´s Hospital — Stockholm, Region Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Eva W Broström, Professor — Astrid Lindgren Children´s Hospital
- Study coordinator: Eva W Broström, Professor
- Email: eva.brostrom@ki.se
- Phone: +4670021670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.