French method with or without a foot abduction brace for infant clubfoot
Official title: Effects Of French Method With And Without Foot Abduction Brace In Children With Congenital Talipes Equinovarus
Run by Riphah International University · NCT07428902 · Data updated 2026-11-12
This study will test whether adding a foot abduction brace to the French method helps babies up to 12 months with clubfoot.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 12 Months |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | Riphah International University Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Status | Recruiting |
| Started | October 28, 2025 |
| Main results expected | February 20, 2026 |
| Study ends | February 23, 2026 |
| Registry record updated | February 24, 2026 |
| Trial ID | NCT07428902 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants aged 0–12 months with idiopathic clubfoot who have not received prior corrective treatment or surgery are the intended participants.
✕Probably not a fit
Children with neuromuscular conditions, other orthopedic comorbidities, prior foot surgery, or severe systemic disorders are unlikely to benefit from this nonoperative comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial will enroll 18 infants with idiopathic clubfoot at two Lahore centers and randomly assign them to the French method alone or the French method plus a foot abduction brace. Clinical measures including foot position, Pirani severity score, and functional mobility will be recorded before and after treatment. Children with prior foot surgery, neuromuscular disorders, other orthopedic problems, or severe systemic illness are excluded. The trial compares outcomes between the two groups to see if routine bracing provides additional benefit over the French method alone.
Why it matters
Potential benefit: If successful, adding a brace could reduce deformity severity, improve functional mobility, and lower the chance of needing later surgery.
How similar studies have gone: Bracing after conservative correction is well supported in Ponseti protocols, but direct evidence comparing bracing versus no bracing with the French method is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients under 12 months of age with clubfeet. * All patients without previous clubfoot surgery were included. * Children who have not received any prior corrective treatment or bracing for CTEV. Exclusion Criteria: * Patients with prior clubfoot surgery were excluded. * Non-idiopathic cases (patients with underlying conditions) typically did not respond well to the nonoperative interventions and were less likely to be included for purely nonoperative treatment.
Where it's running
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Pakistan Society for the Rehabilitation of the Disabled
Lahore, Punjab Province, Pakistan Recruiting
Study contacts
- Principal investigator: Shama Khizar, MSPT — Riphah International University
- Study coordinator: IMRAN AMJAD, PhD
- Email: imran.amjad@riphah.edu.pk
- Phone: 9233224390125
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing standard once-weekly versus accelerated twice-weekly Ponseti casting for club foot
This test will see if doing Ponseti casts twice a week instead of once helps correct club foot in babies younger than six months.
-
Mastisol to help casts stay on for infants with bilateral clubfoot
This trial tests whether applying Mastisol adhesive before casting helps infants with bilateral clubfoot keep their casts on, shorten treatment, and reduce complications during casting and up to five years afterward.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.