French method with or without a foot abduction brace for infant clubfoot
Effects Of French Method With And Without Foot Abduction Brace In Children With Congenital Talipes Equinovarus
This study will test whether adding a foot abduction brace to the French method helps babies up to 12 months with clubfoot.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 1 Day to 12 Months |
| Sex | All |
| Sponsor | Riphah International University Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07428902 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Infants aged 0–12 months with idiopathic clubfoot who have not received prior corrective treatment or surgery are the intended participants.
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.
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 performed: Bracing after conservative correction is well supported in Ponseti protocols, but direct evidence comparing bracing versus no bracing with the French method is limited.
Eligibility criteria
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 this trial is running
Lahore, Punjab Province
- 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
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.