NCT07428902

Effects Of French Method With/Without Brace In Clubfoot Treatment

Effects Of French Method With And Without Foot Abduction Brace In Children With Congenital Talipes Equinovarus

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Riphah International University · Academic / Other
• Sex: All
• Age: 1 Day – 12 Months
• Healthy volunteers: Not accepted

Summary

The current study will be a randomized control trial. Data will be collected from the Pakistan Society for the Rehabilitation of the Disabled, Lahore (PSRD) and the Children Hospital and Institute of Child Health, Lahore. The study will include 18 patients, equally divided into two groups and randomly allocated. Inclusion criteria will be children aged 0 to 12 months diagnosed with CTEV of either gender. Patients with neurological conditions, other orthopedic issues, previous surgical history related to the foot, severe systemic disorders, or neuromuscular disorders will be excluded from the study. The experimental group will receive the French method along with a foot abduction brace, while the control group will receive only the French method without the brace. Outcomes to be analyzed will include foot position, severity of deformity, and functional mobility. Data collection will occur before and after the intervention, utilizing clinical assessments for foot position, the Pirani score for severity of deformity, and standardized mobility assessments. Data will be analyzed using SPSS version 23.00.

Detailed description

Clubfoot, or talipes equinovarus, is a structural deformity of the foot and ankle characterized by hind foot equinus (plantar flexion), Varus of the heel (internal rotation), supination, and forefoot adduction (plantar cavus). The severity can range from mild to extremely rigid, manipulation-resistant cases. The incidence of clubfoot varies geographically, with a prevalence ranging from 0.5 to 2.0 cases per 1,000 live births across different regions. Early and effective intervention is crucial to prevent long-term disability, gait abnormalities, and functional limitations The French method, a conservative approach is widely used in treating CTEV. This approach involved daily manipulation of the newborn's foot, muscle stimulation (especially of the peroneal muscles), and temporary immobilization with adhesive strapping. However, the need for prolonged foot abduction bracing as a complement to the French method remains debatable. This study aims to compare the effects of the French method with and without the use of a foot abduction brace in managing CTEV in children. The current study will be a randomized control trial. Data will be collected from the Pakistan Society for the Rehabilitation of the Disabled, Lahore (PSRD) and the Children Hospital and Institute of Child Health, Lahore. The study will include 18 patients, equally divided into two groups and randomly allocated. Inclusion criteria will be children aged 0 to 12 months diagnosed with CTEV of either gender. Patients with neurological conditions, other orthopedic issues, previous surgical history related to the foot, severe systemic disorders, or neuromuscular disorders will be excluded from the study. The experimental group will receive the French method along with a foot abduction brace, while the control group will receive only the French method without the brace. Outcomes to be analyzed will include foot position, severity of deformity, and functional mobility. Data collection will occur before and after the intervention, utilizing clinical assessments for foot position, the Pirani score for severity of deformity, and standardized mobility assessments. Data will be analyzed using SPSS version 23.00.

Conditions

• Club Foot

Interventions

Type	Name	Description
OTHER	French method and Foot Abduction Brace	The experimental group will follow the French method with the addition of a foot abduction brace, which is worn after each session.
OTHER	French Method only	The control group will receive the French method only, without a foot abduction brace. The intervention includes manual manipulation to correct deformities through soft tissue stretching and joint mobilization; stretching exercises for dorsiflexion, abduction, and eversion to maintain range of motion; and taping for stabilization after manipulation. Gentle calf and foot massage will reduce stiffness and promote relaxation. Daily sessions of 30-45 minutes will be conducted for 2-3 months. Parents will be trained to perform gentle stretches, monitor foot position, recognize signs of poor circulation or discomfort, and apply taping correctly. They will be advised to continue exercises at home between follow-up visits to maintain correction and ensure continued improvement.

Timeline

• Start date: 2025-10-28
• Primary completion: 2026-02-20
• Completion: 2026-02-23
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

1 site across 1 country: Pakistan