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NCT Number: NCT07428902

Effects Of French Method With/Without Brace In Clubfoot Treatment

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.

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Key information

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Society for the Rehabilitation of the Disabled

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Muhammad Asif Javed, MSPT

CONTACT

[email protected]

923224209422

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

French method and Foot Abduction Brace

Other

The experimental group will follow the French method with the addition of a foot abduction brace, which is worn after each session.

French Method only

Other

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.

Primary outcomes

  1. Pirani Scoring System for Clubfoot Assessment & Demeglio Classification System for Clubfoot Severity

    Time frame: Baseline,12 weeks

    Pirani Scoring System for Clubfoot Assessment:The Pirani Score is a widely used clinical tool to assess the severity of congenital talipes equinovarus (clubfoot). This scoring system helps in evaluating the extent of deformity and in monitoring the progress of treatment, especially when using methods like the Ponseti method or the French method. It focuses on six key aspects of the foot, Each of these six components is scored from 0 to 1.The total score ranges from 0 (normal foot) to 6 (severely affected foot). The higher the score, the more severe the clubfoot.

Secondary outcomes

  1. Demeglio Classification System for Clubfoot Severity

    Time frame: Baseline,12 weeks

    DimS is based on correction after applying a gentle reduction force.6 Four parameters are evaluated: varus (VA), equinus (E-Dim), derotation of calcaneo-forefoot block (DER) and midfoot adduction (ADD). Each is scored on a five-point scale (0 to 4 points) resulting in a maximum score of 16 points for the most severe deformity. An additional four points result from the absence/presence (0/1 point) of four pejorative items: posterior crease (PC-Dim), medial crease (MC-Dim), cavus and abnormal musculature (MUSC). Once a total score (0 to 20 points) is calculated, feet are divided in four grades: grade I (0-5 points), II (6-10), III (11-15) and IV (16-20 points).

Study contacts

Contact information is provided by the study sponsor or research team.

IMRAN AMJAD, PhD

CONTACT

[email protected]

9233224390125

Muhammad Asif Javed, MS-PT

CONTACT

[email protected]

923224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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