Effects Of French Method With/Without Brace In Clubfoot Treatment

NCT07428902 | Recruiting DMC

• 1 other identifier: REC/RCR&AHS/SHAMAKHIZAR
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Club Foot

Keywords

Clubfoot, French Method, Foot Abduction Brace

Outcome Measures

Primary Outcomes (1)

• Pirani Scoring System for Clubfoot Assessment & Demeglio Classification System for Clubfoot Severity

  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.

  Baseline,12 weeks

Secondary Outcomes (1)

• Demeglio Classification System for Clubfoot Severity

  Baseline,12 weeks

Study Arms (2)

Group A:Intervention Group(French Method with Foot Abduction Brace)

ACTIVE COMPARATOR

The experimental group will receive the French method with a foot abduction brace worn to maintain correction.

Other: French method and Foot Abduction Brace

Group B:Control Group(French Method only)

ACTIVE COMPARATOR

The control group will receive the French method only, without a foot abduction brace.

Other: French Method only

Interventions

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.

Group A:Intervention Group(French Method with Foot Abduction Brace)

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.

Group B:Control Group(French Method only)

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Society for the Rehabilitation of the Disabled

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

• Bettuzzi C, Abati CN, Salvatori G, Zanardi A, Lampasi M. Interobserver reliability of Dimeglio and Pirani score and their subcomponents in the evaluation of idiopathic clubfoot in a clinical setting: a need for improved scoring systems. J Child Orthop. 2019 Oct 1;13(5):478-485. doi: 10.1302/1863-2548.13.190010.

  PMID: 31695815 BACKGROUND

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Shama Khizar, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IMRAN AMJAD, PhD

CONTACT

9233224390125; imran.amjad@riphah.edu.pk

Muhammad Asif Javed, MS-PT

CONTACT

923224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask both groups about the treatment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This randomized controlled trial will be conducted at the Pakistan Society for the Rehabilitation of the Disabled (PSRD) and the Children's Hospital and Institute of Child Health, Lahore. Eighteen children aged 0-12 months diagnosed with congenital talipes equinovarus (CTEV) will be randomly divided into two equal groups. Children with neurological, orthopedic, or neuromuscular disorders, prior foot surgery, or severe systemic illness will be excluded. The experimental group will receive the French method with a foot abduction brace, while the control group will receive only the French method. Foot position, deformity severity, and functional mobility will be assessed pre- and post-intervention using the Pirani score and standardized clinical measures. Data will be analyzed using SPSS version 23.0.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: February 24, 2026
• Study Start: October 28, 2025
• Primary Completion: February 20, 2026
• Study Completion: February 23, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)