Effects Of French Method With/Without Brace In Clubfoot Treatment

ConditionClub Foot

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age1-12

SponsorRiphah International University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

French method and Foot Abduction Brace
Other intervention
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 intervention
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.

Treatment groups

18 Participants

are divided into 2 treatment groups

Group A: Group A:Intervention Group(French Method with Foot Abduction Brace)Active comparator 1 intervention

Group B: Group B:Control Group(French Method only)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline,12 weeks

Secondary outcomes

Demeglio Classification System for Clubfoot Severity

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).

Time frame

Baseline,12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Riphah International University

Lead sponsor

Source ClinicalTrials.gov

Apply now