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Effects Of French Method With/Without Brace In Clubfoot Treatment

NCT07428902 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-02-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Riphah International University

    lead OTHER

Principal Investigators

  • Shama Khizar, MSPT · Riphah International University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2026-02-20
Completion
2026-02-23

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07428902 on ClinicalTrials.gov