Effects Of French Method With/Without Brace In Clubfoot Treatment

Official title

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

Overview

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.

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

Primary outcome measures

• Pirani Scoring System for Clubfoot Assessment & Demeglio Classification System for Clubfoot Severity [Time frame: Baseline,12 weeks]

Secondary outcome measures (1)

• Demeglio Classification System for Clubfoot Severity [Time frame: Baseline,12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Pakistan · 1 center

• Pakistan Society for the Rehabilitation of the Disabled — Lahore

Publications

• 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

Identifiers

NCT: NCT07428902 · REC/RCR&AHS/SHAMAKHIZAR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗