Effects Of French Method With/Without Brace In Clubfoot Treatment

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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

Первичные конечные точки

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

Вторичные конечные точки (1)

• Demeglio Classification System for Clubfoot Severity [Срок оценки: Baseline,12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Пакистан · 1 центр

• Pakistan Society for the Rehabilitation of the Disabled — Lahore

Публикации

• 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

Идентификаторы

NCT: NCT07428902 · REC/RCR&AHS/SHAMAKHIZAR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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