Effects Of French Method With And Without Foot Abduction Brace In Children With Congenital Talipes Equinovarus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Pirani Scoring System for Clubfoot Assessment & Demeglio Classification System for Clubfoot Severity
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Masking Description
Participants will get separate treatment protocols and possible efforts will be put to mask both groups about the treatment
Eligibility Criteria
- Ages
- 1 Day to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group A:Intervention Group(French Method with Foot Abduction Brace)
The experimental group will receive the French method with a foot abduction brace worn to maintain correction.
Intervention: French method and Foot Abduction Brace (Other)
Group B:Control Group(French Method only)
The control group will receive the French method only, without a foot abduction brace.
Intervention: French Method only (Other)
Outcomes
Primary Outcomes
Pirani Scoring System for Clubfoot Assessment & Demeglio Classification System for Clubfoot Severity
Time Frame: Baseline,12 weeks
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.
Secondary Outcomes
- Demeglio Classification System for Clubfoot Severity(Baseline,12 weeks)