Clinical Effectiveness of the Modified WalkFlex DB Splint in Children With Congenital Talipes Equinovarus (CTEV)

Superior University

Status: Active, not recruiting

Conditions: Congenital Talipes Equinovarus

Treatments: Combination Product: Modified WalkFlex DB Splint (Intervention Arm)

Study type: Interventional

Funder types: Other

Identifiers

NCT07055672

MSRSW/Batch-Fall23/827

Details and patient eligibility

About

This pilot study aims to evaluate the effectiveness of the Modified WalkFlex DB Splint in the maintenance phase of Congenital Talipes Equinovarus (CTEV) treatment following successful correction through the Ponseti method. The traditional Denis Browne splint, though widely used, often limits patient mobility and can result in poor compliance. In response to these limitations, the Modified WalkFlex DB Splint was designed to offer increased flexibility at the knee and hip joints, allowing for improved function and easier ambulation while maintaining foot correction.

Full description

This is a prospective observational study including 12-15 children aged between 3 months to 3 years who have completed the casting phase.

Enrollment: 15 patients

Sex: All

Ages: 3 months to 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children aged 3 months to 3 years diagnosed with idiopathic congenital talipes equinovarus (CTEV)
• who have completed the correction phase using the Ponseti method and are starting the bracing phase.
• Informed consent from parents or guardians and willingness to attend follow-ups at 1 and 3 months is required

Exclusion criteria

• Children with non-idiopathic clubfoot (e.g., syndromic or neuromuscular)
• other congenital limb deformities
• or poor compliance with treatment and follow-up will be excluded

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)