NCT07055672

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

Clinical Effectiveness of the Modified WalkFlex DB Splint in Children With Congenital Talipes Equinovarus (CTEV): A Prospective Pilot Study.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Superior University · Academic / Other
• Sex: All
• Age: 3 Months – 3 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Congenital Talipes Equinovarus

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Modified WalkFlex DB Splint (Intervention Arm)	Application of the Modified WalkFlex Denis Browne (DB) Splint Children with corrected idiopathic clubfoot will use the Modified WalkFlex DB Splint for maintenance. This splint allows knee and some hip movement and includes a detachable bar for walking. It will be used after Ponseti casting, and patients will be followed at 1 and 3 months to check splint tolerance, maintenance of correction (using Pirani score), and any signs of relapse

Timeline

• Start date: 2025-03-17
• Primary completion: 2025-09-01
• Completion: 2026-02-28
• First posted: 2025-07-09
• Last updated: 2025-07-09

Locations

1 site across 1 country: Pakistan