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

NCT ID: NCT07055672

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-17
• Study Completion Date: 2026-02-28

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Interventions

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ghurki trust and teaching hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall23/827

Identifier Type: -

Identifier Source: org_study_id