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

NCT07055672 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-07-09

No results posted yet for this study

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.

Conditions

  • Congenital Talipes Equinovarus

Interventions

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

Sponsors & Collaborators

  • Superior University

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2025-09-01
Completion
2026-02-28

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07055672 on ClinicalTrials.gov