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

Not Applicable

Active, not recruiting

• Conditions: Congenital Talipes Equinovarus

• Registration Number: NCT07055672
• Lead Sponsor: Superior University

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.

Study Timeline

• Study Start: 2025-03-17
• Status Verified: 2025-06
• Study First Submitted: 2025-06-28
• Study First Submitted QC: 2025-06-28
• Last Update Submitted: 2025-06-28
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09
• Primary Completion: 2025-09-01
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pirani Score	12 Months	Used to assess the severity of clubfoot deformity. It consists of six clinical signs divided into midfoot and hindfoot scores. Each sign is scored as 0 (normal), 0.5 (moderate), or 1 (severe). The total score ranges from 0 (normal foot) to 6 (severe deformity).
Relapse Assessment Checklist (Clinical Observation)	12 Months	Observation-based checklist used at 1-month and 3-month follow-ups to check for signs of relapse such as equinus, varus, adductus, or cavus. Relapse is defined as the recurrence of one or more of these deformities after initial correction.
Parental/Guardian Feedback Questionnaire (Custom/Adapted)	12 Months	A structured feedback form to assess splint tolerance, ease of use, and parental satisfaction. Responses are collected using a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree) on questions regarding comfort, usability, and perceived effectiveness of the splint.

Trial Locations

Locations (1)

Ghurki trust and teaching hospital; 🇵🇰 Lahore, Punjab, Pakistan