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

N/AActive Not RecruitingNCT07055672

Superior University15 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Congenital Talipes Equinovarus

Interventions

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

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 3 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pirani Score

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).

Time frame: 12 Months

Relapse Assessment Checklist (Clinical Observation)

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.

Time frame: 12 Months

Parental/Guardian Feedback Questionnaire (Custom/Adapted)

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.

Time frame: 12 Months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes