Congenital Talipes Equinovarus
Conditions
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.
Interventions
COMBINATION_PRODUCTModified 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
Superior University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 3 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Pakistan
Outcome results
None listed