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

NCT07055672 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall23/827
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Talipes Equinovarus

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  12 Months

Interventions

Modified WalkFlex DB Splint (Intervention Arm) COMBINATION_PRODUCT

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 Criteria

• Age: 3 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Ghurki trust and teaching hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 9, 2025
• Study Start: March 17, 2025
• Primary Completion: September 1, 2025
• Study Completion: February 28, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)