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NCT Number: NCT07055672

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

3 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghurki trust and teaching hospital

Lahore, Punjab Province, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Pirani Score

    Time frame: 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).

  2. Relapse Assessment Checklist (Clinical Observation)

    Time frame: 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.

  3. Parental/Guardian Feedback Questionnaire (Custom/Adapted)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Clinical Effectiveness of the Modified WalkFlex DB Splint in Children With Congenital Talipes Equinovarus (CTEV): A Prospective Pilot Study.

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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