Trials Sponsors Conditions Drugs Pricing

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

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Eligibility Criteria

Age3 Months - 3 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (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.

Sponsors & Collaborators

Superior University
Otherlead

Study Sites (1)

Ghurki trust and teaching hospital

Lahore, Punjab Province, Pakistan

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Enrollment

15 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations