Customized Orthosis for Children With Clubfoot

Medical College of Wisconsin3 enrolled

Overview

This study will examine the use of a novel customized Ankle Foot Orthosis (AFO), created using 3D scanning, with children being treated for clubfoot. The AFO is inserted in the standard Mitchell shoe during bracing, following Ponseti casting. The investigators hypothesize that following Ponseti casting, the implementation of customized AFOs with Ponseti bracing will improve patient compliance and functional outcomes as well as lead to fewer relapses in comparison to the standard bracing with Mitchell shoes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congenital Talipes Equinovarus

Interventions

Ankle Foot Orthosis (AFO)DEVICE

The intervention group will receive the custom AFO to use in their standard Mitchell shoe.

Eligibility

Sex: ALLMax age: 12 Months

Medical Language ↔ Plain English

Inclusion Criteria: * less than 12 months old (no age minimum) * no neuromuscular disease involved * treated by Ponseti casting * idiopathic bilateral or unilateral clubfoot * no other congenital foot deformity * no previous open surgeries to treat the deformity Exclusion Criteria: * patients with prior surgical treatment * not treated by Ponseti casting * an underlying syndrome * neurological disorder

Locations (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Assessment of Functional Outcomes of Bracing Treatment Using Dimeglio Scores

Assessed using changes in Dimeglio Scores. The Dimeglio scoring system uses a 20-point system (20 being the most severe and \<5 as benign) by assessing four parameters. The severity of the deformity is then assigned a grade of I-IV with IV being the most severe. (A score of \<5 is given a grade of I, =5\<10 is grade II, =10\<15 is grade III, and =15\<20 is grade IV)

Time frame: Collected when visit where cast is applied, visit when cast is removed, then at 2 weeks, 12 weeks, 24 weeks of bracing

Time Spent in Brace to Assess Brace Compliance

Measured with sensor placed in Mitchell shoe

Time frame: 24 weeks (from start of bracing treatment)

Assessing Treatment Factors that Impact Brace Compliance with Parental Questionnaires

Assessing reasons for poor compliance with parental questionnaires. The questionnaires ask questions about casting, occurrences of skin lesions, history of treatments, bracing information, reasons for not using brace, and brace slippage

Time frame: 24 weeks (from start of bracing treatment)

Secondary Outcomes

Assessing Demographic Factors that Impact Brace Compliance with Parental Questionnaire

The initial questionnaire asks questions about parental demographics to determine what factors may influence brace treatment compliance

Time frame: 24 weeks (from start of bracing treatment)

Data from ClinicalTrials.gov

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