Customized Orthosis for Children With Clubfoot

Study Overview
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Brief Summary
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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.

Official Title
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Customized Orthosis for Children With Clubfoot Following Ponseti Casting

Conditions
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Congenital Talipes Equinovarus

Intervention / Treatment
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* Device: Ankle Foot Orthosis (AFO)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitchell Shoe + AFO<br>Group will receive standard Mitchell shoes along with the custom orthotic insert. | Device: Ankle Foot Orthosis (AFO)<br>* The intervention group will receive the custom AFO to use in their standard Mitchell shoe.<br>|
| No Intervention: Standard Mitchell Shoe (Control - Standard Treatment)<br>Group will receive standard treatment which includes bracing with standard Mitchell shoes (no custom orthotic). Patients would receive this treatment regardless of study participation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | 24 weeks (from start of bracing treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 weeks (from start of bracing treatment) |