Congenital Talipes Equinovarus
Conditions
Brief summary
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.
Interventions
The intervention group will receive the custom AFO to use in their standard Mitchell shoe.
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Functional Outcomes of Bracing Treatment Using Dimeglio Scores | Collected when visit where cast is applied, visit when cast is removed, then at 2 weeks, 12 weeks, 24 weeks of bracing | 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 Spent in Brace to Assess Brace Compliance | 24 weeks (from start of bracing treatment) | Measured with sensor placed in Mitchell shoe |
| Assessing Treatment Factors that Impact Brace Compliance with Parental Questionnaires | 24 weeks (from start of bracing treatment) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessing Demographic Factors that Impact Brace Compliance with Parental Questionnaire | 24 weeks (from start of bracing treatment) | The initial questionnaire asks questions about parental demographics to determine what factors may influence brace treatment compliance |
Countries
United States
Outcome results
None listed