Customized Orthosis for Children With Clubfoot

Congenital Talipes Equinovarus Clinical Trial

Official title:

Customized Orthosis for Children With Clubfoot Following Ponseti Casting

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03853811
• Other study ID #: 1246407
• Status: Terminated
• Phase: N/A
• Start date: April 17, 2019
• Est. completion date: March 2, 2022

Study information

• Verified date: April 2022
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Clubfoot
• Congenital Talipes Equinovarus
• Equinus Deformity

Intervention

Device:
• Ankle Foot Orthosis (AFO)
The intervention group will receive the custom AFO to use in their standard Mitchell shoe.

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time Spent in Brace to Assess Brace Compliance	Measured with sensor placed in Mitchell shoe	24 weeks (from start of bracing treatment)
Primary	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	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)