Customized Orthosis for Children With Clubfoot

Not Applicable

Terminated

• Conditions: Congenital Talipes Equinovarus
• Interventions: Device: Ankle Foot Orthosis (AFO)

• Registration Number: NCT03853811
• Lead Sponsor: Medical College of Wisconsin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-20
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-26
• Study Start: 2019-04-17
• Primary Completion: 2022-03-02
• Study Completion: 2022-03-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-02
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitchell Shoe + AFO	Ankle Foot Orthosis (AFO)	Group will receive standard Mitchell shoes along with the custom orthotic insert.

Primary Outcome Measures

Name	Time	Method
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
Time Spent in Brace to Assess Brace Compliance	24 weeks (from start of bracing treatment)	Measured with sensor placed in Mitchell shoe
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)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States