Customized Orthosis for Children With Clubfoot

Customized Orthosis for Children With Clubfoot Following Ponseti Casting

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 Overview

• Status: Terminated
• Conditions: Congenital Talipes Equinovarus
• Intervention / Treatment: Device: Ankle Foot Orthosis (AFO)

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mitchell Shoe + AFO; Group will receive standard Mitchell shoes along with the custom orthotic insert.	Device: Ankle Foot Orthosis (AFO); The intervention group will receive the custom AFO to use in their standard Mitchell shoe.
No Intervention: Standard Mitchell Shoe (Control - Standard Treatment); 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?

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)

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Scott Van Valin, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Actual): March 2, 2022
• Study Completion (Actual): March 2, 2022

Study Registration Dates

• First Submitted: January 20, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 2, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Clubfoot; Talipes; Equinus Deformity
• Other Study ID Numbers: 1246407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No