Customized Orthosis for Children With Clubfoot

NCT03853811 | Terminated

• 1 other identifier: 1246407
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Talipes Equinovarus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Assessing Demographic Factors that Impact Brace Compliance with Parental Questionnaire

  24 weeks (from start of bracing treatment)

Study Arms (2)

Mitchell Shoe + AFO

EXPERIMENTAL

Group will receive standard Mitchell shoes along with the custom orthotic insert.

Device: Ankle Foot Orthosis (AFO)

Standard Mitchell Shoe (Control - Standard Treatment)

NO INTERVENTION

Group will receive standard treatment which includes bracing with standard Mitchell shoes (no custom orthotic). Patients would receive this treatment regardless of study participation.

Interventions

Ankle Foot Orthosis (AFO) DEVICE

The intervention group will receive the custom AFO to use in their standard Mitchell shoe.

Mitchell Shoe + AFO

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• patients with prior surgical treatment
• not treated by Ponseti casting
• an underlying syndrome
• neurological disorder

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Scott Van Valin, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: February 26, 2019
• Study Start: April 17, 2019
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)