Customized Orthosis for Children With Clubfoot
Primary Purpose
Congenital Talipes Equinovarus
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ankle Foot Orthosis (AFO)
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Talipes Equinovarus
Eligibility Criteria
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
Sites / Locations
- Children's Hospital of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mitchell Shoe + AFO
Standard Mitchell Shoe (Control - Standard Treatment)
Arm Description
Group will receive standard Mitchell shoes along with the custom orthotic insert.
Group will receive standard treatment which includes bracing with standard Mitchell shoes (no custom orthotic). Patients would receive this treatment regardless of study participation.
Outcomes
Primary Outcome Measures
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)
Time Spent in Brace to Assess Brace Compliance
Measured with sensor placed in Mitchell shoe
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03853811
First Posted
January 20, 2019
Last Updated
April 2, 2022
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT03853811
Brief Title
Customized Orthosis for Children With Clubfoot
Official Title
Customized Orthosis for Children With Clubfoot Following Ponseti Casting
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient resources
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
March 2, 2022 (Actual)
Study Completion Date
March 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Talipes Equinovarus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mitchell Shoe + AFO
Arm Type
Experimental
Arm Description
Group will receive standard Mitchell shoes along with the custom orthotic insert.
Arm Title
Standard Mitchell Shoe (Control - Standard Treatment)
Arm Type
No Intervention
Arm Description
Group will receive standard treatment which includes bracing with standard Mitchell shoes (no custom orthotic). Patients would receive this treatment regardless of study participation.
Intervention Type
Device
Intervention Name(s)
Ankle Foot Orthosis (AFO)
Intervention Description
The intervention group will receive the custom AFO to use in their standard Mitchell shoe.
Primary Outcome Measure Information:
Title
Assessment of Functional Outcomes of Bracing Treatment Using Dimeglio Scores
Description
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 Frame
Collected when visit where cast is applied, visit when cast is removed, then at 2 weeks, 12 weeks, 24 weeks of bracing
Title
Time Spent in Brace to Assess Brace Compliance
Description
Measured with sensor placed in Mitchell shoe
Time Frame
24 weeks (from start of bracing treatment)
Title
Assessing Treatment Factors that Impact Brace Compliance with Parental Questionnaires
Description
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 Frame
24 weeks (from start of bracing treatment)
Secondary Outcome Measure Information:
Title
Assessing Demographic Factors that Impact Brace Compliance with Parental Questionnaire
Description
The initial questionnaire asks questions about parental demographics to determine what factors may influence brace treatment compliance
Time Frame
24 weeks (from start of bracing treatment)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Van Valin, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Customized Orthosis for Children With Clubfoot
We'll reach out to this number within 24 hrs