Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2019-04-17
2022-03-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mitchell Shoe + AFO
Group will receive standard Mitchell shoes along with the custom orthotic insert.
Ankle Foot Orthosis (AFO)
The intervention group will receive the custom AFO to use in their standard Mitchell shoe.
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.
No interventions assigned to this group
Interventions
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Ankle Foot Orthosis (AFO)
The intervention group will receive the custom AFO to use in their standard Mitchell shoe.
Eligibility Criteria
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Inclusion Criteria
* 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
* not treated by Ponseti casting
* an underlying syndrome
* neurological disorder
12 Months
ALL
No
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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Scott Van Valin
Assistant Professor
Principal Investigators
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Scott Van Valin, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1246407
Identifier Type: -
Identifier Source: org_study_id
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