Customized Orthosis for Children With Clubfoot

Medical College of Wisconsin

Status: Terminated

Conditions: Congenital Talipes Equinovarus

Treatments: Device: Ankle Foot Orthosis (AFO)

Study type: Interventional

Funder types: Other

Identifiers

NCT03853811

1246407

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Mitchell Shoe + AFO

Experimental group

Description:

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

Treatment:

Device: Ankle Foot Orthosis (AFO)

Standard Mitchell Shoe (Control - Standard Treatment)

No Intervention group

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.