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A study to determine if compliance with brace use is better with Iowa brace as compared with any other conventional brace for children with clubfoot

A quasi-experimental study to determine the difference in compliance rates between the use of any conventional brace and the Iowa brace for idiopathic clubfoot - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093717
Enrollment
238
Registered
2025-08-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q660- Congenital talipes equinovarus

Interventions

Intervention1: Clubfoot brace (Iowa brace): A brace for clubfoot correction Control Intervention1: Conventionally used brace: Any conventionally used brace for idiopathic clubfoot

Sponsors

Clubfoot Solutions
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A child (any gender) who is less than 5 years old and who is diagnosed with unilateral or bilateral idiopathic clubfoot and has been using any brace for at least 6 months, with at least 9 months of brace use remaining.

Exclusion criteria

Exclusion criteria: Refusal of parental consent Current or prior use of Iowa brace

Design outcomes

Primary

MeasureTime frame
the difference in compliance rates among patients with idiopathic clubfoot using any conventional brace and the Iowa braceTimepoint: 3, 6, 9 month follow-up—

Secondary

MeasureTime frame
To determine the brace-related factors associated with compliance with its use among patients diagnosed with idiopathic clubfootTimepoint: 3, 6, 9 month follow-up—

Countries

India

Contacts

Public ContactDr Gauri A Oka

Bharati Vidyapeeth Deemed to be Univerisity Medical College and Hositpal, Pune

gauri.oka@bharatividyapeeth.edu9823828445

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026