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Outcomes of Compliance With Brace Wear in Clubfoot

NCT01481324 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2014-11-24

Study results available
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Summary

It has been shown that compliance with brace wear can significantly improve the treatment outcome of idiopathic clubfoot deformities. Noncompliance rates have been estimated to be around 30-41% with initial orthosis wear after successful treatment with serial castings. These studies have depended on family logs and not objective data. With the development of a monitoring device, this study hopes to examine: (1) actual patient compliance, (2) comparisons of actual wear time and assumed wear time and (3) the relationship of patient wear with clinical outcomes.

Hypothesis:

Actual patient compliance in foot abduction orthoses (FAO) wear is less than self-reported compliance and noncompliance is correlated to future surgeries.

Conditions

  • Clubfoot

Sponsors & Collaborators

  • Kosair Charities, Inc.

    collaborator OTHER

  • Shriners Hospitals for Children

    lead OTHER

Principal Investigators

  • Todd A Milbrandt, MD · Shriners Hospital for Children

Eligibility

Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01481324 on ClinicalTrials.gov