N/A Completed N=67

Outcomes of Compliance With Brace Wear in Clubfoot

Clubfoot

Source: ClinicalTrials.gov NCT01481324 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcomePrimary: Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) — 91.7; NA; NA; 86.8 percentage of time worn

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)	91.7; NA; NA; 86.8; NA; NA	—

Eligibility Criteria

Inclusion Criteria

Unilateral or bilateral clubfoot
Birth to 3 years of age
Has been successfully treated with Ponseti casting protocol

Exclusion Criteria

Any other prior treatment for clubfoot
Other existing diagnoses or conditions

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01481324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.