Outcomes of Compliance With Brace Wear in Clubfoot

Completed

• Conditions: Clubfoot

• Registration Number: NCT01481324
• Lead Sponsor: Shriners Hospitals for Children

Brief 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.

Detailed Description

It is necessary that treatment teams avoid making any assumptions about patient compliance. This study will objectively measure brace wear-rate in patients with clubfoot that have already been prescribed a foot ankle orthosis. The use of a monitoring device will be able to give objective data on actual patient compliance with brace wear. It is hypothesized that objective compliance data will allow physicians to better assess the patient's therapy progress and outcome, troubleshoot problems or issues associated with barriers to brace wear, and better educate families confronted with having a child with clubfoot. Long term goals will then attempt to determine whether certain brace designs can increase wear time thus decreasing the rate of clubfoot recurrence.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2011-11-23
• Study First Posted: 2011-11-29
• Primary Completion: 2012-10
• Study Completion: 2013-10
• Results First Submitted: 2014-05-13
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-17
• Last Update Submitted: 2014-11-17
• Results First Posted: 2014-11-24
• Last Update Posted: 2014-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)	3 months	Number of hours per day in brace will be measured by pressure sensor at the end of month 1, month 2 and month 3. Parent report of brace wear will also be documented at each of these timepoints. Wear rate percentage will be calculated by dividing the number of hours of brace wear (either actual as measured by the sensor or reported by parent diary) by the recommended 24 hours.

Trial Locations

Locations (1)

Shriners Hospital for Children; 🇺🇸 Lexington, Kentucky, United States