Outcomes of Compliance With Brace Wear in Clubfoot

Completed

Conditions studied: Clubfoot

In brief

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.

Key facts

Study ID

NCT01481324

Run by

Shriners Hospitals for Children

People needed

67

Starts

2009-10-01

Expected to finish

2013-10-01

Last updated by the study team

2014-11-24

Who can join

Age: any, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Any other prior treatment for clubfoot
• Other existing diagnoses or conditions

Where it is running

• Shriners Hospital for Children — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.