Outcomes of Compliance With Brace Wear in Clubfoot
|ClinicalTrials.gov Identifier: NCT01481324|
Recruitment Status : Completed
First Posted : November 29, 2011
Results First Posted : November 24, 2014
Last Update Posted : November 24, 2014
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.
Actual patient compliance in foot abduction orthoses (FAO) wear is less than self-reported compliance and noncompliance is correlated to future surgeries.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||67 participants|
|Official Title:||Measurement of Compliance in Clubfoot Bracing Via a Novel Pressure Sensor|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2013|
Functioning Pressure Sensor Group
This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
Non-Functioning Pressure Sensor Group
This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
No Sensor Group
This group will not have a pressure sensor placed on the foot ankle orthosis.
- Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481324
|United States, Kentucky|
|Shriners Hospital for Children|
|Lexington, Kentucky, United States, 40502|
|Principal Investigator:||Todd A Milbrandt, MD||Shriners Hospital for Children|