Outcomes of Compliance With Brace Wear in Clubfoot
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Measurement of Compliance in Clubfoot Bracing Via a Novel Pressure Sensor|
- Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2009|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481324
|United States, Kentucky|
|Shriners Hospital for Children|
|Lexington, Kentucky, United States, 40502|
|Principal Investigator:||Todd A Milbrandt, MD||Shriners Hospital for Children|