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NCT01481324 · ClinicalTrials.gov registry record
Outcomes of Compliance With Brace Wear in Clubfoot
A clinical trial, sponsored by Shriners Hospitals for Children.
- Completed
- Registry status
- 67
- Enrollment target
NCT01481324: Completed study, sponsored by Shriners Hospitals for Children.
NCT01481324 is a clinical trial that has completed, run by Shriners Hospitals for Children. The registered enrollment target is 67 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01481324 has completed, sponsored by Shriners Hospitals for Children.
- COMPLETED
- Registry status
- 67 participants
- Enrollment target
Study 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.
Primary Outcome
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 Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2009-10 |
| Est. Completion | 2013-10 |
What the finished NCT01481324 record still lists
NCT01481324 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 67 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01481324 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01481324 about?
NCT01481324 is a clinical study titled "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...
What is the current status of trial NCT01481324?
This trial is currently completed. The enrollment target is 67 participants. The study started on 2009-10. Estimated completion is 2013-10.
Who is sponsoring clinical trial NCT01481324?
This trial is sponsored by Shriners Hospitals for Children, which has 40 total clinical trials registered on ClinicalTrials.gov.
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