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Outcomes of Compliance With Brace Wear in Clubfoot

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ClinicalTrials.gov Identifier: NCT01481324
Recruitment Status : Completed
First Posted : November 29, 2011
Results First Posted : November 24, 2014
Last Update Posted : November 24, 2014
Kosair Charities, Inc.
Information provided by (Responsible Party):
Todd Milbrandt, 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.


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

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 Type : Observational
Actual Enrollment : 67 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measurement of Compliance in Clubfoot Bracing Via a Novel Pressure Sensor
Study Start Date : October 2009
Primary Completion Date : October 2012
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.

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All clubfoot patients scheduled to be placed in a foot ankle orthosis (FAO)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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
Sponsors and Collaborators
Shriners Hospitals for Children
Kosair Charities, Inc.
Principal Investigator: Todd A Milbrandt, MD Shriners Hospital for Children

Responsible Party: Todd Milbrandt, Principal Investigator, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT01481324     History of Changes
Other Study ID Numbers: SHC-Lex-101
First Posted: November 29, 2011    Key Record Dates
Results First Posted: November 24, 2014
Last Update Posted: November 24, 2014
Last Verified: November 2014

Keywords provided by Todd Milbrandt, Shriners Hospitals for Children:
Brace wear

Additional relevant MeSH terms:
Equinus Deformity
Foot Deformities
Foot Deformities, Acquired
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities