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.

Hypothesis:

Actual patient compliance in foot abduction orthoses (FAO) wear is less than self-reported compliance and noncompliance is correlated to future surgeries.

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Key information

Conditions

Clubfoot Behavior Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Health Behavior Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Patient Acceptance of Health Care Patient Compliance Talipes Treatment Adherence and Compliance

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shriners Hospital for Children

Lexington, Kentucky, 40502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Shriners Hospitals for Children

Other

Collaborators

Kosair Charities, Inc.

Registry information

Official study title

Measurement of Compliance in Clubfoot Bracing Via a Novel Pressure Sensor

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2013
First posted: Nov 29, 2011
Registry last updated: Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed