Outcomes of Compliance With Brace Wear in Clubfoot

Shriners Hospitals for Children

Status: Completed

Conditions: Clubfoot

Study type: Observational

Funder types: Other

Identifiers

NCT01481324

SHC-Lex-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: Under 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

67 participants in 3 patient groups

Functioning Pressure Sensor Group

Description:

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

Description:

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

Description:

This group will not have a pressure sensor placed on the foot ankle orthosis.