Trial record 9 of 22 for:    "Talipes equinovarus"

Outcomes of Compliance With Brace Wear in Clubfoot

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Shriners Hospitals for Children.
Recruitment status was  Recruiting
Kosair Charities, Inc.
Information provided by (Responsible Party):
Todd Milbrandt, Shriners Hospitals for Children Identifier:
First received: November 15, 2011
Last updated: November 23, 2011
Last verified: November 2011

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 FAO wear is less than self-reported compliance and noncompliance is correlated to future surgeries.


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measurement of Compliance in Clubfoot Bracing Via a Novel Pressure Sensor

Resource links provided by NLM:

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • hours per day in brace [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 bracewear will also be documented at each of these timepoints.

Estimated Enrollment: 70
Study Start Date: October 2009
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.

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.


Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01481324

Contact: Rebecca Davis 859-268-5705

United States, Kentucky
Shriners Hospital for Children Recruiting
Lexington, Kentucky, United States, 40502
Contact: Rebecca Davis    859-268-5705   
Principal Investigator: Todd A Milbrandt, MD         
Sponsors and Collaborators
Shriners Hospitals for Children
Kosair Charities, Inc.
Principal Investigator: Todd A Milbrandt, MD Shriners Hospital for Children
  More Information

Responsible Party: Todd Milbrandt, Principal Investigator, Shriners Hospitals for Children Identifier: NCT01481324     History of Changes
Other Study ID Numbers: SHC-Lex-101
Study First Received: November 15, 2011
Last Updated: November 23, 2011
Health Authority: United States: Shriners Hospital for Children Medical Research
United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
Brace wear

Additional relevant MeSH terms:
Equinus Deformity
Foot Deformities, Congenital
Foot Deformities
Musculoskeletal Diseases
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities
Foot Deformities, Acquired processed this record on August 21, 2014