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Outcomes of Compliance With Brace Wear in Clubfoot

This study is currently recruiting participants.
Verified November 2011 by Shriners Hospitals for Children
Sponsor:
Collaborator:
Kosair Charities, Inc.
Information provided by (Responsible Party):
Todd Milbrandt, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT01481324
First received: November 15, 2011
Last updated: November 23, 2011
Last verified: November 2011
History of Changes
  Purpose

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


Condition
Clubfoot

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:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

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
Groups/Cohorts
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.

  Eligibility

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)

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481324

Contacts
Contact: Rebecca Davis 859-268-5705 rfdavis@shrinenet.org

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

Publications:

Responsible Party: Todd Milbrandt, Principal Investigator, Shriners Hospitals for Children
ClinicalTrials.gov 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:
Clubfoot
Compliance
Brace wear

Additional relevant MeSH terms:
Clubfoot
Equinus Deformity
Foot Deformities, Congenital
 Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired

ClinicalTrials.gov processed this record on May 22, 2013