Outcomes of Compliance With Brace Wear in Clubfoot

Clubfoot Clinical Trial

Official title:

Measurement of Compliance in Clubfoot Bracing Via a Novel Pressure Sensor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481324
• Other study ID #: SHC-Lex-101
• Status: Completed
• Phase: N/A
• First received: November 15, 2011
• Last updated: November 17, 2014
• Start date: October 2009
• Est. completion date: October 2013

Study information

• Verified date: November 2014
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Shriners Hospital for Children Medical ResearchUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Hypothesis:

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: October 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity

Locations

Country	Name	City	State
United States	Shriners Hospital for Children	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Shriners Hospitals for Children	Kosair Charities, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

Changulani M, Garg NK, Rajagopal TS, Bass A, Nayagam SN, Sampath J, Bruce CE. Treatment of idiopathic club foot using the Ponseti method. Initial experience. J Bone Joint Surg Br. 2006 Oct;88(10):1385-7. — View Citation

Dobbs MB, Morcuende JA, Gurnett CA, Ponseti IV. Treatment of idiopathic clubfoot: an historical review. Iowa Orthop J. 2000;20:59-64. — View Citation

Dobbs MB, Rudzki JR, Purcell DB, Walton T, Porter KR, Gurnett CA. Factors predictive of outcome after use of the Ponseti method for the treatment of idiopathic clubfeet. J Bone Joint Surg Am. 2004 Jan;86-A(1):22-7. — View Citation

Haft GF, Walker CG, Crawford HA. Early clubfoot recurrence after use of the Ponseti method in a New Zealand population. J Bone Joint Surg Am. 2007 Mar;89(3):487-93. — View Citation

Thacker MM, Scher DM, Sala DA, van Bosse HJ, Feldman DS, Lehman WB. Use of the foot abduction orthosis following Ponseti casts: is it essential? J Pediatr Orthop. 2005 Mar-Apr;25(2):225-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)	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.	3 months	No