Outcomes of Compliance With Brace Wear in Clubfoot

NCT01481324 | Completed Results

• 1 other identifier: SHC-Lex-101
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clubfoot

Keywords

Clubfoot; Compliance; Brace wear

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All clubfoot patients scheduled to be placed in a foot ankle orthosis (FAO)

You may qualify if:

• Unilateral or bilateral clubfoot
• Birth to 3 years of age
• Has been successfully treated with Ponseti casting protocol

You may not qualify if:

• Any other prior treatment for clubfoot
• Other existing diagnoses or conditions

Sponsors & Collaborators

• Shriners Hospitals for Children: lead
• Kosair Charities, Inc.: collaborator

Study Sites (1)

Shriners Hospital for Children

Lexington, Kentucky, 40502, United States

Location

Related 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. doi: 10.1302/0301-620X.88B10.17578.

  PMID: 17012432 BACKGROUND

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

  PMID: 10934626 BACKGROUND

• 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. doi: 10.2106/JBJS.F.00169.

  PMID: 17332096 BACKGROUND

• 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(1):22-7. doi: 10.2106/00004623-200401000-00005.

  PMID: 14711941 BACKGROUND

• 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. doi: 10.1097/01.bpo.0000150814.56790.f9.

  PMID: 15718907 BACKGROUND

MeSH Terms

Conditions

Clubfoot; Patient Compliance

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

As shown in the monthly completion numbers, most families complied during the first month of treatment. After the first month, not only did the wear rates drop significantly, but also the number of subjects reporting sensor and diary data.

Results Point of Contact

• Title: Dr. Todd Milbrandt
• Organization: Shriners Hospital for Children

tmilbrandt@shrinenet.org

859-266-2101

Study Officials

• Todd A Milbrandt, MD

  Shriners Hospital for Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 29, 2011
• Study Start: October 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2013
• Last Updated: November 24, 2014
• Results First Posted: November 24, 2014

Record last verified: 2014-11

Locations

US (1)