Clinical Trial: Bracing Compliance and Personality Traits: A Compliance Assessment Program for Scoliosis and Clubfeet

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Bracing Compliance and Personality Traits: A Compliance Assessment Program for Scoliosis and Clubfeet

Brief Summary:

While studies have shown that better outcomes are associated with brace wear compliance in the scoliosis and clubfoot populations, compliance rates are still poor. Reasons identified by patients, parents and research for not complying with prescribed brace wear include the inconvenience or irritability of the child when in the brace in the case of clubfeet, and fear of looking different from peers, clothes not fitting properly, or discomfort in the case of scoliosis. While reasons for noncompliance are many and can be complex, there has been some research to indicate that personality traits may play a role in brace wear compliance.

The primary purpose of the proposed study is to determine if personality traits are related to compliance patterns for individuals undergoing brace treatment for AIS or Clubfeet.

Detailed Summary:

Bracing compliance, or the ability of patients to tolerate prescribed bracing regimens, has been shown to be related to the success of treatment. In pediatric orthopedics, bracing is used as one treatment option for a number of diagnoses and reasons. Two populations that are commonly prescribed bracing as part of the treatment paradigm are infants with clubfeet following Ponseti casting and adolescents with scoliosis.

For adolescents with idiopathic scoliosis, bracing is used to stop or slow progression of curves with the hope to delay or prevent the need for surgical intervention. Research has shown that bracing significantly decreased curve progression in patients with adolescent idiopathic scoliosis, and that the benefits of bracing increased with longer hours of brace wear.

Likewise, bracing is common practice for treating infants with clubfeet. All infants with clubfeet at SHC-Lexington are prescribed a bracing regimen following the completion of their Ponseti casting protocol. Previous research has shown that noncompliance with brace wear is strongly associated with recurrence of clubfeet in this population. Recurrence often leads to surgical intervention for these infants. Previous Kosair funded research conducted at SHC-Lexington investigated actual brace wear rates compared to the prescribed wear time in a sample of infants with clubfeet. In that study, brace wear rate significantly declined in the first three months of wear. That study did not look at factors related to the compliance with brace wear.

While studies have shown that better outcomes are associated with brace wear compliance in the scoliosis and clubfoot populations, compliance rates are still poor. Reasons identified by patients, parents and research for not complying with prescribed brace wear inclu
Sponsor: Shriners Hospitals for Children

Current Primary Outcome:

• Clubfoot brace compliance via iButton temperature monitor [ Time Frame: 3 months ]

  Study Personnel will monitor brace wear using an iButton temperature monitor molded within the Dennis Browne brace. Orthotics personnel will place the sensor in the brace at the time of fabrication.

  Study Personnel will record if the participant was compliant with the 23 hours a day prescribed wear requirements and download the iButton data.

• Scoliosis brace compliance via iButton temperature monitor [ Time Frame: 6 months ]

  Study Personnel will monitor brace wear using an iButton temperature monitor molded within the TLSO. Orthotics personnel will place the sensor in the brace at the time of fabrication.

  Study Personnel will record if the participant was compliant with the 23 hours a day prescribed wear requirements and download the iButton data.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Personality Assessment Guardian NEO-FFI-3 [ Time Frame: 0 months ]
  The NEO Five Factor Inventory-3 (NEO-FFI-3) is a measure of the five domains of personality: neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness. Guardians will complete this 60 item questionnaire at the initial visit.
• Personality Assessment Baby IBQ-R Very Short [ Time Frame: 3 months ]
  The Infant Behavior Questionnaire-Revised (IBQ-R) Very Short Form will be completed by the guardian to measure infant temperament. The form contains 36 items that measure 3 broad scales of temperament: surgency, negative affect, and effortful control.
• Personality Assessment Adolescent FPPI-C [ Time Frame: 0 months ]
  The Five Factor Personality Inventory (FPPI-C) is a measure of the five factors of personality: agreeableness, extraversion, openness to experience, conscientiousness, and emotional regulation. Participants will complete the 75 items on this assessment.

Original Secondary Outcome: Same as current

Information By: Shriners Hospitals for Children

Dates:
Date Received: March 28, 2016
Date Started: May 6, 2015
Date Completion: October 2018
Last Updated: May 2, 2017
Last Verified: May 2017