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

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ClinicalTrials.gov Identifier: NCT02755766
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Henry J. Iwinski Jr., MD, Shriners Hospitals for Children

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.


Condition or disease
Clubfeet Adolescent Idiopathic Scoliosis

Detailed Description:

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 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. Work done by Rivett looked at personality traits of scoliotic girls who wore a Cheneau brace (a brace not commonly prescribed in North America and the United Kingdom) and found that those who were compliant with their bracing prescription tended to be more emotionally mature, stable and realistic than the noncompliant group. Although not well studied, personality traits of infants with clubfoot and their caregiver might similarly affect their compliance with brace wear.

Past work has shown that when braces are worn as prescribed, treatment outcomes are improved in those with scoliosis and clubfoot, yet bracing compliance is a consistent problem in both populations. With adolescent idiopathic scoliosis and clubfoot being the largest and third largest populations seen at SHC-Lexington, 3700 active patients and 2500 active patients, respectively, it is imperative that we address brace wear compliance in order to offer the best treatment outcome possible. At SHC-Lexington, during 2013 approximately 30 AIS patients and 50 infants with clubfoot were prescribed braces for the first time.

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. This pilot project will examine different measures used to assess personality traits of adolescents with AIS, babies with clubfeet and their parent/guardian/caregiver. Using these identified measures, the association between traits and degree of compliance with the bracing prescriptions will be evaluated. If certain personality traits are identified as indicators for noncompliance, then additional support should be offered to those patients.


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Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bracing Compliance and Personality Traits: A Compliance Assessment Program for Scoliosis and Clubfeet
Actual Study Start Date : May 6, 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Group/Cohort
Clubfeet
Babies, ages 0-1, with a diagnosis with clubfoot or clubfeet who are beginning treatment with foot abduction bracing following casting treatment.
Adolescent Idiopathic Scoliosis
Patients, ages 10-14, with a diagnosis of AIS who are beginning treatment with TLSO (initial bracing).
Guardians (CF babies)
Clubfoot patients' guardians.



Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A total of 105 participants will be enrolled in the study. Of those 105, 35 will be clubfoot patients, 35 clubfoot patients' guardians, and 35 AIS patients.
Criteria

Inclusion criteria for the clubfoot participants include:

  • Less than a year of age
  • Diagnosis of congenital clubfoot (unilateral or bilateral)
  • Beginning treatment with foot abduction bracing following casting treatment

Exclusion criteria for the clubfoot participants include:

  • Other diagnosis in addition to clubfoot
  • Previous foot abduction bracing, and previous surgical correction (excluding tenotomy)

Exclusion criteria for the clubfoot guardians include:

  • Under the age of 18 years
  • Does not speak English

Inclusion for the AIS participants includes:

  • Patients ages 10-14 years old
  • Diagnosis of adolescent idiopathic scoliosis
  • Beginning treatment with TLSO (initial bracing), and able to read
  • Understand study questionnaires

Exclusion criteria for the AIS participants include:

  • Other diagnosis in addition to AIS
  • Previously prescribed brace for treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755766


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

Locations
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United States, Kentucky
Shriners Hospital for Children Recruiting
Lexington, Kentucky, United States, 40502
Contact: Rebecca Davis    859-268-5705    rfdavis@shrinenet.org   
Principal Investigator: Henry Iwinski, MD         
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
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Principal Investigator: Henry Iwinski, MD Shriners Hospital for Children

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Responsible Party: Henry J. Iwinski Jr., MD, Chief of Staff, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT02755766     History of Changes
Other Study ID Numbers: LEX-1501
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Scoliosis
Clubfoot
Talipes
Equinus Deformity
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Foot Deformities, Acquired
Foot Deformities
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities