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



Status:Active, not recruiting
Conditions:Orthopedic, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:Any - 99
Updated:4/6/2019
Start Date:May 6, 2015
End Date:December 2019

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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.

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.

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
We found this trial at
1
site
Lexington, Kentucky 40502
Principal Investigator: Henry Iwinski, MD
Phone: 859-268-5705
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Lexington, KY
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