ClubfeetNCT02755766
Bracing Compliance and Personality Traits: A Compliance Assessment Program for Scoliosis and Clubfeet
An observational study of Clubfeet and Adolescent Idiopathic Scoliosis, run by Shriners Hospitals for Children at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 99 years
- Conditions the study is for
- Clubfeet, Adolescent Idiopathic Scoliosis
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2015to 3 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Less than a year of age
- Diagnosis of congenital clubfoot (unilateral or bilateral)
- Beginning treatment with foot abduction bracing following casting treatment
- Patients ages 10-14 years old
- Diagnosis of adolescent idiopathic scoliosis
- Beginning treatment with TLSO (initial bracing), and able to read
- Understand study questionnaires
Who cannot join
- Other diagnosis in addition to clubfoot
- Previous foot abduction bracing, and previous surgical correction (excluding tenotomy)
- Under the age of 18 years
- Does not speak English
- Other diagnosis in addition to AIS
- Previously prescribed brace for treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospital for Children
Lexington, Kentucky, 40502
About this study
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.
Read the 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.
- Conditions
- Clubfeet, Adolescent Idiopathic Scoliosis
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clubfoot brace compliance via iButton temperature monitor
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.
Measured: 3 months
Scoliosis brace compliance via iButton temperature monitor
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.
Measured: 6 months
Secondary outcomes (3)
Personality Assessment Guardian NEO-FFI-3
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.
Measured: 0 months
Personality Assessment Baby IBQ-R Very Short
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.
Measured: 3 months
Personality Assessment Adolescent FPPI-C
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.
Measured: 0 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start6 May 2015
- Primary completion3 Jul 2019
- Study completion3 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClubfeetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry J. Iwinski Jr., MD, Shriners Hospitals for Children
- Investigators
- Henry Iwinski, MD, Principal investigator, Shriners Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755766
- Sponsor's protocol ID
- LEX-1501
- Status last verified
- Mar 2020
- First submitted
- 28 Mar 2016
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bracing Compliance and Personality Traits: A Compliance Assessment Program for Scoliosis and Clubfeet
- ClinicalTrials.gov ID
- NCT02755766
- Acronym / sponsor ID
- LEX-1501
- Conditions
- Clubfeet, Adolescent Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- 6 May 2015 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 day to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Less than a year of age
- Diagnosis of congenital clubfoot (unilateral or bilateral)
- Beginning treatment with foot abduction bracing following casting treatment
- Patients ages 10-14 years old
- Diagnosis of adolescent idiopathic scoliosis
Key exclusion criteria (6 listed)
- Other diagnosis in addition to clubfoot
- Previous foot abduction bracing, and previous surgical correction (excluding tenotomy)
- Under the age of 18 years
- Does not speak English
- Other diagnosis in addition to AIS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
3 secondary outcomes
Personality Assessment Guardian NEO-FFI-3
Time frame: 0 months
Personality Assessment Baby IBQ-R Very Short
Time frame: 3 months
Personality Assessment Adolescent FPPI-C
Time frame: 0 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Iwinski, MD principal investigator
Shriners Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfeet and Adolescent Idiopathic Scoliosis, run by Shriners Hospitals for Children at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clubfoot brace compliance via iButton temperature monitor (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.