An observational study in Clubfeet and Adolescent Idiopathic Scoliosis, sponsored by Shriners Hospitals for Children. Completed at 1 site in United States. Open to participants aged 1 Day to 99 Years. Per ClinicalTrials.gov, last updated 2020-03-30.
Sponsored by Shriners Hospitals for Children · Observational
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Among 10 studies in Clubfoot with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Clubfoot · United States.
Among the 10 studies in Clubfoot with a site in United States, this one is the only one that started in 2015, is one of 5 observational ones, and was the 6th registered.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
Browse Clubfoot studies →2 of the 10 studies in Clubfoot with a site in United States are open now. Recruiting first, the newest first:
University of Wisconsin, Madison · Sites in United States
Ages 0 wk–12 wk
Texas Scottish Rite Hospital for Children · Sites in United States
Ages up to 18
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 10 Clubfoot studies recruiting now, none (0%) set no upper age limit and 10 (100%) stop at 75 or younger; 9 take children under 18; none take healthy volunteers.
This study: 1 Day to 99 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2015.
This study's planned enrollment of 105 is above the median of 55 across 27 observational studies indexed under Clubfoot.
Median enrollment 100 across the 5 interventional studies, 370 across the 5 observational. Of the 8 that completed or were terminated, 4 (50%) have results posted.
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None of the 10 has an industry lead sponsor. The 8 most frequent:
Shriners Hospitals for Children is the lead sponsor of 56 studies on the registry; none are open to participants now.
Shriners Hospitals for Children has 3 studies filed under Clubfoot — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Clubfoot with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Inclusion criteria for the clubfoot participants include:
Exclusion criteria for the clubfoot participants include:
Exclusion criteria for the clubfoot guardians include:
Inclusion for the AIS participants includes:
Exclusion criteria for the AIS participants include:
Babies, ages 0-1, with a diagnosis with clubfoot or clubfeet who are beginning treatment with foot abduction bracing following casting treatment.
Patients, ages 10-14, with a diagnosis of AIS who are beginning treatment with TLSO (initial bracing).
Clubfoot patients' guardians.
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.
Time frame: 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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 0 months
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2015 to primary completion in Jul 2019, 49 months.
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Shriners Hospitals for Children