NCT02755766|CompletedDMC
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Sponsor study identifier
observational
105
1 country
1
Study Start
May 6, 2015
Actual (reported)Primary Completion
July 3, 2019
Actual (reported)Study Completion
July 3, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 3, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 6, 2015
Actual (reported)March 28, 2016
Actual (reported)April 29, 2016
Actual (reported)July 3, 2019
Actual (reported)July 3, 2019
Actual (reported)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.
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.
6 months
Personality Assessment Guardian NEO-FFI-3
0 months
Personality Assessment Baby IBQ-R Very Short
3 months
Personality Assessment Adolescent FPPI-C
0 months
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.
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.
Shriners Hospital for Children
Lexington, Kentucky, 40502, United States
Henry Iwinski, MD
Shriners Hospital for Children
First Submitted
March 28, 2016
First Posted
April 29, 2016
Study Start
May 6, 2015
Actual (reported)Primary Completion
July 3, 2019
Actual (reported)Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis
Contact the study team to confirm eligibility.
Study Completion
July 3, 2019
Actual (reported)Last Updated
March 30, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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