Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2026-01-01 @ 7:31 AM
Study NCT ID:
NCT02755766
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2016-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bracing Compliance and Personality Traits: A Compliance Assessment Program for Scoliosis and Clubfeet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003025', 'term': 'Clubfoot'}], 'ancestors': [{'id': 'D000070558', 'term': 'Talipes'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005532', 'term': 'Foot Deformities, Congenital'}, {'id': 'D038061', 'term': 'Lower Extremity Deformities, Congenital'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2016-03-28', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clubfoot brace compliance via iButton temperature monitor', 'timeFrame': '3 months', 'description': '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.\n\nStudy Personnel will record if the participant was compliant with the 23 hours a day prescribed wear requirements and download the iButton data.'}, {'measure': 'Scoliosis brace compliance via iButton temperature monitor', 'timeFrame': '6 months', 'description': '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.\n\nStudy Personnel will record if the participant was compliant with the 23 hours a day prescribed wear requirements and download the iButton data.'}], 'secondaryOutcomes': [{'measure': 'Personality Assessment Guardian NEO-FFI-3', 'timeFrame': '0 months', 'description': '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.'}, {'measure': 'Personality Assessment Baby IBQ-R Very Short', 'timeFrame': '3 months', 'description': '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.'}, {'measure': 'Personality Assessment Adolescent FPPI-C', 'timeFrame': '0 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Clubfeet', 'Adolescent Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nFor 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.\n\nLikewise, 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.\n\nWhile 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.\n\nPast 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria for the clubfoot participants include:\n\n* Less than a year of age\n* Diagnosis of congenital clubfoot (unilateral or bilateral)\n* Beginning treatment with foot abduction bracing following casting treatment\n\nExclusion criteria for the clubfoot participants include:\n\n* Other diagnosis in addition to clubfoot\n* Previous foot abduction bracing, and previous surgical correction (excluding tenotomy)\n\nExclusion criteria for the clubfoot guardians include:\n\n* Under the age of 18 years\n* Does not speak English\n\nInclusion for the AIS participants includes:\n\n* Patients ages 10-14 years old\n* Diagnosis of adolescent idiopathic scoliosis\n* Beginning treatment with TLSO (initial bracing), and able to read\n* Understand study questionnaires\n\nExclusion criteria for the AIS participants include:\n\n* Other diagnosis in addition to AIS\n* Previously prescribed brace for treatment'}, 'identificationModule': {'nctId': 'NCT02755766', 'briefTitle': 'Bracing Compliance and Personality Traits: A Compliance Assessment Program for Scoliosis and Clubfeet', 'organization': {'class': 'OTHER', 'fullName': 'Shriners Hospitals for Children'}, 'officialTitle': 'Bracing Compliance and Personality Traits: A Compliance Assessment Program for Scoliosis and Clubfeet', 'orgStudyIdInfo': {'id': 'LEX-1501'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clubfeet', 'description': 'Babies, ages 0-1, with a diagnosis with clubfoot or clubfeet who are beginning treatment with foot abduction bracing following casting treatment.'}, {'label': 'Adolescent Idiopathic Scoliosis', 'description': 'Patients, ages 10-14, with a diagnosis of AIS who are beginning treatment with TLSO (initial bracing).'}, {'label': 'Guardians (CF babies)', 'description': "Clubfoot patients' guardians."}]}, 'contactsLocationsModule': {'locations': [{'zip': '40502', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Shriners Hospital for Children', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Henry Iwinski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shriners Hospital for Children'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shriners Hospitals for Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Staff', 'investigatorFullName': 'Henry J. Iwinski Jr., MD', 'investigatorAffiliation': 'Shriners Hospitals for Children'}}}}