Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-02-03 @ 1:07 PM
Study NCT ID:
NCT05437133
Status:
UNKNOWN
Last Update Posted:
2022-06-29
First Post:
2022-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability and Validity of Self-reported Adherence to Elbow Orthosis Wearing Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D000092482', 'term': 'Elbow Fractures'}], 'ancestors': [{'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-23', 'studyFirstSubmitDate': '2022-06-23', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Orthosis wearing time (sensor measured)', 'timeFrame': '6 weeks', 'description': 'overall time in orthosis as measured by the sensor'}, {'measure': 'Orthosis wearing time (self-reported)', 'timeFrame': '6 weeks', 'description': 'overall time in orthosis reported by the patient'}], 'secondaryOutcomes': [{'measure': 'Elbow ROM', 'timeFrame': '6 months', 'description': 'goniometric measurement'}, {'measure': 'Patient Rated Elbow Evaluation', 'timeFrame': '6 months', 'description': 'patient reported outcome measure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elbow Injury', 'Elbow Fracture', 'Elbow Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to validate whether the use of a self-reported diary for orthosis use is accurate and valid. We will insert a temperature gauge into the orthosis during fabrication that measures temperature to an accuracy of one degree Celcius. This sensor is about the size of a watch battery, and patients will be told that it is measuring the force of stretch applied to the elbow, while in fact, it is measuring the amount of time that the orthosis is being worn. The temperature of the skin while wearing the orthosis heats up the sensor, and we can accurately predict (within 5 minutes of accuracy) how long the orthosis is worn each day.\n\nWe will have patients also fill out a self-report diary outlining how long they are wearing the orthosis each day, and compare these times to the measurements taken by the sensor. As secondary outcomes, we will look at whether the orthoses improve elbow range of motion (ROM), patient satisfaction, and improvement over time on patient reported outcome measures. This study will provide important information about the validity and reliability of using diaries to measure adherence to orthoses, and will be the first to provide objective data regarding the actual use of these orthoses and whether they help to decrease elbow stiffness.', 'detailedDescription': 'The elbow is prone to stiffness following trauma. Orthoses or splints are commonly used to manage this stiffness and prevent flexion contractures following elbow injury. One of the main orthoses used to treat patients who cannot extend their elbow following injury is to make an orthosis or splint to hold the elbow as straight as possible through the night to provide a gentle stretch. As patients gain the ability to straighten their elbow, the orthosis is reshaped over several weeks to continue to provide a stretch at night. This study will investigate the effectiveness of these orthoses for improving ROM, by correlating actual wearing time to ROM measurements. To date, there is no objective way of measuring whether patients actually wear these orthoses at night. Measurement of actual wearing time in the splint has been dependent on self-reported diaries to document wearing time.\n\nThe purpose of this study is to validate whether the use of a self-reported diary for orthosis use is accurate and valid. We will insert a temperature gauge into the orthosis during fabrication that measures temperature to an accuracy of one degree Celcius. This sensor is about the size of a watch battery, and patients will be told that it is measuring the force of stretch applied to the elbow, while in fact, it is measuring the amount of time that the orthosis is being worn. The temperature of the skin while wearing the orthosis heats up the sensor, and we can accurately predict (within 5 minutes of accuracy) how long the orthosis is worn each day.\n\nWe will have patients also fill out a self-report diary outlining how long they are wearing the orthosis each day, and compare these times to the measurements taken by the sensor. As a secondary outcome, we will look at whether the slightly different way the orthosis is made changes elbow stiffness via range of motion measurements of the elbow. Other data collected will include patient reported outcome measures including the Patient Rated Elbow Evaluation, The Disabilities of Arm, Shoulder, and Hand Questionnaire, and a patient satisfaction survey. This study will provide important information about the validity and reliability of using diaries to measure adherence to orthoses, and will be the first to provide objective data regarding the actual use of these orthoses and wearing time to changes in range of motion.\n\nThe Sensors are able to record 2 weeks on continuous data, and patients will be followed for 3 total visits - one for splint fabrication, at 2 weeks, 4 weeks, and 6 weeks, post splint fabrication. Patients will also attend regular therapy visits as needed, independent of these followups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients over age 18, with elbow trauma, referred by the Upper Limb Surgeons at the Roth McFarlane Hand \\& Upper Limb Centre for night time extension splinting of the elbow following trauma. We will enroll patients consecutively.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients over age 18, with elbow trauma, referred by the Upper Limb Surgeons at the Roth McFarlane Hand \\& Upper Limb Centre (HULC) for night time extension splinting of the elbow following trauma\n\nExclusion Criteria:\n\n* Elbow instability, infection, or other condition precluding the use of an extension orthosis at night time. Inability to wear the orthosis due to know skin reactions, claustrophobia, or ability to understand instructions and precautions provided in English. Patients will also be excluded if they are unable to return to HULC for follow up due to driving distance.'}, 'identificationModule': {'nctId': 'NCT05437133', 'briefTitle': 'Reliability and Validity of Self-reported Adherence to Elbow Orthosis Wearing Time', 'organization': {'class': 'OTHER', 'fullName': 'Western University, Canada'}, 'officialTitle': 'Reliability and Validity of Self-reported Adherence to Elbow Orthosis Wearing Time Using Concealed Temperature Sensors', 'orgStudyIdInfo': {'id': '12567'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Custom fabricated elbow extension orthosis', 'type': 'DEVICE', 'description': 'custom low temperature thermoplastic orthosis (Splint) holding the elbow in maximum extension at night'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University, Canada', 'class': 'OTHER'}, 'collaborators': [{'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}