Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-03 @ 6:36 AM
Study NCT ID:
NCT04404205
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2020-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Cochlear Implant on Postural Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-11', 'studyFirstSubmitDate': '2020-05-17', 'studyFirstSubmitQcDate': '2020-05-21', 'lastUpdatePostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Deviation of center of gravity(angle)', 'timeFrame': '3-6 months', 'description': "Deviation of center of gravity(angle) test assesses a patient's ability to maintain a center of balance. It measures how much the patient's position deviates from center and reports the average deviation as the stability index. Therefore, a low score is more desirable than a high score. Postural stability is a calculated value of difference in center of gravity when the subjects tested eyes open/closed, hard and soft surface test conditions. Postural stability will be measured in four conditions: İmplant on, implant off, implant on+music on, implant of again"}, {'measure': 'postural sway velocity(angle/sec)', 'timeFrame': '3-6 months', 'description': 'A high sway velocity when a patient is attempting to stand motionless suggests a deficit in postural control and assessment for lower extremity strength, proprioception, and vestibular or visual deficiencies. Postural sway velocity will be measured in four conditions: İmplant on, implant off, implant on+music on, implant of again'}, {'measure': "Sensory Integration Test(the mean absolute deviation of the patient's average position during a test)", 'timeFrame': '3-6 months', 'description': "The Clinical Test of Sensory Interaction of Balance (CTSIB) is a standard test for balance assessment on a static surface. The test assesses how well a patient can integrate sensory information to maintain balance. The result of the CTSIB test is the patient's sway index, which represents the mean absolute deviation of the patient's average position during a test. The higher the sway index, the more unsteady the person was during the test. Sensory Integration Test will be measured in four conditions: İmplant on, implant off, implant on+music on, implant of again"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cochlear Implant']}, 'descriptionModule': {'briefSummary': 'Some patients are having balance problems after cochlear implant surgery. There are contradictory reports about the effect of the implant on postural control. While the cochlear implant is working, an electrical current is continuously stimulating the cochlear nerve which is in close proximity with vestibular ganglion and nerve. This stimulation may contribute to vestibular signals to the central system. The aim of the study is to investigate if this stimulation has any effect on postural control.', 'detailedDescription': 'Adult patients who had unilateral cochlear implantation will be included. Postural stability measurements will be done by the Biodex Balance System. Three preprogrammed main tests and their 9 subtests will be applied. Postural stability, fall index, sensory integration will be calculated. All tests will be done in four conditions; implant off(1), implant on(2), implant on music on(3), and implant off again(4).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had cochlear implantation in our hospital will be invited to join the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had cochlear implant surgery before\n\nExclusion Criteria:\n\n* Bilateral Cochlear implants\n* Neurologic disease\n* Communication problem\n* Additional disability'}, 'identificationModule': {'nctId': 'NCT04404205', 'briefTitle': 'The Effect of Cochlear Implant on Postural Control', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'The Effect of Cochlear Implant on Postural Control', 'orgStudyIdInfo': {'id': '6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patient with cochlear implant', 'description': 'Adult patients who had cochlear implant surgery before will be included. We will call patients from our cochlear implant list.', 'interventionNames': ['Diagnostic Test: Postural stability measurements by Biodex Balance System']}], 'interventions': [{'name': 'Postural stability measurements by Biodex Balance System', 'type': 'DIAGNOSTIC_TEST', 'description': 'Postural stability measurements will be done by Biodex Balance System. Three preprogrammed main tests will be applied. Postural stability, fall index, sensory integration will be calculated. All tests will be done in four conditions; implant off(1), implant on(2), implant on music on(3), and implant off again(4).', 'armGroupLabels': ['Adult patient with cochlear implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20070', 'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'overallOfficials': [{'name': 'Fazıl N Ardıç, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pamukkale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be available University depository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Department Otolaryngology', 'investigatorFullName': 'Fazıl Necdet Ardıç', 'investigatorAffiliation': 'Pamukkale University'}}}}