Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:15 PM
Study NCT ID:
NCT04367194
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2020-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Objective Examination and Rehabilitation Treatment of Patients With BPPV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014717', 'term': 'Vertigo'}, {'id': 'D019957', 'term': 'Motor Skills Disorders'}], 'ancestors': [{'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-26', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EQ5D-5L', 'timeFrame': '5 weeks', 'description': 'Quality of life testing is taken with a test. The therapist scores the answers to the questions asked on a scale. The end result determines the quality of life.'}, {'measure': 'Beam Walking test', 'timeFrame': '5 weeks', 'description': 'The patient walks on slats of varying width. During the examination, the therapist says the tasks (Eg: counting backwards). The study detects the determination of dynamic equilibrium.'}, {'measure': 'Posturography', 'timeFrame': '5 weeks', 'description': 'Noninvasive intervention where static equilibrium is examined. The program determines the quality and frequency of the displacements.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vertigo', 'balance', 'instability', 'rehabilitation'], 'conditions': ['Postural Vertigo', 'Vertigo, Paroxysmal', 'Vertigo, Positional', 'Coordination Disorder, Developmental', 'Coordination and Balance Disturbances']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=BPPV+rehabilitation', 'label': 'BPPV rehabilitation'}]}, 'descriptionModule': {'briefSummary': 'Dizziness (BPPV) causes severe deterioration in quality of life, incoordination, and instability.\n\nIn the study, we selected a minimum of 100 patients with BPPV who were examined after specialist care. After the acute phase, a physical survey is performed where movement and coordination are examined.\n\nAfter the results, the patients undergo a rehabilitation training. The workout is submaximal and high intensity that is done for 3 weeks.\n\nHypothesis: As a result of training, it is possible that the remaining feeling of dizziness and insecurity, impaired coordination will decrease or disappear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For a patient with BPPV\n* With a lack of coordination\n* Dizziness\n* Ear nose laryngeal examination\n* Neurological examination\n\nExclusion Criteria:\n\n* other neurological diseases\n* cardiological diseases\n* underwent surgery\n* severe joint pain\n* alcoholism\n* dementia\n* drug'}, 'identificationModule': {'nctId': 'NCT04367194', 'briefTitle': 'Objective Examination and Rehabilitation Treatment of Patients With BPPV', 'organization': {'class': 'OTHER', 'fullName': 'Somogy Megyei Kaposi Mór Teaching Hospital'}, 'officialTitle': 'Objective Examination and Rehabilitation Treatment of Patients With BPPV', 'orgStudyIdInfo': {'id': 'IKEB2019/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BPPV intervention', 'description': 'After examination of the patients, the patients undergo neurorehabilitation. We use virtual reality therapy. Patients perform a submaximal load that is monitored by a polar clock. We develop endurance, coordination, sensory integration, visual and acoustic input, vestibular training, proprioception training.', 'interventionNames': ['Behavioral: Neurorehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'BPPV Epley', 'description': 'Only Epley training.', 'interventionNames': ['Behavioral: Neurorehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'BPPV Optocinetic', 'description': 'Only Optocinetic training.', 'interventionNames': ['Behavioral: Neurorehabilitation']}], 'interventions': [{'name': 'Neurorehabilitation', 'type': 'BEHAVIORAL', 'otherNames': ['BPPV group'], 'description': 'After examination of the patients, the patients undergo neurorehabilitation. We use virtual reality therapy. Patients perform a submaximal load that is monitored by a polar clock. We develop endurance, coordination, sensory integration, visual and acoustic input, vestibular training, proprioception training.', 'armGroupLabels': ['BPPV Epley', 'BPPV Optocinetic', 'BPPV intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7400', 'city': 'Kaposvár', 'state': 'Somogy County', 'country': 'Hungary', 'facility': 'Somogy Megyei Kaposi Mór Oktató Kórház', 'geoPoint': {'lat': 46.36667, 'lon': 17.8}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Somogy Megyei Kaposi Mór Teaching Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tollár József', 'investigatorAffiliation': 'Somogy Megyei Kaposi Mór Teaching Hospital'}}}}