Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-31 @ 4:49 AM
Study NCT ID:
NCT01418105
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2011-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2011-07-28', 'studyFirstSubmitQcDate': '2011-08-15', 'lastUpdatePostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in swallowing ability and quality of life by swal-quol questionnaire', 'timeFrame': 'at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year'}, {'measure': "change of swallowing ability by Okuma's questionnaire", 'timeFrame': 'at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year'}, {'measure': 'change of cervical scoliosis measured by Cobb method in x-rays', 'timeFrame': 'at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year'}], 'secondaryOutcomes': [{'measure': 'change of cervical oswestry disability index', 'timeFrame': 'at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year', 'description': 'this questionnaire will be distributed only to patients with previous cervical spine problems'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['spine injuries', 'brain lesions', 'dysphagia'], 'conditions': ['Prevention', 'Rehabilitation']}, 'descriptionModule': {'briefSummary': 'The research is about a prospective study conducted in patients suffering from dysphagia and cervical spine disorders and how they are interrelated. Three questionnaires have been given to patients with neurologic deficits, the first of these investigates the occurence of dysphagia in the three stages of swallowing, the second looks into the quality of life following a stroke or other neurologic damage and the third analyses how cervical spine disorders can affect every day life. After the bedside examination, VFSS or FEES, the patients are submitted to swallowing and cervical resistance exercises in fixed time periods after their hospitalisation. The results will be collected and evaluated using the statistical programme SPSS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* brain lesions and cervical spine disorders\n\nExclusion Criteria:\n\n* age\n* peripheral damages'}, 'identificationModule': {'nctId': 'NCT01418105', 'acronym': 'DysphagCerv', 'briefTitle': 'Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions', 'organization': {'class': 'OTHER', 'fullName': 'University of Ioannina'}, 'officialTitle': 'Dysphagia and Cervical Spine Disorders in Patients With Neurologic Deficits Due to Brain Lesions', 'orgStudyIdInfo': {'id': '85/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Videofluroscopic swallow study (VFSS)', 'description': 'To investigate the swallowing ability of patients with neurologic problems', 'interventionNames': ['Procedure: Videofluroscopic swallow study (VFSS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cervical spine isometric excercises', 'description': 'isometric exercises in patients with cervical spine scoliosis', 'interventionNames': ['Procedure: cervical spine isometric exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fiberoptic endoscopic esophageal study (FEES)', 'description': 'To investigate the anatomic structures during swallowing of patients with neurologic problems', 'interventionNames': ['Procedure: Fiberoptic endoscopic esophageal study (FEES)']}], 'interventions': [{'name': 'Videofluroscopic swallow study (VFSS)', 'type': 'PROCEDURE', 'description': 'Barium, radiation', 'armGroupLabels': ['Videofluroscopic swallow study (VFSS)']}, {'name': 'cervical spine isometric exercises', 'type': 'PROCEDURE', 'description': 'patients with cervical scoliosis will execute isometric exercises of the cervical spine', 'armGroupLabels': ['cervical spine isometric excercises']}, {'name': 'Fiberoptic endoscopic esophageal study (FEES)', 'type': 'PROCEDURE', 'description': 'food for swallowing', 'armGroupLabels': ['Fiberoptic endoscopic esophageal study (FEES)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ioannina', 'country': 'Greece', 'facility': 'University Hospital of Ioannina', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ioannina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of PMR, Orthopaedic Spine Surgeon', 'investigatorFullName': 'Avraam Ploumis', 'investigatorAffiliation': 'University of Ioannina'}}}}