Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 10:53 PM
Study NCT ID:
NCT01131494
Status:
COMPLETED
Last Update Posted:
2011-11-08
First Post:
2010-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Swallowing Training in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D014832', 'term': 'Voice Disorders'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'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'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003679', 'term': 'Deglutition'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D010699', 'term': 'Phonation'}], 'ancestors': [{'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'natyargolo@hotmail.com', 'phone': '55 31 3274 5579', 'title': 'Natalie Argolo Ponte', 'organization': 'University Federal of Bahia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There was a delay because of faulty equipment that performs videofluoroscopy of swallowing.\n\nStudy limitations include small number of participants and no comparison group.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event was not collected after end of study.', 'description': 'No formal tool to collect adverse event was used because there is no report that oral exercise can cause adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'Swallowing Exercise Group', 'description': 'One group made swallowing exercises for five weeks. This group was compared before and after the study.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-intervention Measure', 'description': 'Measurements of the group made before begin intervention.'}, {'id': 'OG001', 'title': 'Post-intervention Measure', 'description': 'Measurements of the group made after the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.33', 'groupId': 'OG000', 'lowerLimit': '40.05', 'upperLimit': '79.8'}, {'value': '70.58', 'groupId': 'OG001', 'lowerLimit': '47.72', 'upperLimit': '77.13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'five weeks', 'description': 'Measured by the Swal-qol (Quality of life in Swallowing disorders). In this questionnaire the score range from 0 to 100 and higher scores is better quality of life.', 'unitOfMeasure': 'scores in a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Oropharyngeal Swallowing Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-intervention Measure', 'description': 'Measurements of the group made before begin intervention.'}, {'id': 'OG001', 'title': 'Post-intervention Measure', 'description': 'Measurements of the group made after the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.15', 'spread': '9.36', 'groupId': 'OG000'}, {'value': '21.93', 'spread': '12.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'five weeks', 'description': 'Based on videofluoroscopy, were awarded points for the swallowing events according to their clinical relevance. The sum of these points results in the OSP (Oropharyngeal Swallowing Score), so that higher scores signify greater impairment in swallowing. OSP-score range from 0 to 243.5. This tool is being validated for that group.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Swallowing Exercise Group', 'description': 'One group made swallowing exercises for five weeks. This group was compared before and after the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Consecutive patients from Movement Disorders Ambulatory of Federal University of Bahia in Brazil with idiopathic Parkinson disease (IPD) and complaint of dysphagia, from March 2009 to June 2010, were invited to participate.', 'preAssignmentDetails': 'Patients with severe dysphagia who needed others interventions (for example: management of food consistency, alternative way of feeding) were excluded. During the study, subjects with absence in three sessions of exercises were excluded from the study and sent to Ambulatory of Speech and Deglutition Disorders at Federal University of Bahia.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Swallowing Exercise Group', 'description': 'One group made swallowing exercises for five weeks. This group was compared before and after the study.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.12', 'spread': '12.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-04', 'studyFirstSubmitDate': '2010-05-25', 'resultsFirstSubmitDate': '2011-05-05', 'studyFirstSubmitQcDate': '2010-05-26', 'lastUpdatePostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-04', 'studyFirstPostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oropharyngeal Swallowing Score', 'timeFrame': 'five weeks', 'description': 'Based on videofluoroscopy, were awarded points for the swallowing events according to their clinical relevance. The sum of these points results in the OSP (Oropharyngeal Swallowing Score), so that higher scores signify greater impairment in swallowing. OSP-score range from 0 to 243.5. This tool is being validated for that group.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'five weeks', 'description': 'Measured by the Swal-qol (Quality of life in Swallowing disorders). In this questionnaire the score range from 0 to 100 and higher scores is better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Dysphagia', 'Treatment'], 'conditions': ["Parkinson's Disease", 'Deglutition Disorders', 'Voice Disorders']}, 'descriptionModule': {'briefSummary': "Dysphagia in Parkinson's disease(PD) is common and its presence is related to motor and sensory abnormalities, and incoordination between swallowing and breathing. Despite harming as respiratory infections and increased risk of death, treatment of this condition remains uncertain. This study aims to evaluate the effect of oral motor exercises on the swallowing dynamics and quality of life of dysphagic Parkinson's disease patients. This study is an open trial, self-paired and blinded to the examiner. The participants will perform oropharyngeal exercises for five weeks and will be evaluated before and after intervention by swallowing videofluoroscopy and questionnaires about quality of life in dysphagia (SWAL-QOL)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson disease\n* Complaint of dysphagia\n\nExclusion Criteria:\n\n* Hoehn and Yahr stage 5\n* Other neurological conditions\n* Therapy for swallowing in the last 3 months\n* Cognitive disorders\n* Psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT01131494', 'briefTitle': "Swallowing Training in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Bahia'}, 'officialTitle': "Dysphagia Therapy for Parkinson's Disease: the Role of the Oral Motor Exercises", 'orgStudyIdInfo': {'id': '249/2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Swallowing exercises', 'interventionNames': ['Other: Motor exercises for swallowing, breathing and phonation']}], 'interventions': [{'name': 'Motor exercises for swallowing, breathing and phonation', 'type': 'OTHER', 'description': 'This exercises aimed to increase strength and range of motion of mouth, larynx and pharynx structures. All patients made sustained vowel phonation of /a/, pushing plosive phonemes /pa/, /ta/, /ka/ in a forceful manner, suction of wet gauze, swallowing with tongue hold and modified supraglottic maneuver, in ten repetitions, ascending and descending gliding phonation of vowel /a/ and /u/, five repetitions of each vowel, and tongue rotation in oral vestibule, 3 series of 5 repetitions to each side. Patients underwent oral motor exercises twice a day, five days a week, for five weeks.', 'armGroupLabels': ['Swallowing exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40110-170', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Federal University of Bahia', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'overallOfficials': [{'name': 'Ana Caline Nóbrega, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of Bahia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Bahia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Natalie Argolo Pereira Ponte', 'investigatorAffiliation': 'Federal University of Bahia'}}}}