Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2026-02-27 @ 12:48 AM
Study NCT ID:
NCT00592761
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2007-12-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Dysphagia Using the Mendelsohn Maneuver
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mcculloughgaryh@uams.edu', 'phone': '501-852-7886', 'title': 'Gary McCullough', 'organization': 'UAMS Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Subjects were followed for up to one year after study completion.', 'eventGroups': [{'id': 'EG000', 'title': 'No Treatment Then Treatment', 'description': 'Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Then No Treatment', 'description': 'Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Duration of Superior Hyolaryngeal Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Treatment Then Treatment', 'description': 'Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.'}, {'id': 'OG001', 'title': 'Treatment Then No Treatment', 'description': 'Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '.213', 'spread': '.154', 'groupId': 'OG000'}, {'value': '.233', 'spread': '.184', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and six weeks', 'description': 'Change in duration of superior elevation of hyoid bone.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol', 'anticipatedPostingDate': '2010-04'}, {'type': 'SECONDARY', 'title': 'Change in Oral Intake Ability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Treatment Then Treatment', 'description': 'Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.'}, {'id': 'OG001', 'title': 'Treatment Then No Treatment', 'description': 'Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '.15', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Oral Intake Ability was measure with the Dysphagia Outcome and Severity Scale. A 7 is normal and a 1 is complete inability to consume any food safely. The means reported for treatment and no treatment periods are mean changes in scores throughout the period.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-01'}, {'type': 'SECONDARY', 'title': 'Change in Duration of Opening of Upper Esophageal Sphincter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Treatment Then Treatment', 'description': 'Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.'}, {'id': 'OG001', 'title': 'Treatment Then No Treatment', 'description': 'Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '.584', 'spread': '.159', 'groupId': 'OG000'}, {'value': '.610', 'spread': '.183', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Change in duration of pre- and post-treatment duration of UES opening.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-01'}, {'type': 'PRIMARY', 'title': 'Change in Duration of Hyoid Maximum Anterior Excursion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Treatment Then Treatment', 'description': 'Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.'}, {'id': 'OG001', 'title': 'Treatment Then No Treatment', 'description': 'Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '.233', 'spread': '.157', 'groupId': 'OG000'}, {'value': '.247', 'spread': '.161', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Change in the duration of maximum anterior movement of the hyoid bone during swallowing.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-04'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Treatment Then Treatment', 'description': 'Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.'}, {'id': 'FG001', 'title': 'Treatment Then No Treatment', 'description': 'Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.'}], 'periods': [{'title': 'First Intervention (2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment of participants occurred through The University of Arkansas for Medical Sciences Medical Center Speech Pathology Clinic and newspaper advertisements between February 2003 and February 2010.', 'preAssignmentDetails': 'Participants were only assigned to a group after their initial evaluation and no exclusions were necessary. Participants were each assigned to receive 2 weeks of treatment and two weeks of no treatment. Assignments were randomized so half began with treatment and half began with no treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'This includes all participants. Half received treatment then no treatment and have received no treatment then treatment.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were analyzed for age effects within analysis of variance.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender effects were analyzed within the analysis of variance.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-21', 'studyFirstSubmitDate': '2007-12-27', 'resultsFirstSubmitDate': '2010-01-25', 'studyFirstSubmitQcDate': '2007-12-27', 'lastUpdatePostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-07-16', 'studyFirstPostDateStruct': {'date': '2008-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Duration of Superior Hyolaryngeal Movement', 'timeFrame': 'baseline and six weeks', 'description': 'Change in duration of superior elevation of hyoid bone.'}, {'measure': 'Change in Duration of Hyoid Maximum Anterior Excursion', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Change in the duration of maximum anterior movement of the hyoid bone during swallowing.'}], 'secondaryOutcomes': [{'measure': 'Change in Oral Intake Ability', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Oral Intake Ability was measure with the Dysphagia Outcome and Severity Scale. A 7 is normal and a 1 is complete inability to consume any food safely. The means reported for treatment and no treatment periods are mean changes in scores throughout the period.'}, {'measure': 'Change in Duration of Opening of Upper Esophageal Sphincter', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Change in duration of pre- and post-treatment duration of UES opening.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Deglutition Disorders', 'Mendelsohn Maneuver', 'SEMG'], 'conditions': ['Stroke', 'Dysphagia']}, 'descriptionModule': {'briefSummary': 'The primary goal of the investigation is to determine the effects of the Mendelsohn maneuver on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs of pharyngeal dysphagia.', 'detailedDescription': 'The primary goal of the investigation is to determine the effects of the Mendelsohn maneuver (voluntary prolongation of laryngeal excursion at the midpoint of the swallow) on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs of pharyngeal dysphagia (specifically, reduced duration of hyoid maximum elevation, reduced extent of hyoid maximum elevation, reduced duration of hyoid maximum anterior excursion, reduced extent of hyoid maximum anterior excursion, and reduced duration of upper esophageal sphincter (UES) opening with subsequent residue in the pyriform sinuses and, potentially, aspiration). Participants are assessed with videofluoroscopy at the initiation of the study and after each week of the study. After the 4 weeks of participation are complete, all participants will be discharged from treatment and will be brought back to the clinic for a final Videofluoroscopic Swallow Study (VFSS) evaluation after 2 weeks. This means that individuals in Group 1 will be re-analyzed after 1 month of additional no-treatment, and Group 2 will be re-analyzed after 2 additional weeks of no-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stroke (1-18 months post)\n* Pharyngeal Dysphagia\n\nExclusion Criteria:\n\n* Other neurologic or structural abnormality to oropharynx\n* History of dysphagia prior to latest stroke'}, 'identificationModule': {'nctId': 'NCT00592761', 'briefTitle': 'Treatment of Dysphagia Using the Mendelsohn Maneuver', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Treatment of Dysphagia Using the Mendelsohn Maneuver', 'orgStudyIdInfo': {'id': 'R03DC004942', 'link': 'https://reporter.nih.gov/quickSearch/R03DC004942', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R03DC004942', 'link': 'https://reporter.nih.gov/quickSearch/R03DC004942', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Within subjects treatment, no-treatment', 'description': 'Within subject, treatment and no-treatment periods. Each participant served as his/her own control in this AABB/BBAA alternating treatment conditions design. Results were also compared across groups (treatment v. no-treatment).', 'interventionNames': ['Behavioral: Mendelsohn Maneuver']}], 'interventions': [{'name': 'Mendelsohn Maneuver', 'type': 'BEHAVIORAL', 'description': 'Mendelsohn Maneuver with Surface Electromyography', 'armGroupLabels': ['Within subjects treatment, no-treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72035', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'UArkansas/UAMS Medical Center', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Gary H McCullough, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}