Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-06-02 @ 8:24 PM
Study NCT ID:
NCT04569968
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2020-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Expiratory Muscle Training in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}], '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': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular 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': 'tamercankaya@hotmail.com', 'phone': '5335519171', 'title': 'Tamer ÇANKAYA', 'phoneExt': '+90', 'organization': 'Bolu Abant İzzet Baysal University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "Due to COVID-19 pandemic, portable maximum expiratory pressure measurement device couldn't be used for this reason expiratory muscle device was calibrated based on patients' subjective feedback."}}, 'adverseEventsModule': {'timeFrame': 'During the patient specific time frame which is 3 weeks no adverse event has occurred.', 'eventGroups': [{'id': 'EG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Consisted of stroke patients using the expiratory muscle training device.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Stroke patients that have enrolled to the hospital conventional physiotherapy program.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Masticatory Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Daily expiratory muscle training for three weeks will be applied.\n\nExpiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Nothing will be applied except for the hospital conventional physiotherapy program.'}], 'classes': [{'title': 'First measurement', 'categories': [{'measurements': [{'value': '24', 'spread': '18', 'groupId': 'OG000'}, {'value': '13', 'spread': '7', 'groupId': 'OG001'}]}]}, {'title': 'Last measurement', 'categories': [{'measurements': [{'value': '25', 'spread': '17', 'groupId': 'OG000'}, {'value': '16', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'To assess masticatory performance of the patients, patients will be asked to chew 3 gr of peanuts with 20 chewing stroke and then spit on a sieve with 10 mesh and 1700 µm width. Then the residue will be collected and put into the centrifuge tube. After that residue will be centrifuged for 3 minutes with 1500 rpm. Same procedure will be used for the sieved content. Then this two values will be divided and recorded as a percentage for the calculation masticatory performance index.', 'unitOfMeasure': 'percentage of masticated peanuts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Temporomandibular Range of Motion Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Daily expiratory muscle training for three weeks will be applied.\n\nExpiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Nothing will be applied except for the hospital conventional physiotherapy program.'}], 'classes': [{'title': 'Mandibular depression first measurement', 'categories': [{'measurements': [{'value': '39.55', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '41.48', 'spread': '7.40', 'groupId': 'OG001'}]}]}, {'title': 'Mandibular depression last measurement', 'categories': [{'measurements': [{'value': '41.90', 'spread': '6.71', 'groupId': 'OG000'}, {'value': '41.09', 'spread': '7.10', 'groupId': 'OG001'}]}]}, {'title': 'Left lateral deviation first measurement', 'categories': [{'measurements': [{'value': '7.61', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '5.25', 'spread': '2.33', 'groupId': 'OG001'}]}]}, {'title': 'Left lateral deviation last measurement', 'categories': [{'measurements': [{'value': '6.84', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '5.49', 'spread': '1.98', 'groupId': 'OG001'}]}]}, {'title': 'Right lateral deviation first measurement', 'categories': [{'measurements': [{'value': '7.44', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '5.54', 'spread': '2.49', 'groupId': 'OG001'}]}]}, {'title': 'Right lateral deviation last measurement', 'categories': [{'measurements': [{'value': '8.09', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '5.61', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': 'Protrusion first measurement', 'categories': [{'measurements': [{'value': '5.28', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '4.17', 'spread': '1.83', 'groupId': 'OG001'}]}]}, {'title': 'Protrusion last measurement', 'categories': [{'measurements': [{'value': '5.56', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '4.62', 'spread': '2.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Mandibular depression, protrusion and bilateral lateral deviation of the patients will be performed by a digital caliper. All measurements will be taken while the patients are seated with their head supported. Digital caliper will be positioned in central incisors for the mandibular depression and the protrusion. For lateral deviation first upper central incisor location in relation to the lower central incisor will be drawn by a biocompatible pen then measurement will be performed. After that, a second drawing made. Then the horizontal distance between these two points will be measured for the lateral deviation range of motion. Reference values for mandibular depression, protrusion and the lateral deviation are as follows: 40 mm, 6 mm, and 8 mm.', 'unitOfMeasure': 'milimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in General Oral Health Assessment Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Daily expiratory muscle training for three weeks will be applied.\n\nExpiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Nothing will be applied except for the hospital conventional physiotherapy program.'}], 'classes': [{'title': 'First assessment', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '52'}, {'value': '52', 'groupId': 'OG001', 'lowerLimit': '34', 'upperLimit': '53'}]}]}, {'title': 'Last assessment', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '52'}, {'value': '52', 'groupId': 'OG001', 'lowerLimit': '34', 'upperLimit': '53'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Oral health of the patients will be assessed with general oral health assessment index. Index consists of twelve questions. Answers of these twelve questions makes up the total score. Minimum and maximum scores of the index are 12 and 60 points. Higher total scores mean higher risk of losing the general oral health.', 'unitOfMeasure': 'Score on index', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Eating Assessment Tool (EAT-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Daily expiratory muscle training for three weeks will be applied.\n\nExpiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Nothing will be applied except for the hospital conventional physiotherapy program.'}], 'classes': [{'title': 'First assessment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Last assessment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Swallowing quality of the patients will be assessed with eating assessment tool (EAT-10). the tool has ten questions and the total score of the tool is 40 points. Minimum score is 0 point and the maximum score is 40 point. Higher total scores mean higher risk of losing the general oral health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Pain Pressure Threshold of the Masticatory Muscles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Daily expiratory muscle training for three weeks will be applied.\n\nExpiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Nothing will be applied except for the hospital conventional physiotherapy program.'}], 'classes': [{'title': 'Right anterior temporalis first measurement', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '3.06'}, {'value': '1.86', 'groupId': 'OG001', 'lowerLimit': '1.56', 'upperLimit': '2.56'}]}]}, {'title': 'Right anterior temporalis last measurement', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2.76'}, {'value': '1.86', 'groupId': 'OG001', 'lowerLimit': '1.66', 'upperLimit': '2.60'}]}]}, {'title': 'Left anterior temporalis first measurement', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '2.96'}, {'value': '1.83', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '2.5'}]}]}, {'title': 'Left anterior temporalis last measurement', 'categories': [{'measurements': [{'value': '2.33', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2.66'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '2.63'}]}]}, {'title': 'Right middle temporalis first measurement', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3.16'}, {'value': '1.91', 'groupId': 'OG001', 'lowerLimit': '1.70', 'upperLimit': '2.73'}]}]}, {'title': 'Right middle temporalis last measurement', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2.86'}, {'value': '1.95', 'groupId': 'OG001', 'lowerLimit': '1.76', 'upperLimit': '2.7'}]}]}, {'title': 'Left middle temporalis first measurement', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3.13'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '2.7'}]}]}, {'title': 'Left middle temporalis last measurement', 'categories': [{'measurements': [{'value': '2.43', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2.83'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '2.73'}]}]}, {'title': 'Right anterior masseter first measurement', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.36', 'upperLimit': '1.86'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.76'}]}]}, {'title': 'Right anterior masseter last measurement', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '1.66'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.83'}]}]}, {'title': 'Left anterior masseter first measurement', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.13', 'upperLimit': '1.83'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.8'}]}]}, {'title': 'Left anterior masseter last measurement', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '1.66'}, {'value': '1.31', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.8'}]}]}, {'title': 'Right inferior masseter first measurement', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '1.8'}, {'value': '1.24', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.66'}]}]}, {'title': 'Right inferior masseter last measurement', 'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '1.73'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.73'}]}]}, {'title': 'Left inferior masseter first measurement', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.13', 'upperLimit': '1.7'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.7'}]}]}, {'title': 'Left inferior masseter last measurement', 'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '1.6'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '2.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Two points in the masseter muscle and two points at the temporalis muscle, in total four points will be measured for the pain pressure threshold assessment. Measurements will be taken four times from every point with two-minute intervals. Due to first measurement values are generally high, average of the last three measurements will be calculated and recorded.', 'unitOfMeasure': 'kilogram', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Craniocervical Angle Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Daily expiratory muscle training for three weeks will be applied.\n\nExpiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Nothing will be applied except for the hospital conventional physiotherapy program.'}], 'classes': [{'title': 'First measurement', 'categories': [{'measurements': [{'value': '28.93', 'spread': '12.54', 'groupId': 'OG000'}, {'value': '29.09', 'spread': '11.95', 'groupId': 'OG001'}]}]}, {'title': 'Last measurement', 'categories': [{'measurements': [{'value': '27.07', 'spread': '12.57', 'groupId': 'OG000'}, {'value': '30.53', 'spread': '11.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Measurement will be taken while the patients are seated and their head in natural position. After that photos of the patients will be taken and then processus spinosus of the C7 and the tragus of the ear will be marked. After that, the angle between those to marking will be measured by the protractor.', 'unitOfMeasure': 'degree', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Repeated Saliva Swallow Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Daily expiratory muscle training for three weeks will be applied.\n\nExpiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Nothing will be applied except for the hospital conventional physiotherapy program.'}], 'classes': [{'title': 'First assessment', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}]}]}, {'title': 'Last assessment', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Patients will be asked to swallow their saliva as much as they can do in thirty seconds.', 'unitOfMeasure': 'mililiter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Fonseca Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Daily expiratory muscle training for three weeks will be applied.\n\nExpiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Nothing will be applied except for the hospital conventional physiotherapy program.'}], 'classes': [{'title': 'First value', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '40'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '40'}]}]}, {'title': 'Last value', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '40'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Temporomandibular joint dysfunction existence and its severity will be assessed with Fonseca Questionnaire. Questionnaire includes 10 questions with yes, sometimes and no answers matching with 10, 5, and 0 point. Total score of the questionnaire is 100 point. Categorization of dysfunction by the questionnaire as follows; 70-100 point: severe dysfunction, 45-65: moderate dysfunction, 20-40: mild dysfunction and 0-15: has no dysfunction at all.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Intraoral pH Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Daily expiratory muscle training for three weeks will be applied.\n\nExpiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Nothing will be applied except for the hospital conventional physiotherapy program.'}], 'classes': [{'title': 'First measurement', 'categories': [{'measurements': [{'value': '6.45', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '6.66', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Last measurement', 'categories': [{'measurements': [{'value': '6.54', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '6.63', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Saliva of the patients will be collected between 08:00-12:00 am. After the saliva collected in centrifuge tube reaches 5 ml, collection process will be stopped and immediately pH of the saliva measured with two decimal digital pH meter', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Neck Flexor Endurance Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Daily expiratory muscle training for three weeks will be applied.\n\nExpiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Nothing will be applied except for the hospital conventional physiotherapy program.'}], 'classes': [{'title': 'First assessment', 'categories': [{'measurements': [{'value': '24.02', 'spread': '10.89', 'groupId': 'OG000'}, {'value': '27.12', 'spread': '11.58', 'groupId': 'OG001'}]}]}, {'title': 'Last assessment', 'categories': [{'measurements': [{'value': '26.97', 'spread': '14.25', 'groupId': 'OG000'}, {'value': '27.92', 'spread': '10.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Test will be performed while the patients are in supine position. After the position is taken patient will be asked to elevate their head about one inch and keep it that way as much as they can do. The period that passes from starting to the positional alteration will be recorded as the test score.', 'unitOfMeasure': 'second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mini Mental State Exame Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Daily expiratory muscle training for three weeks will be applied.\n\nExpiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Nothing will be applied except for the hospital conventional physiotherapy program.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.13', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '25.06', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the enrollment process', 'description': "Mini mental state exam test that consist of eleven articles will be used to assess whether the patients' mental state meets for the study enrollment. Total score is maximum 30 point. Lower score characterized with cognitive dysfunction. Cut off point of the test is 24 point or higher which means no cognitive impairment. 18 to 23 point means mild cognitive dysfunction. Total score below the 18 point means severe cognitive dusfunction. Minimum score is zero maximum score is 30.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Labial Commissure Angle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Daily expiratory muscle training for three weeks will be applied.\n\nExpiratory muscle training: For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Nothing will be applied except for the hospital conventional physiotherapy program.'}], 'classes': [{'title': 'First measurement', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '83.5', 'upperLimit': '93'}, {'value': '92', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': '98'}]}]}, {'title': 'Last measurement', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '92'}, {'value': '90.5', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': '95'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Facial asymmetry of the patients will be assessed with labial commissure angle measurements. Black and white photos of the patients will be taken while the patients are in a seating position. Then photo will be printed in A5 sheet. After that, the angle between bilateral labial commissures, glabella, and the mental protuberance will be measured. Reference value of the labial commissure angle is approximately 90 degrees.', 'unitOfMeasure': 'degree', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Daily expiratory muscle training for three weeks with 50 repetition was applied to the experimental group.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Nothing applied except for the hospital conventional physiotherapy program.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Story of head and/or neck surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Time of stroke onset', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Type of strokr', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Cooperation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Age interval', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Denial of participation to the study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Free of temporomandibular joint dysfunction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of incisor and/or canin tooth', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Quarantine', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Previous recruitment to the expiratory muscle training', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Repetitive stroke', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Insufficient mastication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Infection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients recruited from İzzet Baysal Physical Therapy Education and Research Hospital between 18.08.2020 and 06.09.2021.', 'preAssignmentDetails': 'Patients who had the following situations were excluded from the study; stroke onset of time higher than 3 months, hemorrhagic stroke, cooperation problem, age of 64 or younger, denial of participation to the study, head and/or neck surgery existence, discharge, free of temporomandibular joint dysfunction, existence of infection, incisor and/or canin tooth absence, quarantine, insufficient mastication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Expiratory Muscle Training Group', 'description': 'Daily expiratory muscle training for three weeks with 50 repetition was applied to the experimental group.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Nothing applied except for the hospital conventional physiotherapy program.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-07', 'size': 199883, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-20T04:17', 'hasProtocol': True}, {'date': '2020-04-07', 'size': 146070, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-20T04:17', 'hasProtocol': False}, {'date': '2020-04-07', 'size': 204297, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-06-20T04:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome measures will be performed by an another investigator.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups as an intervention and control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-20', 'studyFirstSubmitDate': '2020-08-26', 'resultsFirstSubmitDate': '2022-01-08', 'studyFirstSubmitQcDate': '2020-09-28', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-20', 'studyFirstPostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Masticatory Performance', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'To assess masticatory performance of the patients, patients will be asked to chew 3 gr of peanuts with 20 chewing stroke and then spit on a sieve with 10 mesh and 1700 µm width. Then the residue will be collected and put into the centrifuge tube. After that residue will be centrifuged for 3 minutes with 1500 rpm. Same procedure will be used for the sieved content. Then this two values will be divided and recorded as a percentage for the calculation masticatory performance index.'}, {'measure': 'Change in Temporomandibular Range of Motion Measurement', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Mandibular depression, protrusion and bilateral lateral deviation of the patients will be performed by a digital caliper. All measurements will be taken while the patients are seated with their head supported. Digital caliper will be positioned in central incisors for the mandibular depression and the protrusion. For lateral deviation first upper central incisor location in relation to the lower central incisor will be drawn by a biocompatible pen then measurement will be performed. After that, a second drawing made. Then the horizontal distance between these two points will be measured for the lateral deviation range of motion. Reference values for mandibular depression, protrusion and the lateral deviation are as follows: 40 mm, 6 mm, and 8 mm.'}, {'measure': 'Change in General Oral Health Assessment Index', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Oral health of the patients will be assessed with general oral health assessment index. Index consists of twelve questions. Answers of these twelve questions makes up the total score. Minimum and maximum scores of the index are 12 and 60 points. Higher total scores mean higher risk of losing the general oral health.'}, {'measure': 'Change in Eating Assessment Tool (EAT-10)', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Swallowing quality of the patients will be assessed with eating assessment tool (EAT-10). the tool has ten questions and the total score of the tool is 40 points. Minimum score is 0 point and the maximum score is 40 point. Higher total scores mean higher risk of losing the general oral health.'}, {'measure': 'Change in Pain Pressure Threshold of the Masticatory Muscles', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Two points in the masseter muscle and two points at the temporalis muscle, in total four points will be measured for the pain pressure threshold assessment. Measurements will be taken four times from every point with two-minute intervals. Due to first measurement values are generally high, average of the last three measurements will be calculated and recorded.'}, {'measure': 'Change in Craniocervical Angle Measurement', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Measurement will be taken while the patients are seated and their head in natural position. After that photos of the patients will be taken and then processus spinosus of the C7 and the tragus of the ear will be marked. After that, the angle between those to marking will be measured by the protractor.'}, {'measure': 'Change in Repeated Saliva Swallow Test', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Patients will be asked to swallow their saliva as much as they can do in thirty seconds.'}, {'measure': 'Change in Fonseca Questionnaire', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Temporomandibular joint dysfunction existence and its severity will be assessed with Fonseca Questionnaire. Questionnaire includes 10 questions with yes, sometimes and no answers matching with 10, 5, and 0 point. Total score of the questionnaire is 100 point. Categorization of dysfunction by the questionnaire as follows; 70-100 point: severe dysfunction, 45-65: moderate dysfunction, 20-40: mild dysfunction and 0-15: has no dysfunction at all.'}, {'measure': 'Change in Intraoral pH Measurement', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Saliva of the patients will be collected between 08:00-12:00 am. After the saliva collected in centrifuge tube reaches 5 ml, collection process will be stopped and immediately pH of the saliva measured with two decimal digital pH meter'}, {'measure': 'Change in Neck Flexor Endurance Test', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Test will be performed while the patients are in supine position. After the position is taken patient will be asked to elevate their head about one inch and keep it that way as much as they can do. The period that passes from starting to the positional alteration will be recorded as the test score.'}], 'secondaryOutcomes': [{'measure': 'Mini Mental State Exame Test', 'timeFrame': 'At the enrollment process', 'description': "Mini mental state exam test that consist of eleven articles will be used to assess whether the patients' mental state meets for the study enrollment. Total score is maximum 30 point. Lower score characterized with cognitive dysfunction. Cut off point of the test is 24 point or higher which means no cognitive impairment. 18 to 23 point means mild cognitive dysfunction. Total score below the 18 point means severe cognitive dusfunction. Minimum score is zero maximum score is 30."}, {'measure': 'Change in Labial Commissure Angle', 'timeFrame': 'Two measurements: At the beginning and after three weeks', 'description': 'Facial asymmetry of the patients will be assessed with labial commissure angle measurements. Black and white photos of the patients will be taken while the patients are in a seating position. Then photo will be printed in A5 sheet. After that, the angle between bilateral labial commissures, glabella, and the mental protuberance will be measured. Reference value of the labial commissure angle is approximately 90 degrees.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Mastication', 'Dysphagia', 'Temporomandibular joint'], 'conditions': ['Stroke', 'Mastication Disorder', 'Temporomandibular Disorders', 'Dysphagia', 'Stomatognathic Diseases']}, 'referencesModule': {'references': [{'pmid': '8756819', 'type': 'BACKGROUND', 'citation': 'Similowski T, Catala M, Rancurel G, Derenne JP. Impairment of central motor conduction to the diaphragm in stroke. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):436-41. doi: 10.1164/ajrccm.154.2.8756819.'}, {'pmid': '7717830', 'type': 'BACKGROUND', 'citation': 'Finestone HM, Greene-Finestone LS, Wilson ES, Teasell RW. Malnutrition in stroke patients on the rehabilitation service and at follow-up: prevalence and predictors. Arch Phys Med Rehabil. 1995 Apr;76(4):310-6. doi: 10.1016/s0003-9993(95)80655-5.'}, {'pmid': '11054135', 'type': 'BACKGROUND', 'citation': 'Khedr EM, El Shinawy O, Khedr T, Abdel aziz ali Y, Awad EM. Assessment of corticodiaphragmatic pathway and pulmonary function in acute ischemic stroke patients. Eur J Neurol. 2000 Sep;7(5):509-16. doi: 10.1046/j.1468-1331.2000.00104.x.'}, {'pmid': '26180145', 'type': 'BACKGROUND', 'citation': 'Messaggi-Sartor M, Guillen-Sola A, Depolo M, Duarte E, Rodriguez DA, Barrera MC, Barreiro E, Escalada F, Orozco-Levi M, Marco E. Inspiratory and expiratory muscle training in subacute stroke: A randomized clinical trial. Neurology. 2015 Aug 18;85(7):564-72. doi: 10.1212/WNL.0000000000001827. Epub 2015 Jul 15.'}, {'pmid': '17132052', 'type': 'BACKGROUND', 'citation': 'Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.'}, {'pmid': '20813995', 'type': 'BACKGROUND', 'citation': 'Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.'}, {'pmid': '18780882', 'type': 'BACKGROUND', 'citation': 'Yelnik AP, Le Breton F, Colle FM, Bonan IV, Hugeron C, Egal V, Lebomin E, Regnaux JP, Perennou D, Vicaut E. Rehabilitation of balance after stroke with multisensorial training: a single-blind randomized controlled study. Neurorehabil Neural Repair. 2008 Sep-Oct;22(5):468-76. doi: 10.1177/1545968308315996.'}, {'pmid': '14684785', 'type': 'BACKGROUND', 'citation': 'Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.'}, {'pmid': '29650380', 'type': 'BACKGROUND', 'citation': 'Dursun O, Cankaya T. Assessment of Temporomandibular Joint Dysfunction in Patients with Stroke. J Stroke Cerebrovasc Dis. 2018 Aug;27(8):2141-2146. doi: 10.1016/j.jstrokecerebrovasdis.2018.03.007. Epub 2018 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'Stroke affects the vital activities of daily living such as breathing and swallowing. After stroke excursion of the diaphragm reduces about 50%, and also the maximum expiratory pressure of the individual 50% or higher. Dysphagia occurs in 29% to 45% of the acute stroke cases.', 'detailedDescription': 'As a third leading cause of death and one of the major causes of disability, stroke still maintain its bad reputation in worldwide. Stroke owes its fame on wide range of symptoms mostly the musculoskeletal system symptoms such as spasticity, equilibrium and gait problems. Although mentioned symptoms keep their popularity devious two dysfunction caused by stroke; stomatognathic system dysfunction and respiratory dysfunction appears to change this equation. Considering the high incidence of dysphagia and the reduced cardiopulmonary capacity of the stroke patients, it seems inevitable. From this perspective aim of this study is to assess the effect of expiratory muscle training on the stomatognathic system in patients with stroke and as mentioned aid to shatter the mentioned equation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mini mental score is 24 or higher\n* 55 years of age or higher\n* Currently not taking respiratory muscle training\n* Fonseca Questionnaire score is 20 or higher\n* Onset of stroke is between 3 months and 5 years\n\nExclusion Criteria:\n\n* Developed dysphagia caused by other diseases rather than stroke\n* Repetitive stroke story\n* Cancer in head and neck region\n* Abdominal or thoracic surgery story\n* Existence of neurodegenerative disease'}, 'identificationModule': {'nctId': 'NCT04569968', 'briefTitle': 'Expiratory Muscle Training in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'Effect of Expiratory Muscle Training on Stomatognathic System in Patients With Stroke', 'orgStudyIdInfo': {'id': 'BAIBU-FTR-ÖD-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Expiratory muscle training group', 'description': 'Daily expiratory muscle training for four weeks will be applied.', 'interventionNames': ['Other: Expiratory muscle training']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Nothing will be applied except for the hospital conventional physiotherapy program.'}], 'interventions': [{'name': 'Expiratory muscle training', 'type': 'OTHER', 'description': 'For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.', 'armGroupLabels': ['Expiratory muscle training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14020', 'city': 'Bolu', 'country': 'Turkey (Türkiye)', 'facility': 'İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}, {'zip': '14280', 'city': 'Bolu', 'country': 'Turkey (Türkiye)', 'facility': 'Bolu Abant İzzet Baysal University', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}], 'overallOfficials': [{'name': 'Ömer Dursun, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bolu Abant İzzet Baysal University'}, {'name': 'Tamer Çankaya, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bolu Abant İzzet Baysal University'}, {'name': 'Erdal Dilekçi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bolu Abant İzzet Baysal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}