Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-29 @ 5:27 AM
Study NCT ID:
NCT06322368
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myofunctional and Respiratory Intervention on Phonation in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016059', 'term': 'Range of Motion, Articular'}], 'ancestors': [{'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume during monologue', 'timeFrame': 'Baseline, 6 weeks', 'description': 'The volumen during a monologue of basic activities of daily living assessed in decibels.'}, {'measure': 'Frequency during monologue', 'timeFrame': 'Baseline, 6 weeks', 'description': 'The frequency during a monologue of basic activities of daily living expressed in hertz.'}], 'secondaryOutcomes': [{'measure': 'Volumen during sustained phonation of /s/ sound', 'timeFrame': 'Baseline, 6 weeks', 'description': 'The decibels during the maximum sustained phonation of s.'}, {'measure': 'Communication effectiveness Index', 'timeFrame': 'Baseline, 6 weeks', 'description': 'This is a questionnaire with the scores ranging from 0 to 100, with lower scores meaning more difficulties associated to effectiveness in communication.'}, {'measure': 'Frequency during sustained phonation of /s/ sound', 'timeFrame': 'Baseline, 6 weeks', 'description': 'The Hertzs during the maximum sustained phonation of s.'}, {'measure': 'Volumen during sustained phonation of /a/ sound', 'timeFrame': 'Baseline, 6 weeks', 'description': 'The decibels during the maximum sustained phonation of a.'}, {'measure': 'Frequency during sustained phonation of /a/ sound', 'timeFrame': 'Baseline, 6 weeks', 'description': 'The Hertzs during the maximum sustained phonation of a'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented in order to improve phonation outcomes.', 'detailedDescription': 'Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented to improve phonation outcomes. Myofunctional therapy is based on exercise training program for the muscles around your face, mouth, and tongue. Respiratory muscle strength training focuses on increasing the force-generating capacity of the inspiratory and expiratory muscles. A combination of both may be of interest to improve phonation parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a clinical diagnosis of chronic stroke (duration above 6 months).\n* Age over 18 years\n\nExclusion Criteria:\n\n* Communication or cognitive deficits that prevented them from following verbal commands.'}, 'identificationModule': {'nctId': 'NCT06322368', 'briefTitle': 'Myofunctional and Respiratory Intervention on Phonation in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Effects of a Combined Myofunctional and Respiratory Intervention on Phonation in Patients With Chronic Stroke', 'orgStudyIdInfo': {'id': 'DF002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myofunctional and respiratory training', 'description': 'Patients with chronic stroke receiving an exercise training program for the muscles around the face, mouth, and tongue and a respiratory training focused on inspiratory and expiratory muscle strengthening.', 'interventionNames': ['Other: Myofunctional and respiratory training program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Range of motion and stimulation exercises', 'description': 'Standard treatment focused mainly on range of motion, such as opening and closing the mouth and stimulation exercises', 'interventionNames': ['Other: Range of motion and thermal and mechanical stimulation exercising']}], 'interventions': [{'name': 'Myofunctional and respiratory training program', 'type': 'OTHER', 'description': 'The patients will receive exercises included in a myofunctional approach and a respiratory training focused on inspiratory and expiratory muscles using a device.', 'armGroupLabels': ['Myofunctional and respiratory training']}, {'name': 'Range of motion and thermal and mechanical stimulation exercising', 'type': 'OTHER', 'description': 'The patients will receive the standard treatment of speech and language therapy including range of motion exercises (open and close the mouth) and thermal and mechanical stimulation in the orofacial region.', 'armGroupLabels': ['Range of motion and stimulation exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18016', 'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Irene Cabrera Martos', 'role': 'CONTACT', 'email': 'irenecm@ugr.es'}, {'role': 'CONTACT', 'email': 'irenecm@ugr.es', 'phoneExt': 'Cabrera Martos'}, {'name': 'Irene Cabrera Martos', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of Health Sciences', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'centralContacts': [{'name': 'Irene Cabrera Martos', 'role': 'CONTACT', 'email': 'irenecm@ugr.es', 'phone': '958248763'}], 'overallOfficials': [{'name': 'Irene Cabrera Martos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UGR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Profesor titular de Universidad', 'investigatorFullName': 'Irene Cabrera Martos', 'investigatorAffiliation': 'Universidad de Granada'}}}}