Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-01-04 @ 2:12 AM
Study NCT ID:
NCT04164420
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2019-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Neuromuscular Training in Stroke Patients With Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to one of two groups in parallel for five weeks. To either oral neuromuscular training and orofacial sensory-vibration stimulation or to only orofacial sensory-vibration stimulation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2019-11-12', 'studyFirstSubmitQcDate': '2019-11-12', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Swallowing ability', 'timeFrame': 'Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up', 'description': 'Change in swallowing function measured by the timed water swallow test'}], 'secondaryOutcomes': [{'measure': 'Lip-force (LF)', 'timeFrame': 'Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up', 'description': 'Change in lip-force measured in newtons (N) with the Lip Force Meter LF100.'}, {'measure': 'Swallowing function', 'timeFrame': 'Baseline, after end-of-treatment (5 weeks), and at 12-18 months follow-up', 'description': 'Change in structural and functional swallowing ability measured by Videofluoroscopy (VFS) by using the penetration-aspiration scale by Rosenbek. The scale ranges from 0 (normal swallowing function) to 8 (aspiration without sufficient coughing/clearance)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Dysphagia', 'Treatment', 'Intervention'], 'conditions': ['Stroke', 'Dysphagia']}, 'referencesModule': {'references': [{'pmid': '33158423', 'type': 'DERIVED', 'citation': 'Hagglund P, Hagg M, Levring Jaghagen E, Larsson B, Wester P. Oral neuromuscular training in patients with dysphagia after stroke: a prospective, randomized, open-label study with blinded evaluators. BMC Neurol. 2020 Nov 7;20(1):405. doi: 10.1186/s12883-020-01980-1.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to explore if oral neuromuscular training is superior to orofacial sensory-vibration stimulation in patients with oropharyngeal dysphagia.\n\nFour weeks after stroke onset, patients with oropharyngeal dysphagia and pathological swallowing according to the timed water swallow test (TWST) will be randomized 1:1 into a 5-week oral neuromuscular training with an oral device in addition to orofacial sensory-vibration stimulation with an electrical toothbrush (intervention group) or orofacial sensory-vibration stimulation only (control group). The participants will be examined with a TWST, lip force test, and videofluoroscopy (VFS) of oropharyngeal swallowing before (baseline), after 5-weeks training (end-of-training) and at a 12-18 months follow-up. The primary endpoint is changes in TWST at the end-of-training compared with baseline, and at late follow-up based on intention-to-treat analyses. The secondary endpoints are the corresponding changes in lip force and aspiration frequency at VFS.', 'detailedDescription': 'This study aims to explore if oral neuromuscular training is superior to orofacial sensory-vibration stimulation in patients with oropharyngeal dysphagia.\n\nStudy design: This 2-center study is an intension-to-treat prospective randomized open-label trial with blinded evaluators (PROBE) design. Evaluations are made at baseline, at end of training, and at late follow-up after a period without training to investigate if any lasting positive training effect was present.\n\nInclusion criteria: First-ever stroke and a pathological timed water swallow test (TWST) at four to five weeks after stroke onset.\n\nExclusion criteria: Inability to cooperate, percutaneous endoscopic gastrostomy (PEG), neurological diseases other than stroke, known history of dysphagia, prominent horizontal overbite, hypersensitivity to the acrylate in the oral device.\n\nStudy procedure: Four weeks after stroke onset, patients with oropharyngeal dysphagia and pathological swallowing according to the timed water swallow test (TWST) will be randomized 1:1 into a 5-week oral neuromuscular training with an oral device in addition to orofacial sensory-vibration stimulation with an electrical toothbrush (intervention group) or orofacial sensory-vibration stimulation only (control group). The participants will be examined with a TWST, lip force test, and videofluoroscopy (VFS) of oropharyngeal swallowing before (baseline), after 5-weeks training (end-of-training) and at a 12-18 months follow-up. The primary endpoint is changes in TWST at the end-of-training compared with baseline, and at late follow-up based on intention-to-treat analyses. The secondary endpoints are the corresponding changes in lip force and aspiration frequency at VFS.\n\nSample size: In order to detect a critical change with a power of 80 %, a sample size of 44 patients (22 in the intervention group and 22 in the control group) that fulfilled the study protocol was required for a type I error of 5 %.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-ever stroke and,\n* Pathological timed water swallow test (TWST) at four to five weeks after stroke onset.\n\nExclusion Criteria:\n\n* Inability to cooperate\n* Percutaneous endoscopic gastrostomy (PEG)\n* Neurological diseases other than stroke\n* Known history of dysphagia\n* Prominent horizontal overbite\n* Hypersensitivity to the acrylate in the oral device.'}, 'identificationModule': {'nctId': 'NCT04164420', 'briefTitle': 'Oral Neuromuscular Training in Stroke Patients With Dysphagia', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Oral Neuromuscular Training in Stroke Patients With Dysphagia', 'orgStudyIdInfo': {'id': '2004:M-435'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral neuromuscular training and orofacial sensory-vibration', 'description': 'Intensive training with oral neuromuscular training and orofacial sensory-vibration stimulation for 5 weeks. The oral neuromuscular training is performed three times per session, and three times daily before eating. Regarding the orofacial sensory-vibration stimulation, the instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal by using a toothbrush.', 'interventionNames': ['Behavioral: Oral neuromuscular training and orofacial sensory-vibration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Orofacial sensory-vibration stimulation', 'description': 'Orofacial sensory-vibration stimulation by using an electrical toothbrush for five weeks. Instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal.', 'interventionNames': ['Behavioral: Orofacial sensory-vibration stimulation']}], 'interventions': [{'name': 'Oral neuromuscular training and orofacial sensory-vibration', 'type': 'BEHAVIORAL', 'description': 'Oral neuromuscular training is performed by using an oral device. The device is placed pre-dentally behind closed lips, and the participant is sitting in an up-right position. The participant is the instructed to hold the device against a gradually-increasing horizontal pulling force for 5-10 s, whilst trying to resist the force by tightening the lips and pressing the head backward against a head rest.', 'armGroupLabels': ['Oral neuromuscular training and orofacial sensory-vibration']}, {'name': 'Orofacial sensory-vibration stimulation', 'type': 'BEHAVIORAL', 'description': 'All participants in the control group is given orofacial sensory-vibration stimulation by using an electrical toothbrush. Instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal.', 'armGroupLabels': ['Orofacial sensory-vibration stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Umeå', 'country': 'Sweden', 'facility': 'Umeå University', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Per Wester, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}